Neuro-ocular Baselines in a Sports Setting

Wave Form Signals Coming From the Eye in a Healthy Cohort Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653936
• Other study ID #: Rebiscan-005
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: Rebiscan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• HITT 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.

Locations

Country	Name	City	State
United States	BlueGrass Orthopaedics	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	BlueGrass Orthopaedics Surgery & Hand Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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