Retinitis Pigmentosa
Conditions
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.
Interventions
DEVICENew visual processing unit (VPU) with asymmetric waveforms
A VPU will apply asymmetric and symmetric stimulation pulses.
DEVICENew VPU with bipolar stimulation
A VPU will apply bipolar stimulus pulses.
Sponsors
National Eye Institute (NEI)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 89 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in stimulus thresholds | 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 | 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. |
Countries
United States
Contacts
Primary ContactJames Weiland
Outcome results
None listed