european society of ophthalmology 10-13...

S@E2017EUROPEAN SOCIETY OF OPHTHALMOLOGY 1 0 -1 3 JUNE 2 0 1 7 I BARCELONA, SPAIN

{C 1 0 }

{AMD lOLs}

{11 June, 2017}

{08:00 - 09:30 hrs}

{Von Graefe}

HAND-OUTS

26/04/2017

INTRAOCULAR LENSES IN AGE-RELATED MACULAR DEGENERATION

Prol. Jorge L. Alió MD, PhD.Professor & Chairman of Ophtalmology

VISSUMInsfituto Offalmológico de Alicante

Universidad Miguel Herndndez Alicante (Spain)

Jo rge L Alio MD PhDVISSUM Institute Oftalmológlco de Alicante

Universidad Miguel Herndndez Alicante (Spain)

Disclosure of Conflict of Interest

UNIVEIttlTAS

s r M hZ L ,

Akkolens C.S • Oculentis c,sBloss L • Oftalcare NutravisionBlue-Green O • Omeros CCarl Zeiss Meditec s,c • Ophthec LCSO s • Presbia CDompe s • Santen c,oHanita Lenses c,s • Schwind Eye-Tech-Solutions L.SInt. Ophth. Consultants o • Slack, Inc. CJaypee Brothers Pub p • Springer Publications PMediphacos 5 Tekia, Inc. PMaghrabi Hosp. c • Topcon Medical Systems cNovagalt s • Vissum Corporation

• VisiDome00

C = Consultant / Advisor E = Employee L = Lecture Fees O = Equity Owner P = Patents / Royalty S = Clinical Reseach Grant

O

UNIVERS

Objective IB te i

• The aim of this work is to review the lenses in age- related macular degeneration with the assessment of their advantages and disadvantages.

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Introduction "”r V K l• Age-related macular degeneration (AMD) is one of the most

disabling disease of visual quality.

• 90% of the severe central visual acuity loss associated with AMD.

• Central scotomas appear in the final stage of macular degeneration. It usually does not affect the peripheral vision.[1,3]

• Age-related macular degeneration has been described as the leading cause of legal blindness, affecting 10%-13% of adults over 65 years of age in North America, Europe, Australia and, recently,Asia. [2]

^ U H IV E R S IT A SIntroduction MS££,I H rn tunJr:

• Visual rehabilitation with low vision magnifiers has been the mainstay of help for these patients:- hand/stand magnifiers, spectacles, hand held telescopes, closed

circuit televisions, and high plus spectacles in conjunction with high minus contact lenses to create a telescopic effect.

• Although these tools maybe effective for correcting overall visual functioning, there are several limitations (cumbersome to use and cosmetically burdensome). [4]

• Since several years, specially designed intraocular implants have become a possible and attractive way to circumvent many of the problems faced in extraocular visual aids.

• I I I I I «UNIVERSirMaterials and methods .;.t-■ We used Pub Med web platform to search for implantable devices in various

stages of AMD.

• We have searched for prospective or retrospective studies and case reports.

■ We selected English language articles.

• We selected articles strictly connected with intraocular lenses used in diagnosed A M } .

• Only lenses with peer reviewed, published clinical outcomes in human patients affected by AMD, were considered for this review.

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Results ...» f e , '

• A total of 7 ty p e s of lO Ls recommended for AMD have described clinical results in AMD patients:- Im p la n ta b le m in ia tu re te le s c o p e (IM T),- lO L-V ip S y stem- Lipshitz m a c u la r im p la n t (LM I)- S u lc u s - im p la n te d Lipshitz m a c u la r im p la n t (LM I-S I)- F resn e l Prism In t ra o c u la r Lens- IO L A M D- S c h a r io th M a c u la Lens.

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Results U L .OPTICAL FUNDAMENTALS OF lOLs for AMDG A L IL E A N TY P E T EL E S C O P E• The G alilean type telescope , is used in lenses IMT, lOL-Vip System and iolAMD• Two optical e lem ent with high positive and negative power should b e used in combination with the

cornea.• IMT ca n ach ieve higher magnification than lOL-Vip System and iolAMD because the positive and

negative lenses are em bedded in air. This configuration increases the dioptric power in ea ch of the lenses in an order of magnitude tha tcanno t be ach ieved with lenses em bedded in an aqueous medium.

• On the other hand it requires the implantation of a long tube through a larger corneal incision.• The IQL-Vip System requires implantation of the positive lens in the anterior cham ber and as in the

iolAMD there is a veision that incorporates a decentration of one of the lOLs to generate a displacem ent of the retinal image from a potentially dam aged central retinal a rea .

• The iolAMD incorporates asphericity in the positive lens to gain depth of focus and be highly tolerant to small changes in the nominal axial distance between both lenses.

• The lenses are smaller and thinner and the positive optical elements is implanted in the sulcus. [6-11, 15-17]

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Results IOPTICAL FUNDAMENTALS OF lOLs for AMDCASSEGRAIN CONFIGURATION• Used in the LMI.• Mirrors instead of lenses.• It can provide high magnification.• Higher manufacturing costs.• Additionally, the use of small mirrors might generate the risk of glare

effects, due to diffraction and ghosts reflections in the elements that should be further investigated in clinical trials. [12,13]

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ResultsOPTICAL FUNDAMENTALS OF lOLs for AMD

FRESN EL PRISAA• Fresnel Prism Intraocular Lens provides no magnification at all.• It only displaces the retinal im age from a potentially dam aged central macula

to a more peripheral healthier a rea in the retina.• The Fresnel approach (the partition of the optical surface in Fresnel zones) is

necessary here to provide the required tilt of the im age, as the introduction of a direct prism in the whole surface o f the lens would not be possible in p ractice (the lens would be too thick in one of the edges).

• A potential problem o f this approach might be diffraction and scattered light by the edges o f e a ch Fresnel zone. As shown in the figure 5 there might be some light that is scattered aw ay from the focal point and might be a source for glare. [14]

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ResultsOPTICAL FUNDAMENTALS OF lOLs for AMD

SCHARIOTH MACULA LENS• Based on magnification by closer distances. The closer the object

to the eye, the higher the magnification is.• This approach needs to consider that the subject is unable to

accommodate and for that reason it incorporates a +10 D central area in the lens.

• Magnification is only achieved when the object is in a range of 10 to 15 cm close to the eye.

• It provides no distance vision magnification. [18]

1. INTRAOCULAR MAGNIFIER TELESCOPE (IMT)

• The “ WA” prefix is used in respect to the two product models availab le differing in magnification: a W de Angle 2 2X and Wide Angle 2.7X. The first one gives full field of view o f 24 degrees, second one- 20. Other features are the sam e for both models.

• The IMT, com bined with the optics of the cornea, produces a telephoto e ffe c t that enlarges images in a patient’s central visual field 3x with a 20-2-4 degree field of view projected onto approximately 55° of the retina.

• monocular implantation• Provides central vision, while the other eye remains “as is” to retain peripheral vision, which is important

for maintaining ba lance and orientation.• IMT allows patients to see in both dynam ic and static situations a t near, intermediate, and distance

vision ranges. [6,19-21]• The IMT is a fixed-focus quartz glass lens with wide-angle micro-optics which is implanted in the

capsular bag through a 10-12 mm incision after the natural lens has been removed, (figure 1). Larger than most implanted devices, the IMT is a A A mm long telescope contained in a PMMA carrying device with an haptic-to-haptic diameter of 13.5 mm. Two modified C-loops facilitate in-the-bag fixation. The lens aperture is 3 2 mm. The IMT extends through the pupil and remains on ave rage 2.5 mm from the postenor cornea, preventing dam age to the endothelium.[5,9,2223]

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',^^UPUVER5ITAS1. INTRAOCULAR MAGNIFIER TELESCOPE (IMT) ....... ..

• First approved in June 2010 (US FDA), since 2014 is restricting implantation to patients older than age 65.

• Alió et al. (first systematic clinica report) performed a multicenter study: IMT was implanted in 40 eyes of 40 patients with dry-type AMD (12 months):- IMT played an imporlanl role In Improving near and far visual acuity In patients with stable dry-

lyp e AMD. However, they stressed the problem of severe visual field restriction and the cumbersome postoperative visual rehablitatlon. [8]

• Disadvantage of IMT implantation is a confined central visual field to 20-degree angle: binocularity is lost with this procedure.[8] (figure 1)

• The IMT is well documented in the literature. Two multi-year clinical studies have been conducted to evaluate the safely and efficacy of the telescope implant: the IMT-002 pivotal safety and e fficacy study and the IMT-002-LTM long-term monitoring safety study. (6.19)

UHIVER5ITAS1. INTRAOCULAR MAGNIFIER TELESCOPE (IMT) •

• At the 12-month mark, an assessment using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) dem onstrated that the te lescope implant significantly Improved quality of life in this study population. [19]

• Ocular complications included endothelial ce ll loss, Inflammatory/pigment deposits, transient cornea edem a and IOP elevation. [6,25,26]

• 3 eyes w as necessary the explantation of the lens because of patient dissatisfaction and w as implanted a conventional posterior cham ber IOL [8].

• Joondeph describes a technique In which these patients can be diagnosed via ocular coherence tomography imaging and treated with the standard ol care , intra-vitreal injection.

• Low vision specialists are an integral part of the procedural team because they teach patients exercises related to static and dynam ic movem ent. [27]

UNIVERSITAS1. INTRAOCULAR MAGNIFIER TELESCOPE (IMT) - I H E * ,

• Limitations of the IMT: Diagnosis and m anag em ent of CNV requires an OCT of the m a cu la .- The first obstacle is due to the IMT itself; it is difficult to get a c le a r view of

the m a cu la through the IMT. Fundus photography or ang iography through the IMT creates a minimized, distorted im age.

- Second limitation is that patients with the IMT m ay b e unab le to focus on the fixation target during an OCT session due to the loss of central vision, resulting in constant scanning or moving of the eye (lubrication ocular surface with artificial tears, best as possible dilation of the pupils, using anato m ica l landm arks such as the optic nerve to locate the m acu la r region). [30,31 ]

• Som e m odifications in certain features of the OCT m ach ine increase the likelihood of detecting retinal fluid in eyes with the IMT.

a UNIVERSITAS1. INTRAOCULAR MAGNIFIER TELESCOPE (IMT) ........

UNIVERSITASIf] Miguel {uHertidndezISSUM

UHIVERMIA

2. IOL-VIP SYSTEM I ł

■ Consists of 2 lOLsthat reproduce an intraocular Galilean te lescope:

- o r i iii-i ph.: p-A'-s- biconvex 11L ( :it pi. t .55 c; n tr e o-iteric r rfm 'ibe' [AC! 3c-s ■::: t-e e lective , (ig r e Z;

■ Both lenses are m ade of polymethyl m ethacrylate, have a 1-plece design, and provide ultraviolet light filtering.

■ The optic of the 2 lenses is 5 mm in diameter, with a maximum axial thickness ot 1.5 mm lor the AC IOL and peripheral thickness of 1.5 mm lor the in-the-bag IOL; their total length is 13 mm. The system provides an estimated magnification for d istance of 1.3.(5,10,11]

• Insertion ol lOL-VipSystem is p receded by a standard phacoem ulsification. Because of the thickness of the lOLs, the surgical protocol recom m end a capsulorrhexis with a diam eter of at least 6 mm to facilitate the implantation of the in-lhe-bag IOL, with the enlargement of the temporal com eal incision to up to 7 m m .[l 1]

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2. IOL-VIP SYSTEM Sgr t e t -• The candidates are selected using ded icated software that collects their

clinical data.• All patients undergo 2-week preoperative training [12 30- minute training

sessions) and a 3-month postoperative rehabilitation program (5 30-minute training sessions per week for 12 weeks) aimed at training and consolidating the preferred retinal locus [PRL).[5,11]

• One report described the outcomes observed in forty eyes of thirty five consecutive patients. [11 ] All patients showed an improvement of visual acuity (VA) due to Ihe surgical and rehabilitative procedure, confirming or exceeding the preoperative expected results.

• Mean postoperative best corrected visual acuity |BCVA) was 0.77 [logarithm of the minimum angle of resolution), com pared with 1.28 preoperatively.

• The mean postoperative best reading magnification gain was 6.2, and the mean postoperative reading distance gain was 7.66 cm .

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2. IOL-VIP SYSTEM -2-

• Well tolerated and did not seem to limit the peripheral vision field or interfere wifh binocular vision, thus making it suitable for monocular or binocular implantation.

• There were no severe complications intra or postoperatively with the exception of pupillary block. Preoperative iridotomy was performed in all ofher cases. [11]

• Given the size of the 2 lOLs and their proximity to critical ocular structures such (corneal endothelium and iris) exceedingly low endothelial cell count, and/or guttata are obvious contraindications.

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3. LIPSHITZ M ACULAR IMPLANT (LMI)

• C reated by dr Lipshitzin tw o versions

• 1-The Lipshitzmacular implant (LMI) conventional lO Lthat incorporates 2 miniature mirrors in the Cassegrain te lescopic configuration, magnifying the reflected im age on the retina 2.5 times. The patient thus sees a magnified central im age through the mirror te lescope and a normal non magnified im age through the periphery of the IOL.[12] (figure 3)

■ Overall diam eter of the IOL is 13.0 mm. and the optic is 6.5 mm. The anterior central mirror is 1.4 m m .The posterior mirror, w hich is doughnut shaped and 2.8 mm in diameter, has a central c lear a rea of 1.4mm in diameter. The peripheral zone of the optic is similar to that of a normal IOL to provide undisturbed peripheral vision. The reflecting surfaces of the LMI are coated with multiple layers of titanium oxide and silicon dioxide (dielectric coatings), which creates a mirror effect. The mirrors are 1 to 2 mm thick. The entire IOL is coated w ith poly-para-xylylenes [Parylene C ) to en h an ce biocompatibility. LMI isp laced through a 6.5 mm corneal tunnel in the capsular bag . [12]

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3. L IP SH ITZM A C U LA R IM PLANT (LM I) - T ! f c w ,

• Implanted in six worse-seeing eyes of 6 patients. However only four of operated eyes had AMD, two were with other m acular pathology. In all patients visual acuity was worse than 20/200 and It improved with a 2.5 magnifying external telescope preoperatively.

• There were no intraoperative complications.

• The m ean gain in d istance acuity was 3.66 lines +-1.88 (SD), and the mean increase in the Early Treatment Diabetic Retinopathy Study (ETDRS) score for near acuity was 50.83 +- 9.15 logMAR. The best corrected d islance acuity and near acuity improved significantly (both P = .014). [12]

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3. LIPSHITZ M ACULAR IMPLANT (LMI) V IS 1 ,• 2-The younger and improved brother of LMI has the same function - to magnify

the central image while the peripheral field remains normal.

• The main difference between the two lenses is that the newer LMI-SI is the equivalent of 2 lOLs and is well supported by placem ent within the capsular bag alone. LMI-SI is a non-foldable one-piece IOL positioned in the sulcus over a regular bag-implanted IOL.

• It is 5 mm or 6 mm in diameter, and it contains loops that have a similar configuration as a regular IOL (loop diameter is 13.5 mm). However, the LMI-SI is thicker, with a central thickness of 1.25 mm. After standard phacoemulsification the incision is then enlarged to 5 mm to 5.5 mm. After implantation a peripheral iridectomy is then done surgically.[13]

3. LIPSHITZ M ACULAR IMPLANT (LMI) ™

• According to a publication three patients were operated using LMI-SI IOL. The inclusion criteria fora pilot trial included patients with bilateral AMD (dry type, wet type or scar stage] or other similar macular lesions in which visual acuity ranged between 20/80 and 20/800 in each eye and improved for distance and/or near when tested with 2.5 magnification using an external telescope. Postoperative visual acuity of these patients is not given in the publication.!! 3]

• The LMI and LMI-SI provide magnified central images up to 2.5 times while maintaining the normal peripheral vision through the peripheral portion of the lens. Because of this, both of them can Be implanted in both eyes of a patient.[12,13] (figure 3)

,» U N IV E R S I7 A S4. FRESNEL PRISM IN TRAO CU LAR LENS tlrmjnArz

• N on-fo ldab le im p lan t m a d e o f PM M A. (figure 4)

• C re a te d for o p tica l d isp lac em en t of the cen tra l s c o to m a c a u se d b y AMD, in stead o f m oving the retina with all the risks in vo lved in m a c u la r trans location su rg ery .[l 4]

• For im p lan ta tion the re is a stan d ard p haco em u ls ifica tio n p erfo rm ed a n d a fte r a sc le ra l tunnel incision is m a d e for insertion.

• The p roto types of the d e v ic e h a v e a single o p tica l p o w er (+20.0 d iopters) for a p h a k ic co rrectio n , with a Fresnel Prism IOL fa sh io n ed o n the posterior su rface of the o ptic p rod ucing a fixed 6 -d eg ree d ev ia tio n , w h ich g ives retinal im a g e d isp lac em en t of 1.8 m m (thus describ ing a c ircu la r a re a of 3 .6 m m d iam ete r) fo r a 23.1 m m a v e ra g e e y e . [14]

UHIVER5ITA5UNivtns

4. FRESNEL PRISM IN TRAO CU LAR LENS ■ B f i S i

Preoperatively direction of the im age deviation w as identified using a handheld visuoscope to identify the preferred retinal locus for extrafoveal fixation. The uncorrected distance visual acuity (UDVA) o f all patients w as 0,05 and corrected distance visual acuity (CVDAJ w as betw een 0,05 - 0,16. After the surgery no objective testing o f scotoma displacement w as performed, however all patients reported displacement of the scotoma peripheral from their central field o f vision and that the scotoma w as less bothersome.

No patient described diplopia. One patient reported that she preferred her unoperated e ye to the e ye with the prismatic IOL, despite having a less obvious eccen tric scotoma in the operated eye. This was because she perceived the image to be clearer in the unoperated eye. Postoperatively UDVA in the 3 eyes was betw een 0.05- 0 .10 and CVDA 0,05 - 0 .16.(14]

Oculomotor functions and fixation stability control change in relation to the new preferred retinal fixation locus. The newly formed oculomotor funct tons c a n be improved by exercising or by spectacle prismatic im age relocation.[l 4] (figure 4)

The only one publication w e found about Fresnel Prism Intraocular Lens reports that the implant was fixed un ila te ral in 3 eyes of 3 patients with bilateral a dvanced nonexudative AMD.

_U N IV E R 5ITA5■ I Miguel Vmm Hernandez

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_ p - _ r». UNIVERSITAS5 . 10IAMD .iVjub 38SK;<• iolAMD is the newest type ot hydrophobic acrylic dev ice to improve vision to people

suffering from AMD.

* Based on a G a lilean te lescope using two lenses m anufactured so that they con bo in jected with a standard soft tip cartridge and injector system for 3.0-mm incision size, [figure 5)

♦ After implantation both implants allow a magnification of the im age and distribution of the retinal picture 3° apart from the fovea due to the slight intended decenfration of sulcus implanted IOL (0.85 mm).

The capsular bag positioned IOL (IOL2j is a high-minus-powerlens (-49 diopters [D]) with a 4.0-mm optic and an overall length of 11.0 mm. The plate haptic is symmetrical and vaulted posteriorly approximately 15°. The sulcus-positioned IOL (IOL 1J is a high-plus- powerlens (+63 D) and the 5.0-mm hyper-aspheric-optic is slightly decentered on the p late haptic . The overall diam efer is 11.75 to 12.0 mm and the haptic is bent anteriorly to enhance the recom m ended distance betw een the optics of 2 mm after im plantation.[15-1 7]

5. iolAMD• 3 eyes of two patientswith visually significant c a ta ract and dry m acu lar degeneration.

» Preoperative corrected d istance visual acu ity ranged from 0.03 to 0.16 and corrected near visual acuity w as 0.03 or less.

• Postoperative, corrected distance and near visual acuities increased to levels betw een 0,5 and 0,8 (uncorrected distance visual acuity wa» 0.3 to 0,6: unconrected near visual acu ity w asO ,I to 0,8).[15]

• All surgeries went without com plication. No intraocular pressure or iris-related problems.

• The patient with bilateral im plantationperceived no double vision because the decentrationaxis in both eyes w as vertical. The other patientw ith singular implantation recognized an increase in visual acu ity but com plained about diplopia in a vertical direction (which could be solved by prismatic spectacle correction). All lenses had been p laced in a vertical axis and the IOL implantations could be obtained safely and w ere stable during the 3-month follow-up. No postoperative rotation was necessary.

I S m ,_ . . . . . _ . . . UNIVERSITAS5. io lA M D .s s . t s t ,

• Another study 18 eyes of 12 patients had iolAMD implanted

« All surgeries were uneventful except in 1 eye in which the high-plus IOL was vaulting anteriorly, causing a reduction in the quality of vision.This high-plus IOL was replaced with a smaller-diameter IOL. after which there were no short to medium term sequelae. A precautionary intraoperative peripheral iridectomy was performed in 9 eyes (including the eye of patient 11 in which the high-plus IOL was rep laced). In 8 eyes, a single 10-0 nylon suture was used to secure the wound as a precaution.There was no difference between the mean preoperative and postoperative intraocular pressure. The mean endothelial cell density was reduced by 18%. The mean decimal CDVA improved from 0.12 preoperatively to 0.20 at 4 months, a 67% gain.[l 7|

♦ D isadvantage: no power ranges availab le, limiting this technology to eyes with an axial length of 21 to 23 mm with a resulting power of 21 D. The IOL power cannot be adapted perfectly to patient anatom y right now.[15] (figure 5)

<I>s'- » i S S L

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6. SCHARIOTH MACULA LENS• S ch ario th M a c u la Lons is a o n e -p ie c e fo ld a b le in trao cu la r h yd ro p h ilic a c ry l ic lens w ith a

c e n tra l m agn ify in g portion im p lan te d in th e c ilia ry su lcus o f p se u d o p h a k ic e y es , w h ic h im p ro ve n e a r vision in p a tie n ts w ith AM D. (figure 6)

■ The overall d iam eter of the IOL is 13.0 mm with 4 symmetric haptics. It has a central portion of 1.5 mm diam eter with an addition of +10,0 Dp and neutral remaining optical zone.[l 8]

■ Can be implanted simultaneously during uncom plicated standard phacoemulsification with in-the-bag posterior cham ber IOL (PC IOL) implantation o ryears after cata ract surgery what makes it unique among other lOLs implanted only during a procedure removing a clouded lens. Another exceptional feature of this dev ice is the smallest incision required for implantation - 2.2 mm.

• The m a c u la r a d d -o n IO L d o es not a ffe c t the perip hera l vision a n d d o e s not re d u c e b in o cu la rity a t no rm a l re ad in g d is ta n c e . B in ocu larity is re d u c e d only a t a re ad in g d is ta n c e o f 15 c m . At this d is ta n ce , th e im a g e o f the o th e r e y e w ill be blurry a n d not c a u s e d ip lo p ia . [18]

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6. SCHARIOTH MACULA LENS■ A minimum C D VA o f 0.1 is recom m end ed to a c h ie v e sufficient results. If CNVA is better a t 15

c m an d the patient is m otivated , might b e a good c a n d id a te for Scharioth M acu la Lens im plantation.

■ Possible contraind ications to im plantation of the m acu la r add-on IOL a re : co m p lica ted c a ta ra c t surgery . excessive zonular w eakness, excessive seco ndary c a ta ra c t , chron ic uveitis, a c t iv e rubeosis iridls, central co rn e a l opacities, an d inability to understand the princip le o f this Im plant (reduced read ing d istan ce , m axim um m agnificatio n).[18]

• The m acu la r add-on IOL w as im planted in the better seeing e y e in eight patients. The preoperative CD VA in the patients was betw een 0.05 and 0.4 . No in traopera live or postoperative co m p licatio ns occu rred . In all patients but o ne , the un corrected near visual a cu ity (UNVA) at 15 cm and CNVA im proved . The patient without im provem ent had a la rge a re a o f retinal pigment epithelia l a trophy o f the posterior po le an d a p reo perative CD VA of 0.05. Excluding the e ye with exud ative AMD, the results were: CN VA im proved by 5.0 lines with the m acu la r add-on IOL a t 15 cm versus with + 2.5 D correction a t 40 cm : it im proved by 2.4 lines with the m a cu la r add-on IOL at 15 cm versus with + 6.0 D correction at 15 c m . No patient had a postoperative d e c re a se in CDVA .[ 18] (figure 6)

J UNIVER5ITAS| ] Miguel i t Hernandez

Implantation of the SML into the ciliary sulcus. Position oF the SML in the ciliary sulcus.

UNIVERSITASI f ] Miguel

Hernandez

DISCUSSIONLIMITATIONS AND COMPLICATIONS OF lOLs FOR AMD

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Incision• The first striking advantage of some ot the lenses implantation is a simple procedure that can perform

e a ch surgeon trained with the facoemulsification surgery. Devices ike Scharioth Macula Lens or iolAMD need no wider incision than 3,0 mm, while IMI needs 10-12 mm. Ihe large incision could cause increased corneal astigmatism and the risk for further complications. In the size ot incision it is decisive whether the lens is foldable or not anrl this determines the material from which it is m ade - both Scharioth Macula Lcnsancl iolAMD a rc acrylc.[15,18]

Pseudophakic eye• Since most lenses or their parts arc implanted into a capsular bag, the result is that they a rc not

appiopiiu le lor pseudophakic patients. Ifle only two implants, which seem to meet these criteria are Scharioth M acula Lens and LMI-SI, the m acular add-ons to a standard IOL have the advantage that they c an be easily implanted in the f ila ry sulcus years after c a ta ra c t surgery without the neerl to cxplant the in-thc-bag IOL or right after standard phacoemulsification with regular bag-implanted IOL. [13,18]

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DISCUSSION “ -LIMITATIONS AND COMPLICATIONS OF lOLs FOR AMDCom pulsory iridoto my/iridectomy• In some cases developed a pupillary block with incleased in liaocular piessure and now a pie oi

intraoperative peripheral iiidotomy/ iridectomy should be done with implantation of lOI-Vip System,IMT and I MI-SI.(A,11,13) For the last one, Nd:YAG laser iridotomy is not recom m ended.[13]

Capsulotom y• Treatment with ncodymium:YAG laser is possible in such cases, but the laser beam should be

directed through the clear pari of Ihe haptic and not the glass optic in the case ol IMI. the posterior par t ot the IMT is pressing against the posterior r aspule, decreasing the incidence of posterior capsule opacification .[fi]

Fundoscopy• An important drawback that refers to some types of lenses such as IMT is a difficult or impossible

fundus examination. Although the IMT allows fundoscopy, the magnification is not enough to evaluate foi microscopic changes in the fovea (eg. progression of AMD) or detect possible postoperative posterior segment complications of catarac t surgery such as cystoid m acular edema or retinal detachm ent. In the case of a sudden and profound decrease in visual acuity, only ultrasonography provides clues to the cause .[9]

• Also LMI shows diffic ulty in seeing the orci sonata due to glare. A good central fundus view is possible around the mirrors however fundus photographs taken from the center ot the Ions for patients with implanted LMI had reflections from the posterior mirror.(12]

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D ISCU SSIO N VU*sr.M ^ HerrifinrfezLIMITATIONS AND COM PLICATIONS OF lOLs FOR AMD

Rehabilitation• .enses such as lOL-Vip System require com plicated v is ja l rehabilhation. There is a special lOL-Vip

software which designs the rehabilitation strategies based on preoperative and postoperative trail .tv ) ol ih ep re ierrea retinal locus. All patients unoergo ?-week preooerative training (12 30-

.orativc rehabfitation proaram (5 30-^11 sessions per week for 12 weeks) a i~ ed at trcin'ng and consolicating preferred retinal locus Tnere were cases of unstable and peripheral preferred retinal locus with large search m oveiro rts that d d not c h a rg e with the rehabilitation tra ir ing .f I]

• Some authors say -hat also patients after IMT implan-ation require intensive training postoperatively and it takes takes 3-6 months but there is no information abou* the -ype of this rehabil'tation. It snould be p c r-ormcd by trained low-visior specialist [6,8.9]

Vision field• What makes 'h e seńous drawback wi*h some cf the lenses like IM~. is that m agnificatior at both long

and shod cistances is achieved at the cost of a reduction in ’ he visual field and depth c f focus. “ [15.16] Thus, bilateral implantation is not poss'ble. The device is implanted in one eye only, leavirg the fe low eye to com pensate for periphera v'sion.[6.11 ]

• On the opposite side are macular cdd-on lOLs which do not affect the per’phera vision and do not reduce binocularity at normal re ad ira distance.(18|

^ UNIVERSIUS

C o n c lu s io n s T J t e L :

• There is no one ideal lens for use in existing AMD free from the drawbacks.• The outcomes reported so far are variable and most probably are only been

focus on short term outcomes.• The main problems found in the use of this technology are the strict patient

selection criteria required to avoid quick evaluative forms of AMD and the need to choose eyes with a potential for visual rehabilitation.

• Patients need visual rehabilitation programs and that much of the success will depend on it.

• An important commercial bias may be present, however, in the reports of some of the iolAMD models due to possible conflict of interest because of financial relations with the companies producing these lenses or are the owners of patent rights.

• Independent clinical studies with longer follow up data are necessary prior to the general use of these optical devices is needed.

VisionCare Ophthalmic Technologies

WA - IMT ł § fi •> , «</

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Eli Aharoni

CentraSiqhtRestore the Center of Your World J

SO E 2017

www.visioncareinc.net

http://www.visioncareinc.net

Disclosure VisionCare'OPHTHALMIC TECHNOLOGIES

My Disclosure :

Eli Aharoni - VP R&DVisionCare Inc.M: + 972-52-2426400 mail: [email protected]: www.CentraSight.com corporate: www.visioncareinc.net



mailto:[email protected]

http://www.centrasight.com/

http://www.visioncareinc.net/


Regulatory status and world approvals

The IMT (by Dr. Lipshitz) approved for use in:

USA, by FDA (PMA with full CMS reimbursement) European countries (CE Marked),Canada - Health Canada LicenceSouth Korea and Australia - In final process .

The NG, Next Generation device is approved in:

European countries (CE Marked),




Implantable Miniature Telescope

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Telescope technology (Galilean concept)

Device Specifications 1 VisionCare/j9 OPHTHALMIC TECHNOLOGIES

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Magnification 2.2X / 2.7X

Optics dia 3.60 mm

Axial length (height) 4.40 mm

Weight 120 Mg(60Mg in aqueous)

Overall diameter (haptic loops) 13.5 mm(adapted for sulcus fixation)




CentraSight™ - Patient Process

Selection• MD (retinal)• Low Vision

Treatment• Surgical Process

Rehabilitation• Optometric team

C e n tra S iq h tA New Vision for End-Stage AMD




Key Criteria

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Key ContraindicationsVisionCare-1 OPHTHALMIC TECHNOLOGIES

Presence or treatment of active CNV (within last 6 months)

Hx RD or retinal vascular disease

Myopia > 6.0 D; Hyperopia > 4.0 D

Steroid-responsive rise in IOP, uncontrolled glaucoma, IOP >22 mm Hg, or on maximum medication

Previous intraocular /cornea surgery in the operative eye




Surgical Procedure

Similar to Cataract on a larger scale


www.visioncareinc.net>


Surgical Technique

12 mm limbal incision

Large 7 mm capsulorrhexis

Multi-viscoelastic technique -

Cohesive & Dispersive




Special device forceps

Lift cornea 5 to 6 mm

Wound ClosureVisionCare'1 OPHTHALMIC TECHNOLOGIES

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Tight incision by multiple interrupted sutures

Peripheral iridectomy

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Operative Pearls

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Long - Term Visual Acuity - FDA study

217 subjects, 5Y follow up


Lines Gained

> 2 lines 80%

> 3 lines 67%

> 4 lines 46%

> 5 lines 27%

> 6 lines 12% Jwww.visioncareinc.net


Visual Acuity - commercial field results **

Patient Pre-Op VA Post-Op VA Lines Improved

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** Curtesy of:Dr. Aaleya Koreishi, MD, Cornea Consultants o f Texas,

Fort Worth, Arlington, TXwww.visioncareinc.net


Visual Acuity - commercial field results **

Pre-op VA Post-op VA Lines Improved

CF @ 4ft 20/60 7

CF @ 3ft 20/100 7

20/400 20/100 6

* * Courtesy of:Dr. Sumit (Sam) Garg M.D., Vice Chair o f Clinical Ophthalmology

Medical Director, Associate Professor Gavin Herbert Eye Institute,

University of California, Irvine




Endo

theli

al Ce

ll De

nsity

(E

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Cells

/mm

24-Yr - Endothelial Cell Density Results

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Distribution of BCDVA Change at 2 Years

1009080706050403020100

(186 study subjects)

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Success with IMT

Patient selection!■ t a < - t J)/° °

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Overall

General Vision

Near Activities

Distant Activities

= Social Functioning

Dependency

Mental Health

Role Difficulties

Color Vision

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General Health

Peripheral Vision

Driving

Ocular Pain

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Clinically Effective / Cost Effective

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10 US peer-reviewed publications Top-tier ophthalmic journals Conclusions: "clinically meaningful improvements" for unmet need

Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting

from End-Stage Age-Related Macular Degeneration: 1-Year Results

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PO visualization & treatments

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Retina Group of Washingtonwww.visioncareinc.net


PCO treatment (Needling)VisionCare-1 OPHTHALMIC TECHNOLOGIES

Rare, 1 case from 250 subjects




Importance of the Peripheral lights restrictor

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Image contrast and brightness are critical parameters in dual optical systems.

Light rays pass through telescope and through the periphery as well creating on retina superposition of two images which have different magnification and light density.

The image brightness formed through the periphery is higher than the image formed by the telescope (due to magnification).

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When those two images formed superposed on the retina, the resulted image contrast is dramatically reduced by power periphery lights.

This is the reason why the periphery light blocked by light restrictor, and assuring best contrast of the telescope image.




A/G Device &

Preloaded Injector

VisionCare'ft

OPHTHALMIC TECHNOLOGIES

NG Device - what is it ? VisionCare'1 OPHTHALMIC TECHNOLOGIES

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What improved ?

Surgery related:

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What improved ? (continued)

Design related:

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NG Device risk reductionVisionCare'1 OPHTHALMIC TECHNOLOGIES

Parameters NG device WA deviceCorneal incision size 7 mm 10-12 mm

Capsulorrhexis size 5.5 mm 7 mm

Surgery duration 30 min 60 min

ECD - density loss(surgery related)

9 -1 4 % 23-25%

Corneal clearance - ACD (avg) 3.5 mm 2.5 mm# of stiches(risk of astigmatism related)

3-4 10-12

Manipulation Low High




NG Device assemblingVisionCare-1 OPHTHALMIC TECHNOLOGIES

■ Same telescope + black haptic & restrictor

■ Sterile Barrier system - manual loading accessories (available)

■ Automatic preloaded injector - phase 2

Cartridge

Loading piston NG Device




Sophisticated injector

1st. 2ndFirst loop acts as Other two loops slide

“Lever of Archimedes” into the bag

Auto-aligned & stable fixation VisionCare'1 OPHTHALMIC TECHNOLOGIES

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\WOrientation dot aligned

to 12 o'clock




Surgeon's point of view....

Same Efficacy - Better Safety - Auto Aligned Fixation,

Credited to Dr, David Keegan




Patients point of v iew ...

■ Fast rehabilitation on week one PO(vs 5 weeks with WA)

■ Better indication basket

■ less traumatised eye post op

Endothelial Cell Loss - comparison

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Human Surgery - Dr. Keegan, Dublin

6.5 mm cut 32 min duration 3 stiches




2nd phase (r&d) - preloaded injector -^oncare-

Objectives (2018):

■ Pre-loaded automatic injection system

■ System embedded with Dual Action Tip (DAT)

■ DAT used with OVD injector + NG injection

VisionCare'1 OPHTHALMIC TECHNOLOGIES

Thank You

Eli Aharoni : [email protected]



mailto:[email protected]


european society of ophthalmology 10-13...

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