FDA Clearance Granted For OCULUS Myopia Master

FDA Clearance Granted For OCULUS Myopia Master

August 17, 2021

The U.S. FDA granted 510(k) clearance to the groundbreaking measurement device, aiding in myopia management.

OCULUS announced that the Myopia Master® received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The contactless device combines three measurement methods for myopia management: axial length, refraction values, and central corneal radii.

Axial length is measured using interferometry, and its accuracy is not influenced by the accommodation-status of the eye.

The space-saving design can be mounted on a workstation or ophthalmic table. Additionally, the software is operated via 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.

The new Myopia Master can replace your standard ARK so that not another spot is needed in the crowded examination room.”

Myopia is a growing concern worldwide. The Brien Holden Vision Institute has predicted that 50% of individuals will be affected by myopia by 2050. Myopia may increase risk of severe eye disease, such as retinal detachment or cataract, and possibly blindness.

According to the American Academy of Ophthalmology, the number of Americans who are nearsighted has nearly doubled over the last 50 years to about 41.6 percent.

This is a trend that is seen around the world, but particularly in East and Southeast Asia, where 80 to 90 percent of children and young adults are myopic.

OCULUS’s Myopia Master combines three key factors in a single quick, contactless and accurate measurement, aiding in earlier detection and efficient management of myopia.