Clinical evaluation of the OptiVis™ multifocal intraocular lens

The purpose of this study was to evaluate the efficacy of the OptiVis™ Multifocal Intraocular Lens (IOL) in patients undergoing bilateral crystalline lens replacement following extracapsular extraction by phacoemulsification.

This was a prospective 6-month, open-label, nonrandomized clinical trial of subjects undergoing bilateral implantation with the OptiVis Multifocal IOL. Of the 121 eyes enrolled, 88 eyes of 44 subjects completed the entire 6-month trial.

After 6 months, the majority of eyes had a distance best-corrected visual acuity of 20/20 or better, with 89.8% achieving that outcome, and 100% with 20/32 or better. At an intermediate distance, most eyes (90.9%) had a distance corrected intermediate visual acuity of 20/40 or better, and 53.4% had an acuity of 20/32 or better. At a near distance, most eyes (95.5%) had a distance corrected near visual acuity of 20/40 or better by month 6. The most commonly reported adverse event was mild-to-moderate halos (n = 30, 36%) and mild-to-moderate glare (n = 15, 18%). In addition, there was one case of cystoid macular edema, one posterior capsular opacification, and one case of severe corneal edema. Postoperative contrast sensitivity was comparable with normal phakic subjects ≥ 60 years of age.

The OptiVis Multifocal IOL provided satisfactory visual acuity at distance, near, and intermediate with no apparent reduction in contrast sensitivity. Additional, longer-term follow-up studies are planned.