1. Unilateral multifocal lens implantation in patients with a contralateral monofocal or phakic eye is 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 implantation for cataract correction 1 –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 supportive 2-3 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 bilateral multifocal group multifocal/monofocal group multifocal/phakic group –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 Implant each 1 ReSTOR multifocal/ mixed supergroup Implant each 1 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), under photopic (81 cd/m 2 ), mesopic (3 cd/m 2 ), 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 supergroup at 31 cm Multifocal/ Phakic, n = 32 Multifocal/ Monofocal, n = 20 Multifocal/ Mixed, n = 52 Bilateral Multifocal, n = 15 -0.05 0 0.05 0.1 0.15 0.2 31 cm50 cm4 m Distance logMAR acuity * *P < 0.05

7.  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) versus unilateral supergroup (100 ± 80 seconds of arc, test score 5.9 ± 2.0). ** Results: Contrast Sensitivity & Stereopsis Photopic 1 1.5 2 log units MesopicMesopic with glare 361218 cycles per degree 61218 cycles per degree 61218 cycles per degree 0.5 1 1.5 2 3 3 log units 0.5 1 1.5 2 * Multifocal/Phakic, n = 32 Multifocal/Mixed, n = 52 Bilateral Multifocal, n = 15 Multifocal/Monofocal, n = 20 *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/phakic patients than multifocal/monofocal patients, likely due to early cataractous changes in the phakic group Multifocal/ Phakic (n = 32) Multifocal/ Monofocal (n = 20)P Multifocal/ Mixed (n = 52) Bilateral Multifocal (n = 15)P Report halo58%55%0.8357%77%0.19 Halo rating † 1.3 0.731.31.40.20 Report glare69%30%0.006*54%39%0.32 Glare rating † 2.12.00.332.12.40.46 *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 choose to have the procedure again  Average rating of satisfaction with vision was higher in the bilateral group than in the unilateral group Multifocal/ Phakic (n = 32) Multifocal/ Monofocal (n = 20)P Multifocal/ Mixed (n = 52) Bilateral Multifocal (n = 15)P Spectacle freedom 56%65%0.5360%77%0.25 Would have procedure again 91%95%0.5692% 1.00 Satisfaction with vision † 7.66.90.247.38.90.001* *Significant at P < 0.05 † Satisfaction scale: 1 (completely unsatisfied) to 10 (completely satisfied)

11. Statistically similar proportions of unilateral and bilateral patients (P = 0.27) rated satisfaction 7 or higher Multifocal/ Phakic, n = 32 Multifocal/ Monofocal, n = 20 Multifocal/ Mixed, n = 52 Bilateral Multifocal, n = 13 0% 20% 40% 60% 80% 100% Satisfaction rating Percent of patients ≥9 or 10 ≥8≥8≥7≥7 * * NS 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 *P < 0.05, unilateral vs bilateral NS = not statistically different, unilateral vs bilateral Results: Distribution of Satisfaction Scores

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 implantation in patients with a contralateral monofocal or phakic eye is a viable presbyopia correction option