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

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• 作者：Jeffrey Whitman ; MD¹ ; ^{whitman@keywhitman.com" class="auth_mail" title="E-mail the corresponding author} ; Paul J. Dougherty ; MD² ; Gregory D. Parkhurst ; MD³ ; John Olkowski ; MD⁴ ; Stephen G. Slade ; MD⁵ ; John Hovanesian ; MD⁶ ; Ralph Chu ; MD⁷ ; Jon Dishler ; MD⁸ ; Dan B. Tran ; MD⁹ ; Robert Lehmann ; MD¹⁰ ; Harvey Carter ; MD¹¹ ; Roger F. Steinert ; MD¹² ; Douglas D. Koch ; MD¹³
• 关键词：CDVA ; corrected distance visual acuity ; CS ; contrast sensitivity ; D ; diopter ; IOL ; intraocular lens ; logMAR ; logarithm of the minimum angle of resolution ; MRSE ; manifest refractive spherical equivalent ; UDVA ; uncorrected distance visual acuity ; UIVA ; uncorrected intermediate visual acuity ; UNVA ; uncorrected near visual acuity
• 刊名：Ophthalmology
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：123
• 期：3
• 页码：466-475
• 全文大小：2622 K

文摘

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, 1373580">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.