Experimental and Clinical Studies of Retinal Stimulation

University of Michigan

Status: Enrolling

Conditions: Retinitis Pigmentosa

Treatments: Device: New visual processing unit (VPU) with asymmetric waveforms; Device: New VPU with bipolar stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03635645

R01EY022931-05 (U.S. NIH Grant/Contract)

HUM00122699

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Retinal stimulation

Experimental group

Description:

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.

Treatment:

Device: New visual processing unit (VPU) with asymmetric waveforms

Device: New VPU with bipolar stimulation