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

Retinitis Pigmentosa Clinical Trial

Official title:
Post-Market Clinical Follow-up Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02588430
Study type Observational [Patient Registry]
Source Retina Implant AG
Contact
Status Withdrawn
Phase
Start date March 2019
Completion date June 2030
View Details
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