FDA Clearance Granted For OCULUS Myopia Master

FDA Clearance Granted For OCULUS Myopia Master

August 17, 2021

The ground-breaking measurement tool that supports myopia treatment received 510(k) clearance from the US FDA.

The U.S. Food and Drug Administration granted the Myopia Master® 510(k) approval, according to OCULUS (FDA). The contactless device combines axial length, refraction values, and central corneal radii as three measurement techniques for managing myopia.

The accuracy of the measurement of axial length using interferometry is unaffected by the eye's level of accommodation. The compact form can be put on an operating table or workstation. The software can also be used with the built-in display.

“We are very happy to announce that we just received FDA clearance for the Myopia Master!” said Christian Kirchhübel, CEO of OCULUS Optikgeräte GmbH. “Two years ago, we presented the first device to the public at the Opti in Munich. Since then, we have been working with BHVI (outside the U.S.) to not only deliver the measurements required but also the metrics scales.

Your ordinary ARK can be replaced with the new Myopia Master, saving space in the packed exam room. Globally, myopia is becoming a bigger problem. By 2050, 50% of people, according to the Brien Holden Vision Institute, will have myopia. Myopia may raise the risk of developing serious eye conditions including cataract or retinal detachment, which could result in blindness.

The American Academy of Ophthalmology estimates that during the past 50 years, the percentage of Americans who are nearsighted has nearly doubled to 41.6 percent. This is a global issue, but East and Southeast Asia stand out in particular since there, 80 to 90 percent of children and young adults have myopia. The Myopia Master from OCULUS combines three crucial elements into a single fast, contactless measurement with high accuracy to help with early myopia detection and effective myopia management.