Vista, California and Heidelberg, Germany – October 5, 2010 – Heidelberg Engineering GmbH, the leading developer of laser diagnostics for ophthalmic applications, announced today the United States Food and Drug Administration (FDA) has granted clearance for the new, SPECTRALIS® age-adjusted RNFL thickness normative database.
This FDA cleared normative database gives clinicians a tool for assessing glaucoma risk from a patient’s very first visit. Combined with unique SPECTRALIS features including FoDi™ fovea-to-disc alignment software and the new, Posterior Pole Asymmetry Analysis, the normative database increases the power of SPECTRALIS for glaucoma risk assessment and progression management.
Because of its unique TruTrack™ active eye tracking capability, the SPECTRALIS system offers image detail and measurement precision not previously available. In peer-reviewed journal articles, SPECTRALIS has been shown to offer precise measurement reproducibly which is important in glaucoma assessment.
“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, Director of Education, Duke University Eye Center. “The combination of SPECTRALIS 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 new features are a part of the SPECTRALIS Version 5.3 software, which debuted at this week’s Vision Expo West meeting and will be presented at the upcoming American Academy of Ophthalmology meeting later this month and the American Academy of Optometry meeting in November. The company plans to begin shipping the new software following these meetings.