Trials / Terminated
TerminatedNCT01860092
New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 53 (actual)
- Sponsor
- Second Sight Medical Products · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.
Detailed description
Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated. There is no study hypothesis.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2013-05-22
- Last updated
- 2021-12-23
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01860092. Inclusion in this directory is not an endorsement.