Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

NeuroTherapia, Inc.

Status: Completed

Conditions: Retinitis Pigmentosa

Treatments: Device: CAREN system training

Study type: Interventional

Funder types: Other

Identifiers

NCT03444961

17-1355

Details and patient eligibility

About

The goal of the current project is to fill the unmet clinical needs around the objective assessment of visual function and develop outcome-oriented visual rehabilitation approach using the computer assisted rehabilitation environment (CAREN) system for Argus recipients.

Enrollment: 4 patients

Sex: All

Ages: 25 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Recipient of the Argus II Retinal Prosthesis System
• Ability to provide informed consent
• Ability to follow two-step commands
• Ability to ambulate 300+ feet with or without visual assistance
• Able to tolerate Argus device turned on for >20 continuous minutes.

Exclusion criteria

• Dementia
• Musculoskeletal contraindication to exercise or walking
• Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

CAREN system training

Experimental group

Description:

CAREN training

Treatment:

Device: CAREN system training