Ophthalmological-focused developer Optovue said today it won FDA clearance for its epithelial thickness mapping software designed for quantitative measurements of the epithelial and stromal layers of the cornea.
The Fremont, Calif.-based company touted it as the 1st and only FDA-cleared product which provides corneal epithelia and stromal measurements meant to aid in diagnosis of ocular health and diseases.
In clinical trials of epi-mapping, issues with the epithelial layer were found in patients with progressive eye disease keratoconus, in which the round cornea thins and begins to bulge in cone-like shape. Epithelial layer irregularities were also observed in dry eye disease, Optovue said.
“The measurement of corneal epithelial thickness is becoming more recognized as a vital part of assessing patients for refractive surgery and following post-operative recovery, as well as managing patients with keratoconus or dry eye disease. I use epi-mapping in my research protocols to scan patients that present with a corneal condition because any sign of an abnormality needs to be taken into consideration when performing other tests, as these tests will be influenced by epithelial irregularities. I believe epi-mapping will change the way we assess the cornea since it is a very reliable indicator of ocular surface health. This non-contact approach could easily become the standard-of-care for anterior segment eye exams because epithelial irregularities often mask stromal abnormalities,” George Asimellis of Kentucky’s University of Pikeville said in a prepared statement.
The epi-mapping software requires a non-contact exam, removing the need for high-frequency digital ultrasound and saline required by traditional epithelial measurements.
“Optovue continues to lead innovation in Optical Coherence Tomography imaging with the first non-contact technique of measuring the epithelial layer of the cornea. Our epi-mapping software has been the subject of more than 200 publications, underscoring its importance and value in the care of patients with corneal and ocular surface conditions. With epi-mapping, physicians are able to quantify epithelial thickness in patients in a manner that is suitable for daily clinical practice,” founder & CEO Jay Wei said in a press release.