Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

NCT03444961 | Completed Results FDA Device

• 1 other identifier: 17-1355
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinitis Pigmentosa

Keywords

Argus II Retinal Prosthesis System; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire

  6 wks

Study Arms (1)

CAREN system training

EXPERIMENTAL

CAREN training

Device: CAREN system training

Interventions

CAREN system training DEVICE

CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.

CAREN system training

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 31937474 DERIVED

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Aleksandra Rachitskaya
• Organization: Cleveland Clinic

rachita@ccf.org

216-445-9519

Study Officials

• Aleksandra Rachitskaya, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: February 26, 2018
• Study Start: January 30, 2018
• Primary Completion: June 20, 2018
• Study Completion: June 20, 2018
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)