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临床试验/NCT07092124
NCT07092124招募中不适用

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

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
repetability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Test visionumVR

Experimental

干预措施: test visionumVR (Device)

结局指标

主要结局

repetability

时间窗: Day 0 and Month 1

Repeatability coefficient of performance on the VisionumVR test

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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