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

Purpose To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. Design Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). Participants 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. Methods The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. Main Outcome Measures 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. Results 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, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. Conclusions The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.