Actively Recruiting
Experimental and Clinical Studies of Retinal Stimulation to Improve Visual Perception in Retinitis Pigmentosa
Led by University of Michigan · Updated on 2022-12-14
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new methods of retinal stimulation and training to improve visual ability in participants with retinal prostheses, specifically those with Retinitis Pigmentosa. The study aims to find ways to make visual perception through the retinal prosthesis easier using auditory-visual training and enhanced shape perception techniques. The trial will test alternative stimulus patterns delivered by new visual processing units (VPUs) applying asymmetric waveforms and bipolar stimulation pulses. These experimental patterns will be tested in the clinic and compared to baseline settings, with participants returning home using the baseline settings. The interventions focus on improving the perception of shapes and stimulus thresholds. Participants will undergo testing sessions in the clinic to measure changes in stimulus thresholds and shape perception over an 8-hour period. Researchers will assess the percent change from baseline to evaluate the effectiveness of the new stimulus patterns. Participants must be implanted with an Argus II Retinal Prosthesis and able to comply with all study procedures during their involvement.
CONDITIONS
Brief Title
Experimental and Clinical Studies of Retinal Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Participating in another investigational drug or device study.
- Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 hours
Participants test alternative retinal stimulation patterns using new visual processing units during clinic visits.
1 in-person clinic visit
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
J
James Weiland
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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