Trials / Completed
CompletedNCT05758883
Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
Post-approval Follow-up Study of the IC-8 Apthera IOL
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 196 (actual)
- Sponsor
- AcuFocus, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2023-01-12
- Primary completion
- 2024-02-16
- Completion
- 2024-02-16
- First posted
- 2023-03-08
- Last updated
- 2024-04-02
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05758883. Inclusion in this directory is not an endorsement.