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NCT Number: NCT03635645

Experimental and Clinical Studies of Retinal Stimulation

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

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

25 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New visual processing unit (VPU) with asymmetric waveforms

Device

A VPU will apply asymmetric and symmetric stimulation pulses.

New VPU with bipolar stimulation

Device

A VPU will apply bipolar stimulus pulses.

Primary outcomes

  1. 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).

  2. 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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