Neuro-ocular Baselines in a Sports Setting

Study Overview
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Brief Summary
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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.

Official Title
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Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction

Conditions
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Wave Form Signals Coming From the Eye in a Healthy Cohort

Intervention / Treatment
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* Device: HITT device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HITT device|Rebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capturing of wave forms from the eye | Screening device will provide a wave form calculation of light reflecting off patient's eye | Screenings will be performed during a normally scheduled visit to the sports facility by the research group enrolling in the study |