EyeBOX
Oculogica, Inc.EyeBOX is a device that uses an eye-tracking camera and software to measure and analyze eye movements as an aid in assessing concussion within one week of head injury for patients aged 5 to 67. It provides clinicians with a score indicating possible brain injury based on abnormal eye movement patterns, helping supplement traditional neurological assessment.
Intended Use
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion.
Technology
The device consists of an integrated stand with an eye-tracking camera that uses infrared illumination to capture eye movement data at 500 frames per second for each eye while the patient watches a predefined video stimulus. The software processes 220 seconds of binocular gaze data, discards initial and final segments, applies blink detection and normalization, and calculates a score (0-20) indicating abnormal eye movement patterns associated with concussion.
Performance
Performance testing included software verification and validation, clinical study with 282 subjects assessing sensitivity (80.4%) and specificity (66.1%) against a clinical reference standard for concussion, test-retest reliability analysis showing 79.3% equivalence, and safety testing including biocompatibility, electromagnetic compatibility, and light hazard assessments. No device-related adverse events were reported.
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