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Stability of distance refraction over 2 years following scleral implants for presbyopic correction

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Session Details

Session Title: Vision & Accommodation Assessment

Session Date/Time: Monday 24/09/2018 | 14:00-16:00

Paper Time: 15:30

Venue: Room A3, Podium 2

First Author: : F.Bucci Jr USA

Co Author(s): :                        

Abstract Details


To report the distance vision refractive stability from baseline through 24 months in patients receiving bilateral scleral implants in a single site subsample of patients participating in a FDA multicenter prospective clinical trial.


Bucci Laser Vision Institute, Wilkes-Barre, PA


360 patients from 13 sites were enrolled in the entire FDA trial. Eligible patients were 45 to 60 years of age with distance corrected near visual acuity (Sloan DCNVA) between 20/50 to 20/80 in each eye and a manifest refraction spherical equivalent (MRSE) between -0.75D to +0.50D with < 1.00D of astigmatism, and a best corrected distance (BCDVA) and near visual acuity (BCNVA) of 20/20 in each eye. A subsample of 10 early bilaterally implanted patients from a single center with a total of 37 surgical subjects were selected for analysis of their distance vision refractive stability through 24 months.


For this 20 eye subsample, the mean MRSE change from baseline was -0.09D (+/-0.21SD), 0.01D (+0.28SD), -0.13 (+/-0.30SD), and -0.07D (+/-0.26SD) at 6, 12, 18, and 24 months, respectively. All 20 eyes were within +/-0.5D of baseline MRSE at all follow-up periods. In addition, 80% (16/20) of eyes gained at least one line of UCDVA. Only 2 of the 20 eyes lost any letters of UCDVA at the 24 months postop visit. This distance refractive stability was observed while the bilateral uncorrected NEAR vision for these 10 patients was 100% J3, 100% J2, and 90% J1 at 24 months.


Patients who achieved excellent uncorrected near visual acuity after undergoing the VisAbility Micro Insert procedure for presbyopia also demonstrated a consistent preservation of their baseline distance MRSE through 24 months post-operatively. Eighty percent of eyes gained at least one line of uncorrected DISTANCE visual acuity.

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