RESUMO
Introduction: In order to obtain FDA Marketing Authorization for aid in the diagnosis of concussion, an eye tracking study in an intended use population was conducted. Methods: Potentially concussed subjects recruited in emergency department and concussion clinic settings prospectively underwent eye tracking and a subset of the Sport Concussion Assessment Tool 3 at 6 sites. The results of an eye tracking-based classifier model were then validated against a pre-specified algorithm with a cutoff for concussed vs. non-concussed. The sensitivity and specificity of eye tracking were calculated after plotting of the receiver operating characteristic curve and calculation of the AUC (area under curve). Results: When concussion is defined by SCAT3 subsets, the sensitivity and specificity of an eye tracking algorithm was 80.4 and 66.1%, The AUC was 0.718. The misclassification rate (n = 282) was 31.6%. Conclusion: A pre-specified algorithm and cutoff for diagnosis of concussion vs. non-concussion has a sensitivity and specificity that is useful as a baseline-free aid in diagnosis of concussion. Eye tracking has potential to serve as an objective "gold-standard" for detection of neurophysiologic disruption due to brain injury.