Cataract extraction with multifocal intraocular lens implantation - A multinational clinical trial evaluating clinical, functional, and quality-of-life outcomes

Objective: Two million cataract extractions are performed annually in the U nited States. The procedure is nearly always accompanied by implantation of a monofocal intraocular lens (IOL), which corrects the patient's distance vision. The authors' objective was to measure visual function and quality-o f-life outcomes associated with bilateral implantation of a multifocal IOL, which corrects distance and near vision, and to compare the outcomes with those of the standard therapy. Design: A prospective, randomized, double-masked, clinical trial was conduc ted at eight sites in the United States, seven sites in Germany, and one si te in Austria. Participants: Participants included 245 cataract patients, 127 of whom rece ived the multifocal IOL bilaterally and 118 of whom received a monofocal IO L of nearly identical construction bilaterally. Methods: Clinical data included visual acuity (VA), complications, and adve rse events. Quality-of-life data were collected using a previously validate d survey instrument at baseline, after first eye surgery, and after second eye surgery. Results: At 3 months after surgery, patients who had received multifocal IO Ls had significantly better uncorrected and distance corrected binocular ne ar VA compared with patients who had received monofocal IOLs (mean uncorrec ted VA, 20/26 multifocal vs. 20/40 monofocal; mean distance corrected VA, 2 0/28 multifocal vs. 20/45 monofocal; P < 0.0001). Additionally, 96% of pati ents who had received multifocal IOLs and 65% of patients who had received monofocal IOLs achieved both 20/40 and J3 (Jaeger) or better uncorrected, b inocular distance and near visual acuities (P < 0.0001), Patients who had r eceived multifocal IOLs were more likely than patients who had received mon ofocal IOLs to never wear glasses overall (32% multifocal vs. 8% monofocal; P < 0.0001). On a LC-point scale, patients who had received multifocal IOL s on average reported having between "a little bit" and "some" glare or hal o, whereas patients who had received monofocal IOLs reported between "none" and "a little bit" of glare or halo (1.57 vs. 0.43; P < 0.001). Patients w ho had received multifocal IOLs rated their vision without glasses better o verall at near and at intermediate distances (P less than or equal to 0.002 ) and demonstrated better visual function for near tasks and social activit ies. Conclusions Cataract patients who received multifocal IOLs at time of surge ry obtained better uncorrected and distance corrected near VA and reported better overall vision, less limitation in visual function, less spectacle d ependency, and more glare or halo than those who received traditional monof ocal IOLs. Ophthalmology 2000; 107:2040-2048 (C) 2000 by the American Acade my of Ophthalmology.