Experimental and Clinical Studies of Retinal Stimulation

Retinitis Pigmentosa Clinical Trial

Official title:

Experimental and Clinical Studies of Retinal Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03635645
• Other study ID #: HUM00122699
• Secondary ID: R01EY022931-05
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2022
• Source: University of Michigan
• Contact: James Weiland
• Phone: 661-713-4603
• Email: weiland[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in stimulus thresholds	Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).	Baseline, 8 hours
Primary	Change in shape perception	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.	Baseline, 8 hours