Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Study Overview
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Brief Summary
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Patients suffering from hereditary retinal degeneration receive a retinal implant to restore sight. Subretinal implant ON results in significant visual acuity improvement, when compared to OFF condition.

Official Title
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Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients: A Prospective Multicenter Clinical Study Based on Randomized Intra-individual Implant Activation in Patients With Degenerative Retinal Diseases

Conditions
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Retinitis Pigmentosa, Retinal Degeneration

Intervention / Treatment
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* Device: Device name: Retina Implant model Alpha. Surgical implantation of medical device into eye


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods & cones. Pseudophakia Angiography shows retinal vessels adequately perfused, despite pathological RP condition. Age between 18 and 78 years. Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation. Ability to read normal print in earlier life, optically corrected without magnifying glass. Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year for Module-2. Exclusion Criteria: Period of appropriate visual functions approx. 12 years / lifetime. Optical Coherence Tomography (OCT) shows significant retina edema &/or scar tissue within target region for implant. Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT). Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP). Heavy clumped pigmentation at posterior pole Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment). Amblyopia reported earlier in life on eye to be implanted Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases). Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression). Hyperthyroidism or hypersensitivity to iodine 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 trial 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device name: Retina Implant model Alpha. Surgical implantation of medical device into eye|Surgical implantation of medical device named Retina Implant into eye to restore vision partially. Randomized intra-individual implant activation in patient under test conditions such as: FrACT, BaLM, BaGA, maze, ADL.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living and mobility significantly improve with implant-ON shown via activities of daily living tasks, recognition tasks, mobility, or a combination thereof. |  | every 3 months for a period of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity/light-perception and/or object-recognition are significantly improved with implant-ON versus OFF as shown via: FrACT/BaLM/BaGA/VFQ-25 or a combination thereof. |  | every 3 months for a period of one year | 
| Patient long term safety and stability of implant function |  | every 3 months for a period of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retina implant, Subretinal, Legal blindness, Genetic Diseases, Inborn, Eye Diseases, Retinitis Pigmentosa, Retinitis, Retinal Degeneration, Eye Diseases, Hereditary, Retinal Diseases