Completed

NCT Number: NCT03653936

Neuro-ocular Baselines in a Sports Setting

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.

Completed

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Key information

Conditions

Wave Form Signals Coming From the Eye in a Healthy Cohort

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

BlueGrass Orthopaedics

Lexington, Kentucky, 40509, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HITT device

Device

Rebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards.

Primary outcomes

Capturing of wave forms from the eye

Time frame: 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

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

BlueGrass Orthopaedics Surgery & Hand Care

Registry information

Official study title

Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction

Acronym: KY

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 31, 2018
Registry last updated: Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.