Neuro-ocular Baselines in a Sports Setting

NCT ID: NCT03653936

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BlueGrass Orthopaedics Surgery & Hand Care

UNKNOWN

Sponsor Role: collaborator

Rebiscan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry Lockstadt, MD

Role: PRINCIPAL_INVESTIGATOR

Bluegrass Orthopaedics

Locations

BlueGrass Orthopaedics

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

Rebiscan-005

Identifier Type: -

Identifier Source: org_study_id