Low VisionVisionumVRNCT07092124
Validation of a Virtual Reality Test for the Assessment of Visually Impaired Patients Undergoing Low Vision Rehabilitation
A study testing test visionumVR in people with Low Vision, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
Low vision rehabilitation is a vital part of care for visually impaired patients, who are usually referred to orthoptists to develop visual strategies and optimize residual vision. This rehabilitation significantly improves quality of life by enhancing autonomy and reducing depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Vision
- What is being tested?
- test visionumVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (regardless of visual pathology) who is about to begin or has begun orthoptic low vision rehabilitation;
- Patient requiring at least five orthoptic rehabilitation sessions that can be completed before the end of the study;
- Binocular visual acuity ≥ 1/20 (≤ 1.3 logMAR), regardless of type of vision loss (central, mixed, or peripheral);
- Sufficient knowledge of the French language.
Who cannot join
- Neurodegenerative diseases or any other condition that could interfere with the planned assessments in this study (known epilepsy and/or history of seizures, dysfunction of the dominant upper limb, etc.);
- Medications that may cause motor, visual, or cognitive impairments (neuroleptics, etc.) or interfere with the study assessments;
- Pregnant women (pregnancy can cause vision fluctuations, and wearing a virtual reality headset is not recommended);
- Participation in another clinical trial that may interfere with the current study;
- Inability to follow instructions or read.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Régional Basse Vision et Trouble de l'Audition
Angers, 49100
Virginie Saoût, +33241363616 ext. +33, Virginie.saout@vyv3.fr
Virginie Saoût, Dr
- Recruiting
Institut de Réadaptation Visuelle Saint-Louis
Paris, 75012
Christophe Pourchez, Dr, +33140021489 ext. +33, cpourchez@15-20.fr
Christophe Pourchez, Dr
About this study
Low vision rehabilitation is a vital part of care for visually impaired patients, who are usually referred to orthoptists to develop visual strategies and optimize residual vision. This rehabilitation significantly improves quality of life by enhancing autonomy and reducing depression. It employs various tools, from traditional exercises to specialized software. Advances in virtual reality (VR) offer new promising opportunities by creating immersive environments tailored to patients' residual vision, increasing motivation and exercise effectiveness. In this context, VisionumVR was developed-a VR test using the Meta Quest 3 headset to assess functional vision during rehabilitation. It evaluates hand-eye coordination, visual discrimination, and visual exploration through a daily-life-inspired task. This standardized 20-minute test aims to measure patients' progress throughout their orthoptic rehabilitation.
- Conditions
- Low Vision
- Being tested
- test visionumVR
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test visionumVRDevice
Two evaluation sessions with VisionumVR one month apart
| Study group | Role | What they receive |
|---|---|---|
| Test visionumVR | Experimental | Not described Receives: Device: test visionumVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
repetability
Repeatability coefficient of performance on the VisionumVR test
Measured: Day 0 and Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Streetlab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092124
- Sponsor's protocol ID
- P_VST_2025_2
- Acronym
- VisionumVR
- Status last verified
- Nov 2025
- First submitted
- 11 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Virtual Reality Test for the Assessment of Visually Impaired Patients Undergoing Low Vision Rehabilitation
- ClinicalTrials.gov ID
- NCT07092124
- Acronym / sponsor ID
- VisionumVR / P_VST_2025_2
- Conditions
- Low Vision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Streetlab
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
Low vision rehabilitation is a vital part of care for visually impaired patients, who are usually referred to orthoptists to develop visual strategies and optimize residual vision. This rehabilitation significantly improves quality of life by enhancing autonomy and reducing depression. It employs various tools, from traditional exercises to specialized software. Advances in virtual reality (VR) offer new promising opportunities by creating immersive environments tailored to patients' residual vision, increasing motivation and exercise effectiveness. In this context, VisionumVR was developed-a VR test using the Meta Quest 3 headset to assess functional vision during rehabilitation. It evaluates hand-eye coordination, visual discrimination, and visual exploration through a daily-life-inspired task. This standardized 20-minute test aims to measure patients' progress throughout their orthoptic rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test visionumVR | Experimental | Device: test visionumVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient (regardless of visual pathology) who is about to begin or has begun orthoptic low vision rehabilitation;
- Patient requiring at least five orthoptic rehabilitation sessions that can be completed before the end of the study;
- Binocular visual acuity ≥ 1/20 (≤ 1.3 logMAR), regardless of type of vision loss (central, mixed, or peripheral);
- Sufficient knowledge of the French language.
Key exclusion criteria (5 listed)
- Neurodegenerative diseases or any other condition that could interfere with the planned assessments in this study (known epilepsy and/or history of seizures, dysfunction of the dominant upper limb, etc.);
- Medications that may cause motor, visual, or cognitive impairments (neuroleptics, etc.) or interfere with the study assessments;
- Pregnant women (pregnancy can cause vision fluctuations, and wearing a virtual reality headset is not recommended);
- Participation in another clinical trial that may interfere with the current study;
- Inability to follow instructions or read.
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 |
|---|---|---|
| test visionumVRTwo evaluation sessions with VisionumVR one month apart | Device | Test visionumVR |
Primary outcome
repetability
Time frame: Day 0 and Month 1
Repeatability coefficient of performance on the VisionumVR test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test visionumVR in people with Low Vision, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz, Dr (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
repetability (time frame: Day 0 and Month 1). 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 Nov 2025.