Scleral implant improving near vision with time

Boston-The preliminary results of the FDA multicenter trial of the Refocus Scleral Implant (Refocus Group) for presbyopia indicated that patients had a significant increase in the near visual acuity, and that the visual acuity improved over time, according to David Schanzlin, MD.

The key benefits of this technology are that it is extraocular, outside the visual axis, bilateral and provides a full range of vision, and is removable, said Dr. Schanzlin, in private practice, San Diego, CA. The procedure involves four implants in the scleral 4 mm behind the limbus. This placement causes a change in the ciliary musculature that causes greater movement than preoperatively, he said.

In the 3-year clinical trial, all patients were between 50 and 60 years of age (average, 54 years) with good preoperative visual acuity, presbyopia (near vision of 20/50 to 20/100), and less than 1 D of astigmatism. A total of 330 patients (645 eyes) were included, 54.3% of whom were men.

The distance-corrected near visual acuity was J3 in 71% of patients 6 months postoperatively, in 81% 12 months postoperatively, and 89% 24 months postoperatively, Dr. Schanzlin noted.

“We saw an increase in the near vision over time,” he said.

He credited the steady improvement in visual acuity with use of an improved incision system used during the last 6 months of the study that resulted in a rapid recovery of vision. This improvement was unexpected, he added.

“The Refocus Scleral Implant seems to be a viable procedure to correct presbyopia,” Dr. Schanzlin said. “The surgery is easy to perform, and the device has a good safety profile.”  

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