FDA Clears Epithelial Thickness Mapping Software from Optovue

Optovue has announced that the US Food and Drug Administration (FDA) granted approval for its epithelial thickness mapping (ETM) technology for non-contact, quantitative measurement s of the epithelial and stromal layers of the cornea.

It is the first approval of a product for this indication, according to Optovue. The ETM is also now available on Optovue’s Avanti Widefield optical coherence tomography (OCT) system. The ETM was previously cleared on the company’s iVue system in 2017.

“ETM will help me better diagnose, treat and follow my patients with dry eyes, keratoconus, and fluctuating vision post-refractive surgery,” said Mihir Parikh, MD, the chief surgeon at NVISION Eye Center in San Diego, California, and a research investigator evaluating Optovue’s ETM software for the past 18 months, in a statement. “The epithelial mapping on Optovue’s OCT can be routinely integrated into the consultation workflow. The technicians can easily acquire the data and the doctors can effectively educate patients about their conditions and adjust treatment protocols to optimize outcomes.”

Corneal epithelial thickness is used, not only as a vital measurement in the management of patients with progressive eye disease and ocular surface disorders but also in the assessment of patients for refractive surgery and post-operative recovery.

The ETM is used in a simple examination compared to the high-frequency digital ultrasound and saline measurements. It also complements other diagnostic tests by providing unique information about ocular health that may be clinically valuable prior to topography-guided procedures including LASIK and PRK.

“Optovue’s ETM software is already changing the way physicians assess the cornea,” Qienyuan Zhou, PhD, the vice president of clinical affairs at Optovue, said. “With the new clearance, it may very well become an integral part of anterior segment eye exams in daily clinical practice. Expanding the ETM map to nine millimeters provides physicians with a critically enlarged scan area for the evaluation of various corneal conditions and diseases. We are determined to offer continued innovation in OCT imaging for anterior segment applications, thereby delivering improved care for patients.”

In clinical trials, the ETM system identified patients with all stages of keratoconus that had disruptions of the epithelial layer, as well as patients with dry eye disease that had irregularities in the epithelial layer.

Additionally, Optovue noted that pre-surgical assessment with ETM could help to pinpoint patients that are appropriate for refractive procedures. It can also provide pertinent information about the healing process of the eye post-surgery.