Neuro-ocular Baselines in a Sports Setting (KY)

Rebiscan

Status: Completed

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

Treatments: Device: HITT device

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03653936

Rebiscan-005

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 11 to 21 years old

Volunteers: Accepts Healthy Volunteers

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)