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Newly designed incisional system provides improved results and recovery times in scleral implant surgery for treatment of presbyopia

Poster Details

First Author: K.Stonecipher USA

Co Author(s):                  

Abstract Details



Purpose:

To evaluate the effect on distance corrected near visual acuity (DCNVA) and rate of recovery after placement of Refocus Scleral Implants using a newly updated incisional system (Refocus-Group, Dallas, TX).

Setting:

The study is being conducted under a U.S. FDA IDE at 14 sites across the United States in a 2 year controlled clinical study.

Methods:

Out of the full cohort of 330 presbyopic, emmetropic subjects that were recruited in this ongoing study, 50 subjects had the Refocus Procedure performed using a newly designed incisional system. Eligibility criteria for this study included: best corrected distance visual acuity (BCDVA) = 20/20; manifest refraction spherical equivalent (MRSE) between +0.75D to -0.50D, with ≤ 1.00D of astigmatism; distance corrected near visual acuity (DCNVA) between 20/50 to 20/100. During the Refocus Procedure, four Refocus Scleral Implants were placed circumferentially in the oblique quadrants of the sclera just posterior to the calculated lens equator. DCNVA was the primary outcome measure and was assessed under standardized mesopic illumination at 40 cm pre- and post-operatively at 3, 6, 12, 18 and 24 months.

Results:

The Refocus Procedure was performed bilaterally on 50 subjects using a newly designed incisional system (mean pre-op DCNVA = 20/76). Postoperatively at 3, 6, 12, and 18 months, 94% (n=47), 94% (n=48), 96% (n=49), and 95% (n=40), respectively, reached 20/40 or better DCNVA, and the mean number of lines of improvement were 2.2, 2.5, 2.8, and 2.8 lines respectively (none of these 50 subjects have reached the 24 month visit as the study is ongoing). Distance visual acuity was not affected and the benefit of improved near vision appears to be functionally significant.

Conclusions:

The Refocus Procedure using the Refocus Scleral Implant shows potential as an effective solution for presbyopia in near emmetropic eyes. The results suggest that this procedure is effective in restoring near visual acuity in presbyopic emmetropic patients without adverse effects, either objectively or subjectively. Key benefits include the procedure being extraocular and outside the visual axis. Advancements in implant design, instrumentation and surgical technique have standardized and simplified the procedure. Improved instrumentation has reduced average surgical times and had a favorable impact on post-operative clinical outcomes. The results are achieved much earlier than the study-wide full cohort. These 50 subjects as a group are more illustrative of the current state of the surgery compared to the remaining cohort. FINANCIAL INTEREST: One of more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, One of more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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