Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery

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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Device: CAREN system training

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAREN system training; CAREN training	Device: CAREN system training; CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of CAREN Virtual Reality System on Obstacle Course Navigation	Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)	6 wks
Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training	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.	6 wks
Effects of CAREN Virtual Reality System on Square Localization Visual Function Test	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.	6 wks
Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.	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.	6 wks
Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test	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.	6 wks
Effects of CAREN Virtual Reality System on Gait Assessment	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).	6 wks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire	The Activities-specific Balance Confidence Scale (ABC Scale) is a structured questionnaire that measures an individual's confidence in performing activities without losing balance. It is a 0% to 100% continuous response scale with 0 representing "no confidence" and 100 representing "complete confidence."	6 wks

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Aleksandra Rachitskaya, MD, The Cleveland Clinic

Publications and helpful links

General Publications

• Rachitskaya A, Yuan A, Davidson S, Streicher M, DeBenedictis M, Rosenfeldt AB, Alberts J. Computer-Assisted Immersive Visual Rehabilitation in Argus II Retinal Prosthesis Recipients. Ophthalmol Retina. 2020 Jun;4(6):613-619. doi: 10.1016/j.oret.2019.11.007. Epub 2019 Nov 15.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Argus II Retinal Prosthesis System
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa
• Other Study ID Numbers: 17-1355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No