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Recruiting

NCT Number: NCT07092124

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Régional Basse Vision et Trouble de l'Audition, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

test visionumVR

Device

Two evaluation sessions with VisionumVR one month apart

Primary outcomes

  1. repetability

    Time frame: Day 0 and Month 1

    Repeatability coefficient of performance on the VisionumVR test

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Yavchitz, Dr

CONTACT

[email protected]

+33148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Collaborators

  • Streetlab

Registry information

Acronym: VisionumVR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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