Retinitis PigmentosaNCT03444961
Computer-Assisted Rehabilitation Environment Training After Argus Retinal Prosthesis
A study testing CAREN system training in people with Retinitis Pigmentosa, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- CAREN system training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia
- Musculoskeletal contraindication to exercise or walking
- Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery
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.
- Conditions
- Retinitis Pigmentosa
- Being tested
- CAREN system training
- Keywords
- Argus II Retinal Prosthesis System, Rehabilitation
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREN system trainingDevice
CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
| Study group | Role | What they receive |
|---|---|---|
| CAREN system training | Experimental | CAREN training Receives: Device: CAREN system training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start30 Jan 2018
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Rachitskaya, MD, The Cleveland Clinic
- Investigators
- Aleksandra Rachitskaya, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444961
- Sponsor's protocol ID
- 17-1355
- Status last verified
- Jun 2021
- First submitted
- 26 Oct 2017
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rachitskaya A, Yuan A, Davidson S, Streicher M, DeBenedictis M, Rosenfeldt AB, Alberts J. Computer-Assisted Immersive Visual Rehabilitation in Argus II Retinal Prosthesis Recipients. Ophthalmol Retina. 2020 Jun;4(6):613-619. doi: 10.1016/j.oret.2019.11.007. Epub 2019 Nov 15.
PubMed 31937474
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Visual and Mobility Training Using Computer-Assisted Rehabilitation Environment (CAREN) After Argus Retinal Prosthesis Surgery
- ClinicalTrials.gov ID
- NCT03444961
- Acronym / sponsor ID
- 17-1355
- Conditions
- Retinitis Pigmentosa
- Keywords
- Argus II Retinal Prosthesis System, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAREN system training | Experimental | Device: CAREN system trainingCAREN training |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Dementia
- Musculoskeletal contraindication to exercise or walking
- Cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREN system trainingCAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment. | Device | CAREN system training |
Primary outcome
Effects of CAREN Virtual Reality System on Obstacle Course Navigation
Time frame: 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
Time frame: 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 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). The higher the mean error/score, the worse the outcome.
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. A lower score is associated with better outcomes with 2.9 being the worst possible score.
Effects of CAREN Virtual Reality System on Gait Assessment
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31937474Rachitskaya A, Yuan A, Davidson S, Streicher M, DeBenedictis M, Rosenfeldt AB, Alberts J. Computer-Assisted Immersive Visual Rehabilitation in Argus II Retinal Prosthesis Recipients. Ophthalmol Retina. 2020 Jun;4(6):613-619. doi: 10.1016/j.oret.2019.11.007. Epub 2019 Nov 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Rachitskaya, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREN system training in people with Retinitis Pigmentosa, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of CAREN Virtual Reality System on Obstacle Course Navigation (time frame: 6 wks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03444961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021; AzTrials last refreshed its copy on 28 Oct 2026.