Amsterdam 2013 Programme Satellite Meetings Registration Exhibition Virtual Exhibition Hotels Visa Letter Invitation
Search Abstracts by author or title
(results will display both Free Papers & Poster)

Multicenter FDA clinical trial of scleral implants for treatment of presbyopia: preliminary findings

Poster Details

First Author: D.Schanzlin USA

Co Author(s):    B. Soloway              

Abstract Details



Purpose:

To evaluate the effect on distance corrected near visual acuity (DCNVA) after placement of PresVIEWTM Scleral Implants (PSI) (Refocus-Group, Dallas, TX) using a multi-center prospective clinical trial design.

Setting:

14 Clinical Sites in a multicentered controlled clinical trial

Methods:

Three hundred thirty presbyopic, emmetropic patients were recruited in this study. 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 to 20/100. During the PresVIEWTM Procedure, four PSI’s 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 6, 12, 18 and 24 months.

Results:

The PresVIEWTM Procedure has been performed on the 330 primary eyes (mean pre-op DCNVA = 20/73) and 315 fellow eyes (mean pre-op DCNVA = 20/74), (total N = 645, mean pre-op DCNVA = 20/73). Preliminary descriptive analyses showed that out of all eyes reassessed post-operatively at 6, 12, 18 and 24 months, 70% (n=595), 78% (n=325), 85% (n=213), and 95% (n=132), respectively, reached 20/40 or better DCNVA.

Conclusions:

These preliminary results suggest that the PresVIEWTM Procedure using the PresVIEWTM Scleral Implant (PSI) device was effective in restoring near visual acuity in presbyopic emmetropic patients.

Financial Disclosure:

... has significant investment interest in a company producing, developing or supplying product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

Back to previous