PURPOSE: To evaluate visual outcomes, spectacle independence, and quality of life among nonastigmatic and astigmatic patients who received AcrySof IQ ReSTOR toric or nontoric multifocal intraocular lenses (IOLs) (Alcon Laboratories, Fort Worth, TX) compared with those who received commercially available nontoric monofocal IOLs after bilateral cataract removal. METHODS: This randomized, patient- and observer-technician-masked study was conducted at 20 sites in Europe. Patients were randomized to receive monofocal (nontoric only) or multifocal (nontoric or toric, as needed) IOLs. Primary efficacy endpoints included percentage of patients achieving binocular uncorrected distance and near acuity of 0.1 logMAR or better (20/25 Snellen), spectacle independence, and scores on the National Eye Institute Refractive Error and Quality of Life questionnaire domains. Safety endpoints included adverse events and refractive error within 0.5 and 1.0 diopters. RESULTS: In the multifocal group (n = 108) versus the monofocal group (n = 100), significantly more patients achieved uncorrected distance and near acuity of 0.1 logMAR or better (45.7% vs 2.1%; P < .0001) and spectacle independence (73.3% vs 25.3%; P < .0001) at 6 months. The percentage of patients who achieved uncorrected distance visual acuity of 20/40 or better at 6 months was 92% in the multifocal group and 97% in the monofocal group. National Eye Institute Refractive Error and Quality of Life scores were significantly better for dependence on correction in the multifocal group (P < .0001) and for glare in the monofocal group (P = .0157); other domain scores were similar between groups. No significant trends in study device-related adverse events were observed. CONCLUSIONS: Monofocal and multifocal IOLs provided good clinical outcomes. More patients receiving multifocal IOLs attained better uncorrected visual acuity at a range of distances and spectacle independence compared with patients who received monofocal IOLs. Monofocal IOLs were associated with better patient-reported scores for glare compared with multifocal IOLs; however, scores for patient satisfaction were significantly better in the multifocal group. Copyright 2015, SLACK Incorporated.
RCT Entities:
PURPOSE: To evaluate visual outcomes, spectacle independence, and quality of life among nonastigmatic and astigmaticpatients who received AcrySof IQ ReSTOR toric or nontoric multifocal intraocular lenses (IOLs) (Alcon Laboratories, Fort Worth, TX) compared with those who received commercially available nontoric monofocal IOLs after bilateral cataract removal. METHODS: This randomized, patient- and observer-technician-masked study was conducted at 20 sites in Europe. Patients were randomized to receive monofocal (nontoric only) or multifocal (nontoric or toric, as needed) IOLs. Primary efficacy endpoints included percentage of patients achieving binocular uncorrected distance and near acuity of 0.1 logMAR or better (20/25 Snellen), spectacle independence, and scores on the National Eye Institute Refractive Error and Quality of Life questionnaire domains. Safety endpoints included adverse events and refractive error within 0.5 and 1.0 diopters. RESULTS: In the multifocal group (n = 108) versus the monofocal group (n = 100), significantly more patients achieved uncorrected distance and near acuity of 0.1 logMAR or better (45.7% vs 2.1%; P < .0001) and spectacle independence (73.3% vs 25.3%; P < .0001) at 6 months. The percentage of patients who achieved uncorrected distance visual acuity of 20/40 or better at 6 months was 92% in the multifocal group and 97% in the monofocal group. National Eye Institute Refractive Error and Quality of Life scores were significantly better for dependence on correction in the multifocal group (P < .0001) and for glare in the monofocal group (P = .0157); other domain scores were similar between groups. No significant trends in study device-related adverse events were observed. CONCLUSIONS: Monofocal and multifocal IOLs provided good clinical outcomes. More patients receiving multifocal IOLs attained better uncorrected visual acuity at a range of distances and spectacle independence compared with patients who received monofocal IOLs. Monofocal IOLs were associated with better patient-reported scores for glare compared with multifocal IOLs; however, scores for patient satisfaction were significantly better in the multifocal group. Copyright 2015, SLACK Incorporated.