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Recruiting NCT03635645

Experimental and Clinical Studies of Retinal Stimulation

No phase Interventional Retinitis Pigmentosa

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: New visual processing unit (VPU) with asymmetric waveforms, New VPU with bipolar stimulation.
Who it may be relevant to
Registry conditions: Retinitis Pigmentosa. Basic parameters: 25 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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]
  • Change in shape perception [Time frame: Baseline, 8 hours]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT03635645 · HUM00122699 · R01EY022931-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗