N/A
N=4
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
Retinitis Pigmentosa
Bottom Line
View on ClinicalTrials.gov: NCT03444961 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Effects of CAREN Virtual Reality System on Obstacle Course Navigation — 51.25; 33.75 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAREN system training (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of CAREN Virtual Reality System on Obstacle Course Navigation |
51.25; 33.75 | — |
| PRIMARY Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training |
52.8; 39.29 | — |
| PRIMARY Effects of CAREN Virtual Reality System on Square Localization Visual Function Test |
274.62; 245.43 | — |
| PRIMARY Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test. |
65.68; 58.12 | — |
| PRIMARY Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test |
2.53 | — |
| PRIMARY Effects of CAREN Virtual Reality System on Gait Assessment |
111.05; 130.7 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03444961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.