An interventional study of CAREN system training in Retinitis Pigmentosa, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 25 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 6 wks
Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire
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."
Time frame: 6 wks
| Milestone | CAREN System Training |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb)
| seconds | Pre-CAREN System Training | Post-CAREN Training |
|---|---|---|
| Effects of CAREN Virtual Reality System on Obstacle Course Navigation | 51.25 (28 to 117) | 33.75 (28 to 117) |
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.
| seconds | Pre - CAREN System Training | Post-CAREN System Training |
|---|---|---|
| Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training | 52.8 ± 6.6 | 39.29 ± 10.86 |
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.
| pixels | Pre-CAREN System Training | Post-CAREN System Training |
|---|---|---|
| Effects of CAREN Virtual Reality System on Square Localization Visual Function Test | 274.62 (104.12 to 463.47) | 245.43 (104.12 to 463.47) |
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.
| degrees | Pre-CAREN System Training | Post-CAREN System Training |
|---|---|---|
| Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test. | 65.68 (14.51 to 95.16) | 58.12 (14.51 to 95.16) |
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.
| logMAR | CAREN System Training |
|---|---|
| Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test | 2.53 (1.7 to 2.9) |
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).
| meters | Pre-CAREN System Training | Post-CAREN System Training |
|---|---|---|
| Effects of CAREN Virtual Reality System on Gait Assessment | 111.05 (72.84 to 159.70) | 130.7 (72.84 to 159.70) |
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."
| units on a scale | Pre-CAREN System Training | Post-CAREN System Training |
|---|---|---|
| Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire | 48.125 (0 to 100) | 34.375 (0 to 100) |
Collected over AE's were collected over the course of 6 months while patients were enrolled/actively participating in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAREN System Training | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | CAREN System Training |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | CAREN System Training |
|---|---|
| Female | 1 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | CAREN System Training |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | CAREN System Training |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CAREN System Training |
|---|---|
| United States | 4 |
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