Measuring outcomes of multifocal intraocular lenses

PURPOSE: To design and validate study instruments for measuring outcomes of cataract extraction with implantation of multifocal Intraocular lenses compared with standard monofocal intraocular lenses. METHODS: A functional status instrument was developed based on the cataract TyPE specification with additional questions to address, uncorrected vision and social function. All 126 U.S. patients who underwent cataract extraction with bilateral implantation of a zonal progressive multifocal IOL under FDA IDE protocol were considered eligible for the study, of whom 100 (79%) completed the study, 103 patients of matched age and postoperative acuity who underwent bilateral implantation of an ICL that was similar except for multifocality were enrolled as controls. RESULTS: Our instrument was valid (Cronbach's α = 0.94) and correlated moderately (Pearsor's r = 0.34) with Snellen acuity. On a 10 point rating scale, subjects with multifocal IOLs rated their overall vision without spectacles 14% higher and their near vision 56% higher than those with monofocal lenses (P