A prospective comparative study of the AMO ARRAY zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens

Objective: To evaluate the safety and effectiveness of a zonal-progressive multifocal silicone intraocular lens (IOL), Design: Prospective, nonrandomized, fellow eye comparative trial, Participants: Four hundred fifty-six subjects were enrolled at 14 investiga tional sites in the United States; 400 subjects achieved I-year follow-up. A subset of 123 subjects (102 at 1 year) were enrolled in a monofocal fello w eye control substudy; subjects were implanted with the multifocal IOL in one eye and a comparable monofocal IOL in the fellow eye. Methods: Cataract extraction and implantation of a zonal-progressive multif ocal silicone IOL was performed using the surgeon's standard technique. Sub jects were followed at six postoperative examination intervals through I ye ar, Main Outcome Measures: The key efficacy measures were mean uncorrected and corrected distance and near visual acuity at 1 year after surgery. Results: In the monofocal fellow eye control substudy, the multifocal eyes showed a mean 2-line increase over monofocal eyes for uncorrected and dista nce-corrected near visual acuity (P < 0.0001). Mean uncorrected distance vi sual acuity was similar between multifocal and monofocal eyes (P = 0.116). A significantly higher proportion of bilateral multifocal subjects reported that they could function comfortably without glasses at near (81%, 96 of 1 18) compared with multifocal/monofocal subjects (56%; 93 of 165, P < 0.001) and unilateral multifocal subjects (58%; 56 of 97; P < 0.001), Low-contras t visual acuity was reduced in multifocal eyes by approximately I Snellen l ine. However, no perceived disadvantages attributable to the reduction in l ow-contrast acuity were found. Although the perception of halos and glare i ncreased in the multifocal eyes, good visual function remained, and nearly all subjects were satisfied with the results of their surgery. Conclusions: In a large study that included a subset of subjects with paire d eye compared with those with monofocal lenses, this zonal-progressive mul tifocal lens provided a high level of uncorrected and corrected distance vi sion, improved uncorrected and distance-corrected near vision, reduced spec tacle dependency, and a high level of patient satisfaction despite some los s of low-contrast visual acuity and increased reports of halos and glare.