Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes

Ophthalmology
Jeffrey WhitmanDouglas D Koch

Abstract

To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, ...Continue Reading

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Citations

Aug 6, 2016·Journal of Cataract and Refractive Surgery·Jeffrey WhitmanRichard Potvin
Aug 6, 2016·Journal of Cataract and Refractive Surgery·Sathish Srinivasan
Oct 5, 2016·American Journal of Ophthalmology·Woong-Joo WhangGeunyoung Yoon
Apr 24, 2018·Case Reports in Ophthalmology·Ralph Chu, Briana R Lee
Dec 11, 2017·Journal of Cataract and Refractive Surgery·Roger F SteinertLuis G Vargas
Jun 16, 2017·Eye & Contact Lens·Perry S Binder
Apr 18, 2017·Eye and Vision·Veronica Vargas-Fragoso, Jorge L Alió
Mar 2, 2019·Investigative Ophthalmology & Visual Science·Beau J FennerJodhbir S Mehta
Dec 24, 2019·Translational Vision Science & Technology·Aritz BidagurenNerea Garagorri
Jul 28, 2020·Eye·Marcus AngJorge L Alió
Sep 8, 2019·Progress in Retinal and Eye Research·Andri K RiauJodhbir S Mehta
Feb 2, 2021·Experimental Eye Research·Beau J FennerJodhbir S Mehta

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