Recruiting

Retinal Stimulation

Sponsor:

University of Michigan

Code:

NCT03635645

Conditions

Retinitis Pigmentosa

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

New visual processing unit (VPU) with asymmetric waveforms

New VPU with bipolar stimulation

Study Details

Brief summary:

The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

Conditions

Retinitis Pigmentosa

Study ID

NCT03635645

Start date

Oct 30, 2017

Status verified date

Dec, 2022

Completion date

Oct 30, 2023

Anticipated

Primary completion date

Oct 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Retinal stimulation

Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus.

Interventions

New visual processing unit (VPU) with asymmetric waveforms

A VPU will apply asymmetric and symmetric stimulation pulses.

New VPU with bipolar stimulation

A VPU will apply bipolar stimulus pulses.

Primary outcome measure

  • Percent change in stimulus thresholds [ Time Frame: Baseline, 8 hours ]
  • Change in shape perception [ Time Frame: Baseline, 8 hours ]

Central Contacts and Locations

Central contacts

James Weiland

661-713-4603weiland@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

James Weiland

661-713-4603weiland@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Dec 14, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2022-12-14.