Clinical outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive design

Abstract

Purpose: To evaluate the effectiveness and safety of the DFT015 intraocular lens (IOL) (AcrySof IQ Vivity Extended Vision) compared with an aspheric monofocal control IOL (AcrySof IQ model SN60WF).

Setting: 11 investigation sites in the U.S.

Design: Prospective randomized controlled clinical study.

Methods: Patients aged 22 years or older with bilateral cataracts were randomized to receive bilateral implantation of DFT015 or SN60WF. The 4 coprimary effectiveness outcomes (6 months postoperatively) were monocular photopic distance-corrected intermediate visual acuity (DCIVA), monocular photopic corrected distance visual acuity (CDVA), monocular depth of focus (DoF), and the percentage of patients achieving a DCIVA of 0.2 logMAR or better. The mean monocular photopic distance-corrected near visual acuity (DCNVA) was a secondary effectiveness outcome. Safety and patient-reported visual disturbances were evaluated through questionnaires.

Results: 218 patients (435 eyes) completed the study. Compared with SN60WF, DFT015 demonstrated superior mean monocular photopic DCIVA ( P < .001), noninferior mean monocular photopic CDVA, and superior mean monocular photopic DCNVA ( P < .001) and provided an extended monocular DoF (increase of 0.54 diopters at 0.2 logMAR). With DFT015, 78 first eyes (72.9%) achieved a DCIVA of 0.2 logMAR or better at 6 months. Incidences of ocular serious adverse events and patient-reported most bothersome visual disturbances were low and consistent between groups.

Conclusions: DFT015 is safe and effective for the visual correction of aphakia, exceeding American National Standards Institute criteria for an extended depth-of-focus IOL by providing superior DCIVA and DCNVA, with comparable CDVA and visual disturbances to the SN60WF monofocal IOL.

Trial registration: ClinicalTrials.gov NCT03274986.

Conflict of interest statement

Disclosures: C. McCabe reports personal fees from EyePoint Pharmaceuticals, Inc. during the conduct of the study and received personal fees from Ocular Therapeutix, Inc., Omidria, Novartis Corp., and Bausch & Lomb, Inc., outside the submitted work. J. Berdahl reports personal fees from Alcon Laboratories, Inc., Bausch & Lomb, Inc., Johnson & Johnson Vision, and RxSight, Inc. during the conduct of the study and personal fees from Aerie Pharmaceuticals, Aerpio, Allergan, Inc., Avedro, Inc., Aurea Medical, CorneaGen, Dakota Lions Eye Bank, Equinox, Expert Opinion, Glaukos Corp., W.L. Gore & Associates, Inc., Imprimis Pharmaceuticals, Inc., iRenix, Iacta Pharmaceuticals, Kala Pharmaceuticals, Inc., Kedalion, MELT Pharm, MicroOptx, New World Medical, Inc., Ocular Surgical Data, Ocular Therapeutix, Inc., Omega Ophthalmics, Orasis, Oyster Point Pharma, Inc., Sight Sciences, Surface, Inc., Tarsus, TearClear, Vertex Ventures, ViaLase, Vittamed, Vance Thompson Vision, Verana Health, Visionary Ventures, and Carl Zeiss Meditec AG, outside the submitted work. H. Reiser reports personal fees from Alcon Laboratories, Inc. T.H. Newsom reports no conflicts of interest. L. Cibik reports no conflicts of interest. D. Koch reports personal fees from Alcon Laboratories, Inc., Carl Zeiss Meditec AG, and Johnson & Johnson Vision, outside the submitted work.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.

Figures

Figure 1.

Illustration showing the mechanism of action of DFT015.

Figure 2.

Mean binocular defocus curves at month 6 (all-implanted analysis set). Error bars represent 95% CIs.

Figure 3.

Proportion of patients reporting “not bothered at all” from visual disturbances at month 6. Error bars represent 95% CIs.

Figure 4.

Mean monocular mesopic contrast sensitivity (a) with glare and (b) without glare at month 6, first eye (safety analysis set). Error bars represent 95% CIs.