Virtual Reality (VR) Based Vision Test in Subjects With Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Usability, tolerability and repeatability
研究概览
简要总结
To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
详细描述
In order to bridge the gap between the existing functional measures and AMD lesions, researchers are considering the use of VR tools.
This study is designed to assess the contrast sensitivity function mapping test (CSF radial sweep) in an elderly population with AMD.
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.
The secondary objective of this study is to assess the relationship between the metrics generated by VR-based functional tasks and the metrics derived from conventional clinical measurements of retinal anatomy and visual function.
The primary efficacy endpoint is the Contrast sensitivity function (CSF) area under curve (AUC) correlation to Snellen BCVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥18 years of age diagnosed with AMD
- •Subject Snellen BCVA score is 20/100 or better
- •Ability to undergo quality optical coherence tomography (OCT) imaging
- •Willing and able to give written informed consent
排除标准
- •Unwilling to use headset
- •Previous negative experience with a VR headset (eg, motion sickness, discomfort)
- •Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
- •Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
- •Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)
结局指标
主要结局
Usability, tolerability and repeatability
时间窗: 20 minutes
The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. To assess the usability and tolerability a patient survey is performed.
次要结局
- Contrast sensitivity function (CSF)(10 minutes)