Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Study Overview
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Brief Summary
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This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

Detailed Description
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This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

Official Title
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Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Conditions
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Outer Retinal Degeneration, Retinitis Pigmentosa

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, age 25 year or older with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration) Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation; Have previous history of useful form vision Have consented to participate in the study Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.). Exclusion Criteria: Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.) 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; choroidal neovascularization in the area of the intended tack location, etc.) Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity) 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 or selective frequency hearing loss that prevents hearing device alarms and alerts Participants who are pregnant or wish to become pregnant during the course of the study Participation 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 an Argus II Retinal Prosthesis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | nature and rate of adverse events | up to 3 years from time of implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual function | Square localization, direction of motion, grating visual acuity | up to 3 years from time of implantation |