IC-8 Apthera IOL New Enrollment Post Approval Study
Start Date
9/8/2023
Completion Date
9/30/2027
Summary
The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.
Detailed Description
Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
Eligibility Criteria
Age Range: 22 years to No maximum
Conditions
Locations
Trinity Research Group, LLC
Dothan, Alabama 36301
United States
Feinerman Vision Center
Newport Beach, California 92663
United States
Argus Research Center
Cape Coral, Florida 33909
United States
Stephenson Eye Associates
Venice, Florida 34285
United States
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois 61201
United States
Price Vision Group
Indianapolis, Indiana 46260
United States
Grene Vision Group
Wichita, Kansas 67206
United States
Oakland Eye
Birmingham, Michigan 48009
United States
Vance Thompson Vision - Omaha
Omaha, Nebraska 68137
United States
Eye Associates of New Jersey
Dover, New Jersey 07801
United States
Northern New Jersey Eye Institute
South Orange, New Jersey 07079
United States
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania 19004
United States
Berkeley Eye Center
Sugar Land, Texas 77478
United States
Utah Eye Centers
Bountiful, Utah 84010
United States