Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

Conditions
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Retinal Degeneration, Inherited Retinal Dystrophy Primarily Involving Sensory Retina

Intervention / Treatment
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* Device: RETINA IMPLANT Alpha AMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 78 Willing and able to give written informed consent Hereditary retinal degeneration of the outer retinal layer i.e. photoreceptors (rods & cones) Pseudophakia or aphakia in the eye to be implanted Retinal vessels with remaining perfusion, despite pathological condition Layering of inner retina in the central region present, as shown by Optical Coherence Tomography (OCT) Thickness of the retina sufficient for subretinal surgery as shown by OCT Inner retina still functional (proven e.g. by light perception or electrically evoked phosphenes (EEP)) Blindness in both eyes, (no light perception or light perception only) Visual acuity sufficient for reading normal print in earlier life, optically corrected Period of appropriate visual functions at least 12 years / lifetime Willing and able to perform study assessments and training during the full time period of 12 months Motivation to get the best possible results through training and realistic expectations about these as assessed in screening interview Exclusion Criteria: OCT shows significant retina edema and/or scar tissue within target region for implant Heavy clumped pigmentation at posterior pole or on the planned route of the implantation atrophy of optic nerve or ganglion cells degeneration Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment) Deep amblyopia reported earlier in life on eye to be implanted Systemic conditions that might imply considerable risks with regard to the surgical interventions and anesthesia (e.g. cardiovascular/pulmonary diseases, severe metabolic diseases) Acute and severe neurological and/or psychiatric diseases Hyperthyroidism or hypersensitivity to iodine Hypersensitivity to fluorescent dye Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study or women unwilling to perform a pregnancy test before entering the study Participation in another interventional clinical study within the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RETINA IMPLANT Alpha AMS<br>All participants receive the subretinal device RETINA IMPLANT Alpha AMS | Device: RETINA IMPLANT Alpha AMS<br>* Implantation of the subretinal RETINA IMPLANT Alpha AMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional vision | Instrumental Activities of Daily Living assessed at baseline (prior to implantation) versus one year after implantation | baseline vs. 12 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision Related Quality of Life - Questionnaire | A validated patient reported outcome questionnaire, IVI-VLV, assessed at baseline versus one year after implantation | 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 | 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 | 2 years | 
| Measure of implant-mediated visual function | Computer test assessed with implant on versus off | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal Degeneration, Artificial Vision, Retinal Prosthesis, Subretinal Implant, Inherited Retinal Dystrophy, Vision Restoration, Bionic Eye, Bionic Vision, Retinitis Pigmentosa, Artificial Retina, Retina Implant, Cone-Rod Dystrophy, Choroideremia, Retinopathia Pigmentosa