Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
- Conditions
- PresbyopiaCataract
- Registration Number
- NCT05758883
- Lead Sponsor
- AcuFocus, Inc.
- Brief Summary
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
- Detailed Description
A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
- 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)
- There are no exclusion criteria for this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of ocular adverse events 3 years post IC-8 Apthera IOL implantation Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
Rates of other serious adverse events 3 years post IC-8 Apthera IOL implantation Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
Rates of subjective visual disturbances 3 years post IC-8 Apthera IOL implantation Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)
Rates of secondary surgical interventions (SSIs) 3 years post IC-8 Apthera IOL implantation Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Kugler Vision
🇺🇸Omaha, Nebraska, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Hoopes Vision
🇺🇸Draper, Utah, United States
Utah Eye Centers
🇺🇸Ogden, Utah, United States
Eye Center of Northern Colorado
🇺🇸Fort Collins, Colorado, United States
Cleveland Eye Clinic
🇺🇸Brecksville, Ohio, United States
Empire Eye & Laser Center
🇺🇸Bakersfield, California, United States
Harvard Eye Associates
🇺🇸Laguna Hills, California, United States
Advanced Vision Care
🇺🇸Los Angeles, California, United States
Philadelphia Eye Associates
🇺🇸Philadelphia, Pennsylvania, United States
Bucci Laser Vision
🇺🇸Wilkes-Barre, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Fishkind, Bakewell, Maltzman, Hunter & Associates Eye Care & Surgery Center
🇺🇸Tucson, Arizona, United States
Altos Eye Physicians
🇺🇸Los Altos, California, United States
Chu Vision Institute
🇺🇸Bloomington, Minnesota, United States
Pepose Vision Institute
🇺🇸Saint Louis, Missouri, United States
Physicians Protocol
🇺🇸Greensboro, North Carolina, United States
Alterman, Modi & Wolter
🇺🇸Poughkeepsie, New York, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Parkhurst NuVision
🇺🇸San Antonio, Texas, United States