A comparison of monocular vs binocular near vision at 24 month post-scleral implants for presbyopia

Session Details

Session Title: Presbyopia Correction

Session Date/Time: Tuesday 13/09/2016 | 16:00-18:00

Paper Time: 16:48

Venue: Auditorium A

First Author: : B.Soloway USA

Co Author(s): :                        

Abstract Details

Purpose:

To compare monocular and binocular 24-month follow-up data for patients receiving bilateral VisAbility Implants (Refocus, Dallas, TX) in a prospective, multicenter FDA monitored IDE clinical trial

Setting:

FDA monitored IDE clinical trial at 11 sites in the United States

Methods:

A total 330 patients from 11 sites were enrolled in the study. Eligible patients: were 50 to 60 years of age with distance corrected near visual acuity Sloan (DCNVA) between 20/50 to 20/100 in each eye and between 50 and 60 years of age, had a manifest refraction spherical equivalent (MRSE) between -0.50D to +0.75D with no more than 1.00D of astigmatism and a best corrected distance (BCDVA) and near visual acuity (BCNVA) of 20/20 in each eye, DCNVA was assessed at the 12, 18, and 24 month follow-up visits monocularly and binocularly

Results:

Monocular DCNVA at 40 cm of 20/40 or better was achieved in 80%, 85%, and 88% of dominant eyes at 12, 18, and 24 months respectively. Binocular DCNVA at 40 cm of 20/40 or better was achieved in 91%, 93%, 95% of patients, over the same periods. During each of those intervals more than half (55%, 53% and 58%) of the patients that did not have DCNVA at 40 cm of 20/40 monocularly were able to cross this threshold binocularly.

Conclusions:

Binocular DCNVA with VisAbility Implants improves upon the monocular results at 12, 18, and 24 months. Long-term follow-up of all implanted patients at these respective intervals demonstrates near visual acuity continued improvement to 24 months of follow-up both monocularly and binocularly. Preliminary analysis of 36-month follow-up data indicates similar results.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the 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