Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Number of Net selection assessed by the SPOT test
研究概览
简要总结
Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrialized countries and affects tens of millions of people worldwide, with a rapidly increasing prevalence. It causes irreversible central vision loss and significant difficulties in daily activities, impairing patients' quality of life and independence. Conventional clinical assessments, which focus on visual acuity and retinal imaging, do not fully reflect the functional impact of the disease.
Virtual reality (VR) makes it possible to create immersive, controlled environments to accurately measure functional vision and simulate real-life situations. The study proposes to develop a standardized and reproducible functional test in virtual reality that can complement conventional examinations and support clinical and industrial research.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years
- •Sufficient knowledge of the French language
- •Ability to give personal, express, free, and informed consent
- •Ability to comply with the requirements of the protocol
- •Person covered by Social Security
- •Clarity of the ocular environment, adequate pupil dilation to allow the collection of good quality images, as determined by the investigator
- •Additional inclusion criteria for group 1, healthy subjects:
- •No detectable visual pathologies
- •Best monocular visual acuity ≥ 8/10
- •Additional inclusion criteria for group 2, subjects with LMA, early AMD, or intermediate AMD without atrophy:
- •Diagnosis of AMD, early AMD, or intermediate AMD
- •Absence of geographic atrophy
- •Presence of drusen (diameter > 63 µm) with or without pigmentary changes
- •Additional inclusion criteria for group 3, subjects with dry AMD with perifoveal atrophy:
- •Diagnosis of atrophic AMD
- •Presence of drusen (diameter > 125 µm)
- •Location of geographic atrophy as determined by the investigator: extrafoveal, juxtafoveal
- •Preservation of central vision confirmed by the investigator based on a comprehensive and integrated interpretation of SD-OCT, FAF, retinography, and best corrected visual acuity examinations.
- •Additional inclusion criteria for group 4, Subject with dry AMD with foveal atrophy:
- •Diagnosis of atrophic AMD
- •Presence of drusen (diameter > 125 µm)
- •Investigator's localization of geographic atrophy: retrofoveal
- •Central vision impairment confirmed by the investigator based on a comprehensive and integrated interpretation of SD-OCT, FAF, retinography, and best corrected visual acuity examinations.
排除标准
- •Pregnant women, women in labor, or breastfeeding women
- •Subjects undergoing drug treatments that may cause motor, visual, vestibular, or cognitive disorders (PSA, neuroleptics, etc.) or that could interfere with the study examinations
- •Any concomitant intraocular condition in the eye being studied (e.g., glaucoma or cataract)
- •Any retinal pathology that could cause retinal atrophy other than AMD (eliminate dystrophy, chronic CRSC, pachyatrophy, resorption of vitelliform material with atrophy, high myopia, etc.)
- •Known systemic disease that, in the investigator's opinion, would prevent active participation in the study
- •Participation in any other therapeutic study evaluating a drug.
- •Subjects with cognitive impairment, illiterate subjects, and subjects who do not speak the national language.
- •Persons subject to enhanced protection or legal safeguards (guardianship, trusteeship).
研究组 & 干预措施
Main
干预措施: Object recognition and selection task (Other)
结局指标
主要结局
Number of Net selection assessed by the SPOT test
时间窗: Baseline
Net selection is the number of selected targets, less the number of selected distractors
Number of Net selection assessed by the SPOT test
时间窗: Hour 1
Net selection is the number of selected targets, less the number of selected distractors
Number of target selection assessed by the SPOT test
时间窗: Baseline
Number of target selection assessed by the SPOT test
时间窗: Hour 1
次要结局
未报告次要终点