This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life. In addition, the study will provide additional information about the safety and efficacy of the CE-certified RETINA IMPLANT Alpha AMS. In several studies it has been shown that patients who received this subretinal implant regain visual function to a certain extent and that its use is safe. So far, all assessments of patients with the RETINA IMPLANT Alpha AMS have been done in a controlled environment within the scope of interventional studies where the benefit in daily life has been assessed anecdotally only. Currently, there is no standard method available for an objective assessment of the impact of such devices in daily life of these patients. Hence, the aim of this study is to further assess the impact in daily life with a combination of already validated and newly developed assessments and questionnaires. This study adheres to the tenets of the Declaration of Helsinki.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Implantation of the subretinal RETINA IMPLANT Alpha AMS
Clinique Saint Jean
Montpellier, Hérault, France
Centre Hospitalier Universitaire La Milétrie de Poitiers
Poitiers, Vienne, France
Change in functional vision
Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation
Time frame: baseline vs. 12 months after implantation
Vision Related Quality of Life - Questionnaire
A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation
Time frame: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Visual Function - Questionnaire
A validated patient reported outcome questionnaire, ULV-VFQ, assessed at baseline versus one year after implantation
Time frame: at baseline and 1, 2.5, 4, 6, 9 and 12 months after implantation (and for longterm review after 18 and 24 months)
Adverse Events
Number, nature and severity of device-related and implantation-related adverse events
Time frame: 2 years
Measure of implant-mediated visual function
Computer test assessed with implant on versus off
Time frame: 2 years
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