European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens

Abstract

Objective: To report the safety and effectiveness of the AcrySof ReSTOR apodized diffractive intraocular lens (IOL), model MA60D3, when implanted into the capsular bag.

Design: Multicenter European study including university clinics, eye hospitals, and private ophthalmic surgical centers.

Participants: One hundred twenty-seven subjects implanted in cataractous eyes in an open multicenter study.

Intervention: After phacoemulsification, the foldable 3-piece hydrophobic acrylic apodized diffractive IOL was implanted in the capsular bag using a Monarch injector with an A-cartridge. The mean preoperative patient age was 68.4+/-12 years. Intraocular lens implant power ranged from 18.0 to 25.0 diopters (D) in 0.5-D increments.

Main outcome measures: Distance visual acuity (VA), near VA, spectacle dependence, unwanted visual symptoms, and patient satisfaction.

Results: At the 6-month postoperative visit, binocular (both eyes simultaneously) mean uncorrected distance and near logarithm of the minimum angle of resolution VAs for the MA60D3 were 0.04+/-0.14 and 0.09+/-0.12 (n = 118), respectively. In addition, 88.0% and 84.6% of ReSTOR subjects achieved spectacle independence for distance and near vision, respectively. Glare and halos were reported as severe by only 8.5% and 4.2% of patients, respectively. Ninety-two percent of patients stated that they would choose to have the same lens implanted again after the first implant, and 95.7% answered likewise after the second implant.

Conclusions: The AcrySof ReSTOR MA60D3 IOL demonstrated excellent near VA without compromising distance vision. Spectacle independence and patient satisfaction were high, whereas unwanted photic phenomena were clinically acceptable.