search
Back to results

Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAREN system training
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Argus II Retinal Prosthesis System, Rehabilitation

Eligibility Criteria

25 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAREN system training

Arm Description

CAREN training

Outcomes

Primary Outcome Measures

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)
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.
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.
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
October 26, 2017
Last Updated
June 24, 2021
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT03444961
Brief Title
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
Official Title
Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Argus II Retinal Prosthesis System, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAREN system training
Arm Type
Experimental
Arm Description
CAREN training
Intervention Type
Device
Intervention Name(s)
CAREN system training
Intervention Description
CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Primary Outcome Measure Information:
Title
Effects of CAREN Virtual Reality System on Obstacle Course Navigation
Description
Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)
Time Frame
6 wks
Title
Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training
Description
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.
Time Frame
6 wks
Title
Effects of CAREN Virtual Reality System on Square Localization Visual Function Test
Description
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.
Time Frame
6 wks
Title
Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test.
Description
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.
Time Frame
6 wks
Title
Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test
Description
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.
Time Frame
6 wks
Title
Effects of CAREN Virtual Reality System on Gait Assessment
Description
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).
Time Frame
6 wks
Other Pre-specified Outcome Measures:
Title
Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire
Description
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."
Time Frame
6 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Rachitskaya, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31937474
Citation
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.
Results Reference
derived

Learn more about this trial

Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

We'll reach out to this number within 24 hrs