Neuro-ocular Baselines in a Sports Setting

NCT03653936 | Completed FDA Device

• 1 other identifier: Rebiscan-005
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Wave Form Signals Coming From the Eye in a Healthy Cohort

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• BlueGrass Orthopaedics Surgery & Hand Care: collaborator

Study Sites (1)

BlueGrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

Study Officials

• Harry Lockstadt, MD

  Bluegrass Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: April 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)