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

Abstract

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(R) foldable multifocal IOL (model SA-40N, Allergan) and 60 of whom had bilateral implantation of an AMO(R)PhacoFlex II(R) 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.