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Neuro-ocular Baselines in a Sports Setting (KY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653936
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
BlueGrass Orthopaedics Surgery & Hand Care
Information provided by (Responsible Party):
Rebiscan, Inc.

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.

Condition or disease Intervention/treatment
Wave Form Signals Coming From the Eye in a Healthy Cohort Device: HITT device

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653936


Locations
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United States, Kentucky
BlueGrass Orthopaedics
Lexington, Kentucky, United States, 40509
Sponsors and Collaborators
Rebiscan, Inc.
BlueGrass Orthopaedics Surgery & Hand Care
Investigators
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Principal Investigator: Harry Lockstadt, MD BlueGrass Orthopaedics

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Responsible Party: Rebiscan, Inc.
ClinicalTrials.gov Identifier: NCT03653936    
Other Study ID Numbers: Rebiscan-005
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No