Efficacy of Presbyopia Treatment With Scleral Implants: 3-Year Results
Purpose
To describe the 36 month results of the Refocus Procedure as a treatment for presbyopia in near emmetropic patients. This study analyzes the efficacy of scleral implants as a presbyopic treatment. This paper discusses the improvement in bilateral near vision observed at our site following this treatment.
Methods
This is an evaluation of the scleral incisional system of a multi-center prospective clinical trial conducted under a U.S. FDA IDE. A total of 645 eyes underwent scleral implant surgery. At our site, forty-eight presbyopic subjects (95 eyes) with near emmetropia underwent the Refocus Procedure (insertion of the Refocus Scleral Implant circumferentially in the four oblique quadrants of the sclera, just posterior to the calculated lens equator). Pre-operative and post-operative measurements of uncorrected and distance corrected near visual acuity (UCNVA and DCNVA), as well as manifest and cycloplegic refractions were compared.
Results
At 1, 12, 24, and 36 months post-op, 80% (n=94), 83% (n=86), 94% (n=82), and 82% (n=22), respectively, reached 20/40 or better DCNVA, and the mean number of lines of improvement were 2.4, 2.2, 2.8, and 2.6 lines respectively. There were no significant adverse reactions noted in the cohort of subjects.
Conclusion
The Refocus Procedure continues to prove an effective solution for presbyopia in near emmetropic eyes. Distance visual acuity was not affected and the benefit of improved near vision appears to be functionally significant. Key benefits include the procedure being extraocular and outside of visual axis.