Night Vision Complaints in Phakic IOL Patients

1. Sherman W. Reeves, MD, MPH1,2,4; Noumia Cloutier-Gill, OD1,2; David R. Hardten, MD1,2,3,4; Marlane J. Brown, OD, FAAO1,2; Kristal Jones1 Elizabeth A. Davis, MD1,3; Night Vision Complaints in Phakic IOL Patients 1 Minnesota Eye Consultants, Minneapolis, Minnesota 2 Illinois College of Optometry, Chicago, Illinois3 Department of Ophthalmology, University of Minnesota, Minneapolis, Minnesota4 Department of Ophthalmology, Regions Medical Center, St. Paul, Minnesota **Financial relationships pertaining to this analysis** DRH, EAD - Consultants for Abbot Medical Optics In the past 3 years, Minnesota Eye Consultants has conducted research for AMO, Alcon Laboratories and STAAR Surgical.

2. Purpose • To compare night vision complaints (NVCs) and satisfaction with postoperative vision in patients who underwent bilateral Visian (Staar Surgical, Monrovia, CA) or Verisyse (Abbott Medical Optics, Santa Ana, CA) phakic intraocular lens (PIOL) implantation. • To assess the role of pupil size in relation to optic size in the risk of NVCs for both lenses. • To identify other possible clinical risk factors for the development of postoperative NVCs after PIOL implantation.

3. Methods • Design • Retrospective cohort, approved by IRB • Setting • Single, private group practice • Subjects • Eligibility: • All patients having undergone bilateral Verisyse or Visian PIOL implantation from 6/30/2004 through 6/30/2008 who consented to participation and completed a questionnaire administered by phone • Exclusions: • Presence of cataract or corneal opacity near the visual axis • Patients who had PIOLs explanted for medical reasons • Patients who had any other refractive or intraocular surgery prior to or subsequent to the implantation of the PIOL • Patients having astigmatism surgery before, during or after PIOL implantation or planned in the future • Monovision patients (Note: monovision patients were included in the preliminary analysis at the time of abstract submission)

4. Methods • Chart review: • Potential subjects identified from computerized billing database • Charts reviewed for: • Preoperative refractive data • Manifest refraction (MR), spherical equivalent (SphEq) and best-corrected distance visual acuity (BCVA) • Preoperative scotopic pupil size in millimeters • Manual measurement and/or pupillometer • Postoperative refractive data • Manifest refraction (MR), spherical equivalent (SphEq), BCVA, uncorrected distance visual acuity (UCVA) • PIOL optic size in millimeters (manufacturer data) • Dry eye syndrome • Presence or absence of clinically significant lens decentration

5. Methods • Questionnaire • 21 questions (ordinal responses) administered by a single telephone interview • Quantified: • Frequency/severity of glare and halos, pre/postoperatively, with/without spectacle or contact lens correction in place • Pre/postoperative satisfaction with daytime/nighttime vision • Analysis • Worse eye / eye with the more extreme clinical data was used for comparison against questionnaire responses • Pupillometer measurement was used whenever available to identify subjects with scotopic pupils larger than the PIOL optical zone; otherwise the manual pupil size was used • Questionnaire scores were compared before and after PIOL implantation for All Subjects, Visian and Verisyse groups • Subjects were stratified by clinical parameters and questionnaire scores compared • T-Tests used for between group comparisons • Paired T-Tests used for pre- vs postoperative comparisons within groups • Fischers Exact test used for comparisons of groups with small numbers

6. Results – Population Data • 17 Bilateral Verisyse and 21 bilateral Visian patients were identified, consented to participation and administered the phone interview • 13 Bilateral Verisyse and 9 bilateral Visian patients met the exclusion criteria based on subsequent chart review • Visian and Verisyse patients were similar in respect to baseline demographic and clinical variables.

7. Results - Questionnaire

8. Results - Questionnaire

9. Results – Clinical Data

10. Conclusion • The frequency/severity of the specific NVCs of glare/halo did not worsen after implantation of either PIOL • Satisfaction with both PIOLs was high in both daytime and nighttime settings • Subjects were slightly less satisfied with their nighttime vision after PIOL implantation in comparison to their daytime vision • Overall, both Verisyse and Visian patients had minimal night vision difficulties and were highly satisfied following bilateral PIOL implantation

11. Limitations • Limitations • Small number of patients, insufficient power to discriminate small differences among groups • Retrospective design limits clinical variables available for analysis • Questionnaire asked about overall NVCs and satisfaction whereas clinical data obtained from chart review was recorded by eye (OD/OS); questionnaire responses may have differed if considered by eye rather than by overall vision • Questionnaire may not have adequately captured NVCs • Summary • Both Verisyse and Visian PIOLs yielded high satisfaction and minimal NVC complaints after bilateral implantation • Larger samples / prospective studies will be helpful to determine clinical factors associated with NVC risk in these patients

12. References • Tahzib NG. MacRae SM. Yoon G. Berendschot TT. Eggink FA. Hendrikse F. Nuijts RM. Higher-order aberrations after implantation of iris-fixated rigid or foldable phakic intraocular lenses.Journal of Cataract & Refractive Surgery. 34(11):1913-20, 2008 Nov. • Tahzib NG. Nuijts RM. Wu WY. Budo CJ. Long-term study of Artisan phakic intraocular lens implantation for the correction of moderate to high myopia: ten-year follow-up results. Ophthalmology. 114(6):1133-42, 2007 Jun. • Tahzib NG. Bootsma SJ. Eggink FA. Nuijts RM. Functional outcome and patient satisfaction after Artisan phakic intraocular lens implantation for the correction of myopia.American Journal of Ophthalmology. 142(1):31-39, 2006 Jul. • Leccisotti A. Phakic intraocular lenses after scleral buckling for retinal detachment.European Journal of Ophthalmology. 17(3):388-91, 2007 May-Jun. • Bootsma SJ. Tahzib NG. Eggink FA. de Brabander J. Nuijts RM. Evaluation of pupil dynamics after implantation of artisan phakic intraocular lenses.Journal of Refractive Surgery. 22(4):367-71, 2006 Apr. • Stulting RD. John ME. Maloney RK. Assil KK. Arrowsmith PN. Thompson VM. U.S. Verisyse Study Group. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.] Ophthalmology. 115(3):464-472.e1, 2008 Mar. • Guell JL. Morral M. Gris O. Gaytan J. Sisquella M. Manero F. Five-year follow-up of 399 phakic Artisan-Verisyse implantation for myopia, hyperopia, and/or astigmatism.Ophthalmology. 115(6):1002-12, 2008 Jun. • Alio JL. Advances in phakic intraocular lenses: indications, efficacy, safety, and new designs. Current Opinion in Ophthalmology. 15(4):350-7, 2004 Aug. • Menezo JL. Peris-Martinez C. Cisneros AL. Martinez-Costa R. Phakic intraocular lenses to correct high myopia: Adatomed, Staar, and Artisan.Journal of Cataract & Refractive Surgery. 30(1):33-44, 2004 Jan.