Neuro-ocular Baselines in a Sports Setting (KY)

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

Study Overview

• Status: Completed
• Conditions: Wave Form Signals Coming From the Eye in a Healthy Cohort
• Intervention / Treatment: Device: HITT device

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort study of individuals tested with the Rebion device followed by SCAT3 examination. Two data sets will be taken and compared: a cohort with non-contact sport athletes (swimmers, tennis, track) and a cohort of contact sport athletes (lacrosse, spring football, and spring soccer).

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rebiscan, Inc.
• Collaborators: BlueGrass Orthopaedics Surgery & Hand Care
• Investigators: Principal Investigator: Harry Lockstadt, MD, Bluegrass Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Rebiscan-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No