Multifocal and Extended Depth of Focus Intraocular Lenses: A Comparison of Data from the United States Food and Drug Administration Premarket Approval Trials

Author(s): Schallhorn, Julie M | Abstract: PurposeTo review and compare the results of unpublished premarket approval studies for recent multifocal extended depth focus (EDOF) intraocular lenses.MethodsLenses without previously published pre-market trials were identified clinical patient-reported outcomes reviewed compared.ResultsLenses included DFT/DAT (Acrysof Vivity) EDOF lens, TFNT/TFAT (PanOptix) trifocal SV25T (ReStor ActiveFocus) lens (all from Alcon Laboratories, Inc), as well ZXR/ZXT (Tecnis Symfony Toric), ZLB00 Multifocal +3.25), ZKB00 +2.75, all Tecnis lenses Johnson a Vision). All produced equivalent distance vision superior intermediate near compared to monofocal controls. Patient-reported difficulty with glare, halos, starbursts was higher in cohort Spectacle independence exception (ActiveFocus) which not significantly different than control lens.ConclusionsClinical trial data U.S. Food Drug Administration supports an effective treatment aphakia presbyopia. [J Refract Surg. 2021;37(2):98-104.].