Enrollment completed for PMA arm of first US clinical trial of artificial iris

An artificial iris is available to an increasing number of patients participating in a clinical trial because of a humanitarian use designation granted by the FDA.The CustomFlex artificial iris prosthesis, manufactured by HumanOptics, is designed for patients with iris defects, iris damage and aniridia. The clinical trial’s sponsor, Clinical Research Consultants, plans to submit a premarket approval (PMA) application to the FDA when the trial is completed.