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

NCT ID: NCT07092124

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2027-02-28

Brief 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.

Conditions

Low Vision

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test visionumVR

Group Type: EXPERIMENTAL

test visionumVR

Intervention Type: DEVICE

Two evaluation sessions with VisionumVR one month apart

Interventions

test visionumVR

Two evaluation sessions with VisionumVR one month apart

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Streetlab

INDUSTRY

Sponsor Role: collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Régional Basse Vision et Trouble de l'Audition

Angers, , France

Site Status: RECRUITING

Institut de Réadaptation Visuelle Saint-Louis

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amelie Yavchitz, Dr

Role: CONTACT

ayavchitz@for.paris

+33148036454

Facility Contacts

Virginie Saoût

Role: primary

Virginie.saout@vyv3.fr

+33241363616 ext. +33

Christophe Pourchez, Dr

Role: primary

cpourchez@15-20.fr

+33140021489 ext. +33

Other Identifiers

P_VST_2025_2

Identifier Type: -

Identifier Source: org_study_id