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Portable Device To Monitor the Blink Reflex Cleared by FDA

Person using EyeStat device
EyeStat delivers five light puffs of food-grade carbon dioxide at random intervals to the corner of the eyes over a 20-second time frame to assess the blink reflex.

By Brandon Young

EyeStat, a portable, lightweight device for measuring the natural blink reflex, received clearance by the U.S. Food and Drug Administration (FDA) in December 2019.

The blink reflex activates when sensory or mechanical stimuli come close to the eye. These stimuli trigger nerves to send a signal through the brain and back out telling us to blink. Ophthalmologists can use the blink reflex to test for a variety of diseases that can cause nerve damage, and neurologists can use it to evaluate brain function.

To elicit the blink reflex, EyeStat delivers five light puffs of food-grade carbon dioxide at random intervals to the corner of the eyes over a 20-second time frame. During those 20 seconds, the device takes over 12,000 pictures to record the natural blink reflex. It specifically measures five things: the time it takes from the moment the air touches the side of the face until the eyelid on the stimulated side begins moving; the lag time between when the stimulated eye begins to move and the nonstimulated eye starts moving; how long the eye stays closed during a blink; the number of blinks immediately after the stimulus; and the distance between the place your eyelid sits when you are simply looking forward and when it is closed.

The FDA clearance enables blinktbi to market EyeStat as a means to measure and display the mechanically induced blink reflex, but not yet as a diagnostic device for particular clinical conditions.
However, blinktbi is currently researching whether the portable device could be used to clinically assess relevant changes in the blink reflex in patients subjectively diagnosed with traumatic brain injury.

“Our clinical trials show our blink reflex changes with any trauma to the brain,” said Ryan Fiorini, Ph.D., blinktbi cofounder and chief operations officer.

The idea of creating a more maneuver- able device for measuring the blink reflex originated from Nancey Tsai, M.D., an assistant professor in the Department of Neurosurgery at MUSC. Tsai wanted to create a portable blink “reflexometer” to measure the blink reflex of athletes on the sidelines during games to monitor for concussions. She worked with the Zucker Institute for Applied Neurosciences (ZIAN), a technology incubator embedded in MUSC, to take the first steps towards producing a research device that could eventually be commercialized by a company such as blinktbi.

“We built some devices that could do preliminary testing, but they were large and had to be wheeled around on carts, and they had no use as an on-field device. They weren’t very practical,” said Mark Semler, coinventor of the device and ZIAN chief executive officer. “Blinktbi was able to shrink the device to a more usable size and obtain FDA clearance.”

EyeStat is currently being sold to high school, collegiate and professional sports teams around the country to measure the mechanically induced blink reflex. These devices “in the field” are helping blinktbi to collect the data needed to assess whether the device can effectively diagnose concussion.

However, the research being done by blinktbi does not stop there, according to Fiorini. “We are starting multiple studies looking at indications in many different fields,” said Fiorini. “Including sobriety testing and early onset of neurological diseases, such as multiple sclerosis and Alzheimer’s disease.”

With the recent FDA approval, the device has cleared an important hurdle, meaning that an idea that began at MUSC is closer to having a national benefit.