Retinitis Pigmentosa
Conditions
Keywords
Argus II Retinal Prosthesis System, Rehabilitation
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.
Interventions
DEVICECAREN system training
CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of CAREN Virtual Reality System on Square Localization Visual Function Test | 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 Obstacle Course Navigation | 6 wks | Obstacle course navigation - time (seconds) to complete an obstacle course (walking forward while navigating over a ramp and curb) |
| Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training | 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. |
| Effects of CAREN Virtual Reality System on Gait Assessment | 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). |
| Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test. | 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. |
| Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | CAREN System Training |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test. | 65.68 degrees |
| Post-CAREN Training | Effects of CAREN Virtual Reality System on Direction of Motion Visual Function Test. | 58.12 degrees |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Gait Assessment | 111.05 meters |
| Post-CAREN Training | Effects of CAREN Virtual Reality System on Gait Assessment | 130.7 meters |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Grating Visual Acuity Visual Function Test | 2.53 logMAR |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Obstacle Course Navigation | 51.25 seconds |
| Post-CAREN Training | Effects of CAREN Virtual Reality System on Obstacle Course Navigation | 33.75 seconds |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Square Localization Visual Function Test | 274.62 pixels |
| Post-CAREN Training | Effects of CAREN Virtual Reality System on Square Localization Visual Function Test | 245.43 pixels |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-CAREN System Training | Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training | 52.8 seconds | Standard Deviation 6.6 |
| Post-CAREN Training | Time to Complete the Timed Up and Go Test Before and After CAREN Virtual Reality System Training | 39.29 seconds | Standard Deviation 10.86 |
Other Pre-specified
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pre-CAREN System Training | Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire | 48.125 units on a scale |
| Post-CAREN Training | Effects of CAREN Virtual Reality System on Activities-specific Balance Confidence (ABC) Scale Questionnaire | 34.375 units on a scale |