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Improvement of near visual acuity using scleral implants for treatment of presbyopia: single center preliminary findings

Poster Details

First Author: D.Schanzlin USA

Co Author(s):    B. Soloway              

Abstract Details



Purpose:

To describe 18-month results of the Refocus Procedure (Refocus-Group, Dallas, TX) as a treatment for presbyopia on distance corrected near visual acuity (DCNVA). This is a single center evaluation of a 2-year, multi-center prospective clinical trial design being conducted under a U.S. FDA IDE.

Setting:

Private Clinical Practice/Clinical Research Trial

Methods:

During the Refocus Procedure, four Refocus Scleral Implants are placed circumferentially in the oblique quadrants of the sclera 4 mm posterior to the limbus. Eligibility criteria 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 and 20/100. DCNVA was the primary outcome measure and was assessed under standardized mesopic illumination at 40cm pre-operatively and post-operatively at 6, 12, 18, and 24 months. At this single center, 28 eyes (14 patients) have completed the procedure and 12 patients have reached the 18 month follow-up visit.

Results:

Preliminary descriptive analyses showed that out of all eyes assessed post-operatively at 6, 12, and 18 months, 86% (n=28), 96% (n=28), and 92% (n=24), respectively, reached 20/40 or better DCNVA, and the mean number of lines of improvement were 2.9, 3.2, and 2.7 lines respectively. There were no significant adverse events and no patient had any loss of BCDVA.

Conclusions:

The improvement in vision has been maintained during the 2 year clinical trial. These preliminary results suggest that the Refocus Procedure using the Refocus Scleral Implant device was effective in restoring near visual acuity in presbyopic emmetropic patients without adverse effects, both objectively and subjectively. Key benefits include the procedure being extraocular and outside of visual axis. 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... travel has been funded, fully or partially, by a competing company, One of more of the authors... travel has been funded, fully or partially, by 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 competing company, One of more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of more of the authors... receives consulting fees, retainer, or contract payments from a competing company

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