An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Device Metrics
研究概览
简要总结
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in normal subjects and those with history of mild-to moderate traumatic brain injury (mTBI).
详细描述
An initial, single-center, prospective, non-masked, non-randomized, parallel-arm clinical study designed to collect Traq™ measurement data from normal subjects (normal arm) and subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months (post-TBI arm) to characterize binocular ocular function measurement outcomes across the two study populations.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12 years or older at the time of enrollment.
- •Able to understand and sign an informed consent form (or with parent/guardian for subjects less than 18 years of age).
- •Willing and able to complete all required study visits and test assessments.
- •Subjects with no history of traumatic brain injury (normal arm).
- •Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).
排除标准
- •Concurrent participation in another drug or device clinical investigation.
- •Subject with a history of eye disease which could reduce, or limit reflected polarized light from the retina, such as corneal scarring, cataract, glaucoma, degenerative retinal conditions (e.g., age-related macular degeneration, diabetic retinopathy), or other conditions which may decrease device signal reflectance.
- •Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
结局指标
主要结局
Device Metrics
时间窗: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
A composite Traq score will be calculated on a scale of 0.00-to-2.00 at each visit. The score will be a calculated combination of the following, additional outcome measures: * Bilateral foveal fixation * Foveal binocularity * Fovea-tracked saccadic latency
Foveal fixation
时间窗: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
The device will capture each individual eye's ability to fixate as a percentage (from 0.00 to 1.00) of time during the scan. A result will be provided for each individual eye.
Device outputs
时间窗: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
次要结局
未报告次要终点