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OPHTHALMOLOGY’S CRISIS FISCAL VOLUME 18 ISSUE 2 FEBRUARY 2013

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A European Outlook on the World of Ophthalmology

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Page 1: Vol 18 - issue 2

OPHTHALMOLOGY’S

CRISISF I S C A L

VOLUME 18 ISSUE 2 FEBRUARY 2013

Page 2: Vol 18 - issue 2

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Page 3: Vol 18 - issue 2

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This issUE...

Cover Story 4 The effects of the economic crisis on ophthalmology

Cataract & Refractive 7 high satisfaction rate with use of topical anaesthesia 8 Experts highlight the pros and cons of femtosecond cataract surgery9 The late David Apple is fondly remembered10 Different presbyopia correcting techniques discussed 11 Controlling pain in MiCs surgery12 survey looks at common causes of iOL explantation14 Combined procedure has very good early outcomes, study shows

Cornea 15 Corneal grafts achieving better visual results 16 Devices for measuring central corneal thickness analysed

Glaucoma 17 is there a connection between iOP fluctuation and glaucoma onset?18 Understanding limitations and strengths of diagnostic tools19 Measuring iOP in children poses many challenges20 Enhancing the success rate of glaucoma filtering surgeries21 Trans-scleral aqueous outflow in glaucoma22 Trials show devices safe treatment for open-angle glaucoma

Retina 23 Telemedicine aids in degenerative retinal disease screening24 Retinal prosthesis helps restore some vision in blind RP patients25 Advances in AMD treatments praised, while new developments anticipated26 Retinal gene therapy shows promising results, but challenges remain27 Evaluating proliferative diabetic retinopathy28 Many advantages of combined surgery, but it also has its risks29 Understanding diabetic retinopathy

Paediatric Ophthalmology 30 Childhood blindness demands more action31 Data presented on treatments for JiA- associated uveitis32 Diagnosing ocular tumours34 Biologicals can be beneficial for treatment of uveitis

Global Ophthalmology 35 study looks at paediatric cataract outreach camps

News 36 EsAsO celebrates fifth anniversary38 EUREQUO paves the way for global outcomes registries

Features 40 Outlook on industry41 Ophthalmologica highlights42 Resident’s Diary43 JCRs highlights46 industry News47 Book Review48 Calendar

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FEBRUARY 2013Volume 18 | Issue 2

EUROTIMESESC

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Publisher Carol FitzpatrickExecutive Editor Colin KerrEditors sean henahan Paul McGinn

Managing Editor Caroline BrickProduction Editor Angela sweetmanSenior Designer Paddy Dunne

Assistant Designer Janice RobbCirculation Manager Angela Morrissey Contributing Editors howard Larkin Dermot McGrath Roibeard Ó hÉineacháin Contributors Devon schuyler Eisele stefanie Petrou-Binder Maryalicia Post

Leigh spielberg Pippa Wysong Gearóid TuohyColour and Print Times PrintersAdvertising Sales EsCRs, Temple house, Temple Road Blackrock, Co. Dublin, ireland Tel: 353 1 209 1100 Fax: 353 1 209 1112 email: [email protected]

Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.

ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes.ISSN 1393-8983

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Published byThe European Society of Cataract and Refractive Surgeons

As certified by ABC, the EuroTimes aver-age net circulation for the 11 issues distributed between 01 January 2011 and 31 December 2011 is 32,332.

Cover concept courtesy of Argyrios Tzamalis MD, 2nd Department of Ophthalmology, Aristotle University of Thessaloniki, Greece

Page 4: Vol 18 - issue 2

by Wojciech Omulecki

it is a great honour for the Polish society of Cataract and Refractive surgery to welcome delegates to the 17th EsCRs Winter Meeting in the Warsaw international Expo XXi. Every year, this meeting is a major focus for ophthalmologists and i

believe this year’s programme will have something for everyone.The meeting opens on Friday 15 February with the Annual

Cornea Day organised by EsCRs and EuCornea. Cornea Day will be chaired by the EuCornea president Dr José Güell with expert keynote lectures and case presentations on a number of topics. These include management of corneal complications, corneal graft surgery and ocular surface disease. On Friday we will also hold didactic courses in cataract surgery and refractive surgery as well as a basic optics course and a surgical skills training course.

On a personal note, i am particularly looking forward to Friday’s symposium on Cataract With Other Disorders: Combined Or sequential surgery? Friday’s programme also sees a new and exciting feature, the Young Ophthalmologists’ Programme. “Learning From the Learners” is an interactive session on cataract training for trainees and will include video cases presented by young ophthalmologists.

The programme continues on saturday with our second training course on surgical skills and a cornea didactic course. We also have symposia on Measuring success in Cataract surgery and strategies for Treating Keratoconus and Live surgery, organised by the Polish society of Cataract and Refractive surgery which will be transmitted from the Department of Ophthalmology, Medical University of Warsaw.

The meeting concludes on sunday with a symposium on Capsular Complications, our final surgical skills training course and a symposium presented by the Polish society of Cataract and Refractive surgery.

We have experienced many changes in Poland but one thing that has not changed is the excellent practice of ophthalmology in our country. Many famous ophthalmologists have come from our country including Wiktor szokalski (1811-1891), Ksawery Gałezowski (1832–1907), Michal Borysiekiewicz (1848- 1899), Wincenty Fukala (1847-1911), Bolesław Wicherkiewicz (1847–1915) and Tadeusz Krwawicz (1910-1988).

i would like to announce that my colleague Andrzej Grzybowski has written an article on “Polish Contributions to international Ophthalmology”. This article is being published in ET Today; the daily newspaper produced by EuroTimes, the official news magazine of the EsCRs, and will be distributed to delegates on saturday 16 February.

Let me conclude by saying a few words about Warsaw, the venue for this meeting. The beginnings of Warsaw go as far back as the 12th and 13th centuries. The city had to be completely rebuilt after the near-total destruction of it during World War ii. The symbol of the capital’s rebirth was an unprecedented post-war re-creation of the Old Town, which in 1980 was put on the UNEsCO list of World heritage sites, as an example of a nearly complete reconstruction of the original settlement using original town plans and architecture.

We are very proud of our city and we hope that you will get a chance to visit some of the main attractions including the magnificent Royal Palace, the National Museum, the Copernicus science Centre, the Neon Museum and the Lazienki Gardens.

in conclusion, i hope that you enjoy our meeting and i look forward to meeting you.

WojCiECh oMulECki

Wojciech omulecki is a co-opted member of the ESCRS Board

EUROTIMES | Volume 18 | Issue 2

2

GUEST EDITORIAL Volume 18 | Issue 2

Editorial

WELCOME TO WARSAW17th Winter Meeting programme has something for everyone

José Güell

Clive Peckar

Emanuel RosenChairman

ESCRS Publications Committee

Ioannis Pallikaris

Paul Rosen

Medical Editors

International Editorial Board

EUROTIMESESC

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Noel Alpins australia

Bekir Aslan turKEY

Bill Aylward uK

Peter Barry irElaND

Roberto Bellucci italY

Hiroko Bissen-Miyajima JaPaN

John Chang CHiNa

Joseph Colin FraNCE

Alaa El Danasoury sauDi araBia

Oliver Findl austria

I Howard Fine usa

Jack Holladay usa

Vikentia Katsanevaki GrEECE

Thomas Kohnen GErMaNY

Anastasios Konstas GrEECE

Dennis Lam HONG KONG

Boris Malyugin russia Marguerite McDonald usa

Cyres Mehta iNDia

Thomas Neuhann GErMaNY

Rudy Nuijts tHE NEtHErlaNDs

Gisbert Richard GErMaNY

Robert Stegmann sOutH aFriCa

Ulf Stenevi sWEDEN

Emrullah Tasindi turKEY

Marie-Jose Tassignon BElGiuM

Manfred Tetz GErMaNY

Carlo Enrico Traverso italY

Roberto Zaldivar arGENtiNa

Oliver Zeitz GErMaNY

Page 5: Vol 18 - issue 2

Cataract Surgery Will Change in a Femtosecond.

With Alcon’s LenSx® Laser, the Possibilities Have Just Begun.Delivering the accuracy of a femtosecond laser to Refractive Cataract Surgery, the LenSx® Laser is designed to predictably perform many of the most challenging aspects of traditional cataract surgery. Creating highly reproducible capsulotomy, lens fragmentation and all corneal incisions with image-guided surgeon control, Alcon’s LenSx® Laser is Putting the Future in Motion.

To learn more about LenSx® Laser technology for Laser Refractive Cataract Surgery, visit lensxlasers.com.

© 2011 Novartis 12/11 LSX11500S0V-D EU

EuroTimes February 2012

77397 LSX11500S0V-D EU ET.indd 1 12/14/11 12:39 PM

Page 6: Vol 18 - issue 2

by Sean Henahan

OPHTHALMOLOGY'S FISCAL CRISIS

The global economic crisis born in 2008 has reached into almost every corner of the world. Europe has been particularly hard hit,

as the fiscal crisis has spread across the continent producing trillion euro bailout schemes, austerity budgets and even riots in the streets.

“We are facing the biggest challenges that this union has ever had to face throughout its history – a financial crisis, an economic and social crisis, but also a crisis of confidence,” proclaimed Jose Manuel Barroso, president of the EU Commission in his EU 2012 state of Union Address.

As a result, governments are desperate to reduce expenditures, particularly in healthcare. The most common reforms across European countries – and especially Greece – have endeavoured to moderate the growing budgets for health services, rationalise the benefit packages and implement wide-reaching reforms in the pharmaceutical market. Ophthalmology has not escaped the fiscal tsunami.

in some parts of Europe, cataracts are not operated as early as in the past, and when patients are considered good candidates, they may have to wait considerably longer before they can be operated. The volume of elective refractive surgeries, often considered an unofficial leading economic indicator, including LAsiK and presbyopic iOL procedures, has declined in many regions as disposable income has diminished.

“The economic crisis has created a new environment in Europe which has already influenced and will continue to influence healthcare in general and ophthalmology in particular. These effects will be greater in countries that suffer the worst, mainly the southern European countries,” ioannis Pallikaris MD, PhD, told EuroTimes.

Dr Pallikaris, professor of ophthalmology, school of Medicine, University of Crete and founder and

director of the Vardinoyannion Eye institute of Crete, noted that in some cases patients who previously would have used private resources to address their needs are now obliged to use public healthcare systems, creating an overload. This overload in the public healthcare system produces a series of complications such as delaying the provision of services such as cataract surgery.

he noted that the economic crisis is causing further shrinkage in government spending for the public healthcare system, which raises the spectre of hospitals being unable to offer high-quality services such as premium lenses cataract surgery due to the expensive consumables such as iOLs, and viscoelastics. This was seen in Greece very recently, where international companies, fearful they would not be reimbursed, refused to extend credit, demanding that Greek providers pay

upfront in cash for supplies. Conversely, medical professionals in the

private sector will experience a decrease in their surgical load and consequently to their incomes, Dr Pallikaris observed.

“Taken together, these factors will cause a decrease of the quality of provided medical services. The final consumers, the patients, will be the ones that will suffer the most due to this situation.”

Global financial crisis Greece has perhaps been hit harder than most countries in Europe, notes Argyrios Tzamalis MD, 2nd Department of Ophthalmology, Aristotle University of Thessaloniki, Greece.

“The global financial crisis has had a tremendous impact on Greece’s economy, exacerbating existing problems. The health sector has been seriously affected by the economic situation, and the three

4

ECONOMIC CRISISCover Story

EuroTimes looks at the diverse effect of the current economic crisis in Europe on all aspects of ophthalmology

EUROTIMES | Volume 18 | Issue 2

The economic crisis has created a new environment in Europe which has already influenced and will continue to influence healthcare in general and ophthalmology in particular

Ioannis Pallikaris MD, PhD

I believe that the impact of the economic crisis on healthcare and ophthalmology in particular has not fully emerged

Argyrios Tzamalis MD

Page 7: Vol 18 - issue 2

Memorandums of Understanding that Greece has signed since 2010 dictate a series of measures that focus on the reduction of public expenditure. A broad range of healthcare reforms and policies have been implemented, which represent the biggest shakeup of the healthcare system in decades. irrespective of their positive policy goals, these measures have started to affect public access to the healthcare system and to increase the financial burden on patients,” he told EuroTimes.

The economic hard times in Greece have had a measurable effect on the delivery of ophthalmology services. Many public hospitals and eye clinics have had problems providing ophthalmic surgical services due to lack of essential materials. indeed, in the last two years some ophthalmology departments have had to suspend even cataract surgery services because companies declined to provide iOLs unless they were first compensated by the government, which did not have the financial ability to do so, Dr Tzamalis confirmed.

“it is a real vicious cycle! And you can imagine what the impact could be on the patients’ health levels. in fact, many patients keep coming to big university eye clinics just to have a simple ophthalmic procedure done since this may not be performed anywhere else or maybe because they cannot afford it going privately. Even eye drops are in short supply.”

The economic crisis has also put the squeeze on residents looking ahead to their first career post. Dr Tzamalis noted that every ophthalmology resident at his institution in the past two years has moved to more prosperous countries, with Germany and the UK being the favourites. Even though many residents would prefer to stay in their home country, because of the dire economic situation in Greece, there has been a hiring freeze, with no hospital positions expected to be available for many years to come.

“i believe that the impact of the economic crisis on healthcare and ophthalmology in particular has not fully emerged. i think that in the next few years the insurance funds won't be able to bear the burden of covering ophthalmic needs, which are continuously increasing with the evolution of technology,” he said.

Economic storm spain is also being buffeted strongly by the economic storm. it has had a real estate meltdown, a capital crisis and has record unemployment. Under these circumstances it is not surprising that ophthalmology would feel some effect.

“i am concerned about the effects of the European economic crisis on ophthalmology. in my own country i can see the effects of the crisis both as a consumer and as a provider. it is affecting all ophthalmologists, those working in both public as well as in private care,” José Güell MD, professor of ophthalmology at Autonoma University of Barcelona and director of the Cornea and Refractive surgery Department at iMO, Barcelona, told EuroTimes.

As in other parts of Europe, there has been a notable decline in demand for elective refractive surgery. But it has affected access to care and options available

to patients in many areas. The public healthcare system is expected to absorb significant budget cuts, meaning longer waits for surgery. As fewer spanish citizens are able to afford private insurance, the insurance companies have had to reduce the coverage they provide, reduce access to some surgeries, reducing physician payments, and increasing the portion of the cost expected from the patient, noted Dr Guell.

“i can only hope that this will not last too long, that things will improve. Meanwhile, i suggest to residents that they focus on medicine and ophthalmology, and remember it is not about focusing on making money, we are here to serve people, with or without the crisis.”

Subtle effects The impact of the recession in Europe has not affected all areas equally. in general, the more northern countries, while not unaffected, are faring better. in the Netherlands for example, the effects have been more subtle, notes Leigh spielberg MD, a resident at the Rotterdam Eye hospital.

“in the Netherlands, the residents themselves aren't particularly having problems. Our contracts are guaranteed for the whole of the five-year training period. We are reasonably paid, despite the relatively high cost of living in holland. Further, the job market for ophthalmologists happens to be quite good here, so finding a job after graduation has not been a problem for anyone who has graduated during the period that i've been here, since mid-2010.”

however, he notes that “further up the ladder” there have been some big changes. The Dutch government is trying to get all physicians to become essentially salaried employees on the payrolls of hospitals. The physicians' rights in The Netherlands have always been very restricted: specialists (as opposed to GPs/family doctors) have always been essentially required to work in hospitals. Although they could work "privately" within these hospitals, they had to have some sort of connection with the hospital. Only recently have specialists discovered a loophole or financial construction to allow them to work separately from hospitals, but this is quite an ordeal. The government is trying to eliminate this across the board.

“Also, there has been a general, across-the-board reduction in fees paid for medical services, up to about 30 per cent in the past few years! The doctors are not happy about this,” he said.

More providers Germany also seems to be holding up pretty well. Refractive surgeon Kaweh schayan-Araghi MD, of the ARTEMis Eye Clinic, Dillenburg, Germany, says his office has not noticed a drop in demand for refractive surgery, but that patients now have more providers to choose from. he did see some sign of the times in pricing, however.

“We do see a trend towards low-cost providers for refractive surgery. Unfortunately, they have to cut corners to meet the price expectations of patients. We experience more patients trying to negotiate about the price since these providers advertise more. Quality seems to be of minor importance to patients, or we seem not to be able to communicate

the difference it makes or can make, for example, to do wet refractions before surgery or to refract several times and to provide post-op care,” he said.

he remains optimistic in the long term, noting that ophthalmology is in a good position as patients age and become aware of the many options for them. he predicts that while refractive surgery will probably not increase much in volume, demand for presbyopic options such as the Kamra corneal inlay does have growth potential.

Dual approach Ophthalmology in the UK, which pioneered the idea of national health insurance after the second World War, is now experiencing a number of challenges related in part to the global recession, notes Richard Packard MD, FRCs, FRCOphth, Windsor, England.

The UK currently has a dual approach to healthcare delivery funding. The vast majority is done through the National health service (Nhs), with the rest covered either through private insurance or self pay by the patient or a combination of both these. While Dr Packard said the euro crisis does not appear to have had a large impact on the Nhs to date, the amount of funding available to commissioning bodies, like primary care trusts (PCTs), has not kept up with inflation. As a result these PCTs are trying to save money.

“One of the ways that they are doing

5

EUROTIMES | Volume 18 | Issue 2

In my own country I can see the effects of the crisis both as a consumer and as a provider. It is affecting all ophthalmologists, those working in both public as well as in private care

José Güell MD

We do see a trend towards low-cost providers for refractive surgery

“Kaweh Schayan-Araghi MD

Across countries hit hard by the crisis, countless vulnerable sections of society are forced to postpone vital treatment and even surgery

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EUROTIMES | Volume 18 | Issue 2

6

ECONOMIC CRISIS

Cover StoryIoannis Pallikaris – [email protected] Tzamalis – [email protected]é L Güell – [email protected] Schayan-Araghi – k.schayan@

artemiskliniken.deRichard Packard – [email protected] Barry – [email protected]

cont

acts

this is to try to restrict cataract surgery by specifying visual thresholds for surgery and also not paying in some instances for second eye surgery. The number of cataract surgeries performed in the UK has thus come down. in the private sector, insurers and most particularly the largest one, BUPA (British United Provident Association), has tried by other means to reduce its spend on cataract surgery. BUPA the largest insurer with more than 40 per cent of the market has slashed the reimbursement for its subscribers by over 60 per cent.”

Dr Packard notes that this reimbursement reduction has not been accepted by the majority of surgeons. in response, BUPA has tried to redirect its subscribers to a chain of high street opticians who do refractive surgery and are now offering cataract surgery. Patients are less than happy, he emphasised.

Postoperative discontent EsCRs president Peter Barry FRCs of Dublin, ireland, echoed Dr Packard’s concerns.

“i am concerned that in parts of the United Kingdom second eye cataract surgery is not permitted for economic reasons and i am also concerned that ‘clinical care pathways’ effectively preclude the surgeon from seeing the patient until the time of surgery and likely not afterwards. This trend will result in more patients having unnecessary surgery and postoperative discontent even if the surgery itself was uncomplicated. Cataract surgery should not become a commodity,” Dr Barry told EuroTimes.

Dr Barry noted that in ireland the debate over new contracts for consultants was having a very serious adverse effect on morale both amongst consultants themselves and specialist registrars at the end of their training who would become the next tranche of consultants. This anxiety for the future is causing more stress than the current economic downturn, he said.

ireland has also seen a reduced demand for elective refractive surgery, as prospective patients have less surplus cash spend, a trend Dr Barry said he expected would continue for some time.

Looking to the future, Dr Barry said: “Ophthalmology will have to fight hard to preserve its slice of the health budget and fight very hard to increase it, which it will need to do if it is to embrace toric and multifocal lenses, anti-VEGF agents and other new treatments,” he said.

This raises the greater issue, that even if and when the current economic crisis passes, ophthalmology is facing an ongoing crisis of sorts, involving factors of access to care, including providing sufficient numbers of surgeons and the programmes to train them to meet the coming demand suggested by the demographics of the ageing population. But perhaps the most vexing question is, who will cover the cost for not only standard services, but for the remarkably effective, but expensive, new treatments becoming available for all manner of eye diseases?

Come 2014, about 14 million Americans will gain health insurance, rising to about

30 million by 2022, thanks to health reforms passed by the Obama administration. But since reform is largely a joint project of the federal and state governments, the details of coverage and how they will affect ophthalmologists will vary greatly by location.

“Decisions made in Washington DC and in state capitals today will have an impact on how we care for our patients,” said susan K Mosier MD, MBA, an ophthalmologist and Medicaid program director for the state of Kansas. however, the overall direction is clear. Payment will move away from fee-for-service reimbursement toward managed care approaches. “There is a lot more performance monitoring and recording on the way.”

The federal Medicare program, which covers those 65-years-of-age and older, already has adopted strict performance-based payment rules, said William L Rich MD, medical director of health policy for the American Academy of Ophthalmology (AAO). in 2015, practices that fail to meet quality and medical record use requirements will lose up to 3.5 per cent of Medicare revenues, rising to 7.0 per cent or more by 2018.

AAO is developing a registry that is designed to enable participating practices to meet the quality reporting requirements, which will tie payments to indicators such as providing screening and prevention services, Dr Rich said. While switching to electronic records can be costly, participating in registries has clinical benefits, including auditing practice performance and monitoring

long-term effects of drugs and devices. About 35 to 40 per cent of Us practices have converted to EMR.

From state-run insurers, ophthalmologists can expect a variety of managed care approaches, Dr Mosier said. Most feature greater involvement of primary care physicians in controlling specialist service use, and restrict patient choice of physicians.

The most common is a comprehensive risk-based plan, in which a contracted network is at risk for care quality and outcomes. Plans support members with health assessment and care coordination, and must report performance and quality measures and submit to external quality reviews to obtain payment. Nearly half of state-run programmes already use this model, and they will likely be greatly expanded under reform, Dr Mosier said. she also expects private insurers to follow suit.

Driving it all is reduced funding, said Michael X Repka MD, MBA, AAO’s medical director of governmental affairs. For decades, total government expenditures on ophthalmology have grown year to year, but they are about to level off even as patient demand grows. he noted, for example, that the advent of intravitreal injections for AMD and other retinal conditions has dramatically increased procedure volume in retinal offices.

Technological advances such as implants that reduce the number of injections required may help relieve this particular problem, Dr Repka said. however, the larger issue is finding ways to deliver services more efficiently and effectively. “We have to find savings in healthcare delivery. More quality and less cost is no longer a mantra, it is a need.”

REFORM In PRACTICEMore patients, electronic records, lower pay under Obama changesby Howard Larkin

The number of cataract surgeries performed in the UK has thus come down

“Richard Packard MD, FRCS, FRCOphth

Ophthalmology will have to fight hard to preserve its slice of the health budget and fight very hard to increase it, which it will need to do if it is to embrace toric and multifocal lenses, anti-VEGF agents and other new treatments

Peter Barry FRCS

COMING SOON IN MARCH EUROTIMES...

Endophthalmitis UpdateThe EuroTimes March Cover Story will provide a retrospective on the ways the prophylaxis of endophthalmitis after cataract surgery has changed over the 10 years since the publication of the ESCRS Endophthalmitis Study.

That study showed that the rate of endophthalmitis among those receiving intracameral cefuroxime was only 0.05 per cent compared to 0.35 per cent among those who did not receive the antibiotic. The article will include a review of the history and inspiration of the study and the impact it has had on cataract surgery around the world as well as reports from several leading surgeons on their current views on the topic of endophthalmitis prophylaxis.

Page 9: Vol 18 - issue 2

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EUROTIMES | Volume 18 | Issue 2

Topical anaesthesia is a safe and effective alternative to sub-Tenon’s block anaesthesia and results in equally high patient

satisfaction without the risk of serious complications associated with sub-Tenon’s use in cataract surgery, according to a study presented at the XXX Congress of the EsCRs.

“Our study highlights the importance of a thorough preoperative assessment to select which patients will best tolerate the topical anaesthesia. The effect of topical anaesthesia delivered by an experienced surgeon will lead to shorter operation time, minimal complications and excellent patient satisfaction,” Minji Jennifer Kim, told delegates.

Noting that sub-Tenon’s block is the most preferred anaesthesia for cataract surgery in the UK, Dr Kim, Barnet hospital London, UK, said that several recent reports have described topical anaesthesia as a safe alternative for injection anaesthesia, particularly in selected patient groups.

“We wanted to test this hypothesis and compare patient satisfaction in sub-Tenon’s block and topical anaesthesia used in phacoemulsification cataract surgery. We also decided to try to identify additional factors which may affect patient satisfaction used in cataract surgery and compare postoperative pain experienced by patients using the two types of anaesthesia,” she said.

Dr Kim’s study included 56 patients who underwent phacoemulsification cataract surgery between December 2011 and March 2012. All operations were performed by two consultant ophthalmologists, one using exclusively sub-Tenon’s block and the other topical anaesthesia. some cases were partly or fully performed by trainee surgeons under consultant supervision, said Dr Kim.

A written postoperative questionnaire was completed by patients following their surgery and patient satisfaction was measured using the modified iowa satisfaction with Anaesthesia scale (isAs). A 10-point visual analogue scale (VAs) was used as an additional measure of pain and a separate questionnaire was filed in by the operating surgeons.

Looking at the results, Dr Kim said that while there was slightly higher patient satisfaction in the sub-Tenon’s group, this was not statistically significant. The

postoperative pain evaluation using the visual analogue scale also showed no statistical significance between sub-Tenon’s block and topical anaesthesia.

A significant difference was seen, however, in patient satisfaction with reduced duration of the operation and the experience of the operating surgeon. No differences were seen in variables including sex, age and previous exposure to cataract surgery.

Two cases of excessive pain experienced with topical anaesthesia necessitated conversion to local anaesthesia. in the sub-Tenon’s block group, one patient experienced severe chemosis, and one patient had incomplete akinesia which interfered with the surgery and required reinforcement of the anaesthesia.

summing up, Dr Kim said that there was no significant difference in patient satisfaction between the groups treated using sub-Tenon’s block or topical anaesthesia.

“Patient satisfaction is, however, affected by the duration of the operation and seniority of the surgeon. We advise that complex cases performed by the senior surgeons will minimise the risk of intraoperative and anaesthesia-related complications,” she said.

SAFE ALTERnATIvETopical anaesthesia another option in phacoemulsification surgeryby Dermot McGrath in Milan

Minji Jennifer Kim – [email protected]

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We advise that complex cases performed by the senior surgeons will minimise the risk of intraoperative and anaesthesia-related complications

Minji Jennifer Kim

Page 10: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

Cataract surgery performed with femtosecond lasers has several potential advantages over conventional phacoemulsification

with ultrasound, but it may also represent another step towards the automation of surgery that will leave the surgeon handicapped by the constraints of the machines that they use when difficult situations arise, according to participants in a debate at a JCRs symposium at the XXX Congress of the EsCRs.

Taking the argument in favour of the new technology, h Burkhard Dick MD, PhD, Ruhr University Eye Clinic, Bochum, Germany, said that femtosecond laser cataract surgery has four principal advantages. “First is the rapid adoption of the procedure, by both surgeons and patients. second is the ease and precision it allows in the creation of corneal incisions and capsulotomies. Third is the reduction or elimination of the need for ultrasound, which is especially true when performing extensive nuclear fragmentation, and fourth is the potential to improve existing techniques and create new ones,” he said.

The main disadvantage of femtosecond laser cataract surgery is the increased expense compared to conventional ultrasound. Currently the various systems cost about half a million euro. in order to break even a surgeon would have to perform femtosecond laser procedures in 250 eyes during the first year and in 350 eyes in the second year with an added surcharge of €1,500 in each case.

however, Dr Dick said that so enthusiastic has been the acceptance of femtosecond laser cataract surgery that he was able to perform more than 960 cases in nine months, on a commercial basis without advertising, and

he expects to exceed three times his quota for breaking even by two years.

One of the driving factors of its popularity is that it can be used in “all comers,” he continued. That includes many of the more difficult cases, such as hard cataracts, small pupils, intraoperative floppy iris syndrome and eyes with comorbidities, including corneal guttata and glaucoma.

he noted that, in the Catalys Precision Laser system (OptiMedica Corp) that he uses, the low suction of the fluid filled Liquid Optics interface leaves the conjunctiva unchanged, even in patients receiving anticoagulant therapy. Moreover, the interface also only increases iOP by a mean of 10.0 mmhg and is therefore safe to use in eyes that have undergone trabeculectomy.

Regarding the reduction in the need for ultrasound in femtosecond laser cataract procedures, Dr Dick said that out of his first 850 cases, 40 per cent required no ultrasound phacoemulsification. in addition,

there was a 96 per cent reduction in effective phaco time across all grades of cataract compared to manual phacoemulsification.

The precision it adds to the performance of capsulorhexes may also make femtosecond laser cataract surgery especially suitable for use with premium iOLs, such as those with aspheric, toric and multifocal designs. A precisely shaped and sized capsulorhexis can help insure the good centration and stability that such lenses require.

“When we look at the literature, laser cataract surgery is better concerning capsulorhexis parameters, iOL position, internal aberrations and optical and predictability of iOL power. The studies also show less corneal trauma and swelling and comparable postoperative macular thickness,” Dr Dick added.

From surgeons to technicians Femtosecond lasers can offer precision and control over many aspects of cataract surgery, but a skilled surgeon using older technology can produce equivalent results at less expense. Moreover, the extra control the machines afford is control that is taken from the surgeon’s hands, said steve Arshinoff MD, University of Toronto, Toronto, Ontario, Canada.

“My issues with femtosecond laser cataract surgery are really that it takes a part of the art of cataract surgery away from us, and it is not as adaptable to the unusual circumstances that we often meet in cataract surgery,” he added.

he noted that for a long time phaco surgeons were considered great artists, but in more recent years various technologies have been developed that are designed to replace surgical technique with commercial products.

Examples include the use of toric iOLs in

place of limbal relaxing incisions, and the use of multifocal iOLs in place of monovision. Now there is the femtosecond laser, which is designed to replace diamond knives for creating incisions and bent needles and forceps for performing capsulorhexes.

“As more and more of the art of our procedures is being removed and taken over by machines, the income trend for doctors will go down and that for companies will go up,” Dr Arshinoff added.

The replacement of surgical skill and experience by technology could, in the whole surgical process, reduce the role of surgeons to that of technician. The future may see companies recruiting surgeons fresh from medical school or residency to work in corporate surgical centres at very little pay for very little skill.

Furthermore, many of the supposed advantages of femtosecond laser are not really proven. The reduction in phaco time most investigators report is around 33 per cent rather than 90 per cent as reported by Dr Dick, he said. in addition, there have been reports of adverse events such as incomplete capsulorhexes.

The expense of the devices will also make them unavailable to most surgeons and to most patients in the world. There are still many places in the world where surgeons cannot afford conventional ultrasound phaco.

he added that history has shown that what ultimately makes any new surgical technology become part of standard practice is its ability to enable surgeons to do things that were previously impossible and which improve patients' outcomes, usually at fairly low cost per case.

“i want the femtosecond laser to make me feel that i can do new things that i could not do before, that my surgical art has been enhanced, not replaced and that i’m not a servant of some big corporation,” Dr Arshinoff added.

H Burkhard Dick – [email protected] A Arshinoff – [email protected]

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nEW TECHnOLOGYFemtosecond cataract surgery is an impressive procedure, but will it supercede ultrasound phaco? by Roibeard O’hEineachain in Milan

8

A femtosecond cataract laser cannot do a posterior capsulorhexis, and capture the IOL

Update

CATAraCT & REFraCTIvE

When we look at the literature, laser cataract surgery is better concerning capsulorhexis parameters, IOL position, internal aberrations and optical and predictability of IOL power

H Burkhard Dick MD

My issues with femtosecond laser cataract surgery are really that it takes a part of the art of cataract surgery away from us, and it is not as adaptable to the unusual circumstances that we often meet in cataract surgery

Steve A Arshinoff MDCo

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Page 11: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

Today everyone knows that a sharp, square edge on an intraocular lens (iOL) helps delay posterior capsule opacification (PCO) by blocking

proliferation of latent lens epithelial cells across the optic zone. it was the pioneering work of the late David Apple MD in iOL pathology that led to this and other insights that have made lens implants safer and more effective for millions of patients worldwide, steve A Arshinoff MD FRCsC, Toronto, Canada, told the XXX Congress of the EsCRs.

As the first pathologist to systematically study how ocular tissues respond to implants, Dr Apple transformed iOL design and implantation from an art based largely on individual clinical observation and surgical insight into a science based on rigorous research, said Dr Arshinoff, who delivered the Apple Commemorative Lecture as president of the international intraocular implant Club. Yet his most valuable contribution may have been to remind implant surgeons that they need to be cautious in adopting new technology.

“sir harold Ridley gave us the intraocular lens but it was really David Apple who made

implantology a science. David was recognised quickly by Dr Ridley as a brilliant young innovator, and in 1985, when sir harold was 79 years old he summoned David to England to meet him. They met pretty much three times a year after that to discuss quality issues and what should be done,” Dr Arshinoff said.

in a characteristic display of devotion to the field, Dr Apple wrote a paper during his last days that summarised his life’s work and thoughts that was published in December 2011 in Survey of Ophthalmology, Dr Arshinoff recalled. “in it he said, ‘please, surgeons, always under promise and over deliver in intraocular lenses’. The companies, he felt, always emphasise and promise best-case scenarios.” All iOLs perform well in the first five years, Dr Apple wrote. it is the long-term complications that must be watched.

Dr Apple remained convinced that the most significant long-term iOL complication is LEC proliferation. it can lead to PCO, which can often be resolved with YAG capsulotomy. But erratic proliferations with variable types and degrees of fibrosis also may affect iOL position, causing tilt, decentration, phimosis and other issues less easily addressed, Dr Arshinoff noted.

Dr Apple also warned that recent studies show that PCO rates are much higher than previously thought, and LEC proliferation, in the form of söemmerring’s rings, occur in 100 per cent of iOL cases after three to six years. All iOL designs are subject to break out of cells from the söemmerring’s rings after 10 to 15 years, and up to 50 per cent of cases experience a breakout. As a result, he advocated much longer test periods for “premium” iOLs both because they are more sensitive to dislocation and söemmerring’s rings-related distortions, and because, for refractive reasons, they are being implanted in younger patients with a commensurate increase in risk of future problems, Dr Arshinoff added.

“he suggested many changes in the lenses that we use. Today’s lenses represent great advances, but David felt there are still many issues to be addressed,” Dr Arshinoff said.

Dr Arshinoff met Dr Apple in 1980 when both sat for the oral portion of the Us ophthalmology boards. They were sequestered in a room together for five days because both were known personally to the board examiners; Dr Apple because of his lectures and publishing in ocular pathology and Dr Arshinoff for papers and publications he had delivered and published relating to gyrate atrophy and metabolic ocular inherited disorders .

“We were forced to sit and talk for five days, and we became very good friends.”

We passed, though neither of us was required to because we did not practice ophthalmology in the Us – a fact noted by the examiners who were impressed with our willingness to sit the exam, Dr Arshinoff said.

The commemorative lecture also included taped remembrances from colleagues including Randall Olson MD, who recruited Dr Apple to the University of Utah; Gerd Aufarth MD, who took possession of many of Dr Apple’s records and specimens to continue his work; industry leader Donnie Munro, president of Rayner; and Dr Apple’s wife and constant companion, Ann.

Dr Apple mentored many young ophthalmologists and researchers, who became known as the “Apple Korps.”

“David was a friend of everyone he met and taught,” Dr Arshinoff said.

“he taught us to respect our heritage; that those who struggle to innovate enrich our abilities to care for our patients, but to remember: most innovations fail. he taught us to be cautious with the latest innovation and to study the long-term effects of each new iOL design or gadget before fully accepting it,” Dr Arshinoff said.

“he made ‘implantology’ a science and we will all miss his leadership and input.”

Steve A Arshinoff – [email protected]

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DAvID APPLE ‘Father of IOL pathology’ made implantology a scienceby Howard Larkin in Milan

9Update

COST EFFICIENT

COMPATIBILITY

a full range of

phaco-accessories for safe and

controlled MICS and CO-MICS techniques

CATAraCT & REFraCTIvE

David Apple MD

Page 12: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

Binocular depth of focus is increased similarly by micro-monovision and a small aperture corneal inlay, suggests an experimental study evaluating the visual function impact of different presbyopia-

correcting techniques. however, while stereoacuity is preserved with the inlay, it is significantly degraded by micro-monovision, reported Pablo Artal PhD, at the XXX Congress of the EsCRs.

The testing was performed in four subjects using a binocular adaptive optics visual analyzer developed by Dr Artal and colleagues in the Optics Laboratory, University of Murcia, spain. Micro-monovision was simulated by setting the refraction to plano in one eye and to -1.25 D in the fellow eye. simulation of vision with the small aperture corneal inlay was done by creating a normal pupil size (4mm) in one eye and limiting the pupil size to 1.6mm in the fellow eye. As a normal control, testing was also performed with a 4.00mm pupil in both eyes.

“The small aperture corneal inlay improves visual acuity over an extended range of object distances by increasing depth of focus, and according to our testing, both the small aperture inlay and micro-monovision increase binocular depth of focus by about 2 D,” said Dr Artal, professor of physics (optics) and founder and director of the Optics Laboratory, University of Murcia.

“however, the small aperture inlay results in only a moderate inter-ocular retinal disparity, so that stereoacuity is not significantly modified. in contrast, stereovision is severely degraded by micro-monovision because it is associated with a large difference in image quality between the two eyes.”

stereoacuity was measured using a three-needle test in which the subject decides if the central stimulus wire is in front of or behind the other two wires. Fifteen runs were completed for each disparity value, and the results were averaged across the four subjects for the normal, micro-monovision, and inlay situations.

Mean stereoacuity for the normal control testing was about 10 arcsecs. it was increased to about 12 arcsecs in testing simulating the small aperture corneal inlay, but the difference compared with control was not statistically significant. Mean

stereoacuity for micro-monovision was about 35 arcsecs. “We know from clinical experience that stereoacuity is not

very good with monovision, and we found that it was severely degraded when there was only a 1.25 D difference between the two eyes,” said Dr Artal.

“in a standard monovision approach where the difference in refraction is even greater, the reduction in stereoacuity is even more significant and can’t even be measured using this instrument.”

Dr Artal explained that the adaptive optics vision analyzer allows simultaneous manipulation and measurement of the optics in the two eyes of a test subject. Thus it allows pre-testing different presbyopic corrections in each patient to select the best compromise for optimum outcomes.

“instead of doing the testing in patients with micro-monovision and a comparator group of those who had undergone the inlay procedure, we wanted to evaluate the pros and cons of the two methods of presbyopia correction using this experimental system that affords full control of the optics while performing the visual testing. We believe that the actual clinical results for the testing we perform follow closely what we measure in the lab,” Dr Artal said.

he added, “in a previous study, we established that we can successfully replicate the results of the real inlay using the binocular adaptive optics vision analyzer, and it also appears useful as a pre-screening tool and to personalise procedures for individuals in terms of optimising centration of the small aperture and residual defocus.”

Pablo Artal – [email protected]

PRESERvInG STEREOPSISSmall aperture inlay shows benefit over micro-monovision despite shared mechanismby Cheryl Guttman Krader in Milan

10 Update

CATAraCT & REFraCTIvE

Summary of the stereovision results for the three situations tested in the study

We believe that the actual clinical results for the testing we perform follow closely what we measure in the lab

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EUROTIMES | Volume 18 | Issue 2

Using an ophthalmic viscosurgical device (OVD) that also contains an anaesthetic leads to reduced discomfort and pain for patients

undergoing microincision cataract surgery (MiCs), according to a study presented at the XXX Congress of the EsCRs.

“Our study found that wound-assisted iOL insertion through a microincision wound was associated with only mild discomfort for the majority of patients. however, the addition of one per cent lidocaine in the viscoelastic reduced the amount of discomfort or pain that patients experience during MiCs and this was statistically significant,” David shahnazaryan MD told delegates.

Dr shahnazaryan, an ophthalmologist at the Royal Victoria Eye and Ear hospital, Dublin, ireland, said that the goal of the study was to compare the intensity of pain during iOL insertion in patients undergoing MiCs, and more specifically iOL insertion through a wound-assisted insertion technique, under topical anaesthesia using two different ocular viscoelastic agents.

“since most of the injectors that we currently use in our practices do not fit through a microincision we wanted to assess whether a wound-assisted technique might be associated with more pain,” he said.

Dr shahnazaryan’s study included 100 eyes of 94 consecutive patients who underwent coaxial microincision cataract surgery through a 2.2mm incision. Patients were randomly assigned to one of two groups based on the type of viscoelastic used during the surgery: in group one, patients received intraoperative Visthesia (Carl Zeiss Meditec), comprising sodium hyaluronate and 1.0 per cent lidocaine, and group two patients received Amvisc (Bausch + Lomb) containing sodium hyaluronate and no anaesthetic.

After signing the informed consent form, all patients were familiarised with the visual analogue pain scale and asked to report their subjective pain scores at three different times during surgery. The first score was obtained five minutes before the surgery after administration of proxymetacaine topical anaesthetic, with all patients also receiving 1.0 per cent lidocaine gel immediately prior to the surgery. The second score was immediately obtained after wound-assisted iOL insertion and the final score was totalled at the end of the procedure.

Dr shahnazaryan noted that the mean pain score, which corresponded to less than mild discomfort in either group on administration of proxymetacaine, was not statistically different between the two groups and served as a control. in group one, however, the mean pain score was less for both the iOL insertion and for the total procedure compared with group two.

None of the patients in group one reported a pain score higher than 3.0 (mild pain), whereas 12 patients (24 per cent) in group two reported moderate pain greater than 4.0. The mean total pain score was less than 3.0, corresponding to mild discomfort in each group, but it was statistically significantly less in group one, said Dr shahnazaryan. The mean duration of surgery was similar for both groups and statistical analysis showed no correlation between the duration of surgery and the pain score in either group.

Dr shahnazaryan said that the pain difference experienced between the two groups was probably related to the wound-assisted technique.

“This can be associated with stretching of the wound in microincision surgery and therefore more pain and discomfort for the patient. however, the use of viscoelastic with anaesthetic achieves adequate pain control and comfortable surgery,” he concluded.

REDUCInG PAInUse of viscoelastic with anaesthetic achieves adequate pain control in MICSby Dermot McGrath in Milan

David Shahnazaryan – [email protected]

contact

ad-EUR-1/2 hoch-1212v2-pva RZ.indd 1 14.12.12 09:45

Update

CATAraCT & REFraCTIvE

Since most of the injectors that we currently use in our practices do not fit through a microincision we wanted to assess whether a wound-assisted technique might be associated with more pain

David Shahnazaryan MD

Page 14: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

The most common complications involving foldable iOLs have changed little over the past five years and may continue to be

avoided by excellent surgical technique, quality manufacturing, careful iOL folding and insertion and accurate iOL measurements, according to Nick Mamalis MD.

“To avoid some of the main complications using foldable iOLs we need rigorous surgical technique, with an intact capsulorhexis and capsular bag fixation of the iOL. This will markedly help to decrease the incidence of dislocation and decentration that remain the most common cause of the explantation of foldable iOLs,” said Dr Mamalis.

Presenting the results of the 14th EsCRs/AsCRs annual survey on foldable iOLs requiring explantation or secondary intervention, Dr Mamalis, professor of ophthalmology, Moran Eye Center, University of Utah, salt Lake City, Us, said that the goal of the survey, written in conjunction with members of the AsCRs Cataract Clinical Committee, was not to single out individual iOLs as being either superior or inferior to other lenses.

“it is difficult to get a clear picture of what iOL causes what complication because we only report on the lenses that were either sent to us or for which the survey form was filled out, so we really do not know the total numerator or the denominator of the lenses that are being implanted. Our study therefore focuses on looking at which type of complications are occurring with which type of lens, and also to determine if some complications are now appearing more frequently or less frequently over time,” he said.

The questionnaire on which the study was based includes details of the type of iOL removed, the patient’s preoperative visual acuity and the symptoms requiring removal of the lens.

The iOLs covered by the survey included one-piece plate-type lenses, one-piece iOLs with haptics, and three-piece iOLs. The joint EsCRs/AsCRs survey also includes multifocal and accommodating

lenses which have become more popular in recent years, said Dr Mamalis. The survey also takes account of iOL material type including silicone, hydrophobic acrylic, hydrophilic acrylic (hydrogel) and collamer, a hybrid material.

Decentration or dislocation was the primary problem associated with the removal or adjustment of one-piece plate-type silicone lenses, accounting for almost 70 per cent of explantations in that category of iOL, followed by incorrect lens power in 32 per cent of cases.

Dislocation or decentration was also the most common reason for explantation of three-piece silicone foldable iOLs, although other factors such as incorrect lens power, optical aberrations, iritis and glaucoma were also implicated in the survey, said Dr Mamalis.

The same pattern emerged for one-piece hydrophobic acrylic lenses with haptics, with dislocation or decentration again the main cause of explantation in 50 per cent of cases. A similar scenario was reported for three-piece acrylic iOLs, with decentration/

dislocation the most commonly cited reason for explantation in half of cases.

A different pattern emerged, however, for hydrophilic acrylic lenses, with calcification and opacification cited as the principal reasons for explanting these iOLs.

in the multifocal iOL category, glare and optical aberrations (over 60 per cent) were the most commonly cited reason for removal of hydrophobic acrylic one-piece multifocal iOLs with haptics. For three-piece hydrophobic acrylic multifocal iOLs, incorrect lens power was the reason for iOL removal in 50 per cent of the explantations, said Dr Mamalis.

“We are seeing an increasing number of explanted multifocal iOLs. This may simply relate to the fact that more of these lenses are being implanted now than was the case previously, but we are definitely seeing more in our survey,” he said.

For one-piece silicone accommodating lenses, Dr Mamalis said that glare and optical aberrations were the most common reason for removal, but emphasised that the numbers included in the data were too

small to draw any firm conclusions.Putting the overall study data into

context, Dr Mamalis said that with the exception of hydrogel iOLs, dislocation or decentration once again proved the most common reasons for removal of foldable iOLs, followed by glare and optical aberrations and then incorrect lens power.

“hydrogel or hydrophilic acrylic lenses are now being explanted less frequently which may be related to the fact that these lenses are no longer calcifying. We have also seen a marked reduction in the removal of plate haptic silicone iOLs in recent years, which may reflect a reduction in the overall usage of such iOLs rather than any improvement in their performance per se,” Dr Mamalis said.

The reduction of incorrect iOL power as a reason for lens removal is another clear trend to emerge over the years of the study, said Dr Mamalis.

“Accurate iOL measurements remain important and we are seeing now that the incidence of incorrect lens power has dropped markedly over the course of the survey. i think that is a result of the improvements in iOL calculations and the fact that we are using interferometry for more accurate axial length measurements,” he said.

The high incidence of glare and visual symptoms as the main cause of multifocal iOL explantation also underscored the importance of proper patient selection and preoperative counselling for these patients, Dr Mamalis added.

Dr Mamalis stressed that the EsCRs/AsCRs explantation study was ongoing and depended on the contributions of ophthalmologists and ophthalmic surgeons to stay abreast of emerging trends in a fast-moving field. he encouraged surgeons to report iOL explantations as they occur using the form available via the EsCRs or AsCRs websites.

Nick Mamalis – [email protected]

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IOL EXPLAnT SURvEYDislocation and decentration remain most common cause of IOL explantationby Dermot McGrath in Milan

12 Update

CATAraCT & REFraCTIvE

Accurate IOL measurements remain important and we are seeing now that the incidence of incorrect lens power has dropped markedly over the course of the survey

Nick Mamalis MD

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Don’t Miss ESASO Update, see page 36

Page 15: Vol 18 - issue 2

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Visit www.tecnisiol.com to learn more.TECNIS is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. ©2012 Abbott Medical Optics Inc.www.AbbottMedicalOptics.com / 2012.11.14-CT81

Page 16: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

simultaneous LAsiK and monocular implantation of a small aperture corneal inlay (Kamra, AcuFocus) is very safe and effective treatment for

presbyopia and ametropia, according to a study presented by David Allamby MD, at the XXX Congress of the EsCRs.

Dr Allamby, director, Focus Clinics, London, UK, reported outcomes for a series of 57 presbyopic patients with refractive prescriptions ranging from moderate myopia to moderate hyperopia. some 89 per cent of patients underwent combined LAsiK and Kamra implantation (“CLK”) for treatment of presbyopia and ametropia while the remaining 11 per cent were treated only for presbyopia using the pocket emmetropic Kamra (“PEK”) procedure. in all patients, the inlay procedure was unilateral with placement in the non-dominant eye.

All 57 patients were seen at three months after surgery. The results of testing in the inlay eyes showed mean near UCVA (measured at 40cm) was J1 and mean distance UCVA was 20/30. Outcomes at six months showed further improvement. Among the 20 patients seen at six months, the inlay eyes had a mean near UCVA of J1 and mean distance UCVA of 20/25, reported Dr Allamby.

“The small aperture corneal inlay has become our preferred option for correcting presbyopia in patients aged 45 to 60 who have a clear lens. The surgery itself presents a little bit of a learning curve. however, once that’s overcome, there is a real wow factor

for this procedure because of the near vision improvement achieved on post-op day one, and data from the salzburg group show that the benefit is maintained with follow-up to five years,” he said.

The inlay procedure has several advantages for presbyopia correction compared with monovision or blended vision, including better distance visual acuity in the reading eye, better stereopsis, and better intermediate vision, he commented.

All of the patients were operated on at Focus Clinic by Dr Allamby or Ali Mearza MD. Patients were eligible for an inlay procedure if they had a clear lens, pupil diameter of 7.0mm or less, and were in the age range between 45 and 65 years old, although the series included one 69-year-old who had a very clear crystalline lens. The usual selection criteria for LAsiK were applied, including an estimated residual stromal bed thickness of at least 300 microns.

“Proper patient selection is very important for achieving good outcomes with the inlay, and in particular, a clear lens and a good tear film are necessary. in our experience, patients on anti-depressants do less well, likely because the medication affects tear function,” Dr Allamby said.

For the 57 patients in the series, preoperative sphere ranged from -6.25 D to almost +3.0 D (median +0.5 D) and cylinder ranged up to -1.75 D (median -0.5 D). Nearly half of the patients (48 per cent) were hyperopes (sE ≥+0.75 D), 30 per cent of the patients were myopes (sE ≤-0.75 D), and the

rest were emmetropes (sE -0.5 to +0.5 D). initially, based on the manufacturer’s

recommendation, target refraction was -1.0 D for hyperopes and -0.75 D for all other eyes so that even some emmetropes underwent CLK to achieve the myopic target instead of having the PEK procedure. however, when it was noted that the refractive outcome was too myopic in some hyperopes, the target refraction was adjusted to -0.75 D for all eyes. For the full CLK cohort, mean target refraction was -0.77 D and mean achieved refraction was -1.1 D.

At baseline, mean near UCVA was J13 for the emmetropes and hyperopes and J2 for the myopes. At three months, near UCVA in

the inlay eye was J5 in one patient (two per cent) and J3 or better in all of the rest, with 65 per cent of eyes achieving J1 or better. The patient with J5 vision underwent inlay explantation.

“Our criteria for explantation are if the patient is not seeing J3 or better and is expressing dissatisfaction. it is important to have a ‘plan B’ for managing patients who are dissatisfied with the outcome of the inlay procedure, and ours is to convert to monovision,” Dr Allamby said.

Baseline mean distance UCVA for all eyes was ~20/40 (20/41 for the emmetropes and hyperopes and 20/120 for the myopes). At three months, distance UCVA was 20/30 or better in 77 per cent of inlay eyes and 20/40 or better in 88 per cent, but it ranged up to 20/100 (one eye, two per cent), reported Dr Allamby.

“The latter case was related to dryness, and we see improvement of distance UCVA over time as post-LAsiK dryness resolves. At six months, distance UCVA for the implanted eyes averaged 20/25 and was 20/30 or better in 90 per cent of eyes. in the few patients in our series with longer follow-up and based on international data, it appears that distance vision continues to improve through one year, typically 20/20,” he said.

safety was good. Mean distance BCVA was 20/16 at baseline and reduced by an average of two letters after the procedure.

Dr Allamby also noted that the list of potential candidates for presbyopia correction with the small aperture corneal inlay continues to expand and now includes eyes that have had previous refractive surgery by LAsiK, radial keratotomy or conductive keratoplasty.

“We have operated on eyes in all of those categories at our clinic with good outcomes. We are also expanding our treatments with PLK2, where first thin-flap LAsiK is performed, followed four weeks after with implantation of the inlay via a pocket,” Dr Allamby said.

David Allamby – [email protected]

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AMETROPIC PRESBYOPIACombined LASIK/corneal inlay procedure ‘wows’ patients with early outcomesby Cheryl Guttman Krader in Milan

14

Update

CATAraCT & REFraCTIvE

We have operated on eyes in all of those categories at our clinic with good outcomes. We are also expanding our treatments with PLK2, where first thin-flap LASIK is performed, followed four weeks after with implantation of the inlay via a pocket

David Allamby MD

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EUROTIMES | Volume 18 | Issue 2

The advent of the femtosecond laser corneal trephination and lamellar keratoplasty procedures has totally changed the kinds of visual results

that corneal grafts can achieve, according to presentations at the XXX Congress of the EsCRs.

“The old days of keratoplasty patients being optical cripples, dependent on hard, rigid, gas permeable contact lenses, are fortunately over,” said Roger steinert MD, Gavin herbert Eye institute, UC irvine, irvine, California, Us. Dr steinert is also a consultant to AMO.

he noted that femtosecond laser trephination enable a much more precise matching of donor buttons to host excision sites in penetrating keratoplasty (PK) procedures. in addition, new femtosecond laser technology is showing promise in excising host tissue right down to Descemet’s membrane in deep anterior lamellar keratoplasty (DALK) procedures.

Zig-zag is best One of the main advantages that femtosecond lasers have over conventional trephination is the range of side-cut options the laser provides, enabling a close interlocking of the graft and host tissue. That can result in better visual outcomes and earlier suture removal. The side-cut patterns include the top hat, the mushroom and the zig-zag, he said

The top-hat pattern has advantages for patients with endothelial disease since it involves the removal of the least amount of corneal tissue and can provide a fairly unbroken contour of the anterior refractive surface. however, the “rim” of the top-hat shaped corneal button does not always self-seal with the host cornea, which means that it can lose some of its advantages over a conventional straight-cut trephination.

The mushroom side-cut pattern has advantages in keratoconus patients in that it sacrifices a relatively small amount of the host endothelium, however, it does not automatically align with the anterior surface or create a hermetic seal.

Meanwhile, the zig-zag side-cut pattern has advantages for indications involving both anterior and endothelial corneal pathology in that it maintains a hermetically sealed wound, requiring minimal suture tension.

in a study Dr steinert’s group presented at ARVO 2012, patients undergoing

keratoplasty with the femtosecond laser had a mean manifest cylinder of around 3.0 D from about three postoperative months onward. That is about 1.5 D less astigmatism than occurs with conventional PK, he noted.

Furthermore, in another study they conducted, visual acuity was 20/40 or better at three month’s follow-up in 81 per cent of eyes that underwent PK with femtosecond laser-enabled zig-zag trephination. By comparison, only 45 per cent of those who underwent the graft procedure with conventional trephination achieved 20/40 (P = 0.03) (Farid et al, Ophthalmology 2009; 116:1638-43).

The superior BCVA results achieved with femtosecond laser-assisted keratoplasty may result from the reduction in irregular astigmatism it provides. Dr steinert noted that in yet another study, the laser-assisted procedures induced fewer anterior surface higher order aberrations than penetrating and Descemet's stripping automated endothelial keratoplasty (DsAEK) induced fewer anterior surface hOAs than the other techniques. however DsAEK induced more posterior surface hOAs than the other two techniques (Chamberlain et al, Cornea 2012;31:6-13).

Dr steinert also described a new procedure for performing DALK. The technique involves ultralow energy multi-pass technique with the 150 khz iFs interlace laser. Results achieved so far in laboratory studies indicate that the technique can cleave the stroma from Descemet’s membrane without the irregular ridges that have occurred with other deep anterior lamellar femtosecond dissection techniques, Dr steinert said.

Keeping the interface clear A smooth, optical lamellar surface, whether it is Descemet’s membrane or a posterior stromal surface in the host cornea in DALK or as graft tissue in DsAEK, is key to achieving optimum visual outcomes with lamellar graft procedures, said Donald Tan MD, singapore National Eye Centre, singapore.

“DALK is now equivalent to penetrating keratoplasty with regards to best spectacle-corrected visual acuity and astigmatism if you reach Descemet’s membrane in your trephination of the host cornea. similarly, DsAEK has faster visual recovery and better uncorrected visual acuity than PK. But, unless

you're talking about DMEK, achieving a best-corrected vision of 6/6 vision may not always be achievable with endothelial keratoplasty procedures,” he said.

he noted that, in a study comparing big bubble-DALK (with complete baring of Descemet’s membrane) and manual dissection DALK (with residual posterior stroma) in keratoconus patients, he and his associates were able to show that big-bubble DALK resulted in visual acuity equal to that achieved with PK (Han et al, Am J Ophthalmol 2009 ;148:744-751).

That is, around two-thirds of patients who underwent PK or DALK with the big-bubble technique achieved a visual acuity of 20/20, compared to only 20 per cent of patients who underwent DALK with manual stromal dissection, he said.

Big bubble better Endothelial keratoplasty procedures like DsAEK typically provide greatly superior uncorrected

and best-corrected visual acuity than PK procedures, since they leave the cornea’s refractive components largely intact and are essentially sutureless. however, the presence of a stroma-to-stroma interface between donor and recipient, and higher order aberrations from the donor may make the visual outcomes of DsAEK less than ideal in some eyes.

Dr Tan noted, for example, that in a retrospective study involving patients who underwent keratoplasty procedures during the years 2006-2010, the mean one-year uncorrected and best corrected visual acuities in eyes that had undergone DsAEK with a sheets Glide insertion technique were 20/40 and 20/30, respectively. That compared to respective values of 20/100 and 20/50, respectively in those that had undergone PK (Ang et al, Ophthalmology 2012; 119: 2239-2244).

Moreover, the mean postoperative astigmatism was only 1.7 D after DsAEK, compared to 3.0 D after PK. in addition, the amount of endothelial cell loss was only 22.4 per cent after DsAEK compared to 40.0 per cent after PK, suggesting that long-term endothelial failure was less likely in DsAEK.

“There is some evidence that ultra-thin DsAEK procedures, or DMEK, can produce better visual outcomes. such procedures however involve more challenging surgery, especially DMEK, and might entail greater endothelial cell loss but still offers the best possible visual quality,” Dr Tan added.

Roger Steinert – [email protected] Tan – [email protected]

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KERATOPLASTY TECHnIQUESBetter surgery is yielding better visual outcomesby Roibeard O’hEineachain in Milan

15David Allamby – [email protected]

Update

CORNEA

Advertisement

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EUROTIMES | Volume 18 | Issue 2

Central corneal thickness (CCT) measurements obtained with a non-contact low-coherence reflectometry ocular biometry

device were reproducible and repeatable, but also significantly greater than values obtained with specular microscopy and contact ultrasound, Jorge Gallardo MD, Barcelona, spain, told the XXX Congress of the EsCRs. he found the reflectometry device reliable for measuring CCT, but advised its greater reported thicknesses be accounted for in clinical and research uses.

The Lenstar Ls900 (haag-streit, Koeniz, switzerland) uses low-coherence reflectometry, a technology similar to OCT that calculates distances in the eye by comparing reflections to a reference beam. in a single, non-contact scan it simultaneously gathers nine biometric values: central corneal thickness, anterior chamber depth, lens thickness, axial length, retinal thickness, K values, white-to-white values, pupillometry and eccentricity of the visual axis relative to the optical axis.

Reported advantages of the technology include greater comfort for patients than with contact ultrasound, low interoperator variability and elimination of separate tests for lens thickness for use with advanced iOL power calculations, including the holladay ii and Olsen formulae.

several published studies have found the accuracy of the Lenstar device comparable to biometry standards including the iOLMaster (Carl Zeiss Meditec, Jena, Germany), OCT devices and manual keratometry, though axial length and other measures are not interchangeable (Crutsberg LP et al. Br J Ophthalmol doi:10.1136/bjo.2009.161729.; Gundersen KG et al. BMC Ophthalmol. 2012 Jul 16;12:21.)

in the current study, Dr Gallardo and colleagues assessed CCT measurements in normal eyes by the Lenstar compared with ultrasound pachymetry and specular microscopy pachymetry. The observational cross-sectional study examined 21 eyes in 21 patients with a mean age of 34.3 years ranging from 29 to 38. All patients had best corrected visual acuity of 20/20, and less than +/- 1.0 D sphere or +/- 1.0 D cylinder refractive defect. Eyes with previous ocular medication, surgery or contact lens use, and those with anterior or posterior chamber defects were excluded.

Patient evaluation was done at a previous visit so no medication was applied before the measurements. All measurements for each subject were obtained at a single session by an experienced technician.

All patients underwent three measurements with specular microscopy using a Topcon sP 2000, five measurements with low-coherence reflectometry using the Lenstar, and five measurements under topical anaesthesia with contact ultrasound using the Accupach system. Mean values were calculated for each patient with each device and the data analysed.

Mean CCT measured by the Lenstar was 549 microns +/- 35.3. That was 16.8 microns more than the mean of 532.2 +/- 33.9 as measured by ultrasound, and 12.2 microns more than the mean of 536.8 +/- 36.3 measured by specular microscopy, both significant at p<0.001.

Using Pearson’s correlation, an association was observed between the measures of the three devices, also significant at p<0.001. Bland-Altman analysis also found reasonable agreement between the Lenstar and the other devices.

Dr Gallardo observed that while the mean CCT obtained with ultrasound and specular microscopy were very similar, the Lenstar mean was slightly thicker.

“The agreement of the values found between the three devices supports use of the Lenstar as an alternative method for measuring central corneal thickness. however, we have to consider that those values are slightly different than the values obtained with other devices currently accepted for assessing central corneal thickness,” he concluded.

Jorge Gallardo – [email protected]

contact

CORnEAL THICKnESSLow-coherence reflectometry is accurate but not interchangeable with ultrasound pachymetryby Howard Larkin in Milan

4TH EUCORNEACONGRESS

AMSTERDAM 2013

4-5 OCTOBER 2013www.eucornea.org

Abstract SubmissionDeadline: 22 March 2013

Update

CORNEA

Contact ultrasound pachymetry

Cour

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orge

Gall

ardo

MD

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EUROTIMES | Volume 18 | Issue 2

The arguments for and against a correlation between iOP fluctuation and glaucoma onset and progression both have their

strong adherents, and better designed studies, specifically focused on iOP fluctuation, may be necessary to settle the debate to the satisfaction of all. That was the apparent conclusion of a debate on the topic held at the 10th European Glaucoma society Congress.

Anders heijl MD, PhD took up the argument that the evidence does not support the theory that greater fluctuations of iOP predict a greater likelihood of glaucomatous damage. “The question has to be, is iOP fluctuation an independent risk factor for glaucoma, even when we take the mean iOP into account? This must be tested with methods that take both fluctuation and iOP levels into account, that is, a multivariate analysis. iOP fluctuations should then be measured during the same time and with the same type of treatment,” said Dr heijl, skåne University hospital Malmö, Lund University, sweden.

he noted that two of the most often cited studies in favour of a correlation for iOP fluctuation and the likelihood of glaucoma onset or progression fail to meet those criteria. One of the studies, by Bengt Bergeå MD and associates in sweden (Bergeå et al, Ophthalmology 1999;106: 997-1005) appeared to show that glaucomatous eyes with lower amounts of daytime iOP fluctuation have a better visual field prognosis compared to those with greater iOP daytime fluctuation.

The study included 82 patients with newly detected untreated glaucoma. All had high iOPs and were participants in a randomised clinical trial comparing primary

laser trabeculoplasty with medication. All underwent automated perimetry and a daytime iOP curve assessment every second month during the two-year follow-up.

Dr heijl noted that, in their analysis, the study’s authors did not include comparisons between patients’ iOP levels and fluctuations from the same time period. Furthermore, they only partially included the iOP values that patients achieved during treatment in their analysis but always included baseline iOP values.

Moreover, the correlation between iOP fluctuation and visual field loss only appeared to hold true in the patients with pseudoexfoliative glaucoma. Primary open-angle glaucoma (POAG) patients with wider iOP fluctuations actually tended to have less visual field progression.

The results of another study, conducted by sanjay Asrani MD and associates (Asrani et al, J Glaucoma. 2000;9:134-142), also seemed to suggest that large diurnal fluctuations in iOP are an independent risk factor in patients with glaucoma. it included 166 patients with a baseline iOP less than 25 mmhg and a baseline fluctuation determined at by home tonometry measurements.

Dr heijl noted that there were several potentially confounding factors built into the design of that study. For example, the authors excluded 61 per cent of initially included patients, most often because of iOP greater or equal to 25 mmhg during follow-up, he said.

in contrast to those studies, diurnal iOP fluctuation was not an independent risk factor for glaucomatous visual field loss in high-risk ocular hypertension in a study that Dr heijl co-authored with Dr Boel Bengtsson PhD (Bengtsson et al, Graefes Arch Clin Exp

Ophthalmol 2005; 243:513 -518). The study included 90 patients recruited

from 1981 to 1987 monitored every three months for 10 years or until glaucomatous field defects developed. The results of a multivariate analysis showed that while mean iOP level was highly significant, iOP range was not significant

“The bottom line is that mean iOP is related to progression. iOP fluctuation is also related to progression, but only because it is higher in eyes with higher mean iOP there is no evidence that iOP fluctuations, diurnal or test-retest are independent risk factors for progression,” Dr heijl added.

Peak IOP higher in eyes with wider range of pressure Anastasios G Konstas MD, PhD presented the argument in favour of a possible link between iOP fluctuation and glaucomatous damage and progression, maintaining that such an association actually has yet to be disproved. We must distinguish between two different parameters: 24-hour iOP fluctuation and long-term iOP fluctuation or variation. Although it remains controversial whether long-term iOP fluctuation established with single, infrequent iOP readings impacts glaucoma progression (vs mean iOP) it should be remembered that many factors influence long-term fluctuation (treatment changes, adherence timing of iOP measurements etc), he said.

“There is considerable evidence suggesting that wide fluctuation of diurnal or 24-hour iOP plays a role in glaucoma development and progression. Moreover, and unlike long-term fluctuations of iOP, there is no convincing evidence that 24-hour fluctuation does not influence glaucoma progression,” said Prof Konstas, from the 1st University Department of Ophthalmology, AhEPA hospital, Thessaloniki, Greece.

he noted that optimisation of 24-hour iOP control has gained acceptance as the best way of reducing the risk of progressive damage to the optic nerve and visual loss. Most clinicians believe that a reduced 24-hour iOP fluctuation with therapy should be a consideration in glaucoma care and will safeguard their patients against long-term progression. Further, cumulative evidence

suggests that a wide fluctuation of 24-hour ocular perfusion pressure is a key risk factor for glaucoma progression. Potentially of greater importance is the reduction of 24-hour fluctuation in advanced glaucoma. he noted that reduced 24-hour fluctuation may be the key benefit provided by successful surgery (Konstas et al Ophthalmology 2006).

he cited two studies supporting an association between diurnal iOP fluctuation and glaucoma onset. in one of the studies, wide diurnal iOP fluctuation was more common among ocular hypertension patients who developed glaucoma (Odberg et al, Acta Ophth 1987, 65: 27–29). in another study wide fluctuation of iOP appeared to be a predictor of retinal nerve fibre layer defects and glaucoma development (Gonzalez et al, Int Ophth 1996; 20: 113-115).

however, it is often difficult to separate the impact upon glaucoma progression achieved through reduction of 24-hour peak iOP from that achieved through reduction of 24-hour iOP fluctuation, he said. it is likely that peak 24-hour pressure may be of greater importance in treated patients who continue to progress despite apparently good pressure control in the clinic. The results of another study, which Prof Konstas and his associates conducted, indicated a strong linear correlation between untreated peak 24-hour iOP in exfoliative glaucoma patients and POAG patients and mean field defect at the time of diagnosis (Konstas et al, Arch Ophth 1997 ;115(2):182-185).

“The evidence we need for the future is a long-term study investigating the precise prognostic impact and value of each 24-hour iOP parameter,” Prof Konstas added.

Anders Heijl – [email protected] G Konstas – [email protected]

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IOP FLUCTUATIOnEvidence for role of IOP fluctuation in glaucomatous pathology remains equivocalby Roibeard O’hEineachain in Copenhagen

17Update

GLAUCOMA

Glaucoma DayESCRS

Friday, 4th October 2013Amsterdam, The Netherlands

Scientific Programme organised by

www.escrs.org

The bottom line is that mean IOP is related to progression

“Anders Heijl MD, PhD

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EUROTIMES | Volume 18 | Issue 2

A combined analysis of structural and functional tests could reduce the seeming discrepancies between the two types of glaucomatous

parameters reported in many large clinical trials, according to a series of related presentations at the Glaucoma Day sessions of the XXX Congress of the EsCRs.

“Knowing the limitations and the strength of every diagnostic tool in the different phases of the disease and in different subtypes of patients may help produce a better interpretation and integration of clinical data,” said Enrico Martini MD, Ospedale di sassuolo, sassuolo, italy.

Among the sources of imprecision in the study of glaucoma’s structure-function relationships is the fact that structural changes are measured on a linear scale and functional changes on a logarithmic scale, he explained. in addition, structure-function maps are based on an average eye and do not take full account of the considerable variability in the correspondence between areas of the optic nerve head and areas of the visual field, Dr Martini said.

Visual field artefacts Visual field is the gold standard to detect damage and progression in glaucomatous patients, however, there are numerous factors that can distort the findings of perimetry, said Michele iester MD, PhD, University of Genoa, Genoa, italy.

For example, patients might have difficulty in fixating, or they might be tired. in addition, sometimes patients don’t initially understand how to do the test or they understand but their performance is not as good as it could be, indeed they get better with practice, he added.

Dr iester noted that fatigue can lead to a patient performing well at the beginning of a test and poorly as the testing progresses. That can result in a “cloverleaf” pattern perimetry reading, characterised by high sensitivity in the central area and reduced sensitivity in the periphery. in such cases, kinetic perimetry may perform better than full-threshold static perimetry, he said.

sometimes a lens that is poorly positioned in a perimetry device’s lens holder can induce lens artefacts, he noted. That can yield paradoxical field results with a higher sensitivity in the periphery. But such findings could also suggest a wide scotoma, Dr iester cautioned.

in those and similar cases, decreasing the field size from 30-2 to 10-2 allows closer scrutiny of scotomas near the fixation point. in addition, increasing the size of the stimulus spot can provide a closer inspection of individual areas of the visual field, he noted.

“if the visual field result does not make sense, check the correlation between the visual field defect and damage in the optic nerve head retinal nerve fibre layer,” Dr iester added.

Machines can’t yet replace clinicians in the early stages of glaucoma it is generally structural changes in the nerve head and retinal nerve fiber layer that first become evident, but interpreting the measurements used to detect the changes requires skill and experience, said Gábor holló MD, PhD, Dsc, semmelweis University, Budapest, hungary.

“The overlap between changes detected with the various optic nerve head and retinal nerve fiber layer analysis techniques and changes detected by visual field tests are different for the different technologies. There is at present no best technique so you have to use the brain computer,” he said.

he noted that there are three main modern imaging technologies currently in use for detecting glaucomatous damage to the optic nerve head. They are the heidelberg Retinal Tomograph (hRT, heidelberg Engineering), the GDx-VCC/ECC scanning laser polarimeter (Carl Zeiss Meditec) and the group of optical coherence tomographs (OCTs).

The hRT is a confocal scanning laser ophthalmoscope developed first of the three technologies. Users of the device have two different program options to interpret the machine’s findings: the Moorfields’ regression analysis for the rim damage, and the glaucoma probability score (GPs), which describes the shape of the peripapillary retinal surface and the transition between rim and cup.

“The classifications for these programs are very straightforward, the findings are classified as within normal limits, borderline or outside the statistically normal limits. But statistical classification may not reflect the biological disease,” Prof holló said.

Potential confounding factors include

optic nerve heads that are either unusually small or unusually large. Peripapillary retinal nerve fiber layer of very small optic nerve heads has a particularly convex shape because the structures are crowded, and large optic nerve heads will have very flat peripapillary surface, he added.

The GDx-VCC/ECC instrument provides an analysis of the retinal nerve fiber layer based on the retardation of the polarised light reflected from the back of the eye. The retardation is primarily caused by retinal nerve fibers, thus the more fibers the greater the retardation and vice versa, he explained.

Prof holló said that the GDx-ECC (enhanced corneal compensation) is superior to the older VCC (variable corneal compensation) technique in all respects (Figure 1). Though the GDx measurements tend to be slightly less reproducible than those with Fourier-domain OCT, it is a much less expensive technology, he added.

Currently there are two main types of OCT technology used for glaucoma diagnostics: the older time-domain OCT and also the more modern and advanced Fourier-domain OCT technology (Figure 2). Of the several Fourier-domain OCT systems the spectralis® (heidelberg Engineering), the RTVue-100® (Optovue),

and the Cirrhus® (Carl Zeiss) are particularly well evaluated for use in glaucoma, he said.

The Fourier-domain OCT machines provide much faster image acquisition, with up to 55,000 A-scans per second compared to 400 A-scans per second for time-domain OCT, Prof holló noted. They therefore have much better resolution and provide much more information regarding the ganglion cell complex (GCC) or inner macular thickness parameters, which are particularly important in glaucoma. Nonetheless, care is necessary to differentiate glaucomatous GCC damage from that caused by other conditions like macular drusen and very small subretinal neovascular membranes, he said.

“instruments that detect structural changes are more sensitive than perimetry in early stages of glaucoma, but it is the opposite in the later stages of disease. Therefore, individual decision on the method to be applied for evaluation of progression is not avoidable,” Prof holló said.

Enrico Martini – [email protected] Iester – [email protected]ábor Holló – [email protected]

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DIAGnOSTICSBetter understanding of technology enhances correlation between findingsby Roibeard O’hEineachain in Milan

18 Update

GLAUCOMA

Knowing the limitations and the strength of every diagnostic tool in the different phases of the disease and in different subtypes of patients may help produce a better interpretation and integration of clinical data

Enrico Martini MD

Figure 1 - Atypical retardation with VCC is neutralised with ECC

Figure 2

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Measuring iOP in infants can be a challenging task, requiring a consistent methodology and an assessment of the

measurements that is in context with a patient’s entire clinical examination, according to Maurizio Uva MD, University of Catania, italy.

“The difficulties in measuring tonometry in infants include the lack of cooperation on the part of the infant, the effects of anaesthesia on iOP and the changing thickness of the cornea as a child ages. Moreover, there is little data as to what is the normal iOP in an infant eye,” Dr Uva said at the Glaucoma Day session of the XXX Congress of the EsCRs.

Dr Uva noted that results from a study carried out at Johns hopkins University school of Medicine indicate that when infants are under sedation with ketamine their iOP will be closer to their iOP without sedation or anaesthesia than is the case when the anaesthetic gas sevoflurane is used (Blumberg et al, Am J Ophthalmol. 2007;143:494-499).

Research supports the use of the Tono-Pen® (Reichert) in paediatric cases, Dr Uva said. he cited a study that compared intraocular tonometry values with those obtained by three different non-invasive tonometers in children’s eyes. it showed that the Tono-pen measurements were closest to the intraocular values. The schiötz tonometer tended to underestimate iOP, and the Perkins tonometer tended to overestimate iOP (Lasseck et al, Graefes Arch Clin Exp Ophthalmol. 2008;246:1463-1466).

The icare® tonometer (icare Finland Oy), which is designed for measurements to be taken at home without a doctor’s supervision, may also be a useful option, Dr Uva said. The new magnetic design in particular could provide advantages in paediatric patients because it allows measurements to be taken while the patient is in a supine position, he added.

he noted that in a study involving 71 eyes of 71 children with known or suspected glaucoma, iOP measured with the icare tonometer was on average within about 3.6 mmhg of measurements obtained with Goldmann applanation tonometry (Flemmons et al, J AAPOS. 2011 Apr;15(2):153-157).

Changes in corneal thickness as an infant’s eyes mature can also influence tonometry readings, Dr Uva said. he noted that in a study he and his associates conducted, newborns had a significantly higher iOP and corneal thickness than full-term newborns (Uva et al, J AAPOS 2011;15(4):367-9).

The findings of another study suggest that iOP increases during the first decade following birth. The study showed that mean iOP measured with a Perkins applanation tonometer is under 8.0 mmhg before age of three months and under 12.0 mmhg between ages of six and nine months and thereafter increases by about 1.0 mmhg per year up to 12 years (Bresson-Dumont, Journal Français d'Ophtalmologie; 32: 176–181).

“The take-home message is to always include pachymetry in clinical examination, always use the same tonometer and, if possible the same anaesthesia. Moreover, since we don’t yet know for certain the normative iOP values in infants, tonometry has to be correlated with the whole clinical examination including biomicroscopy, gonioscopy, oculometry and optic disc evaluation,” Dr Uva concluded.

InFAnT TOnOMETRYSpecial consideration necessary in tonometry in very young childrenby Roibeard O’hEineachain in Milan

Maurizio Uva – [email protected]

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Enrico Martini – [email protected] Iester – [email protected]ábor Holló – [email protected] Update

GLAUCOMA

The take-home message is to always include pachymetry in clinical examination, always use the same tonometer and, if possible the same anaesthesia

Maurizio Uva MD

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EUROTIMES | Volume 18 | Issue 2

Early studies suggest that increasing choroidal aqueous flow could enhance the success rate of glaucoma filtering surgeries, such

as deep sclerectomy, Andre Mermoud MD, Lausanne, Switzerland, told the XXX Congress of the ESCRS.

New implants that promote suprachoroidal outflow, including collagen and injectable viscoelastic devices, show promise and may soon be available, Dr Mermoud noted. However, these devices have not been followed long, and large, long-term studies are needed to determine their safety and efficacy, he said.

Studies show that 45 per cent to 70 per cent of patients who have had non-penetrating filtration surgery have suprachoroidal aqueous flow, Dr Mermoud said. This is the result of communication between intrascleral and suprachoroidal space through the thin layer of sclera left at the bottom of the dissection in deep sclerectomy.

Dr Mermoud noted several possible benefits from increasing suprachoroidal outflow. One is long-term reduction of intraocular pressure (IOP). Unlike trabeculectomy or tube-shunt patients, IOP trends downward in deep sclerectomy patients for 12 years or more, generally staying in the 10 to 15 mmHg range.

“We think this may be due to subchoroidal flow, but we really don’t know.”

Another possible benefit is reduced risk of bleb complications. Dr Mermoud observed that deep sclerectomy patients with subchoroidal spaces and outflow visible on ultrasound (UBM) also have smaller subconjunctival blebs than those with no evidence of choroidal outflow.

Dr Mermoud’s efforts to surgically enhance suprachoroidal flow include a 2005-2006 study in which he compared 25 deep sclerectomy patients with 25 patients receiving very deep sclerectomy, in which small sections of deep sclera are removed at the posterior of the incision. At eight months, there was no statistically significant difference in IOP between the two groups. However, the very deep sclerectomy patients had smaller subconjunctival blebs and more suprachoroidal flow, as well as subchoroidal hyperechoic spaces that could indicate the formation of new uveal outflow pathways.

More recently, Dr Mermoud has attempted to promote aqueous flow in the

suprachoroidal space using devices in the intrascleral and suprachoroidal spaces. He inserted the collagen Aquaflow implant in a sub-scleral pocket, but had better results with a “belt” technique, in which the implant is inserted in two holes in the deep sclera, which creates intrascleral-subchoroidal flow.

The viscoelastic Healaflow was injected into the suprachoroidal space through a hole in the deep sclera, Dr Mermoud said. The scleral flap was sutured over it and additional Healaflow injected and forced into the newly created space. The viscoelastic keeps the passages open after surgery, and may prevent excessive outflow leading to hypotony. Ultrasound confirmed intrascleral and suprachoroidal flow with little or no subconjunctival bleb in patients with deep sclerectomy and Healaflow.

In a study comparing 25 Healaflow patients with 40 sub-scleral pocket and 39 belt (collagen implant) patients, all combined with deep sclerectomy, belt patients saw a greater initial IOP drop, but the numbers were similar at one month, with all three groups showing IOP reduction between 10 and 11.9 mmHg, Dr Mermoud reported.

Complications were also low in all groups, Dr Mermoud said. Hypotony was observed in one sub-scleral and three “belt” patients, of which two occurred after needling. Hyphaema occurred in one sub-scleral, two “belt” and one Healaflow patient, while two suture complications were observed in belt patients and one in Healaflow.

These results are promising, but questions remain, Dr Mermoud said. “How long will it function? That is a big question mark. Will we get hypotony? Yes, in some cases, but probably not many. We really need longer term and comparative studies to better answer these questions.”

Andre Mermoud – [email protected]

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DEEP SCLERECTOMYImplanted devices could make suprachoroidal outflow viable enhancement for glaucoma surgeryby Howard Larkin in Milan

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Update

GLAUCOMA

How long will it function? That is a big question mark

“Andre Mermoud MD

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EUROTIMES | Volume 18 | Issue 2

“in the near future, improving the trans-scleral outflow of aqueous humour could represent an important strategy for reducing

intraocular pressure (iOP) in patients with glaucoma,” said Leonardo Mastropasqua MD, director of the Excellence Eye Centre at the University G d’Annunzio of Chieti-Pescara, Chieti, italy.

During his keynote speech at the Glaucoma Day sessions at the XXX Congress of the EsCRs, Prof Mastropasqua stated: “Trans-scleral outflow is the last step of the uveo-scleral outflow pathway and plays a key role in ocular hydrodynamics. in fact, the sclera has a good hydraulic conductivity and offers poor resistance to aqueous humour passage. The sclera is also a very accessible structure for surgery.” he also noted that the human eye has two main pathways for aqueous outflow: the trabecular and the uveo-scleral outflow pathway. The first accounts for 80 per cent of aqueous outflow and the second for 20 per cent, on average, with measurements ranging from 12 per cent to 54 per cent.

he explained how the aqueous humour that flows out from the anterior chamber through the uveo-scleral pathway first passes between the ciliary muscle bundles into the supraciliary and suprachoroidal spaces. hence, aqueous humour drains either towards the choriocapillaris, reaching the blood circulation, or externally, passing through the sclera and conjunctiva. From here, final aqueous humour resorption is guaranteed by lymphatics vessels and veins, or by trans-conjunctival passage towards the ocular surface. All these terminal outflow pathways bring aqueous to extra-orbital tissue. Adding that uveo-scleral outflow

tends to decrease with age because of an accumulation of fibrillar extracellular material in the ciliary muscle and ciliary processes.

Improving uveo-scleral pathways At present there are both medical and surgical approaches to increase uveo-scleral outflow in eyes with glaucoma. For example, prostaglandin analogues improve this pathway by widening and decompressing the connective tissue in the ciliary muscle and remodelling the extracellular matrix by increasing the secretion of matrix metalloproteinases.

Among surgical procedures, cyclodialysis increases both the rate of uveo-scleral (by a factor of four) and trans-scleral outflow. however, the procedure has a high frequency of complications, which can themselves result in a high rate of failure and elevated iOP.

Another surgical possibility is to place a shunt between the suprachoroidal space and the anterior chamber, Prof Mastropasqua said. Although the treatment is effective at first, the lumen of these implants are prone to encapsulation and obstruction of flow with fibrous connective tissue.

Improving trans-scleral pathways Another possibility is treatments focusing specifically on enhancing the trans-scleral portion of the uveo-scleral outflow, Prof Mastropasqua said. Laboratory studies have shown that the potential outflow of aqueous through the sclera is two to three times higher in vitro than it normally is in vivo, in the eye of a patient.

interestingly, in patients affected with untreated ocular hypertension or medically

treated open angle glaucoma, trans-scleral outflow is two to five times greater than in healthy subjects, probably representing an adaptive mechanism for overcoming the increased trabecular resistance to aqueous outflow. (Ciancaglini et al. Invest Ophthalmol Vis Sci. 2008; 49(7):3042-8. Agnifili et al. Acta Ophthalmol. 2012;90(2):e132-7. doi: 10.1111/j.1755-3768.2011.02255.x.). Exploiting that potential through surgical or medical approaches could represent a useful strategy for iOP reduction, alternative to the current fistulasing procedures.

Besides in vitro measurements, trans-scleral outflow may also be measured in vivo, by using laser scanning confocal microscopy to evaluate the density and surface of conjunctival epithelial microcysts. These microcysts represent the hallmark of the trans-conjunctival passage of the aqueous humour, as reported by Ciancaglini and Mastropasqua in 2008 (1. Ciancaglini et al. Invest Ophthalmol Vis Sci. 2008; 49(7):3042-8) (Figure 1). These structures were first described within the bleb wall of functioning trabeculectomy (Figure 2). Prof Mastropasqua and his associates reported epithelial microcysts were greater in both size P=0.017) and number (P=0.014) in the successful blebs when compared to failed blebs (Ciancaglini et al. J Glaucoma. 2008. 17(4):308-17.).

As is the case with uveo-scleral outflow in general, there are already both medical and surgical techniques that specifically enhance trans-scleral aqueous outflow, he noted. For example, prostaglandin analogues increase the trans-scleral permeability by increasing the secretion of matrix metalloproteinases, which lead to remodeling of collagen fibres .

surgical procedures that thin the sclera may potentially lead to a significant enhancement of the trans-scleral aqueous humour outflow. This was originally reported in the partial thickness laminar dissection of the sclera, he said.

Currently, different surgical approaches work by also reducing the scleral thickness. Canaloplasty, a standardised treatment that improves the trabeculo-canalicular outflow, appears to increase aqueous outflow also through the sclera and conjunctiva. Unlike trabeculectomy, a conjunctival bleb is not created since a watertight suture at the site of surgery is mandatory. however, like trabeculectomy it does increase the size and concentration of epithelial microcysts; probably because the sclera is thinned at the surgical site. in a study involving a series of 30 patients who underwent canaloplasty, there was a four-fold increase from baseline in the number of conjunctival microcysts in the 27 eyes in which the procedure was successful, but the microcyst concentration did not increase significantly in the eyes in which the procedure was unsuccessful (Mastropasqua et al. Br J Ophthalmol 2012; 96:634-639).

New techniques Other techniques now in the pre-clinical phase of investigation include the creation of intrascleral canals injected with non-animal stabilised hyaluronic acid (NAshA). A study involving porcine eyes showed that the scleral canals had a significantly higher rate of aqueous outflow than control eyes (Mavrakanas et al. Invest Ophthalmol Vis Sci. 2009; 50: 3759-3762).

Techniques that create intrascleral canals with femtosecond lasers may be even more promising. A three-dimensional finite element model indicated that creating partial thickness intrascleral channels may reduce iOP from 67.2 per cent to 80.6 per cent (Chai et al. Lasers Surg Med. 2008;40:188-195).

in addition, an in vivo study showed that rabbit eyes that had undergone scleral channel creation with a femtosecond laser had significantly lower iOP than the contralateral control eyes. The iOP reduction appeared to result from an increase in aqueous humour outflow through the sclera (Chai et al. Lasers Surg Med. 2010; 42(7):647- 651). The investigators used a titanium/sapphire laser system tuned to the wavelength of 1.7 microns with an optical parametric amplifier. They scanned the femtosecond laser beam along a rectangular raster pattern to create partial thickness subsurface drainage channels in the sclera.

Prof Mastropasqua concluded, “scleral thinning with a femtosecond laser represents a valuable field of research in glaucoma surgery and may enhance trans-scleral outflow while avoiding sub-conjunctival aqueous humour percolation and bleb formation.”

TRAnS-SCLERAL OUTFLOW Current glaucoma treatments do not fully exploit the trans-scleral outflow pathwayby Roibeard O’hEineachain in Milan

Leonardo Mastropasqua – [email protected]

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Update

GLAUCOMA

Figure 2: Slit-lamp image showing a cystic/diffuse functioning filtering bleb (A). In vivo confocal microscopy the conjunctiva shows numerous and wide fluid-filled hyporeflective microcysts, indicating the aqueous humour passage through the bleb-wall (B)

Figure 1: Planar reconstruction of the superior bulbar conjunctiva in an eye with ocular hypertension. Microcysts appear

as optically clear spaces within the conjunctival epithelium of the bulbar conjunctiva, indicating the trans-scleral

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EUROTIMES | Volume 18 | Issue 2

European trials of the CyPass Micro-stent indicate that the device is a safe and effective treatment for open-angle glaucoma in newly-

diagnosed, medication-näive patients, according to a study presented at the XXX Congress of the EsCRs.

“Our own clinical experience and the results from the early trials show that the CyPass (Transcend Medical) has an excellent safety profile and works extremely well at reducing both iOP and the number of medications necessary to control iOP. The implant enhances the aqueous outflow through the supraciliary space and avoids many of the complications associated with conventional surgical glaucoma procedures such as trabeculectomy or shunts for the treatment of OAG,” Marco Nardi MD told delegates.

Dr Nardi, University of Pisa, italy, described the CyPass as a biocompatible, non-biodegradable polyimide micro-implantable device about 6.35mm in length and with an outer diameter of 500 microns. The device has a small lumen of 300 microns that is designed to improve uveoscleral outflow by providing access and drainage of the aqueous from the anterior chamber to the suprachoroidal space. The implant is inserted with a special inserter that enables it to be easily placed into the suprachoroidal space.

“This is minimally invasive surgery because the technique uses a scleral tunnel through a 1.5mm clear corneal incision and leaves the conjunctiva, sclera and trabecular meshwork intact. it delivers controlled cyclodialysis after being implanted in the supraciliary space with direct outflow from the anterior chamber to the suprachoroidal space,” he said.

implanting the device is very straightforward and entails no learning curve for less experienced glaucoma surgeons, said Dr Nardi.

Dr Nardi presented six-month follow-up data from a prospective, interventional series of 22 eyes of recently diagnosed, medication-näive patients with open-angle glaucoma. Ten of the eyes underwent a combination of CyPass implantation and phacoemulsification for cataract removal,

while the remaining 10 eyes received CyPass without phaco.

The average patient age was 72 years with a mean baseline iOP of 26.5 mmhg, with 22.7 per cent of patients recording a baseline iOP greater than 30 mmhg. No serious intraoperative or postoperative adverse events such as retinal detachment, choroidal detachment or persistent hypotony were reported.

The results in terms of iOP reduction were very impressive, said Dr Nardi, with the mean iOP decreasing by about 42 per cent at three months and 39 per cent at six months postoperatively. Only about

30 per cent of patients required a single topical glaucoma medication to fully control their iOP. The remaining patients were medication free with well-controlled iOP at the six-month follow-up point.

Dr Nardi highlighted a case presentation of one patient with recently diagnosed open-angle glaucoma who had the CyPass implanted without phacoemulsification.

“This patient started with a baseline iOP of 30 mmhg, which reduced to 10 mmhg at one and three months, 13 mmhg at six months and 16 mmhg after one year. And this impressive result was achieved without any glaucoma medicine,” he said.

Dr Nardi added that the device can easily be combined with phacoemulsification. As a primary treatment its safety profile is consistent with a minimally invasive intervention, and the majority of patients remain medication free six months after implantation of the device. it should be considered as a primary treatment when performing phacoemulsification for cataract, or when the physician anticipates patient compliance difficulties or issues with lack of access to glaucoma medication for the patient, he concluded.

Marco Nardi – [email protected]

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OPEn-AnGLE GLAUCOMAnew micro-stent safe and effective at lowering IOP in initial trialsby Dermot McGrath in Milan

22

Our own clinical experience and the results from the early trials show that the CyPass (Transcend Medical) has an excellent safety profile and works extremely well at reducing both IOP and the number of medications necessary to control IOP

Marco Nardi MD

Update

GLAUCOMA

1. Positioning the CyPass with the special inserter is easy. Once the device is in place the inserter is retracted. 2. When the CyPass is positioned it allows free flow from anterior chamber to suprachoroideal space

1. 2.

Gonioscopic appearance of a well-positioned CyPass

Don’t Miss Outlook on Industry, see page 40

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EUROTIMES | Volume 18 | Issue 2

Telemedicine may offer a viable means of relieving some of the pressure on overburdened national health systems by screening

patients for degenerative retinal diseases such as diabetic retinopathy and age-related macular degeneration (AMD), according to a study presented at the 2012 EURETiNA innovation Awards.

“As populations in western countries continue to live longer, the incidence of retinal degenerative diseases that can result in blindness is expected to increase in the coming years,” said Mario R Romano MD, PhD.

“Current screening methods are not adequate for this growing demand, but telemedicine in ophthalmology (TMO) might provide part of the solution,” he added.

Dr Romano, instituto Clinico humanitas iRCss, Milan, italy, proposes an advanced telemedicine project that seeks to overcome some of the shortcomings of current screening methods.

“At present screening for degenerative retinal diseases is mainly provided by dedicated referral centres where patient access is limited. The main problem is providing on-time access to guarantee prevention of disease and also adequate diagnosis to guarantee prompt care for the patient,” he said.

Dr Romano added that screening efforts are currently hampered by the lack of connection between the remote units and the diagnostic units, as well as the dearth of structured databases.

“structured databases, which are the foundation of evidence-based medicine, are needed in order to make patient healthcare easier,” he said.

Discussing the TMO solution in more detail, Dr Romano explained that it essentially involves the integration of technical and medical information.

“The aim is to provide a technological platform for sharing patients’ data in order to improve diagnosis, collect epidemiological data and optimise access to resources. The 'core' of TMO includes five elements: remote diagnosis, telecare, e-learning, video tele-screening, and finally cross doctor-hospital-physician interaction,” he said.

At the heart of the approach is an “expert system connection”, a semi-automatic detection system that combines a vertical and

horizontal intranet, said Dr Romano.“The vertical intranet is between patient

and doctor, while the horizontal net is between medical staff and data managers. Combining them makes sense for faster and more efficient information sharing,” he said.

For the vertical net component, peripheral data in the form of decentralised ophthalmological data and retinal image profiles are collected in remote units. The data is then sent to an automatic recognition system that is able to distinguish normal or pathological patterns based on its algorithm. The filtered information is then sent to specialised reading centres for recognition of the disease and periodic screening.

While the proposed system is still in the development phase, Dr Romano believes that it has the potential to deliver a positive impact on the screening and diagnosis of retinal diseases.

“With such an approach we could reduce diagnosis time, prevent diseases, foster continuous medical education via e-learning, share real-time information and reduce the costs of healthcare. We could also make a major contribution to data collection and evidence-based medicine,” he said.

The horizontal net guarantees connection between the Reading Centers in order to help data-manager collecting clinical data, share real-time information (bad, waiting lists), he added.

Potential users of the service would include hospitals and clinics that need to improve their screening services, as well as data managers in academic settings who need to access large amounts of data for publications, said Dr Romano.

Ophthalmologists who prefer to work in team structures might also be interested in such an approach, he added.

TMO SCREEnInGTelemedicine could help in screening for degenerative retinal diseasesby Dermot McGrath in Milan

Mario R Romano – [email protected]

contact

26–29 September 2013

am ur13th EURETINACongress

Abstract submission deadline: 1 March 2013

www.euretina.org

Marco Nardi – [email protected]

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EUROTIMES | Volume 18 | Issue 2

All six blind retinitis pigmentosa (RP) patients implanted with the Argus ii retinal prosthesis (second sight, Los Angeles, California,

Us), including the first patient to receive the commercial version of the device regained some functional vision and half gained three or more lines of visual acuity, stanislao Rizzo MD, Pisa, italy, told the 12th EURETiNA Congress.

The best vision achieved was 20/1260, or logMAR 1.8, with two patients who previously had no light perception able to read 15cm letters 10 months after surgery.

All patients report using the device in their daily lives, improving performance on visual tasks including orientation and mobility, and that it has a positive impact on their well-being, Dr Rizzo said.

“One young lady who was blind, the first time we turned on the implant, she could follow the light of the floor of the corridor.” These visual acuity and functional results are broadly comparable to other long-term studies of the Argus ii device (Humayun MS et al. Ophthalmol. 2012 Apr; 119(4): 779-88).

No major complications have occurred with the devices, which were implanted between October 2011and May 2012, Dr Rizzo said.

“Our results show this type of implant can reliably withstand long-term implantation with an acceptable safety profile.”

Epi-retinal approach The visual prosthesis is the “holy Grail” of ophthalmology because it can stimulate the visual pathway in many sites, Dr Rizzo said. Possible approaches include cortical prosthesis, optic nerve prosthesis, subretinal prosthesis and epi-retinal prosthesis, such as the Argus ii. The epi-retinal approach takes advantage of remaining function in the inner retina when outer layers have been damaged by RP.

The Argus ii consists of an array of 60 200-micron-diameter electrodes held in contact with the macula with a surgical tack (Figure 1). They provide electrical stimulation that crosses the outer retina, where most photoreceptor cells have been destroyed in severe RP, to inner retina cells, of which about 80 per cent typically remain, and the ganglion cells, of which about 30 per cent survive. Patients are screened before surgery to ensure they still have adequate

residual inner retinal and ganglion cells to respond to electrical stimulation. Electrical signals from the electrodes are interpreted by the brain as light. With intensive rehabilitation, patients learn to interpret them as movement, space and shapes.

The electrode array is attached by a cable threaded through a scleral incision to a coil that wirelessly transmits both power and data to the retinal array (Figure 2). The coil is fixed to the outside of the globe by a scleral band as in a scleral buckle (Figure 3). Power is transmitted by magnetic induction from a coil attached to a pair of spectacles, which also incorporate a camera. images from the camera are processed by a video processing unit worn on the belt (Figure 4). The arrangement allows for software and processor updates without additional surgery.

Dr Rizzo said that surgical time fell from three hours 40 minutes for the first surgery to about two hours 30 minutes for the most recent procedures. he noted that the electrode array and data cable are very fragile, and recommended protecting them with a finger of a surgical glove tied over them during the coil buckling phase of surgery (Figure 5). he also recommended a pair of silicon tipped forceps for handling the cable during insertion through a 4.5mm incision in the sclera (Figure 6). held by a corner to avoid damaging the circuits, the array must be positioned precisely over the macula with one hand and tacked in place with the other to ensure it remains stable (Figure 7). The incision should be covered to prevent leakage and exposure of the cable by pericardium (Figure 8).

Promising results Early postoperative complications occurred in two of the first

six patients. One was a spike in intraocular pressure to 40 mmhg, successfully treated with medications. The other was a shallow choroidal detachment that resolved spontaneously in one week.

Follow-up is intense, Dr Rizzo noted. in the first week after surgery, patients spend four hours a day in rehab. First one electrode is stimulated, then four, working up to all 60 after one month.

Tests used to measure results include light detection, a square localizer in which patients are asked to point to high-contrast lighted squares of variable sizes on a screen, direction of motion, orientation of a visual grating and Landolt C for visual acuity. With the system on, patients with residual light perception were able to accurately locate boxes of about 100 pixels compared with 300 or more with the system off. half gained three or more lines of visual acuity with the system on compared with none with the system off and none in the non-implanted eye. These results

also mirror those seen in longer-term trials (Dorn JD et al. Arch Ophthalmol. 2012 Oct 8:1-7. Ahuja AK et al. Br J Ophthalmol. 2011 Apr;95(4):539-43.)

Field of vision is narrow, about 15 degrees, Dr Rizzo reported. still, the visual acuity and functional results observed give hope for improving the lives of an estimated 1.2 million patients suffering from RP worldwide.

There are many therapeutic strategies for RP, now under investigation, Dr Rizzo said. These include intravitreal growth factor injections, gene therapy, vitamin A supplementation, neuroretinal and retinal pigment epithelium transplantation, ozonotherapy, electrostimulation and vitamin therapy.

“But all these therapies are ineffective,” said Dr Rizzo, noting that the Argus ii device is among the first proven clearly effective in restoring some visual function to blind RP patients.

Stanislao Rizzo – [email protected]

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ARTIFICIAL RETInACommercial Argus II implant restores some vision in blind retinitis pigmentosa patientsby Howard Larkin in Milan

24 Update

RETINA

Our results show this type of implant can reliably withstand long-term implantation with an acceptable safety profile

Stanislao Rizzo MD

Figure 1: The Argus II array on the macula

Figure 3: Scleral band

Figure 5: Surgical glove finger protecting the array

Figure 7: Tackling the array

Figure 2: The Argus II system

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Figure 4: Glasses with camera connected to the video processing unit

Figure 6: Insertion through a 4.5mm incision in the sclera

Figure 8: Pericardium to cover the cable and the sclera incision

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EUROTIMES | Volume 18 | Issue 2

While anti-VEGF therapy has undoubtedly revolutionised the treatment of age-related macular degeneration

(AMD), we are still in the early stages of understanding and treating this and related diseases, said participants in the Amsterdam Retina Debate at the 12th EURETINA Congress

“It is a fact that when thermal laser photocoagulation was the only treatment available for wet AMD and even in the era of photodynamic therapy, our patients were going blind,” said Enrico Peiretti MD, assistant professor of ophthalmology, University of Cagliari, Italy.

“Now, with anti-VEGF therapy, we have an intervention that allows many patients to maintain their vision and quality of life for many years. Nevertheless, research has not stopped after obtaining good results with anti-VEGF therapy, and it is continuing on a track to find even better approaches that will allow us to help as many patients as we can.”

Tim Jackson MD, consultant vitreoretinal surgeon and senior lecturer, King’s College London, England, UK, also expressed hope for future advances in preventing AMD-related vision loss based on the abundance of ongoing research in the field.

“There is no question that anti-VEGF therapy was a quantum leap in the management of AMD, but while we’ve come a long way, we are not at the end of the road. That is not a pessimist’s

view, however, because I believe we are in an accelerated stage of discovery and development that puts us at the dawn of a very exciting time,” said Dr Jackson.

The many shortcomings of anti-VEGF therapy and the lack of any effective treatments for dry AMD speak to the gaps that exist in therapeutic solutions for AMD. Dr Jackson noted that anti-VEGF therapy fails to satisfy many of the criteria of an ideal treatment. While anti-VEGF intravitreal injections may be considered low-risk and are well-tolerated by some patients, the procedure is much less acceptable to others. Furthermore, the efficacy of anti-VEGF intravitreal injections is shorter in duration than desired and is incomplete. Not all patients benefit, and among those who do, efficacy is not always maintained, perhaps because of tachyphylaxis or due to poor compliance with the need for maintenance injections.

Dr Jackson noted that treatment cost is another significant drawback of anti-VEGF therapy, and he cited UK costs showing that the resources being spent on a patient with AMD are approximately equivalent to having hip replacement surgery every six months. In addition, the treatment burden is high. Projecting that the average patient would continue treatment for 13 years and considering the growing numbers of patients who will become candidates, indicates that intravitreal anti-VEGF injections for wet AMD may not be a sustainable modality in its current form, said Dr Jackson.

Looking ahead Despite the existing problems with therapy for AMD, consideration of the magnitude and breadth of ongoing research provides reason for optimism.

“There is no question that AMD is one of the most dynamic and exciting fields in ophthalmology,” said Dr Jackson.

A PubMed literature search shows the number of AMD-related published papers continues to increase. In addition, there are a multitude of therapeutic modalities in the development pipeline, and numerous clinical trials are under way. In preparing his talk, Dr Jackson identified 712 AMD studies on www.clinicaltrials.gov, of which about one-third were actively recruiting patients. These trials, which represent only those registered, are being conducted in multiple countries and encompass a vast array of new approaches to the treatment of wet and dry AMD.

They are evaluating various experimental compounds as monotherapy as well as combinations that may have additive or synergistic activity. The investigational agents represent a variety of novel mechanisms of action and different routes of delivery, including oral and topical. Additionally, there are studies focusing on strategies for optimising dosing regimens for anti-VEGF therapy.

The AMD-related research also incorporates studies of retinal prostheses and implantable telescopes, novel approaches to radiation therapy, cell replacement techniques, biologic therapies and gene therapy. Other novel modalities being explored for use in the management of AMD include pharmacologic therapy to relieve vitreomacular adhesion, transcorneal-delivered electrical stimulation to increase or restore retinal cell viability, and a “restorative” laser for increasing diffusion through Bruch’s membrane.

Research in the field also includes studies focusing on the role of nutrition in AMD development and progression and to further elucidate AMD pathogenesis and risk factors, including genetic predisposition.

“The long list of new drugs being investigated for the management of AMD should convince clinicians of the overwhelming weight of research that is taking place,” said Dr Jackson.

Dr Peiretti stated that because AMD pathogenesis is multifactorial, he believes effective prevention and long-term control might depend on a cocktail approach. Application of current and future understanding of the risk factors, including genetics, will be important for proper patient evaluation, early disease detection, and guiding the best intervention, he said.

Enrico Peiretti – [email protected] Jackson – [email protected]

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TAKING STOCKAdvances applauded, but more answers awaitedby Cheryl Guttman Krader in Milan

25Update

RETINA

YAG Laser Capsulotomy

... you are just one step away:http://yag-laser.arclaser.de

Laser and Slit Lamp Perfection is all that counts.

There is no question that AMD is one of the most dynamic and exciting fields in ophthalmology

“Tim Jackson MD

Now, with anti-VEGF therapy, we have an intervention that allows many patients to maintain their vision and quality of life for many years

Enrico Peiretti MD

Page 28: Vol 18 - issue 2

Update

RETINA

EUROTIMES | Volume 18 | Issue 2

A clinical trial of gene therapy for choroideraemia now under way in the UK provides an opportunity for ophthalmologists to contribute to what could be a revolution in treating genetic retinal

conditions, Robert E MacLaren, DPhil, FRCS, FRCOphth, of Oxford University, Oxford Eye Hospital and Moorfields Eye Hospital, London, UK, told the 12th EURETINA Congress.

Viral-vector gene therapy holds the promise of curing life-long genetic retinal disorders with a single injection of replacement genetic material, Prof MacLaren said. The treatment he developed with Prof Miguel Seabra, Imperial College, London, is the first for choroideraemia, an x chromosome-linked degenerative retinal disease leading to progressive vision loss throughout life.

But many challenges remain, Prof MacLaren noted. These include identifying quantifiable treatment endpoints, and developing safe and effective surgical techniques for injecting viral vectors into delicate retinal structures.

Gene therapy “has reached a stage where, as vitreoretinal surgeons, we need to look at how to use it effectively and improve the techniques of gene delivery,” Prof MacLaren said.

In addition to testing the safety and efficacy of viral-vector approach, the multicentre trial is also designed to involve many ophthalmologists in the technology and objectively assessing outcomes and delivery techniques.

Ideal candidate Prof Frans Cremers originally established that choroideraemia results from a genetic defect in which the Rab escort protein 1 is missing and Prof Seabra identified Rep1 as a chaperone for Rab27, which prenylates proteins involved in the movement of melanosomes within cells. This prenylation is essential to retinal pigment epithelium health and homeostasis. Without Rep1, the retinal pigment layer and other retinal tissues undergo a progressive degeneration, Prof MacLaren said.

While choroideraemia is relatively rare, afflicting about one in 50,000 in northern Europe with the highest incidence in Finland, it is a promising disease entity for gene therapy for several reasons, Prof MacLaren noted.

For one, the choroideraemia phenotype is specific and instantly recognisable, whereas the appearance of the retina in other types of retinitis pigmentosis is similar regardless of the gene involved. This makes possible early identification of choroideraemia patients. Also, the gene involved, CHM, is 1.9 kilobases long, making it an ideal size for delivery by adeno-associated viral vectors, which have been shown safe and effective for retinal applications, Prof MacLaren said.

In addition, the condition typically progresses slowly, from early night vision loss to progressive peripheral vision loss with central vision often maintained until middle age or later, Prof MacLaren added.

Gradual and symmetrical degeneration in both eyes makes it possible to establish a measurable structural endpoint, Prof MacLaren said. Using auto fluorescence, the surviving area of the retina can be seen to shrink by about 10 per cent annually in late disease. Beyond demonstrating safety, the current trial seeks to document a slowing of shrinkage in treated eyes over two years.

Functional retina over the area of the surviving retina also has been plotted using microperimetry, which may provide a measurable functional outcome, Prof MacLaren said. Choroideraemia patients with a normal functional distribution typically have sensitivity which is below age group norms.

“One might expect that following gene transfer, we may see some functional retina pushed back to normal sensitivity.”

Biochemical evidence suggests that Rep1 functions primarily in the retinal pigment epithelium, rather than the choroid. Retinal appearance also suggests that most degeneration begins in the RPE with choroid loss secondary,

Prof MacLaren said. Also, the gene affects the RPE, but not the choroid, in female carriers.

The RPE is the easiest layer to target with adeno-associated vectors, Prof MacLaren said. The treatment uses adeno-associated virus type 2 with the wild genome replaced with the Rep1 coding sequence and regulatory sequences to maximise efficiency of the viral vector. These include a CBA promoter, which switches genes on and off in cells, and a woodchuck hepatitis post-translational regulator, which works with messenger RNA to enhance expression by directing RNA out of the cell. “This is a new development to use an additional viral sequence from another virus to augment expression,” Prof MacLaren said. For safety reasons, regulatory bodies required that no protein other than Rep1 is translated by the woodchuck sequence.

The viral vector is delivered to the subretinal space, where it infects photoreceptors and the RPE. The trial involves a low dose of 1x1010 in the first six patients and a large dose of 1x1011 in six more, all given in a 0.1ml suspension.

Reaching the subretinal space requires detaching the retina, which is accomplished in a separate step by injecting balanced salt solution in as many operations as necessary before injecting the gene therapy. Prof MacLaren was initially concerned about patients’ ability to recover from the detached retina, but it has not been an issue so far. One patient with 20/60 vision and retinal oedema one day after injection recovered to 20/20 at five weeks, he said.

“Because we detach the fovea in patients with relatively good vision, we need to be sure there is no toxic effect of the viral vector.”

The operation involves a 23-gauge vitrectomy, and the therapy is delivered via a 23-gauge cannula with a 41-gauge Teflon tip. The internal limiting membrane must be visualised, using dye if necessary, and avoided. It is very difficult to insert the cannula through the ILM. The fovea also must be avoided to prevent macular holes, Prof MacLaren said.

The first patient in the trial was recruited in October, 2011. “We will report results in due course,” Prof MacLaren said.

Robert MacLaren – [email protected]

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RETINAL GENE THERAPYChoroideraemia trial shows promise and challenges of viral gene replacement approachby Howard Larkin in Milan

26

Figure 1: European collaboration. Prof Robert MacLaren (UK) performs the first choroideraemia gene therapy surgery in Oxford with Dr Martin Zinkernagel (Switzerland).

The surgery was developed as a two-step procedure to detach the fovea gently before injecting vector suspension into the subretinal space

Figure 2: The retina in choroideraemia: colour and corresponding autofluorescence images from a patient with advanced choroideraemia

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Page 29: Vol 18 - issue 2

EUROTIMES | Volume 18 | Issue 2

The proper grading of the vitreoretinal attachments is a very important part of the preoperative evaluation of proliferative diabetic

retinopathy, said Borja Corcostegui MD in a discussion of trends in the surgical treatment of diabetic retinopathy presented at the 12th EURETINA Congress.

It is particularly important because there is a correlation between the vitreal retinal attachments and the surgical outcome, explained Dr Corcostegui of the Institut Microcirurgia Ocular, Barcelona, Spain.

Dr Corcostegui outlined the grading scale for vitreoretinal attachments in eyes undergoing vitrectomy for proliferative diabetic retinopathy. This is a scale from Type 0 to 6. Type 0 refers to a complete PVD. Type 1 has focal vitreoretinal attachment(s). Type 2 has broad vitreoretinal attachments. Type 3 has vitreous attachment at the entire posterior pole, including the optic disc, vascular arcades and macula. Type 4 has attachments at the disc and arcades extending to the periphery, but with no vitreoretinal adhesions at the macula. Type 5 refers to complete vitreoretinal attachment. The fewer adhesions exist, the better the surgical outcome on average, and the wider the surgical indication.

So, for Type 0, surgery would be indicated for a non-clearing vitreous haemorrhage. Complications are unlikely in Types 0 and 1. In Type 2, surgical complications occur in approximately five per cent of cases,

increasing to seven per cent in Type 3 and up to 12 per cent in Type 4. The increased rate of complications is related to the need for extended dissections. Clinical indication for surgery in Type 4 might be, for example, a premacular subhyaloid haemorrhage. Type 5, which is frequently associated with retinal detachment due to proliferation and contraction, is associated with up to a 20 per cent surgical complication rate.

In order to decrease the chances of complications, Dr Corcostegui recommends preoperative preparation of the posterior segment. This includes anti-VEGF treatment and the completion of panretinal photocoagulation as much as possible.

“We inject Avastin or Lucentis four to seven days preoperatively to decrease proliferative neovascularisation, shrink collagen tissue and decrease the calibre of retinal vessels. However, anti-VEGF, while effective for reducing perioperative bleeding, has low efficacy on vitreoretinal adhesions. Fortunately, the newer instrumentation makes the surgery safer and easier,” said Dr Corcostegui.

At the same session Dr Albert J Augustin, professor and chairman of the Department of Ophthalmology, Klinikum Karlsruhe, Karlsruhe, Germany, presented an indepth review of the literature regarding the surgical management of the complications of proliferative diabetic retinopathy.

He began by listing the major complications of proliferative diabetic

retinopathy. These include rubeosis and neovascular glaucoma; tractional retinal detachment; non-clearing vitreous haemorrhage; and macular disorders.

“Surgical management of proliferative diabetic retinopathy has improved substantially, and anti-VEGF drugs and steroids are helpful adjuncts,” said Dr Augustin.

A 2011 study of the effect of intracameral Avastin for iris rubeosis and neovascular glaucoma in proliferative diabetic retinopathy showed a decrease in IOP and stable or improved visual acuity at six months.

Dr Augustin then reviewed a 2011 long-term study (mean follow-up: 23 months) of vitrectomy without endotamponade for tractional retinal detachment. The retina remained anatomically attached in 94 per cent of all eyes. This suggests that endotamponade is not necessary if there are no pre- or intraoperative retinal breaks.

The DRIVE UK Study, published in 2012, studied visual and anatomical outcomes following vitrectomy for proliferative diabetic retinopathy. This study showed a much greater improvement in visual acuity when the surgical indication was non-clearing vitreal haemorrhage alone rather than in combination with tractional retinal detachment, which seems reasonable considering the large difference in severity of the pathology.

One study compared the outcomes of treatment for tractional retinal detachment using microincision vitrectomy and bevacizumab (2005-2007) with outcomes of conventional 20G vitrectomy without anti-VEGF therapy (2003-2005). Although the ultimate anatomic success was 100 per cent in both study arms, improvement in visual acuity at six months post-op was better in the microincision vitrectomy + bevacizumab group than in those treated with 20G.

“Was this due to the effect of the small-gauge surgery, or the anti-VEGF effect, or

both? Or maybe due to an improvement in surgical technique and performance?” asked Dr Augustin. “That’s a difficult question to answer and it highlights the problems with retrospective studies.”

Later studies have shown that 23G vitrectomy is as effective as 20G, and that preoperative intravitreal bevacizumab simplifies the surgical procedure in dense diabetic vitreal haemorrhage. Further, early vitrectomy and endolaser for severe vitreal haemorrhage in proliferative diabetic retinopathy is recommended. A 2011 study demonstrated improvement in visual acuity and a stabilisation of proliferative diabetic retinopathy at short- and long-term follow-up.

“This same conclusion was drawn from the Diabetic Retinopathy Vitrectomy Study in 1990,” Dr Augustin reminded his listeners.

This was a randomised study that included nearly 1000 patients and followed them up for four years after vitrectomy for severe vitreous haemorrhage.

When asked by a delegate what his own clinical impression was regarding the two, Dr Augustin responded, “My impression is that 23G is better. Although 23G used to be for selected patients only, it can now be used for essentially all cases, including complex cases. Our surgical performance is so much better than it was 10 years ago.”

Borja Corcostegui – [email protected] J Augustin – [email protected]

cont

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RETINOPATHYTrends in the surgical treatment of diabetic retinopathy discussed at congressby Leigh Spielberg in Milan

27Update

RETINA

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RETINA

EUROTIMES | Volume 18 | Issue 2

Given that most vitrectomy patients develop cataracts, doing phaco at the same surgery seems to make sense. But it

can be risky. Employing the bag-in-lens designed by Marie-Jose Tassignon MD may eliminate many common complications, making the combined procedure an effective and safe option, Claus Eckardt MD, Frankfurt, Germany, told the 12th EURETINA Congress.

The main advantages of combined phaco-vitrectomy are eliminating a second surgery, better access to the peripheral retina during phaco, and possibly better outcomes, Prof Eckardt said. But intracapsular IOL implantation in complex pathologies, involving issues such as posterior retinal detachments, uveitis, weak zonules and diabetes, can increase postoperative inflammation and result in posterior synechiae.

Decentration and early secondary cataracts are also common in vitrectomy patients, Prof Eckardt added. These often result from pressure from gas or air tamponade, which can lead to dislocation of the anterior capsule behind conventional IOLs soon after surgery.

The bag-in-lens design addresses these issues by capturing the edges of anterior and posterior capsulorhexes in a 360-degree groove, much like a bicycle rim holds a tire, Prof Eckardt said. This makes the lens much

more resistant to pressure from bubbles, seals in lens epithelial cells and holds the lens well away from the iris.

“The Tassignon-designed IOL guarantees excellent centration and never leads to synechiae. I routinely use it in all presbyopic [vitrectomy] patients,” Prof Eckardt said.

Intraoperative issues Of course, pathologies associated with vitrectomy in general can significantly complicate an added phaco procedure. And there is a learning curve to master implantation of the Tassignon lens. Nonetheless, Prof Eckardt believes the issues can be addressed, and the effort is worth it.

“I have used this lens in combined phaco-vitrectomy now for three and a half years, and have done more than 900 cases,” said Prof Eckardt, who presented slides of more than a dozen cases months and years after surgery. Invariably, the lens was centred, the pupil well-dilated and the eye clear, even in cases that had undergone multiple vitrectomy procedures before the lens implant.

“They all look the same. In fact, they sometimes look better than my standard cataract surgery cases,” Prof Eckardt said. And though he has no study to conclusively prove it, he believes his visual outcomes are better in combined surgery patients than in vitrectomy patients undergoing a subsequent separate lens extraction.

Prof Eckardt offered advice on addressing various intraoperative issues seen in combined procedures.

Intravitreal haemorrhage can block the red reflex, making visualisation difficult in phaco. An endoscopic light source placed in the anterior chamber provides excellent illumination, though it may require switching to a one-hand hold on the phaco probe while the other holds the light, Prof Eckardt said.

“When you have removed the nucleus and you do not see the red reflex, you may think everything is removed. But when you put in the light you can see leftover cortical material and remove it. It is a big help,” Prof Eckardt said.

Pressure from behind may cause problems during phaco, but this is not unique to combined procedures, Prof Eckardt pointed out. Using local or topical anaesthesia rather than peribulbar injections helps minimise the problem.

Conversely, a vitrectomised eye may offer no counter pressure, and lens implantation may be difficult. Small pupils may benefit from a bimanual technique or iris hooks, while capsular tension rings should be used to stabilise capsules in patients with pseudoexfoliation syndrome, Prof Eckardt added.

As for the Tassignon lens, several issues must be dealt with. First, the lens requires both anterior and posterior capsulorhexes. Before the posterior rhexis is torn, the anterior hyaloid membrane must be detached to prevent vitreous from entering the anterior chamber. Prof Eckardt recommends injecting viscoelastic behind the posterior chamber, watching to make sure the separation is complete.

The two rhexes also must be concentric, round and about 5.0mm to 5.5mm in

diameter. Prof Eckardt recommends using the anterior rhexis as a guide to placing and sizing the posterior.

Inserting the lens, which requires that the edges of the rhexes be captured 360 degrees by the groove in the lens edge, also takes a little longer, but is not difficult once the technique is mastered, Prof Eckardt said. “If you want a new tire on you bike, this is the same manoeuvre; back and forth, and back and forth, and all of a sudden you have succeeded.”

After implanting 50 lenses, Dr Eckardt said he no longer had to think about the implantation technique. The entire procedure takes about 30 seconds longer than implanting a standard IOL, he said.

While the Tassignon lens eliminates more serious postoperative complications such as posterior synechiae, its 360-degree groove is susceptible to iris incarceration, where the iris slides into the groove. This generally occurs in the early postoperative period, and is brought on by pressure from a tamponade pushing the lens forward, Prof Eckardt said.

The problem can be corrected in about a minute by pushing the lens back behind the iris. But this does require a return to the operating room. The risk can be minimised by avoiding dilating the pupil in the early postoperative period, Prof Eckardt said. Dilation should not be performed until the bubble retreats to about 30 to 40 per cent of its original size.

So are the advantages worth the risks and extra effort? Prof Eckardt believes they are. “I can say combined phaco-vitrectomy is an effective, and in my hands, a safe technique.” He encouraged surgeons to tackle the learning curve to give patients the benefit of reduced complications.

Claus Eckardt – [email protected]

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jOINT SuRGERYBag-in-lens reduces complication risk, making combined surgery more attractiveby Howard Larkin in Milan

28

Figure 2: Perfect centration of the Tassignon lens and absence of any posterior iris synechia, status after four vitreoretinal surgeries including tamponade with Densiron, standard silicone oil and gas

Figure 1: Tassignon lens three months after combined phaco vitrectomy with gas tamponade for macular hole

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EUROTIMES | Volume 18 | Issue 2

Researchers are hopeful that findings from metabolic profiling studies will lead to better understanding of the

pathophysiology of diabetic retinopathy and thus the development of new and personalised treatment regimens.

Speaking at the 12th EURETINA Congress, Milam A Brantley Jr MD, PhD, described the rationale for metabolic profiling, results from proof of concept studies showing that patients with diabetic retinopathy could be discriminated from normal controls based on differences in vitreous and serum metabolic profiles, and the follow-up research programme that is currently under way.

“All ophthalmologists have seen diabetic patients who do not develop diabetic retinopathy despite having a long history of disease and suboptimal blood glucose control as well as those at the other end of the spectrum who present with signs of retinopathy at the time of diabetes diagnosis or with eye disease that is rapidly progressive despite seemingly good glucose control. It is likely that genetics plays some role in these different clinical scenarios, and several genetic polymorphisms have been linked with diabetic retinopathy. However, the identified associations have not been that robust. Therefore, it appears there is more to the story, and environmental factors affecting metabolic pathways are likely the missing piece,” said Dr Brantley, assistant professor of ophthalmology and visual sciences, Vanderbilt University Medical Centre, Nashville, TN.

“We are taking a systems approach using metabolomic analysis to investigate environmental factors impacting diabetic retinopathy. Then we aim to combine information on metabolic and genetic variations to determine profiles associated with disease development and treatment response. We hope this will help us identify patients at risk for diabetic retinopathy and interventions that may be most effective for an individual based on that person’s unique genotype and metabolomic profile.”

The metabolome, which represents a snapshot of an individual’s physiological state, is comprised of 3,000-10,000 unique metabolites. The metabolomic analyses of collected serum and vitreous specimens and bioinformatics are being done in

collaboration with Dean Jones PhD, and Youngja Park PhD at Emory University, Atlanta, GA.

The proof of concept studies discussed by Dr Brantley compared the metabolomic profiles of archived samples collected at the time of vitreoretinal surgery from patients with proliferative diabetic retinopathy to those from non-diabetic controls. For the serum samples, the metabolites that differed significantly between the two groups matched most commonly with pathways of steroid biosynthesis, primary bile acid biosynthesis, arginine and proline metabolism, and arachidonic acid metabolism. Pathway analysis for the vitreous samples also identified significant differences in arginine and proline metabolism separating the diabetic retinopathy patients and controls along with differences in pentose and glucuronate interconversions and ABC transporters.

“Now we are further examining the highly represented pathways, recognising that separating patients with diabetic retinopathy and controls may not be as simple as identifying a difference in a single metabolite,” Dr Brantley said.

Dr Brantley noted that the Metabolomics of Diabetic Retinopathy study under way at the Vanderbilt Eye Institute has entered over 300 patients since it was launched in July, 2011. In addition to comparing patients with diabetic retinopathy and normal controls, work has begun to compare the metabolomics profiles in serum and vitreous samples of diabetic patients with and without retinopathy.

SYSTEmS APPROACHResearchers hopeful metabolic profiling may provide useful clues for elucidating pathogenesisby Cheryl Guttman Krader in Milan

Milam Brantley – [email protected]

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We are taking a systems approach using metabolomic analysis to investigate environmental factors impacting diabetic retinopathy

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EUROTIMES | Volume 18 | Issue 2

Statistics confirming the importance of amblyopia as a cause of childhood and lifetime blindness should be an impetus for increasing efforts to address this issue, said Wagih Aclimandos FRCS, FRCOphth,

FEBO, speaking at the 2nd World Congress of Paediatric Ophthalmology and Strabismus,

“Amblyopia can be easily treated with very good results, but it remains a huge problem worldwide in terms of its prevalence and major socioeconomic impact. In fact, the figures worldwide on blindness due to bilateral amblyopia are almost an embarrassment to the human race,” said Dr Aclimandos, president, European Board of Ophthalmology, and consultant ophthalmic surgeon, King’s College Hospital, London, UK.

“The excellent work being done by some and the short-term initiatives are not enough. We need more funding and a structured, well-conceived plan to tackle this problem.”

Dr Aclimandos pointed out that there are 1.4 million blind children in the world, of which 75 per cent live in developing countries. The vast majority of the cases of childhood blindness (~1 million) are found in Asia and most of the rest (~300,000) involve children in Africa.

Even though children represent a small minority of the world’s blind population (~3 per cent), the burden of childhood blindness is much more significant when regarded in terms of “blind person years”. Considering that almost half of individuals who become blind as children survive and face a lifetime of blindness, childhood blindness is second to cataract as a cause of blind person years.

Putting the problem into perspective Recent studies investigating blindness prevalence and aetiology in different developing countries document amblyopia as a leading cause. Looking at the literature, Dr Aclimandos cited studies from four countries published between 2004 and 2011. Researchers investigating the prevalence and causes of low vision and blindness in Tehran Province, Iran, found that amblyopia due to uncorrected refractive error accounted for 23 per cent of the cases of visual impairment, and it was second only to cataract. A study investigating causes of childhood blindness and visual impairment in Botswana showed refractive error was the most common cause of bilateral visual impairment. In China, a survey of children from birth to six years found that amblyopia was the leading cause of all visual impairment, accounting for about one-third of the affected children. In a study of children living in camps for displaced persons in Khartoum State, Sudan, amblyopia accounted for 33 per cent of cases of blindness and was the second leading cause after corneal opacity.

However, the importance of amblyopia as a leading cause of childhood blindness is a fact that is not sufficiently appreciated. Indeed, some textbook chapters on causes of visual impairment in the paediatric population do not even mention amblyopia, Dr Aclimandos said.

He also pointed out that while amblyopia in more developed countries is generally thought of as a unilateral

problem, and the concept of bilateral amblyopia has been questioned over the years, if amblyopia is defined by poor vision due to lack of stimulation of the visual cortex, then bilateral amblyopia does exist.

“Bilateral amblyopia is very unusual among children living in more developed countries, but it is much more prevalent in third world countries where children are affected by bilateral deprivation, such as from undiagnosed bilateral cataracts, or have uncorrected bilateral high refractive error that is naturally occurring or the result of aphakia after cataract surgery,” Dr Aclimandos explained.

He noted, however, that unilateral amblyopia also has an important impact. These individuals suffer from worry about the loss of vision in the normal eye, and while there are some controversial data on this issue, according to the Rotterdam Study, amblyopia nearly doubles the lifetime risk of losing the use of the fellow eye. In addition, a population-based study in the UK identifying individuals with unilateral amblyopia reported a 23 per cent rate of loss of vision in the non-amblyopic eye over a two-year period.

Fear of losing the good eye leads the individuals with unilateral amblyopia to forego some normal life activities during childhood or as adults, such as participating in contact sports, and these lifestyle restrictions can have a significant effect on emotional well-being.

“These patients worry a lifetime about what might have been, what should have been done and what will not happen as a result of their blindness,” Dr Aclimandos said.

Dr Aclimandos emphasised there is an element of urgency because children with amblyopia who do not receive treatment during the critical period are condemned to blindness forever. The plan for action is multifaceted. It includes greater training of local eye care practitioners who can conduct appropriate vision screening and of personnel able to perform refractions and prescribe glasses. In addition, funding is necessary to pay for glasses to correct high refractive errors or aphakia after cataract surgery.

“However, the needs do not stop there because follow-through and infrastructure are also required to make sure children receive replacement glasses if theirs are broken, lost or the prescription changes,” Dr Aclimandos said.

Even then, there is more that can be done to help those who were unfortunate enough to slip through the cracks and wind up visually impaired. These individuals can be helped by registration programmes, referral to visual impairment educationalists, support groups and interventions to address cosmetic concerns.

“Interpersonal interactions are essential for normal childhood development and may be adversely affected, even within the family, for a child with cosmetic issues associated with visual impairment,” Dr Aclimandos explained.

CHILDHOOD BLINDNESSA major, but under-recognised problem in need of greater action by Cheryl Guttman Krader in Milan

30 Update

PAEDIATRIC OPHTHALMOLOGY

Wagih Aclimandos – [email protected]

contact

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World Society of Paediatric Ophthalmology & Strabismus /

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www.wspos.org

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EUROTIMES | Volume 18 | Issue 2

Danielle Ledoux, of Boston Children’s Hospital in the US, presented the latest data on outcomes of juvenile idiopathic

arthritis (JIA)-associated uveitis treatment with biological agents at a joint session of the 2nd WCPOS and 12th EURETINA Congress.

She reviewed data gathered from patients with her co-authors Rebecca Hunter and Anne Marie Lobo seen between 2006 and 2011 at two academic hospitals in

Boston: the Uveitis Department of the Massachusetts Eye & Ear Infirmary and the Paediatric Ophthalmology Department at Boston Children’s Hospital. Patients were followed for a minimum of six months. Sixty patients participated, of whom 30 underwent TNFα-inhibitor treatment and 30 did not. The two groups were statistically identical in terms of median age at presentation of systemic disease; median age at presentation of uveitis; gender; ANA positivity; and median length of follow-up.

In line with other studies presented at this session, all patients who eventually underwent TNFα-inhibitors therapy had previously been treated with a wide range of medications. These included not only methotrexate (100 per cent), topical steroids (97 per cent), non-steroidals (67 per cent) and oral steroids (50 per cent), but also mycophenolate mofetil (22 per cent), leflunomide (19 per cent), non-TNF biologicals (nine per cent), azathioprine

(three per cent) and cyclosporine (three per cent).

Once treated with TNFα-inhibitors, all three main drugs were used: infliximab (40 per cent); adalimumab (35 per cent); and etanercept (15 per cent). The remaining 10 per cent received “other” TNFα-inhibitors. Visual outcomes in patients on TNFα-inhibitors was encouraging: 82 per cent of patients achieved vision better than or equal to 20/40, while only a minority suffered vision between 20/50 and 20/150 (13 per cent), or worse than 20/200 (five per cent).

On the other hand, ocular complications were clearly more common in those eyes treated with TNFα-inhibitors. These included cataract, posterior synechiae, cystoid macular oedema, glaucoma or ocular hypertension and band keratopathy. Because this was a retrospective study, this might be explained by the fact that there was a selection bias for TNFα-inhibitor therapy, with this treatment modality being reserved for those patients with more severe disease, Dr Ledoux noted.

juVENILE uVEITISOutcomes of jIA-associated uveitis in the age of TNFα-inhibitor therapyby Leigh Spielberg in Milan

Danielle Ledoux – danielle.ledoux@ childrens.harvard.edu

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Update

PAEDIATRIC OPHTHALMOLOGY

Don’t Miss Resident’s Diary, see page 42

Ocular complications were clearly more common in those eyes treated with TNFα-inhibitors

“Danielle Ledoux

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EUROTIMES | Volume 18 | Issue 2

A day after being kicked in the face by his sister, a seven-year-old boy presented with redness and swelling below his left eye. With negative ocular and medical histories, haematoma

seemed the most likely diagnosis. But Jerry A Shields MD, director of the ocular oncology service at Wills Eye Institute, Philadelphia, US, thought the 3.5cm x 2.0cm lump suspicious, so he excised it.

Microscopic examination of the circumscribed mass he removed revealed malignant elongated cells with cross striations. It was rhabdomyosarcoma, the most common malignant orbital tumour seen in children, Dr Shields said in his keynote address to the 2nd World Congress of Paediatric Ophthalmology and Strabismus.

Rhabdomyosarcoma can metastasise to the lungs, lymph nodes and other organs, Dr Shields noted. As recently as the 1970s it had an 80 per cent to 90 per cent mortality rate, but with radiation and chemotherapy, the cure rate today is over 90 per cent – if it is caught in time.

“Rhabdomyosarcomas can occur on the eyelid, they can masquerade as trauma, and you must keep that in mind,” he cautioned.

But appearances can just as easily deceive in the other direction, Dr Shields added. In another case, an eight-month-old boy presented with a lump on his left upper lid that had been enlarging for five weeks. Physical exam and MRI findings suggested it might be rhabdomyosarcoma, so the mass was removed.

This time, the child required no cancer treatment. Pathology revealed fascicles of spindle cells and mitotic figures, leading to a diagnosis of nodular fasciitis.

“It can resemble rhabdomyosarcoma but it is entirely benign and will spontaneously regress. But you need a good pathologist to distinguish them,” said Dr Shields, who spoke on what’s new and interesting in the area of paediatric ocular tumours and pseudotumours.

Adult cancer in children Sometimes tumours seen in adults show up in children, Dr Shields noted. He presented a case in which a mass in the left upper lid of a 10-year-old girl turned out to be adenoid cystic carcinoma, a highly malignant tumour of the lacrimal glands.

“It generally occurs in adults, but actually has a biphasic age distribution and is seen in young children in their first or second decade.”

Historically, adenoid cystic carcinoma has a dismal prognosis and the textbooks recommend orbital exteneration, Dr Shields said. But he questioned if such drastic surgery should be done on a child with 20/20 vision and possibly no residual tumour.

As an option, Dr Shields has had success with orbital plaque brachytherapy. However, the radioactive seeds are placed on the outside of the protective shield so they mainly irradiate the orbit, where microscopic residual is more likely, rather than on the inside, as is typical for treating lesions in the globe.

Retinal astrocytic hamartomas related to tuberous sclerosis complex are thought to be stable with few complications, requiring minimal treatment and follow-up, Dr Shields said. However, he has treated several cases where the lesions were quite aggressive.

A 10-year-old boy presented with a blind, painful right eye. A mass was visible that produced ultrasound echos suggesting retinoblastoma, Dr Shields said. The eye showed calcification and a total retinal detachment, and was enucleated. But the dissected lesion did not look like retinoblastoma, Dr Shields said. It contained large glial cells, gemistocycstic astrocytes and calcospheres, which reflected ultrasound energy.

The final diagnosis? Giant cell astrocytic tumour of the retina associated with tuberous sclerosis.

“It is identical to the brain tumours in children with tuberous sclerosis. We have seen several more. In three cases, each had a mass that looked like retinoblastoma causing retinal detachment,” Dr Shields said.

These findings suggest a re-evaluation of astrocytic hamartomas of TSC may be in order, Dr Shields said.

“This is one of these supposed benign stable lesions that filled the retina, grew out and filled the vitreous cavity and broke out through the limbus producing an extraocular extension. So I wonder now if the astrocytic hamartomas of tuberous sclerosis are all that stable. We are seeing now that some are very aggressive and they may even require enucleation.”

Affecting about 10 per cent of newborns, capillary haemangiomas of the eyelids and orbit are one of the most commonly seen paediatric tumours, Dr Shields noted. Complications of extensive tumours can include amblyopia and strabismus. Traditional management includes refraction, observation, patching and injected or oral corticosteroids. However, while corticosteroids generally are effective, complications can include retinal vascular obstruction, necrosis of the eyelid, subcutaneous fat atrophy and skin de-pigmentation for injections, and adrenal suppression for oral delivery, Dr Shields noted.

Beta-blockers may be a viable option, Dr Shields said. A 2008 study found that two children treated with oral propranolol for cardiomyopathy from capillary haemangioma also saw extensive cutaneous haemangiomas, including on the eyelids, regress (Pieaute-Labreze et al. NEJM 2008). More recently, several studies have demonstrated that topical timolol can successfully treat periocular capillary haemangioma (Guo S et al. Arch Ophthalmol 2010. Ni N et al. Arch Ophthalmol 2011. Chambers CB et al. Ophthal Plast Reconstr Surg 2012).

“They do regress by themselves, but this certainly speeds it up.”

Jerry Shields – [email protected]

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OCuLAR TumOuRSLesions are not always what they seemby Howard Larkin in Milan

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PAEDIATRIC OPHTHALMOLOGY

Page 35: Vol 18 - issue 2

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EUROTIMES | Volume 18 | Issue 2

TNFα-inhibitors, commonly known as biologicals, have become a key component of treatment of uveitis in children, particularly when

steroids are no longer desired and when steroid-sparing treatments fail, according to Joke de Boer MD, a uveitis specialist in Utrecht, the Netherlands.

She provided an update on behalf of Dr Manfred Zierhut during a Joint Symposium on Paediatric Uveitis, organised by WSPOS and EURETINA.

She reviewed the most important studies to date that looked at the use of the three main biologicals (etanercept, infliximab and adalimumab) in paediatric uveitis. The first with etanercept were published as early as 2001, with the drug being used for treatment-resistant chronic uveitis in children. The results were encouraging, but etanercept has since been abandoned in favour of infliximab and adalimumab. A 2005 study by Kotaniemi et al. suggested that infliximab was superior

to etanercept in the treatment of chronic uveitis associated with refractory juvenile idiopathic arthritis (JIA).

Dr Zierhut and his team studied the use of adalimumab in children with chronic anterior uveitis in whom previous therapy had been ineffective. A main inclusion criterion was the unsuccessful use of at least one additional immunosuppressant besides steroids. Indeed, all 18 patients had been previously treated with cyclosporine and methotrexate. Of these 18 patients, many had also undergone treatment with azathioprine (12) mycophenolate mofetil (4) cyclophosphamide (2) and even other biologicals, including etanercept (8) and infliximab (5).

“The extent of the previous treatment characterised the severity of the uveitis seen in the patients included in the study,” said Dr de Boer.

The results were very encouraging. Adalimumab was considered “effective”

in 16 of the 18 patients (88.8 per cent), mildly effective in one (5.6 per cent) and not effective in one (5.6 per cent). No worsening of the uveitis was seen during the study. However, Dr de Boer emphasised the potential for adverse events, including production of autoantibodies. To prevent this problem, the recommendation was to continue methotrexate during treatment with biologicals. All patients must be screened for latent tuberculosis and, using MRI, for demyelinating disease. Regarding the risk of tumours after biologicals, Dr de Boer said that studies have shown no higher incidence than with the traditional disease-modifying anti-rheumatic drugs (DMARDs).

Dr de Boer also introduced delegates to a less well-known drug, rituximab. This is a chimeric monoclonal antibody that binds the CD20 protein found on the surface of B cells, leading to the cells’ death. This biological agent, primarily used to treat hematologic neoplasia, might see use in uveitis treatment in the future.

Joke de Boer – [email protected]

POSITIVE RESuLTSBiological agents a key to treatmentby Leigh Spielberg in Milan

Update

InternatIonal MeetInG on

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Afternoon: 16,30 – 18,30• Instructional

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Morning: 8,30 – 13,00

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DAY 2 Saturday, June 22nd

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2nd Session: REFRACTIVE

Chair: SiMonetta MorSelli, MD• The femto and the

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Morning: 9,00 – 13,30

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Preliminary programme

PAEDIATRIC OPHTHALMOLOGY

The extent of the previous treatment characterised the severity of the uveitis seen in the patients included in the study

Joke de Boer MD

cont

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T he US space programme has always barred its astronauts from having refractive surgery. But last September,

the National Aeronautics and Space Agency (NASA) began allowing astronaut applicants to undergo LASIK.

NASA based its decision on extensive

testing of advanced technology LASIK by the US military. The US Air Force recently approved LASIK for its pilots.

"Many years ago when LASIK was becoming popular in the community we didn't understand the implications of LASIK relative to the environment of the cockpit," said Steven Schallhorn MD, a

NASA consultant who was the director of refractive surgery for the US Navy before his military retirement last year.

Dr Schallhorn said that there were concerns about how LASIK would perform in space, such as how the flap would hold up in a low-oxygen, low-pressure environment.

n From EuroTimes, Volume 13, Issue 2, February 2008

From the ArchiveNASA approves all-laser LASIK for astronauts

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EUROTIMES | Volume 18 | Issue 2

Paediatric cataract surgery with IOL implantation can be successfully done in outreach eye camps in countries with poor socioeconomic

conditions. However, unless systems are in place to ensure proper follow up in outreach facilities, operating on children in hospitals is a better option, according to a study by Jaspreet Sukhija MD and colleagues, Chandigarh, India. On the strength of its rigorous research methodology addressing a complex outcomes quality issue, the paper was awarded the ORBIS Medal at the XXX ESCRS Congress.

In a study comparing outcomes in 96 eyes of 59 patients operated in an eye camp with 64 eyes of 48 patients operated in hospital, all by one surgeon, Dr Sukhija found no significant difference in refractive outcomes at six months. Likewise, rates of postoperative complications, including uveitis, PCO, amblyopia, glaucoma, pupil capture, posterior synechiae or pigment or membrane on the IOL surface, were similar, though rates were slightly higher for the eye camp group in every complication category and overall.

All the children included in this study were operated by Prof Jagat Ram. All patients had their lenses aspirated, and a primary posterior capsulotomy and anterior vitrectomy with endocapsular placement of a PMMA IOL with 6mm optic and 12mm overall length. In the eye camp group, all 48 children had low socioeconomic status, compared with 22 of 48 in the hospital group. Patients ranged in age from five to 16, and those with traumatic cataract, other ocular pathology or major cardio-respiratory or other systemic problem interfering with anesthesia were excluded.

Through six months, follow-up was 100 per cent in both groups. However, beginning at 12 months, roughly twice as many patients were lost to follow-up in the eye camp group, reaching 68 per cent at 48 months compared with 33 per cent in the hospital group (p<0.01). “As the duration of follow-up increases, what goes on? The number of children lost to follow-up in the eye camp group starts to increase,” Dr Sukhija said.

The study results suggest that paediatric cataract surgery with PCIOL implantation

done in outreach facilities is safe and effective. However, the increasing rate of loss to follow-up is a major drawback to the eye camp approach, Dr Sukhija said. Given the need for ongoing treatment for amblyopia, repeated refractions and management of any postoperative complications to achieve a satisfactory visual outcome, ensuring long-term follow-up, is essential particularly for children, he noted.

Dr Sukhija suggested that clinicians devise a default retrieval system for patients operated in eye camps, perhaps through local vision centres, to ensure follow-up continues. This would not only improve long-term outcomes, it would make services more available to children with cataracts in remote areas, much as camps provide affordable and accessible services for people with age-related cataracts. With childhood blindness responsible for 75 million blind years in developing countries, the need is immense.

However, until reliable follow-up support can be given, hospitals remain a better option for paediatric cataract surgery, Dr Sukhija concluded.

n This work is part of a study carried out by Prof Jagat Ram ([email protected]), Dr Jaspreet Sukhija, Dr B.R Thapa and Dr V.K. Arya from Post Graduate Institute of Medical Education and Research, Chandigarh, India.

OuTREACH CAmPSORBIS medal goes to study comparing surgery at eye camp with hospitalby Howard Larkin in Milan

Jaspreet Sukhija – [email protected]

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As the duration of follow-up increases, what goes on? The number of children lost to follow-up in the eye camp group starts to increase

Jaspreet Sukhija MD

Don’t miss Industry News, see page 46

Page 38: Vol 18 - issue 2

36

EUROTIMES | Volume 18 | Issue 2

This year ESASO will celebrate its fifth anniversary.

What started out as a project in 2008 to address the need for

better postgraduate education and also the need for training, has become an independent global institutional network for young ophthalmologists to develop their scientific knowledge and practical skills. Some of the most esteemed experts in the different fields of ophthalmology lecture at ESASO and provide participants with fresh insights and the benefits of face-to-face interaction and their invaluable experience.

ESASO has trained 520 participants at its Lugano Campus in Switzerland in the last four years. It has also started lecturing ESASO modules abroad in Valetta and Ankara in 2012. Both projects have been very successful.

Because the world population of over 65-year-olds will increase by 36 per cent from 532 million in 2010 to 726 million in 2020, according to the US consensus bureau, the workload on young ophthalmologists will increase. The challenge facing ophthalmology is that there will be an estimated shortage of 9,500 ophthalmologists in Europe by 2020 which is why the training of new ophthalmologists has become so important.

“Even though we are in difficult economic times, education and training is becoming increasingly important. Young ophthalmologists invest in their future careers and want to excel in their daily practice for the patients’ benefits,” said Giuseppe Guarnaccia, global executive director at ESASO. “We offer them experience and technical excellence and innovation in our state-of-the-art campus in Lugano, Switzerland,” he said.

Improving daily practice Last year, 13 participants graduated from their studies with the Diplome Specialist Superior in Ophthalmology (DiSSO) totalling 40 graduates and six Fellows to date. A satisfaction survey among the graduates last summer revealed that 88 per cent of the graduates reported having improved their daily practice significantly. In addition, 45 per cent of respondents said that they conducted up to 50 per cent more surgeries after their training with ESASO.

More than half of the graduates (56 per cent) said that their careers had improved and 44 per cent of the respondents changed jobs after taking the DiSSO, within 12 months.

New initiatives Building on this success, ESASO has now taken steps to respond to the increasing demand for training and has extended its modules from six to nine this year. Five modules will be presented at the University of Lugano, and four will be presented in other venues in Europe and the Middle East.

ESASO has also widened its reach by publishing the lectures delivered from the modules. ESASO’s publications series was launched last June and two volumes on Medical and Surgical Retina were published in 2012. Later this year, there will be a new volume in Cataract Surgery and Cornea and Refractive Surgery.

Another major initiative has been the move to a new head office in Lugano. Up to now, ESASO has been quite limited for space at the University of Lugano. However, the honourable and visionary Giorgio Giudici, Mayor of the City of Lugano, recently offered ESASO the unique opportunity of moving to a bigger space and ESASO’s Head Office moved to the picturesque historical Villa Saroli in January.

“We’re excited to move in to our new home to centralise our activities and work on the professionalisation of our organisation to the benefit of all stakeholders,” said Gabriella Skala, general manager, ESASO.

GLOBAL NETwORKESASO is offering young ophthalmologists technical excellence and innovation

www.esaso.org

More information at www.esaso.org

ESASO Programme 2013

Oculoplastic & Orbital Surgery

Surgical Retina

Cataract

Medical Retina

Surgical Retina

Glaucoma

Cornea & Corneal Refractive Surgery

Surgical Retina

Cataract

Valletta, Malta

Lugano, Switzerland

Moscow, Russia

Lugano, Switzerland

Lugano, Switzerland

Lugano, Switzerland

Lugano, Switzerland

Ankara, Turkey

Dubai, UAE

21 – 25 Jan

04 – 08 Feb

20 – 24 May

03 – 07 June

10 – 14 June

09 – 13 Sept

09 – 14 Sept

October

November

ESASOc/o Università della Svizzera italiana (USI)Via Giuseppe Buffi 136904 Lugano, SwitzerlandTel. +41 (0)58 666 4629Fax +41 (0)58 666 4619Email [email protected]

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Mats Lundstrom – [email protected] Rich – [email protected]

EuREquO

A new international working group led by Mats Lundström MD PhD, Karlskrona, Sweden, is developing uniform outcomes

measures for cataract surgery and other ophthalmic treatments. The ophthalmology group is one of several speciality-specific groups organised by the International Consortium for Health Outcomes Measurement (ICHOM).

Harmonising outcomes definitions globally is essential to benchmark performance across borders and compare research conducted in different locations, Dr Lundström told EuroTimes. It may also eventually enable consolidated global outcomes registries.

Founded by the Institute for Strategy and Competitiveness at Harvard Business School, the Boston Consulting Group in the US, and the Karolinska Institutet in Sweden, ICHOM’s goal is to use global outcomes data to drive system changes that increase the value of health services for patients and communities. This will be done in part by giving greater weight to functional outcomes that patients value highly, such as being able to read comfortably or drive at night after cataract surgery.

ICHOM currently partners with 50 disease registries in 20 countries. The not-for-profit

group provides a central repository for information about outcomes measures as well as a forum for designing and harmonising measures and analytic tools such as case severity adjusters among registries. It also facilitates data collection and analysis to support clinical and system process improvement. The consortium held its inaugural conference in November of 2012.

International effort In addition to Dr Lundström, who led development of the ESCRS-supported European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO), the ICHOM ophthalmology working group includes William L Rich III MD, who heads the American Academy of Ophthalmology’s effort to develop its own ophthalmology

registry; Ravi Ravindran MD, of the Aravind Eye Hospital System in India; Nigel Morlet MD, who operates registries in Western Australia; Goh Pik Pin MD of Malaysia; and Anders Bohman MD, also of Sweden. “The group is not complete yet; we need someone from the UK because they also have a large cataract database,” Dr Lundström observed.

The first steps of the working group, which are already under way, include a review of those outcomes measures now in use and an assessment of what measures should be included in all registries. The group will then review, choose and define a limited set of measurements that will be meaningful, but not too burdensome to collect. These will include variables for visual outcome, refractive outcome, complications and patient-reported outcomes. Demographic and case mix variables, as well as risk adjusters, also will be defined to facilitate meaningful comparisons across diverse populations and systems.

Dr Lundström expects that draft cataract outcome measurements will be available for comment by the end of the year. The aim of ICHOM is to cover as many ophthalmic registries as possible. “Cataract surgery should be step one, then retina, glaucoma and corneal transplant.” Experts in each subspecialty will be recruited to develop measurements, he said.

Dr Rich pointed out that standardising outcome measurements, while desirable, requires expertise – which is why Dr Lundström was chosen to lead the working committee. “He knows from EUREQUO the difficulty of harmonising databases.”

Integrating data from India and other developing countries presents even greater issues than harmonising European databases because the populations and health

systems are so different, Dr Lundström noted. However, he believes that it will be possible to develop a meaningful common data set with the help of systems such as Aravind, which does hundreds of thousands of procedures annually and has its own electronic record system, which is much more detailed than a national registry.

EUREQUO is one of several ophthalmology databases AAO is examining as it develops its own registry, Dr Rich added. AAO is also working with the Featherstone Informatics Group on a registry framework that can receive data from any type of electronic record, as well as accommodate new measures and conditions layered on top of an existing database. ICHOM has no working agreement with the AAO or our vendor FIG to make our data or materials available to anyone else, he said.

Such a flexible interface would greatly reduce the cost of changing measures, Dr Lundström said. It also would make it easier for clinics with different electronic record systems to contribute data without the need to develop a specific interface for each software package. “We have to get rid of the need for double entry,” he said.

38

EUROTIMES | Volume 18 | Issue 2

REGISTRIESEuREQuO, AAO and others collaborate on global outcome measuresby Howard Larkin in Chicago

EUREQUO is one of several ophthalmology databases AAO is examining as it develops its own registry

William L Rich III MD

Micro-needles could soon offer clinicians a new and better way to provide intraocular drug administration. US researchers report promising results using needles less than a millimetre in length to administer suprachoroidal injections of fluorescein and fluorescently tagged dextrans (40 and 250 kDa), bevacizumab and polymeric particles (20 nm to 10 μm in diameter) in New Zealand white rabbits. They monitored fluorescence intensity within the eye in each animal using an ocular fluorophotometer to determine the distribution of the injected material in the eye over time as compared with intravitreal injection of fluorescein. They also performed

fundus photography and histology. Molecules and particles injected near the limbus using a micro-needle flowed circumferentially around the eye within the suprachoroidal space. By targeting the suprachoroidal space, the concentration of injected materials was at least 10-fold higher in the back of the eye tissues than in anterior tissues. In contrast, intravitreal injection of fluorescein targeted the vitreous humour with no significant selectivity for posterior versus anterior segment tissues. Half-lives in the suprachoroidal space for molecules of molecular weight from 0.3 to 250 kDa ranged from 1.2 to 7.9 hours. In contrast, particles ranging in size from

20 nm to 10 μm remained primarily in the suprachoroidal space and choroid for a period of months and did not clear the eye. They observed no adverse effects of injection into the suprachoroidal space. The researchers believe this research could lead to a simple and safe procedure that offers a better way to target drugs to specific locations in the eye. They noted that the design and simplicity of the micro-needle device

may make it more likely to be used in the clinic as a way to administer drug formulations into the suprachoroidal space that surrounds the eye.n S Patel et al., Investigative

Ophthalmology & Visual Science, “Targeted Administration into the Suprachoroidal Space Using a Microneedle for Drug Delivery to the Posterior Segment of the Eye”, IOVS 53:4433-4441, doi:10.1167/iovs.12-9872.

Journal WatchSmaller needles could be a big advance

European Registry of Quality Outcomes for Cataract & Refractive Surgery

EUREQUO

cont

acts

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Make the most of your time at the ASCRS•ASOA Symposium & Congress and attend our EyeWorld programs for additional CME and an opportunity to network with your colleagues.

For updates and to register visit

www.EyeWorld.org

San Francisco 2013

Among the topics to be covered in these AMA PRA Category 1 CreditsTM designated sessions are:

• Adiscussiononrecentdevelopmentsinanti-infective andanti-inflammatorytherapeutictreatments• Updatesondiagnosingandtreatingtheocularsurface, includingdryeyedisease• Newdevelopmentsinallergytherapeutics• Newconsiderationsandcontinuingdiscussionsregardingla-ser-assistedcataractrefractivesurgery

• MaximizingoutcomeswithrefractiveIOLs• Updateontheprevalenceandalternativetreatmentfor meibomianglanddisease

These non-CME, ASCRS-authorized educational programs will provide timely and important information on:

• OptionsandconsiderationsintheuseofpremiumIOLs• Advancesintechnologies,techniques,andoutcomesinlaser visioncorrectionsurgery• Aninteractivediscussionontheapplicationsoffemtosecondandexcimerlasersforophthalmicsurgery

EyeWorld Corporate Events are directly developed by industry and hosted by EyeWorld. These non-CME meetings provide valuable information on new products, procedures, and applications of existing products. Included among the topics dis-cussed in these sessions are:

• Livesurgery• Newdevelopmentsinsurgicalinstrumentation• Surgicaloptionsforthetreatmentofdryeye• GrowingtheoverallsizeofthepremiumIOLlensmarket• ConsiderationsintheselectionofapremiumIOL• Newdevelopmentsinlaservisioncorrection• AdvancedIOLtechnology• Discussionoftechnologicaladvancesandbreakthroughsincataractsurgery

• Updateoncrosslinking• Advancesindiagnosticandimagingequipment

Save the DateFriday, April 19 – Monday, April 22, 2013

Page 42: Vol 18 - issue 2

Feature

OuTLOOK ON INDuSTRY

EUROTIMES | Volume 18 | Issue 2

Abbott Medical Optics (AMO), purveyor of such iconic ophthalmic brands as VISX, Intralase, Whitestar and Tecnis,

will retain its laser focus on patient and surgeon needs under its new corporate structure and leadership.

“Nothing changes except AMO becomes twice as important to the new Abbott,” says new senior vice-president Murthy Simhambhatla PhD.

On Jan 1, Abbott spun off its research-based specialty biopharmaceuticals business into a separate, publicly-traded firm, AbbVie. This leaves Abbott as one of the world’s largest diversified health product companies, with market-leading offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Mr Simhambhatla succeeded James V Mazzo as AMO president the same day.

Research-based pharmaceuticals and diversified medical products are very different businesses, with different

product cycles and investment needs, Mr Simhambhatla adds. The split allows both companies to take better advantage of internal synergies, and clarifies their focus for investors.

AMO retains its independent identity within Abbott for similar reasons, Mr Simhambhatla says. “AMO will continue to operate as a separate division so we can remain nimble and focused. We’ve always been very focused on surgeons, and that will not change.”

International leadership experience Mr Simhambhatla brings a wealth of international medical device development and marketing experience to AMO. Most recently he headed Abbott’s Ibis Biosciences business, which makes devices and assays for broad-based screening and identification of bacteria, viruses, fungi and protozoa utilising a library of more than 750,000 entries. Before leading Ibis, he was general manager of Abbott’s vascular business in Australia and divisional vice-president and general manager of Abbott’s drug-eluting stent business. Prior to Abbott, he held several managerial positions at Guidant Corporation, which manufactured stents, pacemakers, implantable defibrillators and other cardiovascular products.

In 2011, Abbott generated $4.7bn net income on revenues of $38.9bn. The new Abbott retains about half of those revenues..

Organic innovation AMO was built in large part through acquisitions, assembling a comprehensive cataract, refractive and eye care product line by adding market-leading manufacturers in segments including diagnostics, lasers and accommodating lenses. “Jim Mazzo and his team have built a very strong foundation,” says Mr Simhambhatla, who now plans to leverage AMO’s deep technological and customer service expertise to advance its operations.

“We’re investing more in the people and technology we have. We may supplement it with acquisitions, but we have a tremendous focus on organic innovation,” Mr Simhambhatla says. Products integrating new and existing technologies that span the cataract and refractive spectrum are hitting the market or in the works.

European focus for cataracts For cataracts, Europe is a major focus. “We can get technologies to market sooner in Europe,” Mr Simhambhatla notes. Preloaded Tecnis 1-Piece IOL inserters were launched in September 2012 with a full commercial roll out scheduled for first-half of 2013; Tecnis multifocal toric also launched in September at ESCRS; and there are plans to launch a low-add Tecnis Multifocal IOL in the second half of 2013. A new generation Synchrony accommodating IOL is under development. AMO continues to develop micro-incision cataract surgery devices, enhance its Whitestar phacoemulsification system, and add to its Healon viscoelastic line.

Further down the road is femtosecond laser-assisted cataract surgery. AMO’s iFS Advanced Femtosecond Laser was approved last year for creating arcuate incisions during cataract surgery. Capsulorhexis and nuclearfractis capabilities are coming, but Mr Simhambhatla won’t say when. “It is too early to give guidance on dates, but we will as we get closer to commercialisation. At this point, we are very focused on ensuring we have the right platform that delivers a high level of product performance. That is key to us.”

Mr Simhambhatla sees the cataract market growing dramatically worldwide. AMO is very focused on further penetrating developing markets in India and China, while offering top-performing products in Europe and the US. Meeting the global need for spectacle independence with lenticular products such as Synchrony and advanced corneal procedures is another major growth opportunity that the firm pursues.

Diagnostic advances for refractive surgery For refractive surgery, diagnostics will play a central role, Mr Simhambhatla says. The iDesign Advanced Wavescan Studio, which received the CE mark last autumn and launches in Europe this spring, will make possible custom corneal laser corrections that may reduce higher order aberrations.

iDesign provides five functions: aberrometry, autorefraction, corneal topography, pupillometry, and keratometry. It incorporates a high definition Hartmann-Shack wavefront sensor and a non-Placido full-gradient topographer that operate simultaneously on a common fixation and measurement axis. It provides five times the resolution and dynamic range of the previous Wavescan aberrometer as well as better resolution topography over a wider zone than Placido disc devices. This provides sufficient resolution to model small but significant topographic flaws and wavefront aberrations, such as those from radial keratotomy scars, and sufficient range to detect large aberrations. The simultaneous co-axial readings also increase accuracy by ensuring that topographic and wavefront readings are perfectly registered and taken over the same pupil zone. This enables much greater precision in separating corneal aberrations from lens aberrations.

Custom corneal ablation profiles Precise iDesign data makes possible customised corneal ablation profiles that may reduce total higher order aberrations by accounting for internal aberrations that offset corneal aberrations. The device is integrated with the iFS flap cutter and the Star S4 IR excimer laser, which provide the surgical precision required to translate the individualised surgical plan into excellent patient vision.“We are quite excited with what iDesign can do,” Mr Simhambhatla says.

Mr Simhambhatla expects great things at AMO. “We have a broad product portfolio, and in every category we have industry-leading products in terms of performance,” he notes. “Our legacy at AMO is innovation and putting the surgeon and patient first, and we will continue to do that.”

Steve Chesterman – [email protected]

cont

act

AmO RETAINS FOCuSContinued development of refractive platforms, IOLs and FS cataract on horizon by Howard Larkin in Chicago

40

iDesign

Tecnis Toric IOL

We’re investing more in the people and technology we have. We may supplement it with acquisitions, but we have a tremendous focus on organic innovation

Murthy Simhambhatla PhD

Page 43: Vol 18 - issue 2

TPA’s efficacyRecombinant tissue plasminogen activator (rtPA) in the treatment of recent-onset submacular haemorrhage in patients with age-related macular degeneration (AMD) appears to be equally effective whether it is injected submacularly with vitrectomy or intravitreally without vitrectomy, according to a review of the literature. The authors analysed the findings of 38 studies involving a total of 1,185 patients, and 28 patients from the Rotterdam Eye hospital. They could find no clear difference in complete displacement or complication rate between the two treatment groups. n (van Zeeburg et al, Ophthalmologica 2013;

DOI: 10.1159/000343066)

Pathology of RP The retinal nerve fibre layer of eyes with retinitis pigmentosa (RP) appears to have characteristic thickness abnormalities which are detectable with scanning laser polarimetry with enhanced corneal compensation (GDxECC) and RTVue-optical coherence

tomography (OCT), according to a new study. The investigation compared the findings of the two technologies in 52 eyes of 26 RP patients with those of 50 eyes of 25 patients without the disease. The RNFL measured by GDxECC was significantly thicker in RP patients than in controls and the RNFL thickness measured by RTVue-OCT was significantly greater in RP patients than in controls in the superior, inferior and temporal regions. The authors said their findings may provide some additional clues to the disease's underlying pathology. n (Xue et al, Ophthalmologica 2013; DOI:

10.1159/000337227)

Microcannula-guided vitrectomy safe optionIntraoperative retinal breaks during vitrectomy are reduced in the microcannula-guided techniques compared to 20-gauge vitrectomy. In this historical cohort study, a total of 221 eyes with a follow-up of at least 30 days were analysed. All patients had undergone vitrectomy with epiretinal

or internal limiting membrane peeling performed by one surgeon between January 2005 and March 2009.The incidence of intraoperative retinal break formation was 25.2 per cent (n = 28/111) for the 20-gauge group, compared to only 12.7 per cent (n = 14/110) for the 23-/25-gauge group. The reduction in retinal breaks among those treated with microcannula-guided techniques may be attributed to the protection of the vitreous base during surgery, the authors said. n (Neuhann et al, Ophthalmologica 2013;

DOI: 10.1159/000343710)

Hyperreflective dotsHyperreflective dots in the retina visible through Spectral-domain optical coherence tomography (SD-OCT) may represent a new clinical marker for prognosis and follow-up in eyes with exudative AMD, according to the findings of a prospective study. The study’s authors examined 100 exudative AMD patients with SD-OCT prior to treatment and at monthly intervals thereafter. In their initial examinations they found previously unseen

hyperreflective dots, mainly in the outer retinal layers. Following treatment there was a regression of the dots which reached statistical significance by one month (p<0.04) and became more pronounced by three months (p<0.001). Furthermore, although regression was evident in all visual acuity and morphological subsets, resolution of the dots was significantly associated with better final visual acuity (p < 0.001). n (Coscas et al, Ophthalmologica 2013; DOI:

10.1159/000342159).

41

EUROTIMES | Volume 18 | Issue 2

Please register online before 5 March 2013 to take advantage of

the Early Bird registration fee

Create your personal itinerary via the new online Scientific Session Planner

www.soe2013.org

Welcome to the S OE 2013 Congress

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José Cunha-VazEDITOR OF OPHTHALMOLOGICA,The peer-reviewed journal of EURETINA

Page 44: Vol 18 - issue 2

Feature

RESIDENT’S DIARY

EUROTIMES | Volume 18 | Issue 2

“It’s upside down,” said Dr Zijlmans. “It’s open, in the bag and upside down.” I stared through the operating

microscope in horror and saw, in my peripheral field of view, Dr Zijlmans making the universally recognised circular hand motion that means: Switch places with me. You messed it up and I need to fix it.

I began to sweat and my throat closed up. A wave of shame crashed over me. Was this the end of my trust-building with the cataract team? If I couldn’t properly complete the simplest step of a cataract operation, how could I be taught to crack a nucleus?

Thus began my first attempt at intraocular surgery. This was not at all the start I had imagined. We’re in training for more than two years before we learn phacoemulsification, and we’re allowed, and expected, to jump right into the action during our first week in the cataract operating room. It’s incredibly exciting. But at the same time, it’s also nerve-wracking. We mostly operate with topical anaesthesia, so a little tetracaine is the only thing standing between us and them. What if they cough? What if they sneeze? What if…?

Dr Zijlmans is a very relaxed character, a cataract specialist with 12 years of experience. A lot of the trickiest cases get referred to him, and he has helped train countless residents and fellows. This upside-down IOL was no big deal for him to fix. Evaluate, flip, reposition – end of story.

While we were scrubbing for the next operation, I joked with him. I wanted to assess the damage I had done. “I think you might have loaded the IOL upside down in the cartridge,” I said. After all, he was my “assistant” during the last case.

“Sure, sure, that’s quite likely,” he quipped, a sarcastic smile barely visible in his eyes behind his operating mask. “Loading an IOL can be tricky.”

The first time we’re present during cataract operations is during our paediatrics rotation, where we assist surgeons who operate both juvenile and senile cataracts. We get to see about 100 procedures and get familiar with the microscope, the equipment and the operation itself. Assisting phacos is not quite as exciting as the strabismus operations that we’re allowed to do ourselves. So besides watching attentively during the procedure, I’d challenge myself with the

routine peri-operative tasks. Unpacking the phaco set – with all its instruments, syringes, needles, tips and sleeves – became a little ritual of precision and speed. I liked to imagine that I was a young child on Christmas morning, unpacking my new Lego set and putting it all together. How smoothly could I do it without making any mistakes? Could I finish setting everything up before the surgeon made the first incision?

But now I was doing the real thing. Intraocular surgery is weird. Fine instruments are manipulated with our hands, yet everything is controlled by our eyes. There is almost no tactile feedback, and so little resistance given by the ocular tissues to the sharp instruments. It’s the purest form of hand-eye coordination and fine motor

skills. Combined with the very small margin of error, it’s enough to cause any attending surgeon to have at least a few sleepless nights. Niels, a resident with 20 full phaco procedures under his belt, had advised me on this: “Make only small, slow, controlled and predictable movements. You don’t want the supervisor to die of a heart attack.”

My next IOL insertion went well and I, ahem, congratulated him for loading the lens correctly this time. However, during my third chance, desperate to avoid the same upside-down mistake, I spent too much mental energy making sure the lens opened as it should. Was it correct? Had it flipped? Doubt. Stress. I hesitated and stopped turning the injector screw. The leading haptic started unfolding in the anterior

chamber, and before I knew it, the lens optic was stuck in the middle of the incision. Oh man, here we go again!

Again the “switch seats” sign: a closed hand, moving in a circular motion with the index finger pointing straight down, as though he were stirring a big bowl of soup. Although the patients are aware that residents and fellows might perform part or all of their operation, there’s no need to alarm the patient. We silently switched seats and Dr Zijlmans continued with the operation, pulling the lens back out.

“Had you ever seen that before?” I asked while we were scrubbing for the next operation.

“I’ve seen everything before, including all the mistakes you’re likely to make in the next four months,” he answered calmly.

During the next few operations, it all went more smoothly. Just stay away from the posterior capsule, I kept telling myself. Pull those nucleus quadrants into the iris plane and emulsify them in the anterior chamber. After all I’d heard about the fragility of the posterior capsule and the drama associated with its rupture, I couldn’t believe my ears when Dr Zijlmans said, “Go ahead and polish the capsule.” What?! You can’t be serious, I thought. It’s four microns thick! I don’t even want to go near it. I hesitated. “Just do it,” he said.

Good teachers have the big picture in mind. That includes the big picture of patient care and favorable outcomes far beyond the eye being operated at that moment. Yes, a trainee is more likely to cause a complication than an attending. Yes, that’s unfortunate for everyone involved. However, if an ideal situation exists for a complication to occur, it’s during an operation under the supervision of an experienced surgeon within a large training hospital with access to vitreoretinal surgeons and general anaesthesia. The outcome of a complication here is likely to be better than that of the same complication in the hands of a first-year ophthalmology graduate operating in a general hospital an hour’s drive away. That is, of course, the setting in which the large majority of recent graduates end up. The net advantage lies in operating early and often, sitting next to the real pros.

So, I slowly polished the posterior capsule, my confidence growing. A week or two later, I had completed my first phaco procedure from beginning to end.

wHEN THINGS GO wRONGLearning from mistakes – quickly corrected by a good teacher – is an integral part of residencyby Leigh Spielberg

42

Leigh Spielberg is an ophthalmology resident at the Rotterdam Eye Hospital in The Netherlands

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EUROTIMES | Volume 18 | Issue 2

The power of one

The one FeMTo plaTForM for cornea, presbyopia and cataract.

Presenting the unparalleled Ziemer FEMTO LDV Z Models – a technical revolution in ocular surgery. No laser is more Precise, more powerful or more progressive when it comes to meeting all your procedural needs in a single platform. With Ziemer’s FEMTO LDV Z Models, now you can operate with a modular femtosecond system that is easy to configure, designed to grow with your practice – cornea and presbyopia today, cataract tomorrow.www.ziemergroup.com

The Ziemer FEMTO LDV Z Models are FDA cleared and CE marked and available for immediate delivery. For some countries, availability may be restricted due to local regulatory requirements; please contact Ziemer for details. The creation of a corneal pocket is part of a presbyopia intervention. Availability of related corneal inlays and implants according to policy of the individual manufacturers and regulatory status in the individual countries. Cataract procedures with the FEMTO LDV Z2, Z4 and Z6 models are not cleared in the United States and in all other countries. An upgrade possibility for these devices is planned once cataract options are available and cleared by the responsible regulatory bodies.

eurotimes_jan2012_FEMTO_LDV_Z_Models_Ad_120x300mm.indd 1 17.12.12 11:46

Support grows for intracameral antibioticThe ESCRS Study of Prophylaxis of Postoperative Endophthalmitis after Cataract Surgery was among the largest study of an antibiotic in the history of medicine. The primary conclusion of the randomised, placebo-controlled, multi-centre European study was that endophthalmitis following cataract surgery could be largely prevented through the use of an intracameral injection of cefuroxime. While the study conclusions have led to changes in practice in Europe, acceptance of the findings has been slower in the US. A new US study of the same scale as the ESCRS study could change this. Peter Barry MD, chairman, ESCRS Endophthalmitis Study Group, comments on the US study in a special JCRS editorial. The article by Shorstein et al. in this issue is the first published American study on the systematic use of intracameral antibiotics, with or without postoperative antibiotic drops, as prophylaxis against endophthalmitis following complicated and uncomplicated clear corneal phacoemulsification. Noting that the “similarities between this study and ESCRS study on endophthalmitis prophylaxis with intracameral cefuroxime are striking”, Dr Barry commends the researchers and concludes that rates of endophthalmitis found in these studies suggest a background rate of three per 1000 may be viable and realistic.

n P Barry, JCRS, “Intracameral antibiotic prophylaxis: American paper mirrors European experience”, Volume 39, Issue 1, 2-3

US studyKaiser Permanente is a large health maintenance organisation whose privately insured members are treated entirely within a network of clinics and hospitals. It is known for economies of scale and for aggregating patient data. Researchers at Kaiser wanted to evaluate post-cataract-surgery endophthalmitis rates in relation to changing practice patterns in antibiotic administration. Over a four year period, they identified three time periods based on increasing adoption of intracameral injections after phacoemulsification cataract surgery. In 2007, patients primarily received postoperative antibiotic drops without intracameral injection. During 2008 and 2009, in addition to the surgeons’ usual postoperative topical drop regimen, patients received intracameral cefuroxime unless contraindicated by allergy or posterior capsule rupture. During 2010 and 2011, all patients received an intracameral injection

of cefuroxime, moxifloxacin or vancomycin while topical antibiotics were used according to surgeon preference. The rates of postoperative endophthalmitis during these three periods declined with the adoption of intracameral cefuroxime prophylaxis. Nineteen cases of endophthalmitis occurred in 16,264 cataract surgeries. The respective rates per 1000 during the three time periods declined from 3.13, to 1.43, to 0.14.

n NH Shorstein et al., JCRS, “Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics in a Northern California eye department”, Volume 39, Issue 1, 8-14.

Swedish studySweden has perhaps the oldest registry of cataract surgeries in existence. In a prospective epidemiologic study, Swedish researchers collected endophthalmitis case reports from 2005 through 2010. Case and control parameters pertaining to patient characteristics and surgical technique were generated from the database. In addition, they analysed information from annual surveys regarding the topical prophylactic protocol. The reports showed that 135 endophthalmitis cases occurred in 464,996 operations, equalling an incidence of 0.029 per cent. Patient age over 85 years, perioperative communication with the vitreous and, above all, nonuse of intracameral cefuroxime showed a statistically significant association with endophthalmitis in the logistic regression. Short-term topical antibiotics given as add-on prophylaxis to the intracameral regimen before, after or before and after the operation did not confer a clear-cut benefit. Groups with topical treatment were small, comprising 14 per cent of the sample.

n E Frilling et al., JCRS, “Six-year incidence of endophthalmitis after cataract surgery: Swedish national study”, Volume 39, Issue 1, 15-21

Review

JCRS HIGHLIGHTSJournal of Cataract and Refractive Surgery

Thomas Kohnenassociate editor of jcrs

FURTHER STUDYBecome a member of ESCRS to receive a copy of EuroTimes and JCRS journal

Page 46: Vol 18 - issue 2

Special 1-Day ProgramsFriday, April 19, 2013

SanFrancisco2013American Society of Cataract and Refractive Surgery

American Society of Ophthalmic Administrators

Symposium & CongressApril 19–23, 2013

OPTIONAL WORKSHOPS2013

ASOA

Meeting Highlights

Tuesday, April 23Hot Off the PressModerator: David F. Chang, MDPanelists: Reay H. Brown, MD, Bonnie An Henderson, MD, Edward J. Holland, MD, and Ronald Yeoh, MD

This session will encompass a free-flowing panel discussion by the specialty section editors of EyeWorld, who will highlight and debate the Best Papers of ASCRS 2013, as selected and presented by EyeWorld editorial board members.

April 20–23

A core selection of CME-designated business courses that provide a comprehensive analysis of your practice to maximize revenue. The program will cover financial and investment strategies, productivity management, profit diversification, and business model analysis. www.ascrs.org/probe

Saturday, April 20Binkhorst Lecture

Intraocular Lens Evolution: What a Long Strange Trip It’s Been

Presented by Nick Mamalis, MD, ASCRS’s 2013 Binkhorst Medal winner is highly respected in ophthalmology for his transformative work in the study and understanding of toxic anterior segment syndrome. He is among the world’s experts in cataract and refractive surgery and has made significant contributions to the science and practice of ophthalmology.

Jerome Groopman, MD, and Pamela Hartzband, MD, are both well-known medical writers and members of the Harvard Medical School faculty. Dr. Groopman has written several books, two of which were New York Times bestsellers. Dr. Hartzband is a noted endocrinologist and is regularly featured among America’s Best Doctors. Most recently, Dr. Groopman and Dr. Hartzband are co-authors of Your Medical Mind, a 2011 release that explains how patients can cut through the myriad information from doctors, drug companies, and friends to arrive at positive medical decisions. They also co-author a bi-monthly column for ACP Internist, the publication of the American College of Physicians, which is read by 150,000 internal medicine physicians in the United States and Canada.

Richard Mackool, MD, is the Director of The Mackool Eye Institute, the first ambulatory surgery center in New York. He has been granted approximately 125 patents, both in the U.S. and internationally, for inventions relating to cataract extraction, phacoemulsification and intraocular lens implant designs. He is also an experienced author, writing hundreds of medical publications.

Monday, April 222013 Charles D. Kelman Innovator’s LectureHumans, Happiness, and the Wonder of New

Sunday, April 21Science and Medicine Lecture

When Experts Disagree: A New Approach to Medical Decision Making

PROBE Practice Revenue Optimizationand Business Efficiency

Discounted Registration Ends on March 1.www.ascrs.org

Page 47: Vol 18 - issue 2

Special 1-Day ProgramsFriday, April 19, 2013

SanFrancisco2013American Society of Cataract and Refractive Surgery

American Society of Ophthalmic Administrators

Symposium & CongressApril 19–23, 2013

OPTIONAL WORKSHOPS2013

ASOA

Meeting Highlights

Tuesday, April 23Hot Off the PressModerator: David F. Chang, MDPanelists: Reay H. Brown, MD, Bonnie An Henderson, MD, Edward J. Holland, MD, and Ronald Yeoh, MD

This session will encompass a free-flowing panel discussion by the specialty section editors of EyeWorld, who will highlight and debate the Best Papers of ASCRS 2013, as selected and presented by EyeWorld editorial board members.

April 20–23

A core selection of CME-designated business courses that provide a comprehensive analysis of your practice to maximize revenue. The program will cover financial and investment strategies, productivity management, profit diversification, and business model analysis. www.ascrs.org/probe

Saturday, April 20Binkhorst Lecture

Intraocular Lens Evolution: What a Long Strange Trip It’s Been

Presented by Nick Mamalis, MD, ASCRS’s 2013 Binkhorst Medal winner is highly respected in ophthalmology for his transformative work in the study and understanding of toxic anterior segment syndrome. He is among the world’s experts in cataract and refractive surgery and has made significant contributions to the science and practice of ophthalmology.

Jerome Groopman, MD, and Pamela Hartzband, MD, are both well-known medical writers and members of the Harvard Medical School faculty. Dr. Groopman has written several books, two of which were New York Times bestsellers. Dr. Hartzband is a noted endocrinologist and is regularly featured among America’s Best Doctors. Most recently, Dr. Groopman and Dr. Hartzband are co-authors of Your Medical Mind, a 2011 release that explains how patients can cut through the myriad information from doctors, drug companies, and friends to arrive at positive medical decisions. They also co-author a bi-monthly column for ACP Internist, the publication of the American College of Physicians, which is read by 150,000 internal medicine physicians in the United States and Canada.

Richard Mackool, MD, is the Director of The Mackool Eye Institute, the first ambulatory surgery center in New York. He has been granted approximately 125 patents, both in the U.S. and internationally, for inventions relating to cataract extraction, phacoemulsification and intraocular lens implant designs. He is also an experienced author, writing hundreds of medical publications.

Monday, April 222013 Charles D. Kelman Innovator’s LectureHumans, Happiness, and the Wonder of New

Sunday, April 21Science and Medicine Lecture

When Experts Disagree: A New Approach to Medical Decision Making

PROBE Practice Revenue Optimizationand Business Efficiency

Discounted Registration Ends on March 1.www.ascrs.org

Page 48: Vol 18 - issue 2

46

EUROTIMES | Volume 18 | Issue 2

European Business AwardContamac Ltd has won an award as a National Champion in the European Business Awards 2012/13.

“This year has been a significant one for Contamac as we celebrated the company’s 25th Anniversary and received The Queen’s Award for Industry: International Trade. To be a National Champion in the European Business Awards is an additional honour that everyone in the Contamac team can be immensely proud of,” said Simon Wyatt, director, who accepted the award.n www.contamac.com

Ocular tracking technologyAlcon has announced the acquisition of the ophthalmic division of SensoMotoric Instruments (SMI), a private company based in Berlin, Germany. Alcon said the acquisition provides it with leading ocular surgical guidance technology, such as real-time eye tracking, automatic registration of ocular imaging, and intraocular lens (IOL) positioning and alignment guidance, in order to help improve patient outcomes in cataract surgery. Alcon plans to integrate the newly acquired ocular surgical guidance technology into its existing global cataract portfolio.

“This acquisition further strengthens Alcon’s position in the cataract surgery market with an expansion into leading ocular tracking technology,” said Sabri Markabi, senior vice-president, research and development at Alcon. “The state-of-the-art guidance technology provides surgeons with customisation options and automated solutions, enabling optimal outcomes for their cataract patients including underlying refractive conditions.”n www.alcon.com.

New OCT platformsCarl Zeiss Meditec has introduced a new family of ZEISS OCT (Optical Coherence Tomography) products.

“The new CIRRUS OCT family is comprised of two new CIRRUS™ HD-OCT products, models 5000 and 500, and two new integrated multi-modality OCT and fundus imaging systems, the CIRRUS™ photo models 800 and 600,” said a company spokeswoman. “The new OCT platforms deliver clinical and workflow solutions that span the spectrum of care and address specific workflow and practice needs,” she said.n www.zeiss.de/press/pr00364827

wide-angle viewing systemOCULUS Surgical is now the sole source for the SDI®/BIOM® non-contact wide angle viewing system in the US, according to a company spokesman. OCULUS Surgical, Inc. is located in Port St Lucy, Florida, US, and is a 100 per cent subsidiary company of OCULUS, the inventor and producer of the SDI®/BIOM® system.

Rainer Kirchhübel, CEO of OCULUS Optikgeräte GmbH, said: “We are looking forward to continuing our positive partnership with our existing customers in the US through OCULUS Surgical, Inc.”n www.oculussurgical.com

ExploreNEWFRONTIERS

40 grants of €1000 to young ophthalmologists

who want to travel abroad to improve their skills

The ESCRS is awarding

Visit www.escrs.orgto apply

Feature

INDuSTRY NEWSRecent developments in the vision care industry

Fundus imaging Heidelberg Engineering has received FDA clearance for MultiColorTM Scanning Laser Imaging as a new dimension in multi-modality fundus imaging with the SPECTRALIS® product family.

“SPECTRALIS MultiColor imaging delivers high contrast, detailed fundus images - even in difficult patients including those with cataracts or nystagmus,” said Prof Sebastian Wolf, Head of Ophthalmology at the Inselspital in Bern, Switzerland. “In my experience with this technology, the overall appearance of MultiColor images is similar to those of colour fundus photographs,” he commented. “In addition, the increased detail and contrast in the MultiColor images has helped me to identify pathologies difficult to see on the corresponding colour fundus images.”n www.Spectralis-MultiColor.com

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EUROTIMES | Volume 18 | Issue 2

Toric IOL powerCalculating the correct toric IOL power for your patient poses a number of challenges, and current calculation formulas may not provide accurate answers.Dr Oliver Findl discusses the ins and outs of toric IOL biometry with Dr Jaime Aramberri, of San Sebastian, Spain, who addressed this question recently at the ESCRS Congress in Milan.

EYE CHAT

Exclusive interviewsUp to date informationProblem solving

podcastwww.eurotimes.org

Also available on iTunes

Scan this QR code to gain access to EuroTimes podcasts

Photorefractive keratectomy (PRK), is less widely ingrained in the popular consciousness than its close relation, LASIK. This is interesting, because PRK has several potential advantages that make it a useful alternative to the more widely known LASIK procedure. Whereas LASIK requires the creation of a flap of corneal stroma, which alters the tissue’s structural integrity, PRK utilises more superficial laser ablation, with less effect on the stromal tissue. This eliminates the risk of the corneal flap dislocation that can be experienced by patients who have undergone LASIK.

On the other hand, patients who undergo PRK might experience more pain and slower visual recovery in the postoperative period. Ideally, both doctor and patient will come to an agreement as to which procedure is most suitable. Indeed, “refractive surgeons must consider all of these techniques as a complete and varied armamentarium to satisfy the surgical needs of all the diverse clinical cases.”

A new text by Drs Lucio Buratto, Stephen Slade, Sebastiano Serrao and Marco Lombardo, aims to provide an overview of PRK in clinical practice. Entitled PRK: The Past, Present and Future of Surface Ablation and published by Slack Incorporated, the text is divided into Parts I and II.

Part I, written by the book’s primary authors, serves as an introduction to the corneal properties relevant to PRK. Chapter 1, “The Corneal Surface,” is an in-depth examination of corneal anatomy, epithelial renewal and remodelling of the epithelium and stroma after ablation by the excimer laser.

Chapter 2, “Optical & Mechanical Properties of the Cornea,” provides a detailed, technical explanation of optical aberrations and corneal biomechanics. What is the difference between lower- and higher-order aberrations? Monochromatic and polychromatic? And which biomechanical properties of the cornea are altered by photoablation? Chapter 3, “Photorefractive Keratectomy,” dives into the actual PRK procedure in its entirety: the dialogue with the refractive patient; the clinical history and preoperative examinations; evaluations for the various types of refractive error; and the surface ablation techniques themselves.

The patients must be seen postoperatively, so what about complications? How are they evaluated, categorised and most importantly, managed? Which can be expected to be

temporary, and which are likely to be permanent without correction? Enhancement treatments are also discussed. Although “the percentage of eyes retreated following PRK has been reduced considerably over the past 10 years,” there is still a need for those eyes that end up overcorrected or undercorrected, which are relatively simple to correct, as well as those that experience refractive regression.

The chapters in Part I, written by invited specialists, approach specific concepts rather than PRK as a whole. These include PRK enhancement following previous radial keratotomy and LASIK, smoothing in refractive surgery and a guide to performing custom ablation. “The Athens protocol: same-day topography-guided partial PRK and cross-linking” describes a procedure for visual rehabilitation in patients with corneal ectasia. The last chapter covers surface ablation to enhance previous LASIK.

All in all, this 100-page book provides the reader with a good introduction to PRK, its effect on the corneal surface and the results that both physician and patient can expect after the procedure. Reading it is a good investment for residents during their corneal or refractive surgery rotation; cornea fellows who are interested in applying these procedures in clinical practice; general ophthalmologists, who are frequently asked about refractive procedures by their patients; and even refractive specialists who are interested in new insights into the corneal microstructure and biomechanics.

Review

BOOK REVIEW

Tried and true

If you have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland

BOOKS EDITORLeigh Spielberg

PUBLICATIONPRK: The PaST, PReSenT, and FuTuRe oF SuRFace abLaTion

AUThORSLucio buratto, Stephen Slade, Sebastiano Serrao and Marco Lombardo

PubLiShed bY SLacK incoRPoRaTed

Page 50: Vol 18 - issue 2

Reference

CALENDAR OF EVENTSDates for your Diary

Advertising Directory: Abbott Medical Optics: Page: 13; Alcon: Pages: 3, IBC ; A.R.C. Laser Ag: Pages: 25, 27; ASCRS: Pages: 39, 44-45; Benz Research and Development: Page: OBC; Croma: Page: 11; D.O.R.C.: Page: 7; ESASO: Page: 36; Geuder: Page: 29; Haag Streit: Page: 19; Katena: Page: 32; Maya Idee s.r.l.: Page: 34; Medicel: Page: 9; Oculus: Page: 35; Oertli Instruments Ag: Page: IFC; Pranav Eye Care Centre: Page: 15; Rayner: Page: 10; SOE: Page: 41; Topcon: Page: 31; Ziemer: Page: 43

June

October

April MayMay

February

April

February March February

September October

June July July

November

20132013

2013

2013 20132013

2013

2013

2013 20132013

2013 2013

2013 2013

2013

European Society of Ophthalmology (SOE) 20138-11 COPENHAGEN, DENMARKwww.soe2013.org

10th Congress SEEOS and 3rd Congress of Macedonian Ophthalmologists20-23 OHRID, MACEDONIAwww.zom.mk

4th EuCornea Congress4-5 AMSTERDAM, THE NETHERLANDSwww.eucornea.org

4th World Congress on Controversies in Ophthalmology (COPHy)4-7 BUDAPEST, HUNGARYwww.comtecmed.com/cophy/2013/

Th e Visions of Gullstrand – 600 year jubilee31-2 JUNE LANDSKRONA, SWEDENwww.feinpat.hemsida24.se

ARVO5-9 SEATTLE, WASHINGTON, USAwww.arvo.org

Black Sea Ophthalmology Society Meeting24-26 TBILISI, GEORGIAwww.bs-os.org

3rd EURETINA Winter Meeting1-2 ROME, ITALYwww.euretina.org

ASCRS•ASOA Symposium and Congress19-23 SAN FRANCISCO, USAwww.ascrs.orgwww.asoa.org

27th International Congress of HSIOIRS28-3 MARCH ATHENS, GREECEwww.hsioirs.org

EuroLam 3rd Macula and Retina Congress22-23 FLORIDA, USAwww.euro-lam.org

17th ESCRS Winter Meeting15-17 WARSAW, POLANDwww.escrs.org

13th EURETINA Congress26-29 HAMBURG, GERMANYwww.euretina.org

XXXI Congress of the ESCRS5-9 AMSTERDAM, THE NETHERLANDSwww.escrs.org

International Meeting on Anterior segment surgery22-23 VERONA, ITALYwww.femtocongress.com

26th APACRS Annual Meeting11-14 SINGAPOREwww.apacrs.org

5th World Glaucoma Congress17-20 VANCOUVER, CANADAwww.worldglaucoma.org

AAO Annual Meeting16-19 NEW ORLEANS, USAwww.aao.org

48

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© 2012 Novartis 7/12 RES12175JAD_A-EU

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