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CAREN Argus Rehab (CARE) Study (CARE)

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ClinicalTrials.gov Identifier: NCT03444961
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Aleksandra Rachitskaya, MD, 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.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: CAREN system training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comprehensive Visual and Mobility Training After Retinal Prosthesis Surgery
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. Effects of CAREN virtual reality system on obstacle course navigation [ Time Frame: 6 wks ]
    Obstacle course navigation

  2. Effects of CAREN virtual reality system on Timed Up and Go testing [ Time Frame: 6 wks ]
    Timed Up and Go testing

  3. Effects of CAREN virtual reality system on Activities-specific Balance Confidence (ABC) scale questionnaire [ Time Frame: 6 wks ]
    ABC scale questionnaire is a validated balance confidence questionnaire about household and community tasks. The Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence).

  4. Effects of CAREN virtual reality system on square localization visual function test [ Time Frame: 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.

  5. Effects of CAREN virtual reality system on direction of motion visual function test. [ Time Frame: 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).

  6. Effects of CAREN virtual reality system on grating visual acuity visual function test [ Time Frame: 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.

  7. Effects of CAREN virtual reality system on gait assessment [ Time Frame: 6 wks ]
    Subject's gait during regular walking and with a visual task on the CAREN system.



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Ages Eligible for Study:   25 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444961


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Aleksandra Rachitskaya, MD The Cleveland Clinic

Responsible Party: Aleksandra Rachitskaya, MD, Assistant Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03444961     History of Changes
Other Study ID Numbers: 17-1355
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Aleksandra Rachitskaya, MD, The Cleveland Clinic:
Argus II Retinal Prosthesis System
Rehabilitation

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn