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Neuro-ocular Baselines in a Sports Setting

NCT03653936 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2019-04-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BlueGrass Orthopaedics Surgery & Hand Care

    collaborator UNKNOWN

  • Rebiscan, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry Lockstadt, MD · Bluegrass Orthopaedics

Eligibility

Min Age
11 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653936 on ClinicalTrials.gov