Neuro-ocular Baselines in a Sports Setting
Completed
Conditions studied: Wave Form Signals Coming From the Eye in a Healthy Cohort
In brief
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.
Key facts
- Study ID
- NCT03653936
- Run by
- Rebiscan, Inc.
- People needed
- 63
- Starts
- 2018-04-01
- Expected to finish
- 2018-11-30
- Last updated by the study team
- 2019-04-18
Who can join
Age: 11 and older, up to 21. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- BlueGrass Orthopaedics — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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