Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- Retina Implant AG
- Locations
- 1
- Primary Endpoint
- Time to device failure
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who received a RETINA IMPLANT Alpha AMS.
- •Patients willing and able to give written informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to device failure
Time Frame: 6 Years
Recording of device failures
Number, nature and severity of challenges or complications during surgical procedures
Time Frame: 6 Years
Recording of adverse events
Number, nature and severity of device-related adverse events and incidents until device failure or explantation
Time Frame: 6 Years
Recording of adverse events
Secondary Outcomes
- 1. Functional Vision Test(6 Years)
- 4. Functional Vision Tests(6 Years)
- 2. Functional Vision Test(6 Years)
- 3. Functional Vision Test(6 Years)
- Visual related quality of life (Patient reported outcome)(6 Years)