Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.

Detailed Description
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The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects. This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.

Official Title
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Chronic Retinal Electrodes to Provide Electrical Stimulation of the Retina to Elicit Visual Percepts in Blind Subjects

Conditions
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Retinitis Pigmentosa

Intervention / Treatment
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* Device: Argus 16 Retinal Stimulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery. History of former useful form vision in worse-seeing eye Acceptable ability to describe visual percepts Age eighteen (18) or older Exclusion Criteria: History of glaucoma Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage Presence of communicable disease/infection Pregnancy History of claustrophobia Inconsistent flash detection thresholds Any other diseases that can effect the function of the retina Subjects with a Beck Depression Inventory Interpretation score of >30 and subsequent diagnosis of depression by a psychiatrist. Corneal degeneration

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm study<br>Argus 16 Retinal Stimulation System-single arm study. | Device: Argus 16 Retinal Stimulation System<br>* The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events From 2 Weeks Post-op Until the End of the Study | All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications. | From 2 weeks post-op until end of device usage, up to 10 years. |