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Study follow-up completed for VisAbility micro-insert system

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A 12-month follow-up on 360 patients in a phase 3 clinical trial of the VisAbility micro-insert system for presbyopia has been completed, Refocus Group announced in a press release.

The company said it can now prepare a premarket approval submission to the FDA.

VisAbility was developed to restore near vision without compromising distance vision or depth perception. The procedure does not alter the cornea or natural lens, the release said, and is performed in the sclera.

The current clinical trial included 360 patients between 45 and 60 years old at 13 U.S. clinical sites.

Performed on both eyes, the VisAbility procedure consists of inserting four micro-thin inserts below the surface of the sclera. The inserts help to restore the eye’s ability to refocus near vision.