Surgeon Presentation

Surgeon Presentation

Outline Future of Myopic Refractive Surgery Phakic IOLs: Evolution & Technology The Verisyse Anterior Chamber, Iris-Fixated Phakic IOL Product features Clinical data Patient selection, Pre-op Assessment Implantation

Future of Myopic Refractive Surgery

Myopic Refractive Surgery Total US Population = 286,158,000 Myopic 72,000,000 25% Mild (<-2.00 D) 46,080,000 64% Moderate (-2.00 to -6.00 D) 23,040,000 32% High (>-6.00 D) 2,880,000 4% Surgeons are becoming progressively less willing to attempt LASIK in high myopes ( 12 D) (U.S. Bureau of Census, International Database/Archives of Ophthalmology, March 1983 / Market Scope 2003 / WrongDiagnosis.com / Tay Study of 412,000 Singapore males.)

Refractive Surgery Trends New technologies will expand the total elective refractive market high myopia Phakic IOLs Pseudoaccommodative IOLs Refractive surgeries will grow to 2.5 to 3.0 million procedure per year by 2010 58% of U.S. surgeons not currently performing phakic IOL implantations plan to do so in the future (2003 Survey of ASCRS)

Verisyse Phakic IOL Larger 7 mm effective optical zone (vs. 5.0 mm to 6.0 mm with LASIK) Diopter range (US): -5.00 to -20.0 D Additive technology IOL can be removed Stable, removable split-haptic/iris fixation Endothelial cell loss within acceptable range Opens refractive market to vision correctionminded cataract surgeons

Verisyse Phakic IOL Challenges Requires large incision and suturing Enclavation process can be technically challenging, learning curve Risk of infection (lower with fourth-generation fluoroquinolones)

Verisyse Phakic IOL Benefit Tradeoff for greater surgical challenge is fewer functional visual complications and high-quality, high-contrast vision for patients who are not good Custom LASIK candidates

Phakic Lenses Evolution & Technology

Early Anterior Chamber Lenses 1950 s Strampelli 1953 Dannaheim 1954 Cogan Boberg-Ans 1954 Barraquer 1954 Significant Complications Poor fit / heavy Poor lens quality Poor surgical technique Angle-fixated lenses associated with complications

The Verisyse Phakic IOL Verisyse (Artisan in Europe) Design introduced in 1991 after 5 year trial Concave- Convex configuration (low profile) Decreased risk of endothelial damage Twice the effective power range

The Verisyse Phakic IOL (-5 TO -20 D) for the Correction of Myopia: Product Features

Verisyse Features Perspex CQ-UV PMMA 8.5 mm overall length Myopic Lenses VRSM5US050 5 mm Optic VRSM6US060 6 mm Optic -3.00 to -23.5 D in 0.50 D steps (in Europe)

Verisyse Features Enclavation site attaches to peripheral iris leaving anterior chamber angles unobstructed Maintains 1.5 to 2.0 mm distance from corneal endothelium at the angle Allows wide dilation 0.95 mm 1.5 to 2.0 mm

Verisyse Features Split haptic fixation Attaches to peripheral iris without inhibiting iris function Less risk of pupil ovalization than with angle-fixated AC phakic IOLs Avoids issues of PC phakic IOLs (e.g. cataract formation)

Verisyse Features Lens is vaulted anteriorly to ensure clearance from anterior lens capsule Vault range 0.35 to 0.93 mm, dependent on lens power Occupies ~ 30% of anterior chamber Lens / endothelium separation 2.03 to 3.25 mm 0.92 mm 0.92 mm

Verisyse Features Holds 60% of European market share for phakic IOLs #1 design worldwide Resolves high degrees of ametropia while retaining full range of natural accommodation Design has been in use for >18 years More than 150,000 phakic procedures have been performed worldwide using the Verisyse lens design

Clinical Data: The FDA Study Verisyse vs LASIK

FDA Study: Investigational Sites Assil Sinskey Eye Institute Arrowsmith Eye Institute Eye Surgery Center of LA Koch Eye Associates Price Vision Group Hunkeler Eye Center Anis Eye institute LSU Eye Center Stanford University Rothchild Eye Institute Emory University UCLA/Maloney Vision Institute John-Kenyon Eye Center Minnesota Eye Consultants Kremer Laser Eye Center Ophthalmology Ltd Manhattan Eye Ear & Throat Bascom Palmer Eye Institute Mackool Eye Institute Moran Eye Center, U of Utah Shiley Eye Institute, UCSD

FDA Study Prospective, nonrandomized study of 662 subjects (mean age 39.6 years) 493 of which were followed for one year and 231 followed for three years Correction of axial myopia with lens powers from -5.00 D to -20 D Mean lens power (n=662): -12.6 D

BSCVA 20/40 or Better BSCVA 20/40 or Better First Eyes (n=662) 100 80 60 40 20 0 100 98.5 99.2 100 99.6 99.6 100 100 Percentage of Eyes 20/40 or Better 3 Years 2 Years 1 Year 7-11 Months 4-6 Months 1-2 Months 2-3 Weeks Preop

Best Spectacle Corrected Visual Acuity Percentage of Eyes 100 80 60 40 20 60 100 94 81 99 99 94 79 100 99 94 83 79 100 99 90 20/20 or better 20/25 or better 20/30 or better 20/40 or better 0 preop 1 year 2 years 3 years n=662 n=491 n=355 n=228 Time After Surgery

Change in BSCVA at Three Years Percentage of Eyes Snellen Lines Gained/Lost 6% 49% 0.3 % -2 5.9% -1 44.7% 0 38.8% +1 8.4% +2 1.9% >+2

Induced Astigmatism Incision size: 5.2 to 6.2 mm Some cylinder reduction by selective incision placement Refractive cylinder change >2.0 D 2.4% of first eyes at one year (n=492) 2.0% of first eyes at two years (n=355) 3.5% of first eyes at three years (n=226) FDA safety target: <5%

Uncorrected Visual Acuity First Eyes at Three Years Percentage of Eyes 100 90 80 70 60 50 40 30 20 10 0 31 20/20 or better 50 52 68 20/25 or better 71 20/30 or better 82 84 92 20/40 or better All first eyes (n=231) First eyes targeted for emmetropoia and pre-op BCVA 20/20 or better (n=88) Uncorrected Visual Acuity

Predictability Achieved Correction (D) 24.0 23.0 22.0 21.0 20.0 19.0 18.0 17.0 16.0 15.0 14.0 13.0 12.0 11.0 10.0 9.0 8.0 7,0 6.0 5.0 4.0 3.0 2.0 1.0 Intended vs. Achieved Manifest Spherical Equivalent 6 Months 86% + 1.0 D 61% + 0.5 D (with no enhancements) 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Intended Correction (D)

Stability 2.00 0.00-2.00-4.00-6.00-8.00-10.00-12.00-0.019 D from 6 mos. to 1 yr. - 0.062 D from 2 yr. to 3 yr. -14.00-16.00 Preop 1 d 1 wk 1 mo 3 mo 6 mo Time After Surgery 1 yr 2 yr 3 yr

Visual Symptoms at Night Subjects With At Least 1 Year Follow-up (n=412) Subjects with Change in Symptom: Subject Response Pre-op=No Post-op=Yes Pre-op=Yes Post-op=No p-value Glare (26.4%; 98/371) 51% 49% 0.840 Halo (28.0%; 104/372) 65% 35% 0.002 Starburst (21.5%; 80/372) 55% 45% 0.371 *McNemar Chi-square test Majority of subjects had no change

Contrast Sensitivity Mesopic With Glare Contrast Sensitivity 300 n=31* 100 30 10 Preop Postop 3.0 p= 0.03 1.5 3 6 12 18 Cycles per Degree *One eye analysis

Patient Satisfaction Subjects With At Least 1 Year Follow-up (n=412) Percentage of Subjects 100 90 80 70 60 50 40 30 20 10 0 Favorable Neutral Unfavorable Quality of Vision Satisfaction with Surgery Recommend Procedure

Conclusions Excellent uncorrected visual acuity Excellent predictability Good stability Contrast sensitivity unchanged or improved High subjective satisfaction rates

Verisyse Phakic IOL Implantation Versus LASIK Investigators conducted a prospective, randomized comparison of Verisyse Phakic IOL implantation with Excimer LASIK in myopic patients correcting between -9.00 and -19.50 diopters. (El Danasoury MA, et al. Ophthalmology. 2002;109:955-964) n=61 patients (90 eyes) mean SE refraction ~ 13.5 D 29.5% of patients received a Verisyse lens in one eye and LASIK in the other eye The Verisyse Phakic IOL is sold under the Artisan name outside the US.

One-Year Outcomes Mean SE Refraction UCVA 20/20 or better, % UCVA 20/40 or better, % 2 or more Snellen lines lost on BSCVA, % 2 or more Snellen lines gained on BSCVA (n)% Contrast sensitivity 2 or more lines (n)% Verisyse (n=43 eyes) -0.64 ± 0.8 D 20.9 88.4 0.0 16.3 4.7 LASIK (n=41 eyes) -0.87 ± 0.8 D 12.2 58.5 14.6 2.4 14.6 The Verisyse Phakic IOL is sold under the Artisan name outside the US.

Author Conclusions The Verisyse Phakic IOL and LASIK were found to be similarly effective, stable and reasonably safe for the correction of moderate to severe myopia. The lens offered significantly better UCVA and BSCVA, better contrast sensitivity, and a lower enhancement rate.

Author Conclusions Patient preference was significantly in favor of the Verisyse Phakic IOL, mainly because of the higher quality vision; 72.2% of patients who received both surgeries preferred the Verisyse Phakic IOL.

Patient Selection & Preoperative Assessment

FDA Indication The reduction or elimination of myopia in adults with myopia ranging from -5 D to -20 D with less than 2.5 D of astigmatism at the spectacle plane Patients with documented stability of manifest refraction for the prior 6 months, as demonstrated by a spherical equivalent change of less than 0.50 D

The Right Patient Dissatisfied with quality of vision or tired of depending on glasses Unable to wear contact lenses Outside the optimal range of laser refractive surgery Considers risks of natural lens exchange not acceptable Likes the idea of a reversible procedure that offers high-quality, high-contrast vision

The Wrong Patient Age <21 years or with unstable refraction Anterior chamber depth <3.2 mm Less than the age-adjusted recommended endothelial cell density Abnormal iris, such as peaked pupil or elevated iris margin IOP >21 mm Hg Pupil width under mesopic conditions >5 mm (5.0 mm optic) Inappropriate expectations

Patient Assessment Standard intraocular surgical workup and measurement Lens selection dependent Precise Refraction Precise manual keratometry Accurate Biometry Anterior Chamber Depth (IOL Master ) Endothelial Cell Count Target refraction is emmetropia

VERICALC 1.1 Program Note: Refraction is automatically corrected for vertex distance & ACD is automatically corrected for lens vault value

Verisyse Implantation and Post-surgical Protocol

Pre-Op Patient Prep Informed consent Elective surgery! Pre-Op Meds DO NOT DILATE Antibiotic/Non-steroidal anti-inflammatory Pilocarpine 1% Anesthesia Peri or Retrobulbar for initial eyes Local when experienced

Intraoperative Considerations Standard implant instrument set + enclavation needle Scleral or limbal incision recommended Avoids post-op wound leaks Cohesive viscoelastic Easy removal - avoid post-op pressure spikes Avoid highly viscous brands (i.e. Healon 5) < 1.4% sodium hyaluronate Recommended Healon, Healon GV Incision placement for astigmatism correction when possible Clear corneal incision with sutures

Iridectomy / Iridotomy Iridectomy/iridotomy is essential YAG iridectomy can be performed prior to surgery Peripheral Iridectomy Laser Iridectomy

Define Landmarks Anatomical landmarks at enclavation sites Alternatively, mark longitudinal axis of lens on conjunctiva 3:00 6 mm Enclavation Sites 5 mm 9:00 12:00

Paracentesis 6:00 Two (2) incisions at 10:00 & 2:00 0.50 mm Angle incisions toward enclavation sites Enclavation Sites 2:00 4:00 8:00 10:00 12:00

Inject Viscoelastic Use cohesive viscoelastic (Healon, Healon GV, etc.) Always fill from periphery both paracentesis Do not overfill

Incisions 5 to 6 mm incision Consider astigmatism Stepped Limbal Clear Corneal

Insert Lens Ensure sufficient miosis Use implant forceps Visualize Iris/Pupil

Rotate Implant Inject viscoelastic over lens Rotate haptic to 3:00 & 9:00 Center optic on pupil

Verisyse Instruments Implant Forceps Lens Manipulator, Straight

Enclavation Needle

Enclavation Pearls 1st Haptic Maintain chamber Viscoelastic PRN Start with your non-dominant hand & enclavate the corresponding haptic first If ambidextrous, temporal haptic first Insert enclavation needle in paracentesis first

Position Lens Align vertical & longitudinal lens axis with reference marks

The Enclavation Process Lens forceps stabilizes & positions lens Enclavation needle pulls iris tissues into haptics

The Enclavation Process After aligning lens, peripheral iris tissue is drawn into the split lens haptics Stable anchor minimal tissue trauma Reversible

The Enclavation Process Create small fold of iris tissue & pull into haptic Move needle down & create a larger fold of iris tissue Pull fold of iris & needle through haptic aperture

Enclavation Tissue Enclavate tissues from directly below split haptics

Enclavation Draw small amounts of superficial iris tissue into haptic in a circular fashion Repeat process until lens is securely anchored to the iris

Watch Alignment During Enclavation Lens moving inferiorly Enclavate tissue directly below superior split haptic to pull lens superiorly

Watch Alignment During Enclavation Lens moving superiorly Enclavate tissue directly below inferior split haptic to pull lens inferiorly

Lens Fixation: Posterior View Post-mortem specimen from 86 year-old with Verisyse aphakic IOL in place for 6 years

Position Lens 1st Haptic Position haptic over enclavation site & identify anatomical landmarks or reference marks

Enclavation 1 st Haptic

How Much is Enough? If you think you have too much iris, you probably don t! Take multiple small bites in a clockwise, circular fashion Too Little Too Much

Check Alignment If significant misalignment Reduce enclavation Place enclavation needle on top of enclavated iris & push through split haptic Realign & re-enclavate

Position Lens 2nd Haptic Maintain chamber Viscoelastic PRN Insert needle through paracentesis Center optic on pupil (vertically) Define landmarks under haptic Feed slightly peripheral iris to avoid oval pupil

Enclavation 2nd Haptic

Inspect Lens Reform chamber Verify centration & pupil Verify adequate enclavation Re-position or re-enclavate if necessary

Remove Viscoelastic Place sutures & tie Leave one suture untied to facilitate viscoelastic removal Carefully remove ALL viscoelastic Tie remaining suture, reform chamber, check for leaks

Verisyse Implantation

Intraoperative Astigmatism 1 to 2 diopters Corneal & limbal incisions Incision placement & sutures Scleral incision LRI or corneal incisions (CI) 2 or more diopter Corneal & limbal Wait for cornea to stabilize LRI, CI, laser LRI or corneal incisions

Post-Operative Astigmatism Evaluate patient satisfaction & functionality Correct astigmatism if patient is complaining or if vision is not functional (drivers license, etc.) Wait for the cornea to stabilize LRI, CI, Laser corneal surgery

Post-Surgical Protocol Standard post-intraocular surgery meds Antibiotic, steroid, NSAID Eye shield for 1 week Return 1 day post-op to check: IOP Lens position & pupil Visual acuity Routine F/U and visual rehabilitation

Fair Balance Intended Use Statement: Verisyse Phakic Intraocular Lenses are intended for the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2 mm, and for patients with documented stability of manifest refraction for the prior six months as demonstrated by a spherical equivalent change of less than or equal to 0.50 diopter. Rx Only. Precautions: Do not resterilize this lens by any method; do not store the lens at temperatures over 45 C (113 F). Warnings: Surgeons should consider the risk/benefit ratio for adults with preoperative ocular pathology, including but not limited to inflammation, distorted eye and microbial infection. Adverse Events: Adverse events that have been documented as having occurred following lens implantation include, but are not limited to, hyphema, retinal detachment and lens dislocation. For a complete listing of precautions, warnings and adverse events, refer to the package insert.