Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Capturing of wave forms from the eye
研究概览
简要总结
Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults and children. The proprietary technology uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. The project described herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain Injury) patients through the use of the developed device, which is called the Head and Intraocular Trauma Test (HITT) device.
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
- 11 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
- •Engaged in sports
- •Older or equal to 11 years of age, and less than 21 years of age.
- •Provide informed consent; youths must have their parents sign the informed consent document. Children will be presented with a written assent statement and that they will be asked to sign the assent document.
排除标准
- •Catastrophic polytrauma that would interfere with follow-up and outcome assessment
- •Amblyopia/strabismus
- •Pregnancy in female subjects
- •Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
- •History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
- •Intoxication or chemical impairment at time of examination (upon initial presentation)
结局指标
主要结局
Capturing of wave forms from the eye
时间窗: Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study
Screening device will provide a wave form calculation of light reflecting off patient's eye
次要结局
未报告次要终点