Oculogica Inc. announces publication of the initial 5-site study performed to obtain FDA Marketing Authorization for its EyeBOX technology as an aid in the diagnosis of concussion. EyeBOX uses eye tracking to assess pupil size and position to determine whether a person has sustained damage to brain regions that control those functions.
The study, published in Frontiers in Neurology December 1, 2022, was performed on 282 emergency room or concussion clinic patients ages 5 to 67 within 2 weeks of injury. Study participants were evaluated at New York City’s Bellevue Hospital, Rochester’s Mayo Clinic, Pittsburgh’s Allegheny Hospital, Denver’s Rocky Mountain Hospital for Children, and Beaver Dam Wisconsin’s Community Hospital.
The study demonstrated that patients who had symptoms of concussion and scored poorly on a cognition assessment were more likely to have abnormal eye tracking, as assessed by the technology’s proprietary BOX (Brain injury associated Ocular motility dysfunction) Score. The BOX Score diagnosed concussion with over 80% sensitivity.
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