PURPOSE: To review and compare the results of unpublished premarket approval studies for recent multifocal and extended depth of focus (EDOF) intraocular lenses. METHODS: Lenses without previously published pre-market approval trials were identified and clinical and patient-reported outcomes were reviewed and compared. RESULTS: Lenses included the DFT/DAT (Acrysof Vivity) EDOF lens, the TFNT/TFAT (PanOptix) trifocal lens, and the SV25T (ReStor ActiveFocus) lens (all from Alcon Laboratories, Inc), as well as the ZXR/ZXT (Tecnis Symfony and Symfony Toric), the ZLB00 (Tecnis Multifocal +3.25), and the ZKB00 (Tecnis Multifocal +2.75, all Tecnis lenses from Johnson & Johnson Vision). All lenses produced equivalent distance vision and superior intermediate and near vision compared to monofocal controls. Patient-reported difficulty with glare, halos, and starbursts was higher in the multifocal and EDOF lens cohort compared to monofocal controls. Spectacle independence was higher in the multifocal and EDOF cohort with the exception of the SV25T (ActiveFocus) lens, which was not significantly different than the control lens. CONCLUSIONS: Clinical trial data from the U.S. Food and Drug Administration premarket approval studies supports multifocal and EDOF lenses as an effective treatment for aphakia and presbyopia. [J Refract Surg. 2021;37(2):98-104.]. Copyright 2021, SLACK Incorporated.
PURPOSE: To review and compare the results of unpublished premarket approval studies for recent multifocal and extended depth of focus (EDOF) intraocular lenses. METHODS: Lenses without previously published pre-market approval trials were identified and clinical and patient-reported outcomes were reviewed and compared. RESULTS: Lenses included the DFT/DAT (Acrysof Vivity) EDOF lens, the TFNT/TFAT (PanOptix) trifocal lens, and the SV25T (ReStor ActiveFocus) lens (all from Alcon Laboratories, Inc), as well as the ZXR/ZXT (Tecnis Symfony and Symfony Toric), the ZLB00 (Tecnis Multifocal +3.25), and the ZKB00 (Tecnis Multifocal +2.75, all Tecnis lenses from Johnson & Johnson Vision). All lenses produced equivalent distance vision and superior intermediate and near vision compared to monofocal controls. Patient-reported difficulty with glare, halos, and starbursts was higher in the multifocal and EDOF lens cohort compared to monofocal controls. Spectacle independence was higher in the multifocal and EDOF cohort with the exception of the SV25T (ActiveFocus) lens, which was not significantly different than the control lens. CONCLUSIONS: Clinical trial data from the U.S. Food and Drug Administration premarket approval studies supports multifocal and EDOF lenses as an effective treatment for aphakia and presbyopia. [J Refract Surg. 2021;37(2):98-104.]. Copyright 2021, SLACK Incorporated.
Authors: Daniele Tognetto; Rosa Giglio; Chiara De Giacinto; Marco R Pastore; Gabriella Cirigliano; David P Piñero; Gianluca Turco Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-10-04 Impact factor: 3.117