Sponsored as an educational service by Advanced Medical Optics

January 1, 2005

Kerry K. Assil, MD,is the medical director for the Assil Sinskey Eye Institute inSanta Monica, Calif.

Eric D. Donnenfeld, MD,is the medical director of the TLC Laser Center in New York.He is also a partner with Ophthalmic Consultants of LongIsland and Connecticut and is on the Cornea/External Diseaseeditorial advisory board of OCULAR SURGERY NEWS.

R. Doyle Stulting, MD, PhD,is professor of ophthalmology at Emory University School ofMedicine and is a practicing ophthalmologist at Emory VisionCorrection Center in Atlanta, Ga.

John D. Hunkeler, MD, is chairman of the Department of Ophthalmology at theUniversity of Kansas School of Medicine and is the founderand medical director of the Hunkeler Eye Institute in OverlandPark, Kan.

Elizabeth A. Davis, MD,is assistant clinical professor of ophthalmology at theUniversity of Minnesota and is a practicing ophthalmologist atMinnesota Eye Consultants in Minneapolis.

Francis W. Price, MD,is president of the Price Vision Group in Indianapolis, Ind.

Phakic IOL technology is an alternativetreatment for patients with myopia, hyperopiaand astigmatism. First introduced in 1978 for thecorrection of aphakia, the phakic IOL already hasa successful 18-year track record in Europe.According to the National Eye Institute, myopiaaffects up to 25% of the U.S. adult population.Thus, phakic IOL technology fills a need foradditional treatment approaches for thecorrection of refractive errors. On Sept. 10, 2004,the Food and Drug Administration (FDA)approved the Verisyse phakic IOL (AdvancedMedical Optics [AMO], Santa Ana, Calif.). Thisroundtable symposium addresses the clinicalaspects, surgical techniques and ongoingresearch associated with phakic IOLs, whilespecifically addressing the treatment of myopiawith the Verisyse phakic IOL.

Richard L. Lindstrom, MDChief Medical EditorOCULAR SURGERY NEWS

Richard L. Lindstrom, MDChief Medical Editor, OCULAR SURGERY NEWS

Moderator

Copyright © 2004. SLACK Incorporated. All rights reserved. The ideas and opinionsexpressed in this OCULAR SURGERY NEWS monograph do not necessarily reflect those of theeditor, the editorial board, or the publisher, and in no way imply endorsement by the editor,the editorial board, or the publisher.

INTRODUCTION

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Patient criteria for phakic IOL implantationRichard L. Lindstrom, MD: Verisyse (AdvancedMedical Optics [AMO], Santa Ana, Calif.) is the firstapproved phakic IOL approved by the Food andDrug Administration for the correction of myopiafrom 5 D to 20 D. What are your patient criteria forimplanting a phakic IOL?

Eric D. Donnenfeld, MD: A variety of patients aregood candidates for phakic IOL implantation.Generally, patients who have higher degrees ofmyopia are not candidates for LASIK or PRK. Thesepatients will now be able to achieve visual clarity,better contrast sensitivity and a higher quality ofvision with phakic IOLs. Additionally, patients whoare contraindicated for laser corneal ablative proce-dures because of thinner corneas or topographicirregularities will benefit from phakic IOL implanta-tion.

Elizabeth A. Davis, MD: I would consider implan-tation with the Verisyse IOL for any patient whoserefractive error is -8 D and higher. The highest degreeof myopia that I will treat with a laser corneal abla-tive procedure is 12 D for patients who have no othercontraindications.

Francis W. Price, MD: Phakic IOLs definitely seemto provide a better quality of vision than laser refrac-tive surgery for those with refractions of minus 10 Dor more. They may also be better for those over 8 D,but that still may be debatable. I also recommend theVerisyse for any one over 5 D of myopia whosecorneas may be too thin for laser refractive surgery,or who may have questionable topography.

R. Doyle Stulting, MD, PhD: When determiningwhether a patient is a candidate for phakic IOLimplantation, I will consider not only refractive error,but also corneal thickness, topography and keratom-etry readings. Patients with thin corneas are not goodcandidates for LASIK because these are risk factorsfor ectasia. Patients with high myopia and flat

corneas may have poor quality of vision afterLASIK.

Kerry K. Assil, MD: For patients with refractiveerrors higher than 10 D, I will implant the VerisyseIOL. Between 7 D and 10 D of refractive error is agray zone and my procedure depends upon corneal

thickness, pupil size, anterior chamber depth andcorneal curvature. For eyes with thinner corneas,larger pupils, deeper chambers and flatter corneas Iwill implant the Verisyse. Below 7 D of refractiveerror, I will typically perform LASIK or PRK. Theonly exception is when a patient has mild cornealectasia — if this is the case, I will implant theVerisyse down to 5 D of refractive error.

Lindstrom: Dr. Hunkeler, your practice has focusedon cataract surgery for some time. With the approvalof the Verisyse, your patient base will expand toinclude patients who are seeking refractive

The New Refractive Option:

Iris-fixated Phakic IOLs

Phakic IOLs definitely seem to provide

a better quality of vision than laser

refractive surgery for those with

refractions of minus 10 D or more.

— Francis W. Price, MD

4

procedures. At what level refractive error wouldpatients have to be for you to begin discussing phakic IOLs?

John D. Hunkeler, MD: My personal practice hasfocused on cataract surgery for over 30 years but Ialso monitored refractive surgery and oversaw thedevelopment of PRK and LASIK and monitored this

carefully. As a result, I am interested in offering pha-kic IOLs certainly for patients who are over -8 D andconsider Verisyse for patients from –5 D to -8 D as analternative to LASIK.

Lindstrom: It is my understanding that approxi-mately 20% of the surgeons who have expressedinterest in phakic IOL courses are actually cataractsurgeons who do not perform laser refractive surgery.

Donnenfeld: The approval of a phakic IOL instantlyprovides surgeons who have essentially ignoredrefractive surgery for the last 10 years the opportuni-ty to perform refractive procedures. Implanting pha-kic IOLs does not involve a new skill set for cataract-only surgeons — in fact, many of the techniques thatthey have perfected over the years will help to ensurethe safety of the procedure.

Lindstrom: I would estimate that most surgeonswho are currently performing laser surgery wouldcontinue to use laser surgery for patients up to –8 Dto –10 D. Dr. Hunkeler, because you do not perform

laser refractive surgery, would you implant theVerisyse in a patient with myopia as low as 5 D andwho would otherwise be a candidate for lasersurgery?

Hunkeler: That is not correct. I now perform LASIKand, based on information from John Vukich, MD,comparing phakic IOLs to LASIK, even lower levelsthan -8 D to -12 D would have better visual outcomewith the phakic IOL than LASIK.1 I will be comfort-able offering LASIK up to -7 D to -8 D but for lowerpowers, I will recommend LASIK.

Assil: During the clinical trials with the VerisyseIOL, one of our biggest challenges to find patientswho were willing to have this IOL implanted becausethey had never heard of it. One of the benefits of FDAapproval is that it has increased public awareness tothe point where patient are asking to have theVerisyse implanted without solicitation. Ironically, Iam finding that a small subset of patient who ask forthe Verisyse have only 2 D or 3 D of myopia and theyare disappointed that I will not implant a phakic IOL.

Price: It will be interesting to see how LASIK willstand up to the competition of phakic IOLs becausethe IOLs are so stable and predictable.

Lindstrom: I agree. Additionally, the quality ofvision with phakic IOLs is high.

Price: With LASIK, as the amount of correctionincreases, the amount of scatter from the intendedcorrection increases regardless of the platform that isused. However in the Verisyse study, we have foundthat the results are very consistent and close to theintended correction regardless of the amount ofrefractive error and the quality of the visual resultwas excellent even with the higher amounts of cor-rection.

Donnenfeld: In any refractive procedure, I am mostconcerned with how the cornea looks after surgery. Inthe past, refractive surgeons have adhered to anunwritten rule that corneas should be no flatter than akeratometry reading of 35 D or 35.5 D after surgerybecause the postoperative visual degradation in flat-ter corneas is significant.

Perhaps we should strive for keratometry readingsof 36.0 D or 36.5 D instead and use phakic IOLs toimprove the quality of vision for these patients.Patients who have keratometry readings between

OCULAR SURGERY NEWS

I am interested in offering phakic

IOLs certainly for patients who are

over -8 D and consider Verisyse for

patients from –5 D to -8 D as an

alternative to LASIK.

— John D. Hunkeler, MD

5

39 D to 40 D with a refractive error of -6 D may havebetter results with a phakic IOL than with LASIK.The postoperative cornea should be a considerationwhen deciding between these two procedures.

Lindstrom: Another type of patient who will benefitfrom Verisyse phakic IOL technology is one withthinner corneas. Currently, patients who are -6 D andwho have corneas in the range of 480 µm to 500 µmwould not be good candidates for laser ablation.

Hunkeler: I believe a significant number of patientswho have avoided laser correction will now be drawnto phakic IOL implantation.

Price: One of the major advantages to phakic IOLimplantation is that it is reversible, which is helpfulfor a patient who later develops a cataract. The lenscan easily be removed and it does not complicate thecalculation for the pseudophakic correction asLASIK and PRK often do.

Lindstrom: What are the contraindications forimplanting a phakic IOL?

Donnenfeld: First, patients with a pre-existingcataract would not be candidates for this procedureand should consider other refractive options. Second,while long-term follow-up with the Verisyse hasshown little endothelial cell loss over time, patientswho have pre-existing Fuchs’ dystrophy or a lowendothelial cell count would not be good candidatesfor phakic IOL implantation. Additionally, patientswho have a history of or ongoing chronic inflamma-tion, persistent uveitis, iritis, significant wound-heal-ing abnormalities, rubeosis irides, significant macu-lar degeneration or corneal irregularities would notbe candidates. In my opinion, surgeons who are con-sidering this procedure should have a specular micro-scope in their office or be comfortable performingspecular reflection.

Price: Two other contraindications for phakic IOLimplantation are a shallow anterior chamber (lessthan 3.2 mm) and a large pupil diameter (larger than7 mm).

Lindstrom: The FDA trial for Verisyse was basedon 5-mm and 6-mm optic lenses. The trial guide-lines indicated that patients whose pupils were larg-er than the optic size in mesopic conditions shouldnot be implanted with the IOL. The most common

postoperative side effect with Verisyse is nighttimehalos, which may be related to pupils dilating outpast the optic edge.

In LASIK, night vision symptoms are not corre-lated to pupil size, but to residual myopia, astigma-tism or various optic aberrations (personal communi-cation, 2004). I believe that this will also be found tobe the case with the Verisyse.

I will implant the Verisyse in patients with largerpupils, but require informed consent before doing so.

Donnenfeld: A scotopic pupil should be no morethan 1.5 mm larger than the size of the IOL. If apatient has a 7.5-mm pupil, I then am comfortableimplanting a 6-mm optic IOL.

Assil: In the clinical trials, we noted greaterdegrees of glare and halos associated with 5-mmvs. 6-mm optics. A centered 6-mm IOL seems to betolerated well, even in eyes with an 8-mm pupil. Ifound that glare is more often associated with anover-aggressive peripheral iridectomy (PI) than it iswith a mismatch between pupil and optic size, aslong the optic is well-centered over the entrancepupil. And so, for that reason, I’ve switched todoing exclusively inferior PIs.

Hunkeler: A major contraindication for LASIK isdry eye. Is dry eye an indication for phakic IOLimplantation for patients who would otherwise becandidates for LASIK?

Donnenfeld: For a patient who has pre-existing dryeye and wants refractive surgery, I would consider aphakic IOL. Phakic IOL implantation does notchange the corneal contour, normal tear mechanismsare kept in place and, postoperatively, the lid movesover the cornea normally, so dry eye is neitherinduced nor exacerbated.

Patient management with phakic IOLsLindstrom: When you have a good candidate forthe Verisyse, what are the key issues in informedconsent?

Davis: First, I will discuss vision-threatening com-plications such as the risk for infections and cataractformation. I will also discuss retinal detachment —although Verisyse is not associated with this compli-cation, any patient who has a high degree of myopiawill be at higher risk for retinal detachment over thecourse of their lifetime, independent of surgery. I

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6

clarify this with patients because they typicallyattribute negative postoperative events to the proce-dure when this is not always the case.

Donnenfeld: Patients who are more than -8 D andwant a refractive procedure I refer for a preoperativeretinal consultation. I also instruct patients postoper-atively that they will continue to have added risksbecause of the nature of high myopia. These patientsshould have routine ophthalmic evaluations.

Davis: It behooves every surgeon to bring up thepotential for loss of vision and impress upon eachpatient the seriousness of the surgery. I also discussthe side effects, such as glare and halos, that are asso-ciated with every type of refractive surgery. There isalso a potential for bleeding or inflammation fromthis procedure, as well as the possibility for overcor-rection or undercorrection, both of which mayrequire either IOL exchange or LASIK enhancement.

I discuss the importance of protecting the eye aftersurgery with all patients who undergo a cataract orrefractive procedure.

Donnenfeld: I have found that the informed consentprocedure for the Verisyse phakic IOL is a combina-tion of the discussions that I have with my cataractand laser refractive surgery patients. I talk to patientsabout some of the risks associated with an intraocu-lar procedure, but most of my time is spent on therisks and benefits of the refractive procedure, includ-ing glare and halos, as well as the possibility that thepatient may need an enhancement postoperatively.

Stulting: Candidates for phakic IOL implantationmust know is that a phakic IOL may not complete-ly correct their refractive error and that the incisionitself may induce astigmatism. Patients must beaware that they may have residual myopia orhyperopia postoperatively. The surgeon must alsoexplain that intraocular surgery carries with it thepotential risk of infection, cataract formation anddamage to the cornea. While these complicationsare unlikely to occur, patients must be informed ofthe risk.

The retinal detachment rate is not significantlydifferent from that which is seen in patients withmyopia. However, I will still include this risk in ourinformed consent because patients with highmyopia who have retinal detachments after phakicIOL implantation may attribute the detachment tothe phakic IOL.

Lindstrom: How do you counsel patients on thetopic of visual recovery and when they can resumetheir normal activities?

Davis: Visual recovery is fairly quick in eyes that areimplanted with Verisyse. Most patients are function-al the next day after surgery. However, the final visu-al outcome might not occur until I remove the threesutures at the 6-week postoperative visit. I also tellpatients to avoid any heavy exertion for the first 2 weeks.

Stulting: I tell patients that postoperatively, theywill see an immediate improvement in their uncor-rected visual acuity (UCVA) if their surgery wasperformed under topical anesthesia. If their surgeryis performed under local anesthesia, I will tell themthat their UCVA will improve 1 day postoperative-ly. Generally, patients are able to resume normalactivities within 1 day.

Lindstrom: How long do you wait before implant-ing the Verisyse in the fellow eye?

Davis: I typically wait 1 week before performinganother surgery, but I may consider performingsurgery even earlier in certain cases. In Europe,some surgeons are performing bilateral proceduresunder general anesthesia. Although I will not per-form bilateral surgery, I would consider shorteningmy waiting time to a few days for certain patientswho make this request.

Assil: There are some surgeons who are alreadyperforming bilateral implantation with the VerisyseIOL. However, I would caution against this — Icurrently am implanting them 1 day apart. I findthat waiting 1 day is significant because a smallnumber of patients are at risk for acute IOP spikesand severe inflammation.

Lindstrom: What kind of anesthesia do you use toperform Verisyse implantation?

Price: I offer my patients a choice between a generalor topical anesthesia. However, no patient hasrequested general anesthesia in several years. I haveadministered general anesthesia in the past becausesome patients had difficulty laying still for the proce-dure. Most cases are easily handled with topical anes-thesia. I use pledgets soaked in Xylocaine 2% (lido-caine, AstraZeneca) on the site where I will make my

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7

posterior limbal incision. There are several advan-tages to topical anesthesia, including the ability tohave the patient change their direction of gaze asneeded during the procedure for wound construction,lens insertion and such. I have not found problemswith patient discomfort either during the woundmanipulation or enclavation of the lens.

Davis: I prefer to use a peribulbar block. Although Ihave not performed any procedures with generalanesthesia, I would not hesitate to use it for a patientwho is unable to remain still.

Donnenfeld: I also perform all my cases with aperibulbar anesthesia. For new surgeons, it isimportant to differentiate between retrobulbar andperibulbar anesthesia. Patients with high degreesof myopia have long eyes, so a blunt-tip needleshould be used instead of considering a retrobul-bar injection. I could administer topical anesthe-sia, but my patients who are receiving the VerisyseIOL are typically younger so I have greater con-cern about movement and resulting damage to thecrystalline lens.

Lindstrom: Do you use preoperative eyedrops?

Stulting: I use topical antibiotics preoperatively andtopical antibiotics with steroids and non-steroidalanti-inflammatory drugs (NSAIDs) postoperatively.

Donnenfeld: Preoperatively, my two primary con-cerns are to prevent infection and to make the pro-cedure as comfortable as possible for the patient.To address these concerns, I use a preoperativeantibiotic and an NSAID. Using an NSAID for sev-eral days preoperatively yields a more comfortableeye, so I use both Zymar (gatifloxacin, Allergan)and Acular LS (ketorolac tromethamine 0.4%,Allergan), four times a day, beginning 3 days priorto surgery.

Lindstrom: I agree that patients should be treatedwith preoperative antibiotics and NSAIDs. I followthe same regimen as Dr. Donnenfeld, except that Ialso pretreat with a steroid on the day of surgery.

Dr. Price, do you constrict the pupil?

Price: I have performed some Verisyse implanta-tions without constricting the pupil because thebright lights of the microscope often create enoughconstriction. However, I have found that somepatients can dilate during the case if pre-operativepilocarpine is not used. As a result, in most cases Iuse 1% pilocarpine preoperatively two times in theoperating room. However, I am hesitant to use pilo-carpine on patients with significantly high myopia.

Davis: I use one drop of 1% pilocarpine preopera-tively and I supplement it with intraocular Miochol-E (acetycholine chloride, Novartis Ophthalmics)because peribulbar anesthesia typically causes somepupil dilation.

Lindstrom: I use Isopto Carbachol (carbachol,Alcon Laboratories, Inc.) rather than Miocholbecause of its longer duration of action. One of myconcerns is the postoperative IOP spike and I havefound that Isopto Carbochol and 1% pilocarpine areeffective tools.

Assil: I use 2% pilocarpine prior to the capsuloto-my and Miochol-E intraoperatively. I do not rec-ommend using topical anesthesia because theMiochol-E will cause significant ciliary painbecause of the intense constriction of the pupil.Instead, I use intracameral lidocaine.

OCULAR SURGERY NEWS

The surgeon must also explain that

intraocular surgery carries with it the

potential risk of infection, cataract

formation and damage to the cornea.

While these complications are

unlikely to occur, patients must be

informed of the risk.

— R. Doyle Stulting, MD, PhD

8

Surgical techniquesLindstrom: How do you create the incision forimplanting the Verisyse?

Hunkeler: I perform an abbreviated limbal perime-try, cauterize the limbus and make a groove in theposterior limbus dissecting into the clear cornea withthe appropriate diamond paracentesis on each side. Akeratome entry is made in the center of the 5.5-mmor 6.0-mm superior incision.

Donnenfeld: I prefer to use a three-plane limbal inci-sion with a 2.65-mm keratome, which I also use forcataract surgery. However, I differentiate the incisionfor the Verisyse by extending it to the left and theright. I then use 10-0 polypropylene sutures to closethe wound, which works well.

Davis: I use a limbal incision and suture the woundwith three interrupted 10-0 polypropylene sutures.

Stulting: I create a tri-plane incision in clear corneawith metal blades at the limbus centered on the steepmeridian to reduce postoperative astigmatism. Theincision closes easily with two or three interrupted10-0 nylon sutures.

Lindstrom: What is enclavation?

Price: Enclavation refers to the means of fixation ofan iris-fixated IOL. The Verisyse has split haptics thatcome together when the IOL is implanted. To fixatethe Verisyse, the surgeon must use an enclavationtool to capture a “knuckle” of the iris (Figure 1) andbring it up so that the two sides of the split hapticcome to rest underneath the knuckle, thus fixating inthe iris (Figure 2).

While it has been suggested that this method offixation may cause the haptics to rub against the iris,leading to inflammation and, eventually, a free-float-ing IOL, I have been implanting the Verisyse for 6years and have seen no evidence of any damage tothe iris. Additionally, the fixation is permanent — theIOL does not drift or pull loose with accommodationor tension to the pupil.

Lindstrom: What about the Verisyse makes you feelcomfortable that this will be a long-term solution foryour patients?

Davis: I have to admit that before I began implantingthe Verisyse, I was skeptical about its abilities to

work long- or even short-term. However, I have beenimplanting this IOL since 2000 and when I seepatients from 4 years ago, the Verisyse remained wellfixated with stable and excellent visual outcomes.

A few years ago, I had the opportunity to speakwith the inventor of the iris-fixated phakic IOL, JanG. F. Worst, MD, at the American Academy ofOphthalmology annual meeting. He said that he hasperformed follow-up on patients in whom heimplanted the Verisyse 20 years ago in pseudophakicor aphakic situations. He has seen no progressivedamage to the iris in any of these patients and theIOLs look as if they were implanted yesterday. Thisindicates that the Verisyse has excellent long-termstability.

Lindstrom: The anterior iris is a much tougher tissuethan had been anticipated. Dr. Worst has made claimsto suggest that the mid-peripheral portion of the iris,where the Verisyse’s split haptics attach, is relativelyimmobile. This may be one of the reasons that theVerisyse is better tolerated than iris-supported IOLs.

Dr. Hunkeler, you have performed many IOLimplantations over several decades. Do you feel com-fortable that the Verisyse is a long-term solution forpatients?

Hunkeler: The procedure of reversing the enclava-tion is straightforward. I predict that when a surgeonperforms cataract surgery on an eye with a VerisyseIOL, the implant will be easily removed and thecataract procedure performed. Because I tend to per-form these procedures superiorally, I will remove theVerisyse through the previous superior incision andswitch to a clear corneal temporal incision for thecataract procedure. I have used this in one case withgood results.

Donnenfeld: The track record of the Verisyse inEurope is longer than many of the anterior and pos-terior IOLs that we commonly implant. The VerisyseFDA trial was one of the largest ever performed —these parameters all show that this IOL stands the testof time.

When the Verisyse is implanted, the pupil contin-ues to function normally. Fluorescein angiographyhas been performed and no iris leakage has beendetected. Finally, postmortem studies have been per-formed on patients implanted with the Verisyse.

Stulting: Over 100,000 Verisyse phakic IOLs havebeen implanted outside of the United States by over

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9

5,000 ophthalmologists with no reports of long-termcomplications. It is rare for clinicians to have thismuch long-term experience with a newly approveddevice in the United States. The extensive non-U.S.experience with this IOL makes me comfortable withits safety profile.

Lindstrom: Dr. Donnenfeld, please describe yourimplantation procedure with the Verisyse IOL.

Donnenfeld: I perform a YAG peripheral iridoto-my superiorly the day of surgery. I implant theVerisyse through a superior incision. I place myenclavation incisions at 10 o’clock and 2 o’clockand bevel the incisions minimally with a 1.2-mmdiamond keratome. My goal is to aim the incisionstoward the peripheral iris at 3 o’clock and 9o’clock. I place Miochol-E in the anterior chamberand then Healon (AMO). I enter the eye with mydominant hand holding the enclavation needle first.I then grasp the IOL with my nondominant handusing Budo forceps and, while holding the IOL inplace, I use my enclavation needle to push the irisin a “snowplow” maneuver, in which I actually

push the iris so that a portion of the tissue is pushedupwards and into the split haptics. The snowplow-ing force also moves the haptics as if a gate is open-ing, enabling them to catch onto the iris tissue.

If I find that, after enclavation is complete, I needto add or subtract the amount of iris that has beencaught in the split haptics, I can go back and, withmultiple passes, make the necessary adjustments. Iremove the Healon with an irrigation and aspirationcannula and suture the wound with three 10-0 nylonsutures (Figure 3).

My main concern with this procedure is that mynondominant hand is able to hold the IOL steadily,so I hold the Verisyse at the iris plane or lower. Thenormal reflex of a surgeon is to enclavate superior-ly, but this will result in a decentered IOL. Thus, Iprefer to either directly center the IOL to the pupilor to center inferiorly, so that the superior eyelidwill cover the IOL.

Assil: With respect to wound closure, I recentlyswitched to using 10-0 vicryl sutures because theydo not require removal. I continue to use a figure-8stitch, entering through the cornea and exitingthrough the sclera. I then grasp the suture as secondtime through the cornea and out through the scleraand tie it off, rotating it towards the conjunctivalside. Besides not requiring removal, vicryl suturesseem to induce a mild degree of wound inflamma-tion, which is good for firm adhesion. The draw-backs to vicryl sutures include a greater tensilestrength than nylon, increasing the possibility ofgreater degrees of cylinder postoperatively, and thatthe material is slightly less visible to the surgeon’seye while performing the procedure.

Lindstrom: I do not think that implantation of theVerisyse will present any difficulties for the experi-enced anterior segment surgeon, except that the IOLmust be passed up and over the crystalline lens, thenrotated to where it is parallel to the incision.

Assil: The best way to ensure that the crystalline lenswill not be in any way traumatized during IOL inser-tion is to have a myotic pupil and a sufficiently largeopening to insert the IOL. I achieve this by firstinserting a 2.5-mm keratome, immediately followedby a 6-mm keratome. I then grasp the optic of theIOL closer to proximal haptics, pointing towardmyself rather than the central belly of the IOL. Igrasp the optic in this way because during IOL inser-tion, the volume of the IOL does not compete with

OCULAR SURGERY NEWS

Figure 1. The enclavation tool is used to lift a portionof the iris.

Figure 2. Once enclavated, the IOL’s split haptics cometo rest underneath the “knuckle” of iris.

Figures 1 and 2 courtesy of AMO.

10

the insertion forceps. Thus, the interior haptics andthe inferior portion of the optic have already clearedthe pupil by the time the insertion forceps arrive atthe wound, at which point I can either continue toinsert the IOL entirely or I can simply let go and pushthe remainder of the IOL into the anterior chamber.

Surgical pearlsLindstrom: What pearls do you have to help sur-geons navigate enclavation better?

Assil: It is important to remember that when thepupil is constricted, the surgeon must adjust for theinherent slight movement both nasally and superior-ly. Intraoperative Miochol-E or Miostat (Carbochol,Alcon Laboratories), as well as stab incisions, vis-coelastic and the opening of the eye, will cause thepupil to move even more. Because of these factors,the eye must be marked on the conjunctiva near thelimbus in three locations — two on the horizontal,just below the midline of the pupil and the third infe-riorly, just temporal to the vertical midline of thepupil. The inferior mark should be temporal to thevertical midline of the pupil because the pupil hasmoved nasally from constriction. The reason the twoin the horizontal midline should be below midline isthreefold. First, the pupils move superiorly from pilo-carpine or Miochol-E. Additionally, the tendency inenclavation is to feed the iris from above, through thehaptics, which causes the IOL to progressivelymigrate superiorly. Lastly, if the IOL is off center, itis better to have it be slightly below midline thanabove, because superiorly, the upper lid will cover theedge of the IOL. Thus, marking is critical to the suc-cess of enclavation.

The enclavation calipers should be used to mark

an 11-mm cord length superiorly at the limbus, andthe 15º-blade should enter centrally at the ink mark-ing with its cutting edge so that the incision expandscentrally as it is made. The 11-mm cord lengthdefines the outer limits of the distance between theenclavation paracentesis sites. The direction of theblade should be oriented towards the position ofenclavation, meaning that rather then entering radial-ly like we do with cataract surgery, if we enter at the2 o’clock position the blade should be aiming moretowards 4 o’clock. If we enter at 10 o’clock, weshould be aiming more towards 8 o’clock.Furthermore, a long-tunnel paracentesis is undesir-able because the enclavation needles will becomeoar-locked, either making it difficult to get under-neath the haptics or making visibility more cumber-some due to distortion of the cornea.

A moderate amount of Healon should be placedabove the lens to help push the IOL against the iristo prevent against deepening the anterior chamberand causing the iris to become concave. Theenclavation needle should be inserted into the eyefirst, followed by the optic forceps. Temporalenclavation should be performed first to help guidenasal enclavation. Because the cord length is longertemporally than nasally between the enclavationpoint and the chamber angle, any tugging on theIOL during secondary enclavation will not trauma-tize the iris root.

The surgeon must not rush the enclavation proce-dure. If too much iris is passed through the haptics inone motion, the surgeon risks the possibility that thehaptics will grasp full thickness of iris rather than irisstroma. Three or 4 passes should be made before thehaptics are securely fastened.

Hunkeler: One of the most important things is toensure that the IOL is not damaged while taking itout of the container or during insertion. With foldablelens implants, the surgical technician loads the fold-able lens into the inserter. With the Verisyse, the sur-geon must grasp the IOL and its angle edges canmake this more challenging.

I would recommend grasping the IOL at the edgeof the optic near the base of the haptic and then slid-ing the implant into the anterior chamber. I prefer totemporarily close the lateral sides of the incision withsutures to maintain absolute control of the chamberdepth. Additionally, temporal closure of the lateralsides with sutures does not require additional Healoninsertion during the enclavation. This is a safety fea-ture for surgeons who are learning to implant the

OCULAR SURGERY NEWS

Figure 3. In the above figure, a clear corneal incisionwas closed with three 10-0 nylon sutures and theVerisyse is centered in the eye.

Figure 3 courtesy of Eric D. Donnenfeld, MD.

11

Verisyse because he or she can avoid viscoelastic oriris egress during the enclavation.

Stulting: Placement of the viscoelastic is critical. Itis best to inject a small amount of Healon, enough toprotect the endothelium but not so much that the irisposition is distorted.

When positioning the IOL, the surgeon shouldnote the iris anatomy and identify the optical enclava-tion points. Bimanual dexterity is necessary for theenclavation procedure. The IOL must be held in posi-tion away from the cornea and the crystalline lens.The second hand is used to create and lift a knuckleof the iris.

Davis: I make my incision superiorly at 12 o’clock. Ifind it easier to insert the IOL while inferiorly rotat-ing the eye. Otherwise, the brow gets in the way, par-ticularly in deep-set eyes.

Also, Healon should always be injected on top ofthe IOL, so that the lens floats downward toward theiris and the endothelium is protected.

Finally, during enclavation, it is important to picka landmark on the iris to target. Unless the surgeonuses sutures particularly close to the wound to stabi-lize the anterior chamber, when the Budo forceps areused to grab the IOLs, some viscoelastic normallycomes out. This causes the chamber to shallow andthe implant will shift slightly.

Price: Because I use topical anesthesia, it is easy tohave the patient look down during the incision.Before I make the incision, I mark the limbus at thelocation where I want to fixate the IOL, usually 3o’clock and 9 o’clock.

The placement of the paracentesis is also impor-tant. Incisions for cataract surgery often move par-allel to the iris, whereas when implanting theVerisyse, it is better to angle the incision down-ward, especially for the nasal side where nasal dis-placement of pupil is common causing the site ofenclavation to be closer to the angle and the para-centesis site.

Surgeons must consider where the enclavationwill occur — I have found that if I place my para-centesis track too far central in the cornea as com-pared to keeping it peripheral and close to the limbus,the corneal surface becomes distorted duringenclavation and the procedure is hard to visualize. Iprefer beginning on the nasal side because it is moredifficult to place the first haptic due to the nasal dis-placement of the pupil.

Lindstrom: I always insert the enclavation needlefirst and reach in and grasp the optic second. Ienclavate with my dominant hand and, when the irisis fixated with the IOL, I rotate the IOL with theenclavation needle to center it. Usually, I will have toinject more Healon in over the optic and push it downbefore I enclavate the other side of the iris.

If I am not satisfied with the centration of the IOL,I will undo the enclavation on the left side and redo iton the right side, because I am right-hand dominant.

Donnenfeld: Once a surgeon has taken a course inhow to implant the Verisyse or has observed a proce-dure, it is easy to become comfortable with thesurgery. I apply Healon two to three times during theprocedure to maintain a deep anterior chamber.However, I am careful not to overfill the eye and toplace the Healon on top of the IOL to force it downtoward the iris.

The biggest mistake that surgeons make whenimplanting the Verisyse is trying to use the enclava-tion needle to insert the iris into the split haptics. Thistechnique is incorrect. The iris should come up withthe snowplow motion and the haptics should fall intoplace.

Lindstrom: After I have placed the IOL and the hap-tics are fixated in the iris, I perform a small surgicalperipheral iridotomy. However, some surgeons preferto perform Nd:YAG laser iridotomy preoperatively.

Dr. Price, what is your preference?

OCULAR SURGERY NEWS

The surgeon must not rush the

enclavation procedure. If too much

iris is passed through the haptics in

one motion, the surgeon risks

the possibility that the haptics will

grasp full thickness of iris rather

than iris stroma.

— Kerry K. Assil, MD

12

Price: One of the advantages to the Verisyse proce-dure is that it allows a surgical iridotomy as the laststep. I would think most surgeons, especially high-volume surgeons, would prefer to not have to per-form two surgeries, such as one would have to dowith preoperative Nd:YAG laser iridotomy.

Hunkeler: As a matter fact, during my routine surgi-cal day I perform Nd:YAG capsulotomies betweenpatients, so adding an additional YAG laser iridotomywould not interfere with my workflow.

The surgeon can perform a laser iridotomy or asurgical iridectomy but either of these procedures isnecessary to reduce the likelihood of an IOP spikeafter the procedure from pupillary block.

Lindstrom: If a surgeon were to forget to performeither the iridotomy or iridectomy, what would be thebest course of action? Would you perform anNd:YAG laser iridotomy later?

Donnenfeld: For beginning surgeons, performing aPI is a good strategy because it is an easier procedure.I perform Nd:YAG laser iridotomy with two pulsesper burst of 4 milliJoule (mJ) to 5 mJ and passthrough the iris with one or two shots of the laser,depending on the color of the iris. This is an easy, 1-minute procedure.

Lindstrom: In terms of surgical tools, I prefer to usea cohesive viscoelastic such as Healon. Verisyseimplantation is not a good setting for Healon5(AMO) because of the potential IOP spikes duringthis procedure. How do you remove Healon?

Price: I irrigate Healon out through the paracentesis.Although some patients experience discomfort withthis method, there have been no IOP spikes in mypatients. Early in the FDA clinical trial, it was rec-ommended that we use Healon5 with the Verisyse. Ihad a case in which I used Healon5 and had problemsbecause I could not tell if the IOL was centered dur-ing enclavation. I would not use Healon5 again whenimplanting the Verisyse.

Davis: I place three 10-0 nylon sutures in the incisionand tie the central suture. Then, I use bimanual I&A.Healon comes out quickly with this method.

Donnenfeld: I perform two I&As. I lower the irriga-tion bottle farther than I do for cataract surgery, toapproximately 2 feet over the patient’s head, because

I want to avoid large amounts of fluid entering theeye and putting pressure on the iris. I can be morecertain that the Healon is exiting the eye with I&Athan I am with manual flushing.

Assil: I use Healon GV and a two-port I&A proce-dure, using a 21-gauge aspiration port and a 19-gauge irrigation port, on the paracentesis sitesafter closing the primary incision. The most commoncause of complications from Verisyse implantation islack of complete viscoelastic removal. This can causespikes in IOP, papillary sphincter atrophy and loss ofreactive ability of the patient’s pupil.

Lindstrom: Dr. Hunkeler, what is the protocol forextracting a cataract from a patient with a VerisyseIOL?

Hunkeler: I make my routine calculations and sim-ply enlarge the incision from what I used to implantthe Verisyse. I remove the IOL, suture the incisionand perform a clear corneal temporal incision forphacoemulsification.

Davis: Did you use the same preoperative A-scan foryour IOL calculations for cataract surgery that youdid for the Verisyse?

Hunkeler: Yes. Biometry was on target.

Davis: This correlation between A-scans is importantbecause it demonstrates the need to take an A-scanprior to implanting a phakic IOL so that the A-scancan be referred to later if cataract surgery is neces-sary.

Does the ultrasound velocity need to be adjustedfor cataract surgery?

Hunkeler: The ultrasound velocity varies slightly,but the IOL is so thin in the center that it makes nosignificant difference in the postoperative refraction.

Assil: I began implanting the Verisyse IOL in 1977,and have performed 10 LASIK procedures and twoPRK procedures to date, with an approximate 6% to7% enhancement rate over 7 years follow-up. I thinkthat’s an accurate number, 6% or 7%. LASIK or PRKtechniques do not require any modification whatsoev-er in order to performed over Verisyse implantation.

Lindstrom: Dr. Donnenfeld, have you performedLASIK enhancements after implanting the Verisyse?

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13

Donnenfeld: I have performed one LASIK enhance-ment over Verisyse in a case where the IOL had beenpreviously implanted in Europe. The results wereexcellent. Dr. Davis has provided positive data thatshow the IOL most likely will not touch the corneabecause the anterior chamber deepens during aLASIK procedure.

LASIK enhancement offers the opportunity tocorrect minimal postoperative refractive errors afterVerisyse implantation. At the same time, wavefront

ablation technology can be used to achieve a newlevel of visual acuity and quality.

Fixation and centrationLindstrom: Are you comfortable with anteriorchamber iris fixation for an IOL?

Price: The Verisyse’s iris-fixation is safe and thevisual results have been excellent.

I am slightly biased because part of my practiceover the years has included patients with complica-tions, such as iris deformation and inflammation, dueto angle-supported anterior chamber IOLs. As aresult, I have not implanted an angle-supported lenssince 1986.

Davis: I agree that iris fixation is safe and theresults are good. The risk of inducing a cataract islower than with posterior chamber IOLs becausethere is protection from the iris especially when thepupil is constricted.

Lindstrom: The iris-fixated IOL has a history dat-ing to the 1970s and has been used to correct

myopia in Europe since 1991, so it has a long trackrecord of good tolerance in the eye. Some ophthal-mologists have bad memories of pupil-fixatedIOLs and complications. The Verisyse is complete-ly different from a pupil-fixated IOL. I had origi-nally worried that the iris-fixation would lead toendothelial cell loss or chronic inflammation fromthe possible phacodynesis of the lens tugging onthe iris. Has anyone seen endothelial cell loss orinflammation with the Verisyse IOL?

Donnenfeld: No. In the FDA clinical trial,endothelial cell counts were taken on a regularbasis. The Verisyse is well tolerated in the eyewith no cases of corneal decompensation; mini-mal endothelial cell loss over time that is similarto what occurs in a normal physiological eye; andin more than 1,000 cases, only three patientsrequired cataract extraction, which is similar tonon-surgical eyes. In addition, the retinal detach-ment rates with this lens are similar to that in non-surgical eyes.

There are no significant cornea, lens or retinacomplications associated with the Verisyse IOL. AnyIOL that sits in the anterior chamber too close to thecornea will cause damage and IOLs that are too closeto the crystalline lens will cause cataract formation,so phakic IOLs function best when placed furthestfrom the lens and the cornea. The iris-fixatedVerisyse sits in this location.

Hunkeler: When implantation with the Verisyse iscomplete, one should be certain that the implant isproperly positioned and the outcome can easily bepredicted. With posterior chamber phakic IOLs, it isnot possible to measure the posterior chamber sizeand this measurement appears to be a significant fac-tor in cataract prevention.

Lindstrom: The most common complications thatcataract surgeons and refractive IOL surgeons alikeface are IOL subluxation or decentration and powercalculation error. These will most likely be theissues that we encounter with the Verisyse IOL sosurgeons are already accomplished at managingthese complications.

Donnenfeld: Something that we have learned inrefractive surgery is the importance of centering theablation to the pupil center or the center of the wave-front map. The Verisyse is the only IOL that can becentered on the pupil.

OCULAR SURGERY NEWS

The risk of inducing a cataract is

lower than with posterior chamber

IOLs because there is protection from

the iris especially when the pupil is

constricted.

— Elizabeth A. Davis, MD

14

Price: I recently implanted the Verisyse in a womanwith a markedly decentered pupil. Because the sur-geon decides where to fixate, or enclavate, theVerisyse lens, I was able to center the lens on herdecentered pupil. This would not have been possiblewith other phakic lenses because IOLs which fixateeither in the angle or posterior chamber of the eye bynecessity center on the geometric center of either theanterior or posterior chamber, and in this case theother lenses would have been decentered relative toher pupil. Many patients have small amounts ofdecentration to their pupils, and the Verisyse allowsus to compensate for that.

Correcting astigmatismLindstrom: What is your technique when implanti-ng the Verisyse in a patient with astigmatism?

Price: Most patients have some astigmatism. Anadvantage of the Verisyse lens is that we need tomake either a 6 or 5mm incision. This can be used toour advantage to decrease preoperative astigmatism.I vary the degree of beveling of the incision and tim-ing of suture removal to eliminate preoperative astig-matism. I vary the axis of the incision to correspondto the axis of the steepest keratometry reading. Incases where temporal incisions are used, I place theVerisyse lens vertically instead of horizontally, and Ihave seen no difference in eyes with either lens ori-entation.

Surgeons must remember that using a clearcorneal incision increases the risk of developing flat-tening at the incision’s axis.

Davis: If there is a significant amount of astigma-tism, I prefer to use a limbal incision so that, if I oper-ate on the axis, some of the astigmatism will beaddressed. However, if there is astigmatism postop-eratively, I usually manage it with LASIK.

Lindstrom: Do you make an intraoperative limbalrelaxing incision or perform astigmatic keratotomy(AK)?

Davis: No. I find that LASIK is more predictableonce I know the patient’s exact refractive error andalso allows me to address any residual sphericalerror.

Donnenfeld: Most patients who are highly myopicalso have small amounts of cylinder, so I make mostof my incisions superiorly and cut my sutures earlier

for 1 D or less of cylinder. When the patient has 1 Dto 3 D of cylinder, I make a standard superior incisionand add a limbal relaxing incision during surgery. Ifmore than 3 D of cylinder is present, I prefer to per-form a limbal relaxing incision preoperatively. I wait1 month to perform the phakic IOL implantation. Iwill also make the incision larger than I would nor-mally, because there is a coupling effect with largercylindrical corrections — I can then apply LASIK tothe patient after the IOL implantation.

Hunkeler: I use a superior incision and prefer toleave the polypropylene sutures in place becausethey tend to last indefinitely. I try to adjust thesuture tension enough so that there is no inducedcylinder and that it is not necessary to remove thesutures at a later time. Necessary astigmatic kera-totomy may be performed to help reduce cylinderas well as LASIK for cylinder and spherical cylin-drical errors post-operatively.

Lindstrom: It seems that to achieve good uncorrect-ed visual acuity with phakic IOLs, 1 D or less ofastigmatism is needed.

Clinical results with phakic IOLsLindstrom: Dr. Donnenfeld, please discuss the U.S.clinical trial for Verisyse.

Donnenfeld: There were actually two U.S. clinicaltrials reported for Verisyse. The first was an enroll-ment trial for visual outcomes and the second was asafety enrollment trial. A total of 684 patients wereenrolled between 1997 and 2003 and 478 of thesepatients were bilaterally implanted. Patients olderthan 21 years of age and younger than 50 years of ageand with less than 2.5 D of cylinder were implantedwith the Verisyse to correct between -5 D and -20 Dof refractive error. The most common IOL implantedwas 13 D, so it is clear that most patients in the trialhad high degrees of myopia.

Stulting: The results of the trials showed that almostall the patients achieved best-corrected visual acuity(BCVA) of 20/40 or better. The most impressiveaspect of the postoperative results was that 49% ofthe patients who had the Verisyse phakic IOLimplanted gained one to two lines of visual acuityand 2% of patients gained more than two lines ofBCVA. Only 6% of patients lost either one or twolines of BCVA. Ten percent of patients gained morethan 2 lines of visual acuity in the trial.

OCULAR SURGERY NEWS

15

Donnenfeld: I have never seen refractive outcomesanalysis this favorable, which speaks to the superi-or quality of vision that the Verisyse providespatients. The follow-up showed that the stability ofrefractive results is also excellent. Eighty-six per-cent of patients who achieved less than 1 D ofhyperopia or myopia were followed up for 3 yearsand showed almost no difference between day 1,month 1 and year 3. Additionally, patient satisfac-tion was high with the Verisyse. Some patientsexperienced glare and halos after implantation, butthe effects were similar to what they experiencedpreoperatively.

The complications that were associated with theVerisyse were minimal in the clinical trials. Early on,some of the patients required re-enclavation, but afterseveral procedures were performed this was nolonger necessary in any patients.

Stulting: A small number of patients developedcataracts — only 3 cataracts out of 1,179 patientsenrolled required extraction. There were few retinaldetachments and, based on regression analysis, thesecases would most likely have occurred with or with-out Verisyse implantation. Minimal endothelial cellloss (3.8%) was shown at the 3-year follow-up,showing the Verisyse is well tolerated in the eye.Additionally, no IOLs were removed because ofchronic inflammation.

Price: We have implanted more than 100 VerisyseIOLs and have seen only two patients with slightlydecreased endothelial cell counts and one of thesecases may have been due to poor quality preoperativephotographs, the other was possibly related to thesurgery itself.

We have also implanted the Verisyse in patientswho were outside the study parameters, such asthose who required myopic correction greater than20 D. There is also a significant differencebetween LASIK and phakic IOL implantation inhighly myopic patients that is interesting. Forexample, it is common to worry about inducingvisual loss in patients with high degrees of myopiawith LASIK, whereas in my experience mostpatients with high myopia achieve an overallimprovement in best-corrected vision with theVerisyse, and even if there is no improvement,there is no loss of visual acuity.

Lindstrom: Did you have any lens subluxations orpower errors?

Price: We had one power error in a patient forwhom we were basing the correction on the cyclo-plegic refraction. We had another power error in apatient who may have had an unstable refraction, oran unusual amount of accommodation. However,overall we have had excellent results with ourpower calculations.

When I perform LASIK for higher levels ofmyopia, I find that there is some variability.

However, in the Verisyse trials, the results were ontarget with our preoperative calculations.Considering that during the study, the Verisyse wasavailable only in power steps of 1 D, these resultsare exceptional.

Lindstrom: Have you seen the postoperative inflam-mation course that is typical with cataract surgery?

Price: I have seen a lower incidence of postoperativeinflammation with Verisyse implantations than withcataract surgeries. The only case where there wouldbe more postoperative inflammation would be whenthere is bleeding from the peripheral iridotomy orcomplicated enclavation.

OCULAR SURGERY NEWS

The most impressive aspect of the

postoperative results was that 49%

of the patients who had the

Verisyse phakic IOL implanted

gained one to two lines of visual

acuity and 2% of patients gained

more than two lines of BCVA.

— R. Doyle Stulting, MD

16

Lindstrom: Do you recommend a postoperative reg-imen of steroids or NSAIDs?

Price: Yes. I prescribe topical NSAIDs for 3 to 4 weeks and then discontinue them. I have seen somepatients who have pigment deposition and have putthem back on NSAIDs for a few weeks and this hasalways worked well. I have had no cases of persistentinflammation or pigment deposition.

Transitioning to phakic IOL technologyLindstrom: Dr. Donnenfeld, what is the learningcurve with the Verisyse?

Stulting: The incision used for implanting theVerisyse IOL is one that all interior segment sur-geons should be able to create without any difficul-ty. Additionally, astigmatically neutral incisionswith suturing should be part of the anterior segmentsurgeon’s skill set. The challenge will be properplacement of the IOL, the selection of the fixationpoint and mechanical incorporation of the iris tothe haptics. The learning curve will involve biman-ual dexterity and knowledge of the appropriateamount of iris tissue to use in enclavation. Anteriorsegment surgeons will be able to master these skillswithout difficulty.

Donnenfeld: Verisyse implantation is not difficult tolearn. As with all intraocular surgeries, preparation ismore important than the actual surgical procedure. Ifa surgeon understands the procedure before headinginto the operating room — meaning that he or she hasresearched the procedure and has been trained well— it should only take one or two surgeries to becomecomfortable with implanting the Verisyse. The experience that we have all had with the Verisyseis that our patients are among the most satisfied aftersurgery. These patients are not seeking cosmeticimprovement. They are visually handicapped, andtheir lives are improved dramatically with a phakicIOL. The quality of vision that they obtain is betterthan they can achieve with any other procedure.

Patients in whom I have implanted the Verisysephakic IOL have become my ambassadors for refrac-tive surgery. They not only refer patients for phakicIOLs, but they also refer patients with lower degreesof myopia who are candidates for LASIK. I havefound that postoperatively, patients who havereceived a phakic IOL are so enthused that they wantto talk to everyone they know about their positiveexperience.

Lindstrom: How long did it take you to becomecomfortable with the implantation and enclavationprocedure with the Verisyse?

Price: It took me approximately four or five proce-dures to feel comfortable with the procedure.However, I started implanting the Verisyse within theconfines of a clinical trial. Surgeons now have theadvantage of FDA approval, so it is easier to gettogether groups of patients for the procedure.

In phase 2 of the trial, we were implanting theVerisyse in sporadic populations of patients and wait-ing long periods of time between procedures.

Davis: We have found that results with the VerisyseIOL are predictable and stable.

In the study, we did not see significant or ongoingendothelial cell loss. Two patients experienced trau-matic, non-spontaneous dislocations of the IOL —one whose wife struck him in the eye during a seizureand another who was punched in the eye. However,repositioning the IOLs was uneventful in both cases.Early in the study, a few patients experienced woundleaks that were managed with resuturing. One patienthad the Verisyse removed because her boyfriend didnot like the appearance of the IOL in her eye. Noinfections, cataract formations or losses of BCVAwere seen, and many patients had consistent gains inlines of BCVA. Overall, a high rate of patient satis-faction was seen.

Hunkeler: I represent the cataract surgeon who,unlike a LASIK surgeon, is accustomed to olderpatients who are not always satisfied with the visualacuity that an IOL provides. Since I have startedimplanting the Verisyse, I have patients who are uni-formly grateful for what I have been able to accom-plish for their visual acuity and quality of life. For thecataract surgeon, phakic IOLs represent a new vista.

I implanted the Verisyse in 30 eyes and had onepatient who had subluxation of the lens after sheinadvertently flipped a towel and hit herself in theeye. Re-enclavation was simple and successful.

Lindstrom: A “wow” factor definitely exists withthis procedure, even more so than with LASIK, pro-vided the sutures are not so tight and that they induceastigmatism. Most patients in whom I implanted thislens see better on the first day without correction thanthey ever did with glasses.

Stulting: Patient word-of-mouth is always the most

OCULAR SURGERY NEWS

17

stable and reliable source of marketing for any refrac-tive procedure and this will be no different. This pro-cedure will generate truly happy patients who willtell their friends, especially because the Verisyse IOLwill be implanted in patients with the highest degreesof myopia. This procedure will change the quality oflife for a patient who receives it. I enjoy seeing myphakic IOL patients because they invariably greet mewith a smile and a thank you.

Davis: The opportunity to market a practice throughpatient referrals from those who have undergoneVerisyse implantation is great. In our practice, wehold patient seminars on refractive surgery in whichthe Verisyse IOL is one of the options and is recom-mended for patients who are too myopic to be candi-dates for LASIK.

Other marketing might include press releases orhaving office staff contact local newspapers to see ifthey are interested in running a story about phakicIOLs. Because patients have become savvy due to theinformation that is available on the Internet, I wouldrecommend that surgeons who perform Verisyseimplantation include it on their Web site.

Lindstrom: We also must inform referring ophthal-mologists and optometrists about the phakic IOL

procedure so that they will be able to discuss it withtheir patients.

Dr. Hunkeler, what challenges does the cataract-only surgeon face in marketing phakic refractive IOLprocedures?

Hunkeler: Rather than challenges, phakic IOLs pro-vide an opportunity for surgeons who have only beenperforming cataract procedures to become involvedin the refractive arena. The high level of patient satis-faction following phakic IOL implantation will be anew experience for cataract surgeons.

I think that the greatest challenge is going to begetting office staff on board with the Verisyse IOLimplantation procedure.

Lindstrom: Will you market the Verisyse proce-dure externally?

Hunkeler: We have communicated directly in writ-ing with information about the Verisyse and soon wewill be having a seminar to discuss the Verisyse lenswith our optometric referral doctors.

Lindstrom: Where are you positioning the value ofthe Verisyse procedure?

Hunkeler: I will place the Verisyse procedure some-where between the crystalens (eyeonics, inc., AlisoViejo, Calif.) accommodating IOL and a wavefront-guided LASIK procedure.

Lindstrom: I see Verisyse implantation as a premi-um procedure — it fits in the same category as RLEwith an accommodating IOL.

Donnenfeld: I agree. The value of this procedure iswell beyond anything we would offer patients withemmetropia or low refractive errors. Patients who arecandidates for implantation with the Verisyse are themost visually handicapped patients we see in ourpractice and the need for this type of procedure istremendous.

A surgeon will generally spend more time withpatients who undergo phakic IOL implantationbecause of the longer informed consent and becausecurrently, the procedure is performed unilaterally.Additionally, the postoperative care will involvemore time initially, although in the long-term, follow-up will most likely take less time because the resultswith the Verisyse are so stable.

Financially speaking, I would place the Verisyse

OCULAR SURGERY NEWS

I think that the greatest challenge is

going to be getting office staff on

board with the Verisyse IOL

implantation procedure.

— John D. Hunkeler, MD

procedure at approximately $800 more than wave-front-guided LASIK and at the same price as anaccommodating IOL.

Davis: I also agree that Verisyse implantationshould be a premium-priced procedure, placedsomewhere in the price range between LASIK andRLE. Patients should understand that IOL implan-tation is an invasive procedure that will be done inthe operating room with nurses and anesthetistscaring for them. Knowing this will help themunderstand and appreciate the cost of the proce-dure. Additionally, I agree with Dr. Donnenfeldthat a majority of patients who will undergo thisprocedure have a severe visual handicap, so theyknow that it is no small feat to correct it.

Price: A Verisyse IOL procedure involves morecosts than laser refractive procedures and includesthe surgeon’s fee, facility fees, anesthetist’s fee andthe cost of the IOL. So it should not be priced thesame as LASIK.

Lindstrom: Surgeons who choose to perform pha-kic IOL implantation will differentiate their prac-tices from other ophthalmologists’ in that offeringthe newest technology involves additional skill andtraining.

Hunkeler: There are surgeons in the ophthalmiccommunity who have distinguished themselves aspremium. For example, if I were a patient in theMinneapolis/St. Paul area, I would expect you tooffer the latest, best technology in anterior segmentsurgery. Surgeons who have distinguished them-selves in that way enjoy the higher reputation thatthey have and want to maintain that.

I have just begun performing LASIK but feel thatthe technology is such that the learning curve hasrapidly accelerated to increase my comfort with thisprocedure. To properly help our patients achieve thebest results with refractive surgery and with refrac-tive cataract surgery, one must offer LASIK as anadjunct to optimize the outcome. This is why I havebegun performing LASIK — to compliment the oth-ers procedures with which I have been involved.

Lindstrom: Dr. Donnenfeld, even though you per-form various types of ophthalmic surgery, you arewidely known as a refractive surgeon. Do you see theFDA approval of the Verisyse IOL as a big step forthe refractive surgeon?

Donnenfeld: This is the biggest step in refractivesurgery since the introduction of the excimer laser.We have seen incremental improvements inexcimer laser technology with myopia, hyperopia,astigmatism and wavefront-guided procedures, butthese have been small changes. This is the first pro-cedure that is completely different and I believe it

will serve as a launching pad for future technolog-ical inventions and improvements that will changethe landscape of refractive surgery. Having phakicIOLs and RLE technology allows the refractivesurgeon now to be more comprehensive.

Many refractive surgeons have made the error ofbeing solely laser surgery practitioners, ignoringcataract surgery. Just as Dr. Hunkeler stated that pha-kic IOLs will allow cataract surgeons to venture intothe world of refractive surgery, so will this procedurebe a bridge for refractive surgeons to cataract proce-dures.

While phakic IOL procedures are not suitablefor every ophthalmic surgeon, the majority ofexperts in cataract and refractive surgery willadapt to this procedure because it has such animportant role.

18

OCULAR SURGERY NEWS

Patients who are candidates for

implantation with the Verisyse are the

most visually handicapped patients we

see in our practice and the need for

this type of procedure is tremendous.

— Eric D. Donnenfeld, MD

19

Davis: Premium surgeons should be able to offerpatients a variety of options for refractive surgery.If all you have is a hammer, then everything lookslike a nail. In the case of refractive surgery, whenthere are multiple methods of approaching correc-tion available, being adept at all of the these pro-cedures ensures a greater chance that the patientwill have the safest and best visual outcome. So,rather than looking at LASIK as the only optionfor a patient with higher refractive error and aslightly suspicious topography, a surgeon will beable to offer a better option within phakic IOLimplantation.

Lindstrom: As technology has evolved during theyears in which I have performed refractive surgery, Ihave learned that it is important to decide which pro-cedure to recommend to a patient, because if a patientis presented with too many options, they lose confi-dence in the ability of the surgeon. An ophthalmolo-gist should say to a patient, “You could have LASIKor have a phakic IOL, but for your particular case, Irecommend …” The ophthalmologist cannot remainneutral because patients trust us to know what is bestfor their visual outcome.

FutureLindstrom: This year has been crucial to lens-basedrefractive surgery. RLE procedures are becomingmore common, the first accommodative IOL, thecrystalens, was approved and we now have the firstFDA-approved phakic IOL. What impact will thishave on laser refractive surgery?

Stulting: Phakic IOLs will expand the refractive sur-gical market. I do not see phakic IOL implantation ascompetition for LASIK, but rather an addition to ourarmamentarium. For every patient who has a phakicIOL lens implant instead of LASIK, there will be anadditional patient who is not a LASIK candidate butwho has a phakic IOL lens implant followed byLASIK enhancement.

In the future, I would like to see a foldable versionof the Verisyse IOL and instrumentation to makeimplantation easier.

Price: The quality of vision with phakic IOLs is pre-cise and pristine. Just a few changes to the Verisysecould possibly make the IOL adjustable once it is in

the eye. This would be a significant technologicaladvance.

Donnenfeld: I see phakic IOLs as important to thefuture of refractive surgery and a technology that willhave a significant impact on the base of patients whoundergo refractive procedures.

It will not be long before foldable, astigmatic pha-kic IOLs become available.

Davis: I agree that foldable, toric and multifocal pha-kic IOLs will be available in the near future. In themore distant future, phakic IOLs will be adjustableand adaptable to wavefront platforms.

Hunkeler: Once we have an adjustable phakic IOL,the bar will be raised significantly for refractivesurgery. There is a fear factor to refractive surgeryand such technology would help potential patientsconquer that fear.

Lindstrom: Phakic IOLs are an exciting innovationin ophthalmology and I look forward to watchinghow they will impact refractive surgery.

I would like to thank the faculty members for theirparticipation in this interesting symposium, OCULAR

SURGERY NEWS for organizing the meeting andAMO for its support.

Reference1. Sarver EJ, Sanders DR, Vukich JA. Image quality in myopic eyes

corrected with laser in situ keratomileusis and phakic intraoc-ular lens. J Refract Surg. 2003;19(4):397-404.

OCULAR SURGERY NEWS

The ophthalmologist cannot remain

neutral because patients trust us to

know what is best for their visual

outcome.

— Richard L. Lindstrom, MD

6900 Grove Road, Thorofare, NJ 08086 USAphone: 856-848-1000 • fax: 856-848-6091 • www.slackinc.com • www.osnsupersite.com

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