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.
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.
Study Type
OBSERVATIONAL
Enrollment
53
University of Southern California
Los Angeles, California, United States
University of Colorado, Denver
Denver, Colorado, United States
Safety subjects have reached 2 years post-implant.
Adverse event rates with the main safety analysis performed when all visits completed
Time frame: 5 Years
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.
Time frame: 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.
Time frame: 5 Years
Device Reliability
Device reliability will be measured by calculating the rate of implant failure over time.
Time frame: 5 Years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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