February 19, 2019
A noninvasive test that doesn’t require comparison with a baseline assessment before an injury occurred has received FDA approval to help diagnose concussion in children and adults.
Marketed as EyeBox, the test is approved for use in pediatric patients aged 5 years or older and in adults 67 years or younger. It tracks a person’s eye movements while he or she watches a 4-minute video clip that moves clockwise around a computer monitor. Research has correlated certain eye movements with a higher likelihood of concussion. Abnormalities in eye movements also have been linked with elevated intracranial pressure.
The FDA’s approval was based on a study involving 282 patients at 6 independent US clinical sites. Investigators compared the patients’ Eyebox results with a clinical reference standard for concussion in patients presenting to emergency departments and sports medicine clinics with a suspected head injury. EyeBox was both sensitive in identifying patients with concussion and specific in ruling out concussion.
“Development of treatments for concussion is challenging because there are few reliable outcome measures,” John Leddy, MD, medical director of the University at Buffalo Concussion Management Clinic, said in a statement from EyeBox’s New York City-based manufacturer, Oculogica Inc. The recently approved test “may offer one solution to this challenge, providing researchers with an objective oculomotor assessment,” Leddy added.