Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

Not Applicable

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Device: CAREN system training

• Registration Number: NCT03444961
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-26
• Study Start: 2018-01-30
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Results First Submitted: 2019-07-25
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-24
• Last Update Submitted: 2021-06-24
• Results First Posted: 2021-07-14
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAREN system training	CAREN system training	CAREN training

Primary Outcome Measures

Name	Time	Method
Effects of CAREN Virtual Reality System on Obstacle Course Navigation	6 wks	Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)
Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training	6 wks	Timed Up and Go testing - functional mobility test that requires the individual to stand from a chair, ambulate three meters to a target, turn around, return to the chair, and sit down. Participants were asked to complete two trials was recorded, with a maximum time of 60 seconds per trial.
Effects of CAREN Virtual Reality System on Gait Assessment	6 wks	Subject's gait assessed by meters traveled while localizing objects on the CAREN system. The higher scores are associated with better outcomes (further distance walked).
Effects of CAREN Virtual Reality System on Square Localization Visual Function Test	6 wks	The square localization test presents a 2.75" square (250 pixels) at a random location on a black background and the patient is instructed to try to touch the square. The test measures the patient's ability to locate an object and results are calculated as a mean error (how far away in pixels from the square the patient touches the screen). A lower mean error (the distance from the square) indicates better patient performance.
Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.	6 wks	The direction of motion test assesses the patient's ability to determine the direction an object is moving. The patient is presented with a white line (1.4'' wide) that moves across the screen in a random series of directions and angles. Patients are instructed to trace their finger on the monitor in the direction they perceived the line moved. Results are calculated as a mean error (how far off, in degrees, was the patient from the direction of the moving line). The higher the mean error/score, the worse the outcome.
Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test	6 wks	The grating visual acuity test measures the patient's visual acuity using the principles of acuity charts modified for ultra-low vision subjects. The patients are presented with black and white bars in one of four orientations (horizontal, vertical, diagonal to the left or diagonal to the right). The bars are present on the screen for 5 seconds during which the patient may scan the screen and then provide a verbal response as to which orientation they perceived the bars. The widths of the bars are varied to evaluate different levels of visual acuity. A lower score is associated with better outcomes with 2.9 being the worst possible score.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States