PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Retina Implant AG

Status: Withdrawn

Conditions: Retinitis Pigmentosa

Study type: Observational

Funder types: Industry

Identifiers

NCT02588430

RI-PMCF1-EU

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received a RETINA IMPLANT Alpha AMS.
• Patients willing and able to give written informed consent.

Exclusion criteria

• none