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Preliminary results from scleral spacing procedure for presbyopia look promising
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DALLAS — In a phase 2 clinical trial of a scleral spacing procedure for the treatment of presbyopia, 80% of patients had reading visual acuity improved to the equivalent of J3 or better, preliminary results show.
Refocus Group, the developer of the procedure, said 50 patients of an expected 100 have undergone the procedure, and an additional 26 of a planned 50 have been enrolled as control patients. Of the patients who have undergone the procedure, 15 experienced an improvement of four lines of Snellen near vision acuity or more, with some experiencing a gain of six or seven lines. On average, patients who underwent the procedure gained three lines of near vision acuity.
Virtually no change was noticed in the patients’ best corrected distance visual acuity as a result of the procedure, the company said. Refocus expects to submit formal data to the Food and Drug Administration next year, according to the release.