New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

Study Overview
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Brief Summary
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This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.

Detailed Description
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Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated. There is no study hypothesis.

Official Title
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New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

Conditions
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Retinitis Pigmentosa

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are adults, age 25 year or older; Have severe to profound retinitis pigmentosa; Bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed; Have previous history of useful form vision. Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.) Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation; Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently consent to participate in this study; At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and Exclusion Criteria: Ocular diseases or conditions that could prevent Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus); Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length <20.5 mm or >26 mm, corneal ulcers, etc.); Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.); Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery; Metallic or active implantable device(s) (e.g. cochlear implant) in the head; Pre-disposition to eye rubbing; Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease, psychiatric disease including diagnosed forms of depression; does not speak a principal language associated with the region, and deafness; Pregnant or wish to become pregnant during the course of the study; Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study; Conditions likely to limit life to less than 1 year from the time of inclusion.

Ages Eligible for Study
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Minimum Age: 25 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Argus II Retinal Prosthesis<br>Patients implanted with the Argus II Retinal Prosthesis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety subjects have reached 2 years post-implant. | Adverse event rates with the main safety analysis performed when all visits completed | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual function | Visual function means how to the eye works (e.g. visual acuity). Visual function will be measured using the following test: Square Localization, Direction of Motion and Grating Visual Acuity (GVA).In addition to these tests, a photographic flash test will be performed with the System OFF only to determine if subjects' native residual vision is bare light perception or no light perception. | 5 Years | 
| Functional Vision | Functional vision means how subjects perform in vision-related activities of daily living. Function vision will be assessed using the Functional Low-Vision Observer Rated Assessment (FLORA). A utilization questionnaire will also be administered to track how subjects are using the Argus II System. | 5 Years | 
| Device Reliability | Device reliability will be measured by calculating the rate of implant failure over time. | 5 Years |