Neuro-ocular Baselines in a Sports Setting

Completed

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

• Registration Number: NCT03653936
• Lead Sponsor: Rebiscan, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capturing of wave forms from the eye	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

Trial Locations

Locations (1)

BlueGrass Orthopaedics; 🇺🇸 Lexington, Kentucky, United States