Zeiss has secured the 510(k) clearance from the US Food and Drug Administration (FDA) for epithelial thickness mapping (ETM) for CIRRUS HD-OCT, enabling more detailed assessment of refractive surgery patients.
Image: Zeiss wins FDA clearance for epithelial thickness mapping in CIRRUS HD-OCT platform. Photo: Courtesy of Free-Photos/Pixabay.
The approval expands the capabilities of its Anterior Segment Premier Module to include ETM, said Zeiss.
According to refractive specialist John Doane of Discover Vision Center in Kansas City, the epithelium is the outermost layer of the cornea and is known to actively remodel itself in response to subtle changes in corneal shape due to pathologies like early keratoconus that could be missed if using corneal topography alone.
ETM with CIRRUS HD-OCT platform is claimed to offer a detailed nine-millimeter map of epithelial thickness that enables more thorough assessment of patients before refractive surgery.
It allows monitoring cornea’s response to treatment and supports in managing patients with ocular surface disorders such as dry eye and progressive corneal diseases such as keratoconus. With ETM, patients could expect quick, non-contact exam of the eye that takes less than one second.
Carl Zeiss Meditec ophthalmic devices global president Jim Mazzo said: “The addition of this new software is another testament of our continued commitment to providing our customers innovative platforms so they can provide their patients the highest level of care.
“From early detection to post-operative evaluation, we’re here to support our customers, every step of the way.”
The company will showcase the new ETM feature at the upcoming Vision Expo East in New York to be held this month.
Last October, the company introduced Total Keratometry (TK) for IOLMaster 700 in the US. The new product offers cataract surgeons to replace assumption an about the posterior corneal surface with precise measurements. The measurements can help in improving outcomes.
The company also secured FDA approval for its ReLEx SMILE to offer myopia treatment to patients with astigmatism. SMILE uses femtosecond laser VisuMax to create a lenticule inside the cornea and access incision in a single treatment step. VisuMax laser is claimed to be better platform for advanced corneal surgery.