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Retinal Stimulation for Argus II Retinal Prosthesis Users

This study is for people with Retinitis Pigmentosa who have an Argus II Retinal Prosthesis system. It's testing new ways to stimulate the retina using two different visual processing units (VPUs): one with asymmetric waveforms and another with bipolar stimulation. The goal is to improve your visual ability and make it easier to perceive shapes. To join, you must be between 25 and 89 years old, have at least 5 electrodes that create a perception with stimulation, and be able to follow the study's requirements. We'll know if the study is successful by looking at changes in how well you perceive shapes and your stimulus thresholds (how much stimulation is needed to see something). The current recruitment status is unclear.

Study design
This interventional study plans to enroll 20 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
The study measures changes in stimulus thresholds and shape perception at baseline and 8 hours later. It also involves auditory-visual training.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 8 hours after baseline measurements.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03635645

Experimental and Clinical Studies of Retinal Stimulation

Recruiting
NAAges 25–89Interventional
University of Michigan
~20 participants
Updated 2022-12-14 on ClinicalTrials.gov
What's tested:New visual processing unit (VPU) with asymmetric waveformsNew VPU with bipolar stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change in stimulus thresholds
Measured over Baseline, 8 hours
+1 more outcome measured

Conditions

Retinitis Pigmentosa

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Retinitis Pigmentosa

NCT03635645

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • James Weiland · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

James Weiland
[email protected]
661-713-4603
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent change in stimulus thresholdsBaseline, 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 perceptionBaseline, 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.