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# Staar Surgical to Begin Trials with Collamer Lens
- URL: https://www.fdaweb.com/staar-surgical-to-begin-trials-with-collamer-lens/
- Published: 2019-08-27T12:00:00.000Z
- Updated: 2026-09-15T01:46:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144866

FDA has given Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for myopia with astigmatism. Under the IDE, FDA recommended study design modifications, which Staar says it plans to incorporate into the investigational plan in a revised submission in the coming month. “Staar’s current plan for the study reflects FDA’s recommendations from on-going interactive dialog regarding the investigational protocol, including 300 subjects with a primary endpoint at six months follow up,” the company says. Subjects enrolled in the trial will not undergo planned peripheral iridotomies, it says.