NCT03418753已完成不适用
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.
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
- 4 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes.
- •Be between the ages of 4 and 70 years old.
- •Have baseline vision correctable to within 20/500 bilaterally.
- •Have no prior history of ocular dysmotility.
- •Be awake with spontaneous eye opening at the time when eye tracking is performed.
排除标准
- •Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI.
- •Be blind (no light perception), have missing eyes, be unable to open their eyes.
- •Have a prior history of ocular motility dysfunction.
- •Have had extensive prior eye surgery.
- •Have any physical or mental injury or baseline disability rendering task completion difficult.
- •Be intoxicated or have blood alcohol level greater than 0.
- •Be a prisoner or in the company of a police officer or law enforcement officer pending arrest.
结局指标
主要结局
Sensitivity and Specificity
时间窗: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks
EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor
次要结局
未报告次要终点
研究者
研究点 (3)
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