Improvements in patient-reported outcomes and visual acuity after bilateral implantation of multifocal intraocular lenses with +3.0 diopter addition: Multicenter clinical trial

Abstract

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. Twelve study centers, United States. Randomized multicenter clinical trial. 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. 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). 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.