NCT03653936

Neuro-ocular Baselines in a Sports Setting

Neuro-ocular Baselines in a Sports Setting: Feasibility Study for Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Rebiscan, Inc. · Industry
• Sex: All
• Age: 11 Years – 21 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2018-08-31
• Last updated: 2019-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study