Cataract extraction with multifocal intraocular lens implantation: Clinical, functional, and quality‐of‐life outcomes: Multicenter clinical trial in Germany and Austria

Purpose: To compare bilateral implantation of a multifocal intraocular lens (IOL) versus a monofocal lens with respect to visual function, patient satisfaction, and quality of life. Setting: Seven clinical sites in Germany and 1 site in Austria. Methods: A prospective randomized masked clinical trial included 124 randomly assigned bilateral pseudophakic individuals, 64 of whom had bilateral implantation of an Array® foldable multifocal IOL (model SA‐40N, Allergan) and 60 of whom had bilateral implantation of an AMO®PhacoFlex II® silicone monofocal IOL (model SI‐40NB). Clinical data included binocular uncorrected and corrected distance and near visual acuities, complications, adverse events, and reports of halos and glare. Quality‐of‐life data were collected on 3 occasions using the modified Cataract TyPE Specification instrument. The functional status of the 2 groups was compared from baseline to final postoperative interview. Results: Three months after surgery, a higher proportion in the Array group achieved a Jaeger value of J3 (20/40 Snellen) or better uncorrected binocular near visual acuity and 0.5 (20/40) or better distance‐corrected binocular near visual acuity than in the monofocal groups (97% versus 68% and 95% versus 59%, respectively; P < .001). A higher proportion in the multifocal group achieved both 0.5 (20/40) and J3 or better uncorrected binocular distance and near visual acuities (97% versus 66%; P < .001). Those in the Array group were more likely than those in the monofocal group to never wear glasses overall (41% versus 12%; P < .001). Multifocal patients rated their vision without glasses better overall, at near and at intermediate distances (P < .05), and demonstrated better visual function for near tasks and social activities. Conclusions: Those who had bilateral implantation of the Array multifocal IOL obtained better uncorrected and distance‐corrected near visual acuities and reported better overall vision, less limitation in visual function, and less spectacle dependency than patients with bilateral monofocal IOLs.