Christ Church, Barbados – December 5, 2023
Evolution Optiks Limited, a privately held companyand forerunner in light field technology, announced today the successful completion of data collection in a US FDA-authorized clinical study to assess the safety and efficacy of its DeCon device for the evaluation of human vestibular disorders. The study findings will be included in the application to the FDA to support the request for approval which the company currently expects to obtain in the first quarter of 2024.
“The prospective, single-site, randomized, controlled study involved 25 patients and was conducted to compare the performance of the DeCon system to the current industry standard in videonystagmography”, says Dr. Anne Reuter, a highly regarded specialist in neuro-optometry, binocular vision and neurological rehabilitation and principal investigator of the study. “The results are very promising and we look forward to sharing the final analysis with the neuro-ophthalmological community.”
DeCon, the flagship product of the NeuroDynamiksTM brand of Evolution Optiks, is a portable head-mounted device that uses proprietary light field technology to track and analyze involuntary movements of the eyeball in response to visual stimuli and positional changes. This is essential in the diagnosis of vestibular disorders which are commonly caused by external trauma to the brain such as a fall, a blow or jolt to the head. DeCon can perform dozens of established neurological tests, the results of which are simultaneously recorded on the device and, if required, can be made available remotely for interpretation by a qualified medical practitioner.
“We are very pleased with the timely and professional manner in which the clinical study was conducted and would like to thank all the test subjects for their kind support and the investigators for their hard work and dedication”, comments Raul Mihali, President & CEO of Evolution Optiks. “Vestibular dysfunction as a result of traumatic brain injury is extremely common, with most cases being due to falls or motor vehicle accidents, and we would like to play our part in tackling this problem. The light field engine at the core of DeCon as well as its lightweight portable design and telehealth capabilities may open a new chapter in the diagnosis, treatment and rehabilitation of vestibular disorders.”
Founded in 2014, Evolution Optiks Limited is commercializing an extensive and ongoing portfolio of innovation and is on track to revolutionizing how digital information is being consumed. The company’s primary categories of interest are optometry instruments, neuro-optical screening and training devices and, more broadly, it is exploring solutions based on vision-adapted, multi-view and light field displays, with applications in medicine, consumer solutions, advertising and media, automotive and avionics.