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RecruitingNCT07092124VisionumVRUpdated Nov 28, 2025

Validation of a Virtual Reality Test for the Assessment of Visually Impaired Patients Undergoing Low Vision Rehabilitation

An interventional study of test visionumVR in Low Vision, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Low Vision

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03

In context

Vision, Low

98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 78 interventional studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Test visionumVR

    Device: test visionumVR

Interventions

  • Devicetest visionumVR

    Two evaluation sessions with VisionumVR one month apart

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What researchers measure

Primary outcomes

  1. repetability

    Repeatability coefficient of performance on the VisionumVR test

    Time frame: Day 0 and Month 1

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Study locations

2 of 2 sites recruiting
  • Centre Régional Basse Vision et Trouble de l'Audition
    Angers, 49100, France
    Recruiting
    • Virginie Saoût · ContactVirginie.saout@vyv3.fr · +33241363616
    • Virginie Saoût, Dr · Principal investigator
  • Institut de Réadaptation Visuelle Saint-Louis
    Paris, 75012, France
    Recruiting
    • Christophe Pourchez, Dr · Contactcpourchez@15-20.fr · +33140021489
    • Christophe Pourchez, Dr · Principal investigator
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07092124
Collaborators
Streetlab
Responsible party
Sponsor
First posted
Jul 29, 2025
Start date
Oct 30, 2025
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 28, 2025

Study contacts

Amelie Yavchitz, Dr
Contact
ayavchitz@for.paris
+33148036454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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