Post-approval Follow-up Study of the IC-8 Apthera IOL
Status: Completed
Location: See all (20) locations...
Study Type: Observational
SUMMARY
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:
• Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
• Able to comprehend and have signed a statement of informed consent
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
Locations
United States
Arizona
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
Tucson
California
Empire Eye & Laser Center
Bakersfield
Harvard Eye Associates
Laguna Hills
Altos Eye Physicians
Los Altos
Advanced Vision Care
Los Angeles
Colorado
Eye Center of Northern Colorado
Fort Collins
Minnesota
Chu Vision Institute
Bloomington
Missouri
Pepose Vision Institute
St Louis
North Carolina
Physicians Protocol
Greensboro
Nebraska
Kugler Vision
Omaha
New York
Alterman, Modi & Wolter
Poughkeepsie
Ohio
Cleveland Eye Clinic
Brecksville
Pennsylvania
Philadelphia Eye Associates
Philadelphia
Bucci Laser Vision
Wilkes-barre
South Dakota
Vance Thompson Vision
Sioux Falls
Texas
Baylor College of Medicine
Houston
Parkhurst NuVision
San Antonio
Utah
Hoopes Vision
Draper
Utah Eye Centers
Ogden
Virginia
Virginia Eye Consultants
Norfolk
Time Frame
Start Date: 2023-01-12
Completion Date: 2024-02-16
Participants
Target number of participants: 196
Treatments
IC-8 Apthera intraocular lens (IOL) Group
Patients previously enrolled in the IC-8 Apthera IOL Investigational Device Exemption (IDE) study (G180075) and implanted with the IC-8 Apthera IOL.
Related Therapeutic Areas
Sponsors
Leads: AcuFocus, Inc.