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

Withdrawn

• Conditions: Retinitis Pigmentosa

• Registration Number: NCT02588430
• Lead Sponsor: Retina Implant AG

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.

Study Timeline

• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Study Start: 2019-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19
• Primary Completion: 2029-12
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to device failure	6 Years	Recording of device failures
Number, nature and severity of challenges or complications during surgical procedures	6 Years	Recording of adverse events
Number, nature and severity of device-related adverse events and incidents until device failure or explantation	6 Years	Recording of adverse events

Secondary Outcome Measures

Name	Time	Method
1. Functional Vision Test	6 Years	Eye-hand coordination: a cup should be placed in the middle of a plate
4. Functional Vision Tests	6 Years	Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described
2. Functional Vision Test	6 Years	Activity of daily living - Table test: 4 white items of big plate, small plate, bowl, cup and cutlery are placed on a black table cloth and should be identified and touched
3. Functional Vision Test	6 Years	Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted
Visual related quality of life (Patient reported outcome)	6 Years	Impact of Vision Impairment - Very Low Vision Questionnaire (IVI-VLV) (Finger et al., 2014) is asking for vision-related quality of life by rating impact of eyesight on various tasks, referring to the last month

Trial Locations

Locations (1)

Katharinenhospital Stuttgart; 🇩🇪 Stuttgart, Germany