Experimental and Clinical Studies of Retinal Stimulation
Purpose
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
Condition
- Retinitis Pigmentosa
Eligibility
- Eligible Ages
- Between 25 Years and 89 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Retinal stimulation |
Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus. |
|
Recruiting Locations
University of Michigan
Ann Arbor, Michigan 48105
Ann Arbor, Michigan 48105
More Details
- Status
- Recruiting
- Sponsor
- University of Michigan
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.