Actively Recruiting

Phase Not Applicable
Age: 25Years - 89Years
All Genders
ID03635645

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

Age: 25Years - 89Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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

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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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