Experimental and Clinical Studies of Retinal Stimulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Retinitis Pigmentosa
- Sponsor
- University of Michigan
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Percent change in stimulus thresholds
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
Detailed Description
The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.
Investigators
James Weiland
Professor of Biomedical Engineering
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Must be implanted with an Argus II Retinal Prosthesis system.
- •Have 5 or more electrodes that create a perception with stimulation.
- •Must be willing and able to comply with the protocol testing requirements.
Exclusion Criteria
- •Subjects participating in another investigatory drug or device study
- •Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
Outcomes
Primary Outcomes
Percent change in stimulus thresholds
Time Frame: Baseline, 8 hours
Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).
Change in shape perception
Time Frame: Baseline, 8 hours
As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.