1. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston P91: Clinical performance of phakic angle-supported investigational IOL in prospective global trials Thomas Kohnen Department of Ophthalmology Goethe-University Frankfurt am Main Financial disclosure in field of phakic IOL : Alcon, Ft.Worth, Tex, USA: Scientific consultant, research funding and travel expense reimbursement

2. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Purpose  To evaluate the safety and effectiveness of an angle- supported phakic lens (PIOL) in clinical trials conducted in the U.S., Europe and Canada

3. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Methods  Prospective, global clinical studies  360 subjects underwent implantation of the AcrySof Cachet phakic lens  United States: 50 subjects  Canada: 120 subjects  Europe: 190 subjects  Study participants  ≥18 years of age (age cap of 49 years for U.S. & Canada studies)  Stable moderate to high myopia (refractions within ±0.5 D at least 12 months prior to surgery)  No previous corneal or ocular surgery  ≤2.0 D of preop corneal astigmatism  ≤7.0 mm mesopic pupil size  Preop endothelial cell density per age criteria

4. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Methods / materials  Angle-Supported Phakic Lens  Single piece design  Soft acrylic IOL material  Foldable insertion via Monarch® II IOL Delivery System  Lens placement in irido-corneal junction  Peripheral iridotomy or iridectomy optional (preventive iridotomy performed in 1 of 360 subjects) Optic Size: 6.0 mm Overall length (OAL): 12.5 mm to 14.0 mm Diopter range: -6.0 to -16.5 D Investigational Lens

5. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Methods  Clinical evaluation at 3 year visit  1 st eye outcomes  Spherical equivalent (SE)  Uncorrected visual acuity (UCVA)  Endothelial cell density (ECD)  Contrast sensitivity substudy  VectorVision CSV-1000E  Mesopic lighting conditions with & without glare  @ 3, 6, 12, 18 cycles per degree (cpd )

6. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Spherical equivalent Postop SE at 3 years was within ± 0.5 D of target in 75.6% (239/316) of subjects. Mean and Standard Deviation

7. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Uncorrected visual acuity at 3 year visit Mean logMAR UCVA: 0.03 ± 0.17

8. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Corrected visual acuity at 3 year visit Mean logMAR CVA: -0.09 ± 0.11

9. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Central endothelial cell density % Change= -0.4% @ 3 yrs from 6 m (N=311) % Change= -0.4% @ 3 yrs from 6 m (N=311) Corneal endothelium response stable over time. Mean and Standard Deviation

10. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Peripheral endothelial cell density % Change= -0.7% @ 3 yrs from 6 m (N=299) % Change= -0.7% @ 3 yrs from 6 m (N=299) Mean and Standard Deviation Corneal endothelium response stable over time.

11. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Change in mean contrast sensitivity Preop vs. 3 Year Visit Mean mesopic contrast sensitivity, with and without glare, improved at all spatial frequencies, with greatest improvement observed at higher spatial frequencies. Mean CS and 90% lower confidence limit

12. P91: Clinical Performance of Phakic Angle-Supported Investigational IOL in Prospective Global Trials, ASCRS 2010, Boston Conclusions  3 year visit outcomes demonstrated:  Good visual acuity  Accurate predictability of refraction  Maintenance of endothelial cell density  Improvements in contrast sensitivity  Clinical investigation continuing through 5 years postoperative