Non-inferiority Study for Visual Field Measurements Using a Virtual Reality Device on Participants With Normal and Glaucomatous Visual Fields
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter
研究概览
简要总结
It is hypothesized that performing VF measurements with a Virtual Reality headset using similar testing strategies as implemented in conventional perimeters, allow for a non-inferior quality in VF acquisitions. The results of this study will show if valid measurements of such devices in human subjects can be obtained.
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Exclusion criteria are subjects younger than 40 and older than 80 years
- •Inability to follow the procedure
- •Insufficient knowledge of project language
- •The history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
- •Any history of epilepsy
结局指标
主要结局
non-inferiority estimation quality of mean defect (MD) measured in decibels (dB) between the virtual reality perimeter and the OCTOPUS 900 perimeter
时间窗: 2 weeks
The primary endpoint of this study is the non-inferiority estimation quality of participant's mean defect (MD) measured in decibel (dB) between the head-mounted display and an OCTOPUS perimeter using the dynamic strategy (DS) for participants with normal or glaucomatous visual field. The MD is a clinical measure for the average loss of visual function calculated from the visual field of a participant.
次要结局
未报告次要终点