PMCF Study for Partial Vision Restoration Using the Subretinal ImplantRETINA IMPLANT Alpha AMS
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ClinicalTrials.gov Identifier: NCT02588430
Recruitment Status :
(Manufacturer of the investigational device has ceased all business activities)
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.
Condition or disease
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.
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 Outcome Measures :
1. Functional Vision Test [ Time Frame: 6 Years ]
Eye-hand coordination: a cup should be placed in the middle of a plate
2. Functional Vision Test [ Time Frame: 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 [ Time Frame: 6 Years ]
Activity of daily living - Clothes sorting: socks in white, grey and black should be sorted
4. Functional Vision Tests [ Time Frame: 6 Years ]
Assessment of grating acuity: cards with grid patterns of different widths are presented and should be described
Visual related quality of life (Patient reported outcome) [ Time Frame: 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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who received a Retina Implant Alpha at the study site. Patients who are fulfilling specific criteria to receive a RETINA IMPLANT Alpha AMS.
Patients who received a RETINA IMPLANT Alpha AMS.
Patients willing and able to give written informed consent.