CAREN Argus Rehab (CARE) Study (CARE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03444961|
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Device: CAREN system training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comprehensive Visual and Mobility Training After Retinal Prosthesis Surgery|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||July 31, 2018|
Experimental: CAREN system training
Device: CAREN system training
CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
- Effects of CAREN virtual reality system on obstacle course navigation [ Time Frame: 6 wks ]Obstacle course navigation
- Effects of CAREN virtual reality system on Timed Up and Go testing [ Time Frame: 6 wks ]Timed Up and Go testing
- 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).
- 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.
- 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).
- 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.
- 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.
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
|Contact: Meghan J DeBenedictis, MS, LGC, MEdfirstname.lastname@example.org|
|Contact: Aleksandra Rachitskaya, MDemail@example.com|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Meghan DeBenedictis, MS, LGC, MEd 216-445-7671 firstname.lastname@example.org|
|Principal Investigator:||Aleksandra Rachitskaya, MD||The Cleveland Clinic|