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| Name | Class |
|---|---|
| BlueGrass Orthopaedics Surgery & Hand Care | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Harry Lockstadt, MD | Bluegrass Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BlueGrass Orthopaedics | Lexington | Kentucky | 40509 | United States |
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