NCT04799093已完成不适用
Eye Movement Tracking to Detect Impairment Due to Acute Cannabis Intoxication
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Impairment assessment correlation with EyeBOX assessment
研究概览
简要总结
The purpose of this study is to determine the accuracy of an impairment algorithm based on eye tracking while watching a short film clip, in comparison to a clinical reference standard of impairment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent.
- •Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
- •Be at least 18 years old.
排除标准
- •Be blind (no light perception), have missing or non-functional eyes.
- •Be unable to open their eyes.
- •Have a history of unresolved strabismus, diplopia, amblyopia.
- •Have a history of unresolved cranial nerve III, IV, or VI palsy.
- •Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- •Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
- •Have a prior history of unresolved ocular-motor dysfunctions.
- •Have used cannabis, alcohol etc. 24 hours before study commences.
- •Be 100% naïve to cannabis usage.
- •Be pregnant.
结局指标
主要结局
Impairment assessment correlation with EyeBOX assessment
时间窗: Within an hour
A correlation between impairment as assessed by standard impairment tests and the EyeBOX assessment of impairment as determined by an algorithm.
次要结局
未报告次要终点
研究者
研究点 (1)
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