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 United 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-of-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 conducted at eight sites in the United States, seven sites in Germany, and one site in Austria.

PARTICIPANTS: Participants included 245 cataract patients, 127 of whom received the multifocal IOL bilaterally and 118 of whom received a monofocal IOL of nearly identical construction bilaterally.

METHODS: Clinical data included visual acuity (VA), complications, and adverse events. Quality-of-life data were collected using a previously validated survey instrument at baseline, after first eye surgery, and after second eye surgery.

RESULTS: At 3 months after surgery, patients who had received multifocal IOLs had significantly better uncorrected and distance corrected binocular near VA compared with patients who had received monofocal IOLs (mean uncorrected VA, 20/26 multifocal vs. 20/40 monofocal; mean distance corrected VA, 20/28 multifocal vs. 20/45 monofocal; P < 0.0001). Additionally, 96% of patients who had received multifocal IOLs and 65% of patients who had received monofocal IOLs achieved both 20/40 and J3 (Jaeger) or better uncorrected, binocular distance and near visual acuities (P < 0. 0001). Patients who had received multifocal IOLs were more likely than patients who had received monofocal IOLs to never wear glasses overall (32% multifocal vs. 8% monofocal; P < 0.0001). On a 4-point scale, patients who had received multifocal IOLs on average reported having between "a little bit" and "some" glare or halo, 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 who had received multifocal IOLs rated their vision without glasses better overall at near and at intermediate distances (P < or = 0.002) and demonstrated better visual function for near tasks and social activities.

CONCLUSIONS: Cataract patients who received multifocal IOLs at time of surgery obtained better uncorrected and distance corrected near VA and reported better overall vision, less limitation in visual function, less spectacle dependency, and more glare or halo than those who received traditional monofocal IOLs.