Neuro-ocular Baselines in a Sports Setting



Status:Recruiting
Healthy:No
Age Range:11 - 21
Updated:9/2/2018
Start Date:April 1, 2018
End Date:August 2018
Contact:Justin Shaka
Email:jgshaka@rebiscan.com
Phone:857-600-0982

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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

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 patients through the
use of the developed device, which is called the Head and Intraocular Trauma Test (HITT)
device.


Inclusion Criteria:

- Student-athletes who present to schools affiliated with the Bluegrass Sports Clinica
and are engaged in spring sports are eligible for enrollment in the study. Study
participants must be older or equal to 11 years of age, and less than 21 years of age.

All participants must provide informed consent; youths must have their parents signed 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:

1. Catastrophic polytrauma that would interfere with follow-up and outcome assessment

2. Amblyopia/strabismus

3. Pregnancy in female subjects

4. 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.

5. History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)

6. Intoxication or chemical impairment at time of examination (upon initial presentation)
We found this trial at
1
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Lexington, Kentucky 40509
Phone: 888-422-3170
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