Distance refractive stability after presbyopia correction with scleral micro-insert surgery

Session Details

Session Title: Corneal, Scleral and Pharmaceutical Treatment of Presbyopia

Session Date/Time: Monday 09/10/2017 | 16:30-18:00

Paper Time: 17:26

Venue: Meeting Center Room I

First Author: : B.Soloway USA

Co Author(s): :                        

Abstract Details

Purpose:

To analyze the distance manifest refraction spherical equivalent (MRSE) stability from baseline in patients after presbyopia correction with bilateral VisAbility Micro-inserts (Refocus, Dallas, TX)

Setting:

A 13 site multicenter FDA IDE study of VisAbility Micro-inserts (Refocus, Dallas, TX) at private practice clinics in the United States

Methods:

A prospective multicenter randomized control study of 708 eyes in 360 patients under an FDA IDE is currently underway. Eligible patients are between 45 to 60 years of age and each eye had: no prior surgery, MRSE between -0.75D to +0.50D and < 1.00D of astigmatism, Sloan distance corrected near visual acuity (DCNVA) between 20/50 to 20/80, best corrected distance (BCDVA) of 20/20 and best corrected near visual acuity (BCNVA) of 20/20. MRSE, BCDVA, DCNVA and BCNVA is assessed at 3, 6 and 12 month post-op.

Results:

To date,181 of 708 total implanted eyes have reached the12 month post-op milestone. In this cohort at 3, 6, and 12 months, At those exams MRSE change from baseline was minimal at -0.08D (+0.24SD), -0.03D (+0.24SD) and 0.03D (+0.26SD). With 98% (177/181), 99% (174/176), and 96% (174/181) staying within +0.5D of baseline MRSE

Conclusions:

Patients who had presbyopia correction with VisAbility Micro-inserts demonstrate an improvement in DCNVA with preservation of their baseline MRSE distance vision out to 12 months post-operatively.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a competing company, research is funded, fully or partially, by a competing company