Adam GrossAdam Gross
The FDA has granted a breakthrough device designation to the RightEye Vision System, an investigational eye-tracking technology that is being assessed as a test to diagnose Parkinson disease.1

RightEye, its developer, noted in its announcement that this system is the first and only such designation for a device that uses objective eye movement measurements to aid in the assessment of Parkinson. By using the current methods of diagnosing Parkinson, physicians remain challenged by inaccuracy, making misdiagnosis an ongoing issue.

“When assessing Parkinson’s disease, 60% of patients are misdiagnosed at least once, with one-third of patients misdiagnosed twice. That is a terrifying and unacceptable statistic in the age of modern medicine,” George Gitchel, PhD, director, Clinical Research, Southeast Parkinson’s Disease Research, Education, and Clinical Center (PADRECC), Richmond Veterans Affairs Medical Center, said in a statement. “In my experience. Parkinson’s patients often struggle for years, going from doctor to doctor trying to get a correct diagnosis.”

According to RightEye, its eye-tracking system is designed to identify the ocular tremors that persist for patients with Parkinson disease that do not allow the eyes to stabilize during gaze fixation. This ability of the system, the company noted, might not only aid in easing the process of diagnosis but could potentially, and critically, allow for the earlier identification of the disease, as these ocular tremors often occur well before other symptoms.
 
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“By providing quantitative, objective data to assist clinicians, I truly believe that RightEye will play a key role addressing this issue, while its FDA Breakthrough Designation will accelerate the availability,” Gitchel said.

The system also aids in the communication between provider and patient regarding its results by producing its results in an EyeQ report, a clearly organized, patient-friendly report featuring graphics and charts displaying the opportunities recognized from the hundreds of collected metrics.

“With this FDA Breakthrough Device Designation, RightEye has an opportunity to address a critical unmet need in the fight against Parkinson’s Disease,” Adam Gross, co-founder and CEO, RightEye, in a statement. “The annual cost of Parkinson’s disease in America is estimated at approximately $52 billion. Earlier assessment, intervention, and more accurate diagnoses is anticipated to reduce these costs, while also improving patient outcomes and quality of life.”

The system itself is screen, not much larger than that of a laptop, and works by calibrating to each patient’s eyes, then conducting a visual screening via saccades and pursuits which track each eye individually and provide analytics based on more than 1400 baseline metrics.

In 2018, the FDA granted clearance to the system for the recording, viewing, and analyzing of eye movements in support of identifying visual tracking impairment in patients.2 At the time, Gross said that they would “continue to pioneer the field of eye-tracking technology, we’ll advance the science and discover new solutions and applications that will benefit patients and doctors alike.”

That clearance included the system’s ability to do functional vision screening, reading assessments, sports vision training and evaluation, and to measure oculomotor issues related t brain health.

“The RightEye system has been an asset to my practice for its ability to help identify conditions that may have otherwise gone unnoticed,” said Adam Clarin, OD, practicing optometrist at Clarin Eye Care in Miami, Florida, in 2018. “The quick and easy-to-administer tests, coupled with the objective and quantifiable reports, not only guides my decision on the type of treatment to recommend but also makes it simple to explain issues to patients and parents.”
REFERENCES
1. The RightEye Vision System Receives Breakthrough Device Designation from U.S. FDA for Parkinson’s Disease Test [press release]. Bethesda, MD: RightEye LLC; Published December 3, 2019. righteye.com/fda-grants-righteyes-vision-system-breakthrough-device-designation-for-parkinsons-disease-test. Accessed December 3. 2019.
2. RightEye Eye-Tracking System Receives FDA 510(k) Clearance [press release]. Bethesda, MD: RightEye LLC; Published October 9, 2018. righteye.com/righteye-eye-tracking-system-receives-fda-510k-clearance. Accessed December 2, 2019.