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

Retina Implant AG

Overview

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.

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 Type

OBSERVATIONAL

Conditions

Retinitis Pigmentosa

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who received a RETINA IMPLANT Alpha AMS. * Patients willing and able to give written informed consent. Exclusion Criteria: * none

Locations (1)

Katharinenhospital Stuttgart

Stuttgart, Germany

Outcomes

Primary Outcomes

Time to device failure

Recording of device failures

Time frame: 6 Years

Number, nature and severity of challenges or complications during surgical procedures

Recording of adverse events

Time frame: 6 Years

Number, nature and severity of device-related adverse events and incidents until device failure or explantation

Recording of adverse events

Time frame: 6 Years

Secondary Outcomes

1. Functional Vision Test

Eye-hand coordination: a cup should be placed in the middle of a plate

Time frame: 6 Years

2. Functional Vision Test

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

Time frame: 6 Years

3. Functional Vision Test

Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted

Time frame: 6 Years

4. Functional Vision Tests

Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described

Time frame: 6 Years

Visual related quality of life (Patient reported outcome)

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

Data from ClinicalTrials.gov

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