PURPOSE: To assess changes in patient-reported outcomes, satisfaction, vision quality, and visual acuity after bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D addition (add) in cataract patients. SETTING: Twelve study centers, United States. DESIGN: Randomized multicenter clinical trial. METHODS: In this 6-month trial, cataract patients had bilateral implantation of the AcrySof IQ ReSTOR +3.0 IOL (model SN6AD1). Patient-reported outcomes were collected using the Cataract TyPE questionnaire. Clinical outcomes included uncorrected near (UNVA), uncorrected intermediate (UIVA), and uncorrected distance (UDVA) visual acuities. RESULTS: The study comprised 147 patients. From preoperatively to 6 months postoperatively, the mean UDVA improved from 0.45 logMAR (approximate Snellen, 20/56) to 0.04 logMAR (20/22 Snellen), the mean UIVA from 0.56 logMAR (20/73) to 0.17 logMAR (20/30), and the mean UNVA from 0.62 logMAR (20/83) to 0.10 logMAR (20/25); all improvements were clinically and statistically significant (P<.0001). There was also a statistically significant improvement in patient satisfaction with uncorrected vision (P<.0001). Clinically and statistical significant reductions occurred in trouble with vision (daytime and nighttime), trouble with glare, limitations with UDVA, limitations with UNVA, and limitations in social activities (P<.0001). CONCLUSIONS:Bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D add produced statistically significant and clinically relevant postoperative improvements in UNVA, UIVA, and UDVA. Commensurate significant postoperative improvements were observed in the patient-reported uncorrected functional vision, satisfaction with uncorrected vision, and social activities.
RCT Entities:
PURPOSE: To assess changes in patient-reported outcomes, satisfaction, vision quality, and visual acuity after bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D addition (add) in cataractpatients. SETTING: Twelve study centers, United States. DESIGN: Randomized multicenter clinical trial. METHODS: In this 6-month trial, cataractpatients had bilateral implantation of the AcrySof IQ ReSTOR +3.0 IOL (model SN6AD1). Patient-reported outcomes were collected using the Cataract TyPE questionnaire. Clinical outcomes included uncorrected near (UNVA), uncorrected intermediate (UIVA), and uncorrected distance (UDVA) visual acuities. RESULTS: The study comprised 147 patients. From preoperatively to 6 months postoperatively, the mean UDVA improved from 0.45 logMAR (approximate Snellen, 20/56) to 0.04 logMAR (20/22 Snellen), the mean UIVA from 0.56 logMAR (20/73) to 0.17 logMAR (20/30), and the mean UNVA from 0.62 logMAR (20/83) to 0.10 logMAR (20/25); all improvements were clinically and statistically significant (P<.0001). There was also a statistically significant improvement in patient satisfaction with uncorrected vision (P<.0001). Clinically and statistical significant reductions occurred in trouble with vision (daytime and nighttime), trouble with glare, limitations with UDVA, limitations with UNVA, and limitations in social activities (P<.0001). CONCLUSIONS: Bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D add produced statistically significant and clinically relevant postoperative improvements in UNVA, UIVA, and UDVA. Commensurate significant postoperative improvements were observed in the patient-reported uncorrected functional vision, satisfaction with uncorrected vision, and social activities.
Authors: Jorge L Alió; Pilar Yébana; Mario Cantó; Ana B Plaza; Alfredo Vega; Jorge L Alió Del Barrio; Francisco Lugo Journal: Eye Vis (Lond) Date: 2020-07-18