EyeBOX EBX-4.1
Oculogica, Inc.The EyeBOX EBX-4.1 is an eye-tracking device designed to help diagnose concussions by measuring eye movements. It uses a high-speed infrared camera to record gaze while the patient watches a video stimulus. The device automatically analyzes the data and produces a BOX score indicating the likelihood of concussion, comparing the eye tracking metrics to a normative database of uninjured individuals. This helps clinicians assess brain injury more objectively and quickly.
Intended Use
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion (mild traumatic brain injury) in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. It provides a BOX score to indicate likelihood of concussion within one week of injury.
Technology
The device consists of a host PC with touchscreen, eye tracking camera with a high-speed near-infrared sensor recording gaze position 500 times per second, a stimulus LCD screen, and head stabilization hardware. It uses a data processing algorithm that analyzes recorded eye movement data to detect subtle changes indicative of concussion. It produces a diagnostic BOX score and additional eye-tracking and pupillometry metrics compared against a normative database.
Performance
Performance testing included software verification, user acceptance testing, normative database testing, and output report metric validation. Accuracy and precision of eye-tracking metrics (gaze position, pupil size, blink detection) were confirmed. Test-retest reliability was evaluated with 30 healthy individuals, demonstrating reproducibility of the metrics. Added eye-tracking parameters did not negatively impact device accuracy or safety.
Predicate Devices
No predicate devices specified
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