Trial Outcomes & Findings for Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis (NCT NCT03444961)

Last Updated: 2021-07-14

Results Overview

Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

6 wks

Results posted on

2021-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	CAREN System Training CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 wks

Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training 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	51.25 seconds Interval 28.0 to 117.0	33.75 seconds Interval 28.0 to 117.0

PRIMARY outcome

Timeframe: 6 wks

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.

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training	52.8 seconds Standard Deviation 6.6	39.29 seconds Standard Deviation 10.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training 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 Square Localization Visual Function Test	274.62 pixels Interval 104.12 to 463.47	245.43 pixels Interval 104.12 to 463.47

PRIMARY outcome

Timeframe: 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). The higher the mean error/score, the worse the outcome.

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training 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 Direction of Motion Visual Function Test.	65.68 degrees Interval 14.51 to 95.16	58.12 degrees Interval 14.51 to 95.16

PRIMARY outcome

Timeframe: 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. A lower score is associated with better outcomes with 2.9 being the worst possible score.

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training CAREN training 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 Grating Visual Acuity Visual Function Test	2.53 logMAR Interval 1.7 to 2.9	—

PRIMARY outcome

Timeframe: 6 wks

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).

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training 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 Gait Assessment	111.05 meters Interval 72.84 to 159.7	130.7 meters Interval 72.84 to 159.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 wks

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."

Outcome measures

Outcome measures
Measure	Pre-CAREN System Training n=4 Participants CAREN training CAREN system training: CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.	Post-CAREN Training n=4 Participants CAREN training 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 Activities-specific Balance Confidence (ABC) Scale Questionnaire	48.125 units on a scale Interval 0.0 to 100.0	34.375 units on a scale Interval 0.0 to 100.0

Adverse Events

CAREN System Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Aleksandra Rachitskaya

Cleveland Clinic

Phone: 216-445-9519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place