NCT04281732Unknown不适用
Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Test repeatability
研究概览
简要总结
Purpose:
To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.
详细描述
Aims of the Research Project:
- To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
- To quantify the reproducibility of the performance-based tests.
- To gather acceptability and ease-of-use data from patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants
- •Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
- •Sight impairment criteria are as follows:
- •Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
- •Visual acuity of up to 6 / 24 with a moderate reduction of field of vision
排除标准
- •Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
- •A history of vertigo or dizziness.
结局指标
主要结局
Test repeatability
时间窗: All statistical analysis will take place once all data collection has ended, average 1 year.
Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.
次要结局
- Ease of use and acceptability questionnaire(Responses from all participants will be collated and summarised at the end of the study, average 1 year.)
研究者
Ruth Hogg
Principal Investigator
Queen's University, Belfast
研究点 (1)
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