Visual ImpairmentVIRARENCT03646786
Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
A study testing Virtual reality tests in people with Visual Impairment, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Virtual reality tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2020to 11 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient signed the consent form
- The patient is affiliated to a health insurance programme
- The patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...).
- The patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the Goldmann binocular visual field or homonymous hemianopia) of category I, II, III or IV of the WHO classification.
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by another study
- The patient is under safeguard of justice.
- The patient is under judicial protection.
- It is not possible to give the patient (or his/her trusted-person) informed information.
- The patient is pregnant or breastfeeding.
- The patient has a sensory or cognitive disability with a given scale (MMS < 24)
- The patient has difficulty moving including major locomotor difficulties.
Trial locations and contacts
1 site in 1 country.
About this study
Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.
- Conditions
- Visual Impairment
- Being tested
- Virtual reality tests
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality testsDevice
The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality:
- 10 minutes sitting test: detection of 5 targets in a 360 ° field of vision
- 10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe
- Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe
| Study group | Role | What they receive |
|---|---|---|
| visually impaired patients | Experimental | Not described Receives: Device: Virtual reality tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
dizziness felt by the patient
Yes/no
Measured: Day 0
Nausea felt by the patient
Yes/no
Measured: Day 0
headache felt by the patient
Yes/no
Measured: Day 0
dazzle felt by the patient
Yes/no
Measured: Day 0
watering of the patient
Yes/no
Measured: Day 0
eye burns felt by the patient
Yes/no
Measured: Day 0
Pain due to the mobilization of the eyeballs felt by the patient
Yes/no
Measured: Day 0
Extraocular pain felt by the patient
Yes/no
Measured: Day 0
diplopia
Yes/no
Measured: Day 0
amaurosis
Yes/no
Measured: Day 0
Fear
Yes/no
Measured: Day 0
conformity of the session according to the patient point of view
Yes/no
Measured: Day 0
unpleasantness of the session from the patient point of view
Yes/no
Measured: Day 0
Difficulty of the session according to the patient point of view
Yes/no
Measured: Day 0
Willingness to continue the following tests according to the patient point of view
Yes/no
Measured: Day 0
Cervical pain felt by the patient
Yes/no
Measured: Day 0
oculomotricity of the patient according to the therapist
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Measured: Day 0
head movements of the patient according to the therapist
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Measured: Day 0
body movements of the patient according to the therapist
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
Measured: Day 0
target tracking by the patient according to the therapist
0 = 0 target detected
- 1 or 2 targets detected
- 3 or 4 targets detected
- 5 targets detected
Measured: Day 0
Time lapse to find targets
minutes
Measured: Day 0
The patient asked for a pause during the test
Yes/no
Measured: Day 0
The patient asked to permanently stop the tests
Yes/no
Measured: Day 0
The patient went to the right place during the 3rd test
Yes/no
Measured: Day 0
The patient has correctly performed the requested task
Yes/no
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start11 Dec 2020
- Primary completion12 Nov 2021
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JEANJEAN, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646786
- Sponsor's protocol ID
- IDIL/2016/LJ-01
- Acronym
- VIRARE
- Status last verified
- Sep 2022
- First submitted
- 23 Aug 2018
- Last updated
- 28 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Multi-actor Tolerance Evaluation Using the VIRARE Device (VIrtual Reality Assisted Rehabilitation) in Visually Impaired Patients
- ClinicalTrials.gov ID
- NCT03646786
- Acronym / sponsor ID
- VIRARE / IDIL/2016/LJ-01
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims to validate the relevance of a virtual reality tool (VIRARE: VIrtual REality Assisted Rehabilitation) in the assessment and rehabilitation of visually impaired subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| visually impaired patients | Experimental | Device: Virtual reality tests |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient signed the consent form
- The patient is affiliated to a health insurance programme
- The patient presents ophthalmological or neurological pathologies with impact on visual function (retinopathy pigmentosa, macular dystrophy, glaucoma, age-related macular degeneration, cerebrovascular accident ...).
- The patient is visually impaired (visual acuity less than 3/10 of both eyes or concentric narrowing of the Goldmann binocular visual field or homonymous hemianopia) of category I, II, III or IV of the WHO classification.
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by another study
- The patient is under safeguard of justice.
- The patient is under judicial protection.
- It is not possible to give the patient (or his/her trusted-person) informed information.
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 |
|---|---|---|
| Virtual reality testsThe patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality: 1. 10 minutes sitting test: detection of 5 targets in a 360 ° field of vision 2. 10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe 3. Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe | Device | visually impaired patients |
Primary outcome
dizziness felt by the patient
Time frame: Day 0
Yes/no
Nausea felt by the patient
Time frame: Day 0
Yes/no
headache felt by the patient
Time frame: Day 0
Yes/no
dazzle felt by the patient
Time frame: Day 0
Yes/no
watering of the patient
Time frame: Day 0
Yes/no
eye burns felt by the patient
Time frame: Day 0
Yes/no
Pain due to the mobilization of the eyeballs felt by the patient
Time frame: Day 0
Yes/no
Extraocular pain felt by the patient
Time frame: Day 0
Yes/no
diplopia
Time frame: Day 0
Yes/no
amaurosis
Time frame: Day 0
Yes/no
Fear
Time frame: Day 0
Yes/no
conformity of the session according to the patient point of view
Time frame: Day 0
Yes/no
unpleasantness of the session from the patient point of view
Time frame: Day 0
Yes/no
Difficulty of the session according to the patient point of view
Time frame: Day 0
Yes/no
Willingness to continue the following tests according to the patient point of view
Time frame: Day 0
Yes/no
Cervical pain felt by the patient
Time frame: Day 0
Yes/no
oculomotricity of the patient according to the therapist
Time frame: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
head movements of the patient according to the therapist
Time frame: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
body movements of the patient according to the therapist
Time frame: Day 0
Rank: 0-missing, 1-insufficient, 2-medium, 3-suitable
target tracking by the patient according to the therapist
Time frame: Day 0
0 = 0 target detected 1. 1 or 2 targets detected 2. 3 or 4 targets detected 3. 5 targets detected
Time lapse to find targets
Time frame: Day 0
minutes
The patient asked for a pause during the test
Time frame: Day 0
Yes/no
The patient asked to permanently stop the tests
Time frame: Day 0
Yes/no
The patient went to the right place during the 3rd test
Time frame: Day 0
Yes/no
The patient has correctly performed the requested task
Time frame: Day 0
Yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
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Iopidine to Decrease Intraocular Pressure Rise After Injections
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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.
Luc JEANJEAN principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality tests in people with Visual Impairment, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 4 inclusion and 8 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 28 Sep 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dizziness felt by the patient (time frame: Day 0). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.