R F Steinert1, B L Aker, D J Trentacost, P J Smith, N Tarantino. 1. Center for Eye Research and Education, Ophthalmic Consultants of Boston, and the Department of Ophthalmology, Harvard Medical School, Massachusetts, USA. www.Dr_steinert@eyeboston.com
Abstract
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 investigational sites in the United States; 400 subjects achieved 1-year follow-up. A subset of 123 subjects (102 at 1 year) were enrolled in a monofocal fellow 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 multifocal silicone IOL was performed using the surgeon's standard technique. Subjects were followed at six postoperative examination intervals through 1 year. 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 distance-corrected near visual acuity (P < 0.0001). Mean uncorrected distance visual 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 118) compared with multifocal/monofocal subjects (56%; 93 of 165; P < 0.001) and unilateral multifocal subjects (58%; 56 of 97; P < 0.001). Low-contrast visual acuity was reduced in multifocal eyes by approximately 1 Snellen line. However, no perceived disadvantages attributable to the reduction in low-contrast acuity were found. Although the perception of halos and glare increased 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 paired eye compared with those with monofocal lenses, this zonal-progressive multifocal lens provided a high level of uncorrected and corrected distance vision, improved uncorrected and distance-corrected near vision, reduced spectacle dependency, and a high level of patient satisfaction despite some loss of low-contrast visual acuity and increased reports of halos and glare.
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 investigational sites in the United States; 400 subjects achieved 1-year follow-up. A subset of 123 subjects (102 at 1 year) were enrolled in a monofocal fellow 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 multifocal silicone IOL was performed using the surgeon's standard technique. Subjects were followed at six postoperative examination intervals through 1 year. 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 distance-corrected near visual acuity (P < 0.0001). Mean uncorrected distance visual 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 118) compared with multifocal/monofocal subjects (56%; 93 of 165; P < 0.001) and unilateral multifocal subjects (58%; 56 of 97; P < 0.001). Low-contrast visual acuity was reduced in multifocal eyes by approximately 1 Snellen line. However, no perceived disadvantages attributable to the reduction in low-contrast acuity were found. Although the perception of halos and glare increased 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 paired eye compared with those with monofocal lenses, this zonal-progressive multifocal lens provided a high level of uncorrected and corrected distance vision, improved uncorrected and distance-corrected near vision, reduced spectacle dependency, and a high level of patient satisfaction despite some loss of low-contrast visual acuity and increased reports of halos and glare.