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First Author: M.Endl USA
Co Author(s): B. Soloway
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To evaluate the effect on distance corrected near visual acuity (DCNVA) after placement of Scleral Implants for the treatment of presbyopia. This paper will discuss the results of a single long-running site that has achieved high enrollment.
This multi-center IDE clinical trial consists of 14 sites across the United States in a 2 year controlled study.
Thirty three (33) presbyopic emmetropes were enrolled at this site as part of the cohort of 330 subjects. The primary eye eligibility criteria consisted of best corrected distance visual acuity (BCDVA) = 20/20; manifest refraction spherical equivalent (MRSE) between +0.75D and -0.50D, with ? 1.00D of astigmatism; distance corrected near visual acuity (DCNVA) between 20/50 and 20/100. During the procedure, PresVIEWTM ScleraI Implants are placed circumferentially in oblique quadrants of the sclera, posterior to the lens equator. Both eyes were implanted, with the fellow eye treated a minimum of 15 days following primary eye treatment. The primary outcome measure is DCNVA and was assessed under standard mesopic illumination pre-operatively and at 6, 12, 18 and 24 months post-operatively.
The PresVIEW procedure has been performed on 33 primary eyes (mean pre-operative DCNVA = 20/71) and 30 fellow eyes (mean pre-op DCNVA = 20/69), (N=63, mean pre-operative DCNVA 20/70). Preliminary descriptive analyses of all eyes reaching DCNVA of 20/40 or better is as follows: 87% (n=63) at 6 months, 90% (n=60) at 12 months, 89% (n=54) at 18 months and 95% (n=40) at 24 months. The mean lines of improvement accessed with the ETDRS 2000 near vision chart at the 6, 12, 18 and 24 month visits were 2.38, 2.65, 2.70 and 3.03 lines respectively.
These preliminary results suggest that the PresVIEWTM Scleral Implant device is effective in improving near vision in emmetropic presbyopes. The improvement in vision is maintained to improved over the 2 year trial.
... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented