Retinal Degeneration Clinical Trial
Official title:
Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
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.
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