Robert J. Cionni, MD Cincinnati Eye Institute, Cincinnati, OH

1. Unilateral multifocal lens implantationin patients witha contralateral monofocal or phakic eyeis a viable presbyopic correction option Robert J. Cionni, MD Cincinnati Eye Institute, Cincinnati, OH This study was supported by a research grant from Alcon Laboratories, Inc.The author is a consultant for Alcon but has no direct financial interest in any product mentioned.

2. Purpose • To report visual outcome data and patient-reported measures on 52 patients unilaterally implanted with an aspheric apodized diffractive lens • Many presbyopic patients require only one lens implantationfor cataract correction1 • No documented studies show whether unilateral patients • might avoid some halo or glare experienced by some bilateral patients • will benefit from a ReSTOR multifocal intraocular lens (IOL),though results from other multifocal IOLs are supportive2-3 1.Williams A, et al. Arch Ophthalmol 2006;124:1308-1314. 2.Shoji N, Shimizu K. J Cataract Refract Surg 2002;28:1012-1017. 3.Haring G, et al. J Cataract Refract Surg 1999;25:1151-1156. 4. Steinert RF, et al. Ophthalmology 1999;106:1243-1255.

3. Methods:Patient Enrollment • During a six-month window, enrolled 67 patients under age 71 without ocular comorbidities and with ≤1 D astigmatism • any eligible patient with 1 previous ReSTOR IOL was recruited: yield n = 15 • recruited for unilateral group until each group reached at least 20 patients • Monofocal IOLs (any model) were present in one eye of 20 patients • 32 patients had no previous cataract surgery and needed an IOL in only one eye bilateral multifocalgroup Implant each1 ReSTOR Implant each1 ReSTOR multifocal/monofocalgroup multifocal/mixedsupergroup multifocal/phakicgroup Implant each1 ReSTOR

4. Methods:Surgical Technique • Clear corneal incision (2.8 mm) at a location based on reducing any preexisting corneal astigmatism • Complete hydrodissection • Circular capsulorhexis (5.5 mm) • Lens removed via bimanual phacoemulsification • Posterior lens capsule polished • SN60D3 ReSTOR IOL (Alcon Laboratories, Inc.)implanted via Monarch II injector system • No posterior lens capsule breakage or outward vitreous flow • Patients received standard postoperative medications and a routine 1‑day postoperative exam

5. Methods:Testing and Analysis • All examinations were conducted six months (±30 days) postoperatively • Visual acuity • Best corrected and uncorrected visual acuity at 31 cm, 50 cm, and 4 m assessed using ETDRS charts • Contrast sensitivity tested using a CSV-1000 (VectorVision), underphotopic (81 cd/m2), mesopic (3 cd/m2), and mesopic + glare conditions • Stereopsis assessed with the Titmus Fly stereo ring test • Lifestyle vision • Patients completed a 28-question survey assessing the lifestyle impact of the apodized diffractive lens, including questions about • visual difficulty of performing everyday tasks, such as reading a newspaper, driving, playing board games, watching television, playing sports, cooking • visual disturbances (such as halos and glare) • night vision • patient satisfaction • spectacle freedom ETDRS = Early Treatment of Diabetic Retinopathy Study

6. Results:Uncorrected Visual Acuity • No statistical differences between the two unilateral subgroups • Bilateral group significantly better than the unilateral supergroupat 31 cm 0.2 Multifocal/Phakic,n = 32 Multifocal/Monofocal, n = 20 Multifocal/Mixed, n = 52 BilateralMultifocal,n = 15 0.15 0.1 logMAR acuity 0.05 * 0 -0.05 31 cm 50 cm 4 m Distance *P < 0.05

7. Results:Contrast Sensitivity & Stereopsis • Few significant differences or trends in contrast sensitivity • Stereopsis • similar between the two unilateral subgroups • significantly different,bilateral group (60 ± 30 seconds of arc, test score 7.9 ± 1.6) versusunilateral supergroup (100 ± 80 seconds of arc, test score 5.9 ± 2.0). Mesopic Mesopic with glare Photopic 2 2 2 ** 1.5 1.5 log units log units log units 1 1.5 1 * 0.5 0.5 1 6 12 18 3 6 12 18 3 6 12 18 3 cycles per degree cycles per degree cycles per degree Multifocal/Phakic,n = 32 Multifocal/Monofocal, n = 20 Multifocal/Mixed, n = 52 Bilateral Multifocal,n = 15 *P < 0.05, multifocal/phakic versus multifocal/monofocal **P < 0.05, multifocal bilateral versus multifocal/mixed

8. Results:Patient Survey of Everyday Tasks • Difficulty of far-distance tasks without spectacles:no significant differences among any groups • Difficulty of intermediate/near tasks without spectacles • Unilateral versus bilateral multifocal • 6 tasks similar between groups: reading a book or newspaper, reading large print, recognizing people, using a computer, cooking, playing board games or card games • 4 tasks significantly different: performing fine handwork, writing checks or paying bills, reading small print, reading a restaurant menu in dim light(all easier for the bilateral group than for the unilateral group) • Unilateral multifocal subgroups: phakic versus monofocal • results for 8 questions were similar between groups • two significant differences • favored phakic group for using a computer • favored monofocal group for reading large print

9. Results:Visual Disturbances • Halos were reported by a smaller proportion of unilateral patients (57%) than bilateral patients (77%), but difference was not significant • Problems with glare were reported by a larger percentage of multifocal/phakicpatients than multifocal/monofocal patients, likely due to early cataractous changes in the phakic group *Significant at P < 0.05†Halo/glare scale: 1 (not bothersome), 2 (mildly bothersome), 3 (moderately bothersome), 4 (severely bothersome)

10. Results:Patient Satisfaction • A majority of all patients achieved spectacle independence(60% unilateral, 77% bilateral, no statistical difference) • Almost all patients (>91% in any group) would chooseto have the procedure again • Average rating of satisfaction with vision was higherin the bilateral group than in the unilateral group *Significant at P < 0.05†Satisfaction scale: 1 (completely unsatisfied) to 10 (completely satisfied)

11. Results:Distribution of Satisfaction Scores Statistically similar proportions of unilateral and bilateral patients (P = 0.27) rated satisfaction 7 or higher A majority of patients in all groups (75% to 92%)were satisfied with their vision (score ≥7 out of 10) More bilateral than unilateral patients rated their vision ≥8 or ≥9 100% NS * Multifocal/Phakic, n = 32 Multifocal/Monofocal, n = 20 Multifocal/Mixed, n = 52 BilateralMultifocal, n = 13 * 80% 60% Percent of patients 40% 20% 0% ≥8 ≥7 ≥9 or 10 Satisfaction rating *P < 0.05, unilateral vs bilateral NS = not statistically different, unilateral vs bilateral

12. Conclusions The unilateral implantation of an aspheric apodized diffractive multifocal IOL provided patients in this population with • functional near, intermediate, and distance vision • contrast sensitivity that was similar to bilateral ReSTOR patients • spectacle freedom in 60% of cases • vision that 75% of patients rated at satisfaction of 7 or higher (out of 10) Unilateral multifocal lens implantationin patients witha contralateral monofocal or phakic eyeis a viable presbyopia correction option