Improving visual ability in patients with retinal prosthesis
Experimental and Clinical Studies of Retinal Stimulation
This study is testing new ways to improve vision for people with retinal prostheses by using special stimulation methods and training to help them see shapes better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 89 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT03635645 on ClinicalTrials.gov |
What this trial studies
This study evaluates innovative methods of retinal stimulation and training aimed at enhancing the visual capabilities of participants with retinal prostheses. It focuses on testing new visual processing units (VPUs) that utilize asymmetric waveforms and bipolar stimulation to improve shape perception. Participants will undergo auditory-visual training to facilitate better integration of visual information from the prosthesis. The goal is to optimize the functionality of the retinal prosthesis and improve overall visual perception.
Who should consider this trial
Good fit: Ideal candidates are individuals implanted with an Argus II Retinal Prosthesis system who can perceive stimulation from at least five electrodes.
Not a fit: Patients who are currently participating in other investigatory drug or device studies or have conditions that impair their ability to understand or communicate informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the visual abilities of patients with retinal prostheses, leading to improved quality of life.
How similar studies have performed: Other studies have shown promise in enhancing visual perception through similar approaches, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: James Weiland — University of Michigan
- Study coordinator: James Weiland
- Email: weiland@umich.edu
- Phone: 661-713-4603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.