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

Purpose: To compare bilateral implantation of a multifocal intraocular lens (IOL) versus a monofocal lens with respect to visual function, patient sat isfaction, and quality of life. Setting: Seven clinical sites in Germany and 1 site in Austria. Methods: A prospective randomized masked clinical trial included 124 random ly assigned bilateral pseudophakic individuals, 64 of whom had bilateral im plantation 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) silic one monofocal IOL (model SI-40NB). Clinical data included binocular uncorre cted and corrected distance and near visual acuities, complications, advers e events, and reports of halos and glare. Quality-of-life data were collect ed 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 binocu lar near visual acuity and 0.5 (20/40) or better distance-corrected binocul ar 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 dist ance and near visual acuilies (97% versus 864b; P < .001), Those in the Arr ay group were more likely than those in the monofocal group to never wear g lasses overall (41% versus 12%; P < .001). Multifocal patients rated their vision without glasses better overall, at near and at intermediate distance s (P < .05), and demonstrated better visual function for near tasks and soc ial activities. Conclusions: Those who had bilateral implantation of the Array multifocal I OL 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. (C) 2000 ASCRS and ESCRS.