NCT03635645 · University of Michigan
Experimental and Clinical Studies of Retinal Stimulation
What this study is about
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
View original scientific description
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
Interventions
DEVICE
New visual processing unit (VPU) with asymmetric waveforms
A VPU will apply asymmetric and symmetric stimulation pulses.
DEVICE
New VPU with bipolar stimulation
A VPU will apply bipolar stimulus pulses.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Ann Arbor, Michigan
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 14, 2022 · Source of record for eligibility and locations