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

Not Applicable

Not yet recruiting

• Conditions: Low Vision

• Registration Number: NCT07092124
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Study Start: 2025-09-01
• Primary Completion: 2027-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
repetability	Day 0 and Month 1	Repeatability coefficient of performance on the VisionumVR test