Trials / Withdrawn
WithdrawnNCT02588430
PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Retina Implant AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS.
Detailed description
This study is a post-market clinical follow-up (PMCF) study to monitor the safety, lifetime and efficacy of patients using the CE-certified RETINA IMPLANT Alpha AMS. For Germany, it is under the exceptions mentioned in §23b MPG (Medizinproduktegesetz, German Medical Device Law). Its purpose is to collect data that is created during the regular therapy with the implant. No additional examinations are performed, except a patient questionnaire.
Conditions
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2029-12-01
- Completion
- 2030-06-01
- First posted
- 2015-10-27
- Last updated
- 2019-04-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02588430. Inclusion in this directory is not an endorsement.