FDA clears normative database for OCT device

November 3, 2010

The FDA has cleared a new, age-adjusted retinal nerve fiber layer thickness normative database for a proprietary ocular coherence tomography (OCT) device (Spectralis, Heidelberg Engineering GmbH).

Vista, CA, and Heidelberg, Germany-The FDA has cleared a new, age-adjusted retinal nerve fiber layer thickness normative database for a proprietary ocular coherence tomography (OCT) device (Spectralis, Heidelberg Engineering GmbH), according to the company.

The database is designed to give clinicians a tool to assess glaucoma risk from a patient’s first office visit. Combined with proprietary fovea-to-disc alignment software (FoDi, Heidelberg) and new posterior pole asymmetry analysis, the database aims to increase the power of the OCT instrument for glaucoma risk assessment and progression management.

“This new technology is an important addition to our glaucoma assessment toolbox,” said Sanjay Asrani, MD, associate professor of ophthalmology, head of the Glaucoma OCT Reading Center, and director of education at the Duke University Eye Center, Durham, NC. “The combination of [the OCT device’s] precision with the new normative data and the asymmetry analysis adds to our ability to detect glaucomatous changes as well as changes over time.”

The new normative database, asymmetry analysis, and other features are a part of the instrument’s version 5.3 software. The company plans to begin shipping the new software before the end of the year.