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Barbara Michalek, Frank A Bucci, Breanne Michalek; Scleral Implants Improved Near Visual Acuity: A Subsample Analysis of Patients Treated for Presbyopia. Invest. Ophthalmol. Vis. Sci. 2018;59(9):251.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the visual acuity outcomes of eyes receiving scleral implants from a two-site subsample of patients participating in a multicenter IDE prospective clinical trial.
The multicenter clinical trial enrolled 360 subjects at 13 separate sites ranging in age between 45 and 60 years with preop distance corrected near visual acuity (DCNVA) and uncorrected near visual acuity (UCNVA) between 20/50 and 20/80 (inclusive). The primary endpoints of the FDA were DCNVA of Snellen equivalent 20/40 or better at 40 cm and at least 10 letters (ETDRS) of improvement in DCNVA in the primary eye at 12 months postop. Two centers were selected for analysis and a subsample of 20 early bilaterally implanted patients (consecutive patients, surgeries 6-15 from each center) were analyzed for their preliminary near visual acuity results.
A subsample of 20 patients from two centers in a multi-center FDA trial were implanted with VisAbility™ Implants and have been followed for 24 months to date. One hundred percent (20 of 20) of primary eyes achieved DCNVA of 20/40 or better at 40cm by the end of 24 months. Additionally, 92.5% of all eyes (37 of 40) achieved an improvement of at least 10 ETDRS letters of near visual acuity. For uncorrected near visual acuity (UCNVA OU), 100% (20 of 20) of the patients achieved J2 (20/32) or better, and 90% (18 of 20) achieved J1(20/25) or better. The amount of refractive add needed to achieve optimal DCNVA improved from a mean of 1.65 D at baseline (range: 0.50 D to 2.25 D) to a mean of 0.63 D (range: 0 to 1.5 D) at 6 months, and a mean of 0.46 D (range: 0.0 D to 2.00 D) at 12 months. There were no serious adverse events reported in the patient base at either of the two centers in this study.
The results of this subsample evaluation of patients from a two-center analysis suggest that the VisAbilityTM Implant System may provide clinically significant improvement in near visual acuity, both with and without distance correction.The VisAbility™ Implant System is an investigational device and is limited by United States law to investigational use.This device holds a CE mark and is currently for sale and use in the European Union.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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