NCT04140877撤回不适用
Choroidal Changes Post Short Term Exposure To Virtual Reality Devices
Visu, Inc.0 个研究点开始时间: 2020年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Choroidal thickness
研究概览
简要总结
This is a prospective, randomized, controlled, contralateral eye, clinical study. The objective of the study is to determine the impact of Virtual Reality (VR) usage on choroidal thickness when viewed through a test display compared to a control (standard) VR display. The hypothesis is that there will be less choroidal thinning in the eye viewing the test VR screen compared to the eye viewing the control VR screen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 13 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Visual Acuity of +0.20 logMAR or better in each eye;
- •Is willing and able to follow instructions and maintain the appointment schedule.
排除标准
- •Is participating in any concurrent clinical or research study;
- •Has any known active ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is amblyopic in either eye;
- •Has a colour vision abnormality;
- •Commonly experiences motion sickness.
结局指标
主要结局
Choroidal thickness
时间窗: 2 hours
次要结局
- Axial length(3 months)
- Choroidal thickness(3 months)
研究者
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