Carl Zeiss Meditec announced U.S. Food and Drug Administration's (FDA) clearance of the retinal nerve fiber layer (RNFL) normative database for its Stratus OCT (optical coherence tomographer) diagnostic device. The FDA notice was received one day before the opening of the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) where more than 120 presentations and posters are scheduled to discuss this emerging technology.
"We are extremely pleased with the news of the FDA decision," said Dr. Michael Patella, vice president of professional affairs. "We can now provide clinicians with a guidepost to determine how a patient's retinal nerve fiber layer compares to a normal range. We believe that this is a significant step in establishing the role of the Stratus OCT as part of the standard of care in glaucoma management."
Carl Zeiss Meditec developed its normative database using a protocol reviewed and conducted in conformance with U.S FDA regulations. The company believes this is the only device in its category to follow this review process, therefore providing clinicians with a higher level of confidence in judging a patient's condition.
"When we launched the Stratus OCT early last year, we were confident that the technology offered significant clinical value for our customers. However, even we were surprised by the speed of market acceptance in the first year of sales," said Jim Taylor, president and CEO. "The immediate availability of normative data will add even more diagnostic utility, and demonstrates our commitment to continuously enhancing the capabilities of this important technology."
The Stratus OCT is the first instrument that permits doctors see direct cross-sectional images of the retina, similar to CT scans of internal organs but without the use of X-rays. Instead, the Stratus OCT uses a beam of light to rapidly scan the eye and generate an image without ever touching the patient. Studies have shown that changes in the thickness of the retinal nerve fiber layer may be an early indicator of glaucoma.
The technology behind the Stratus OCT eliminates the need to contact the eye, which improves patient comfort and allows the test to be performed in less time. And for certain conditions, like age-related macular degeneration (AMD), the Stratus OCT is able to reduce or eliminate the need for fluorescein angiography for some patients. That test requires that a florescent dye be injected into a vein, which helps make the internal structures of the eye more visible on a radiographic image. However, any injection carries inherent risks to patients and healthcare providers, and the fluorescein injection itself can lead to rare but serious complications.
Images of retinal layers are critical to assess the anatomical structure and determine whether changes have occurred that could indicate an underlying problem. Employing proprietary software, the Stratus OCT compares test results to its database of healthy subjects to determine whether the patient falls within normal ranges.