WASHINGTON AND SAN FRANCISCO – The American Academy of Ophthalmology today announced that it is partnering with the U.S. Food and Drug Administration on a program that will help ophthalmologists reduce a rare, but potentially sight-stealing complication in patients who have undergone cataract surgery. As a part of the FDA's Proactive TASS Program, an initiative created to curtail the spread of Toxic Anterior Segment Syndrome (TASS), the Academy will help to create a physician registry to track TASS occurrences. The registry, which is currently in a pilot stage, will assist the FDA in determining the cause of the condition in order to prevent future outbreaks.
TASS is a rare inflammatory condition most often associated with cataract surgery. The condition usually occurs within 48 hours after surgery on the front portion of the eye that includes the cornea, iris, lens and anterior chamber (the fluid-filled space between the lens and the cornea). TASS symptoms include blurry vision and redness resulting from swelling of the cornea and a build up of white blood cells, protein, or fibrin deposits in the anterior chamber. While many cases resolve in a few weeks without treatment, some TASS cases can develop serious complications leading to additional surgeries and vision loss.
Currently, the identification of TASS outbreaks is dependent on surgeons and surgical centers keeping detailed records of all products and equipment used during cataract surgery. However, this can be cumbersome and underreporting is suspected. The new online reporting mechanism will be housed with the Academy-sponsored registry for Physician Quality Reporting System, a system that ophthalmologists use regularly, making reporting more convenient.
The Academy, through its Hoskins Center for Quality Eye Care, is partnering with Outcome Sciences, Inc., a company that provides services and technologies focused on evaluating safety, effectiveness, and quality in healthcare, to create the registry. The Academy will serve as a consultant in the program, helping to determine the data to be collected and to recruit cataract surgeons to participate. The Academy also will be involved in the analysis of the data collected at the end of the pilot to determine if changes are needed prior to the creation of a permanent registry.
"The Academy's partnership with the FDA establishes a means for active surveillance and early detection of Toxic Anterior Segment Syndrome," said Richard L. Abbott, MD, president of the Academy. "With the number of cataract procedures significantly increasing as a result of the aging baby-boomer population, this initiative will help to ensure patient safety through the establishment of important quality of care standards through which this complication can be effectively managed."
The Academy's efforts are part of a broader FDA program that is one of the first proactive surveillance programs to monitor the multiple medical devices used in cataract surgery and to aid in early identification of a national TASS outbreak. The FDA will use the pilot to develop the permanent registry that can be used by regulatory agencies as well as clinicians. The registry will provide a better understanding of factors present in the development of adverse events and outbreaks in patients who have received intraocular lenses.
"Information gathered by the FDA's Proactive TASS Program will lead to the earlier investigation of national TASS outbreaks and determination of whether a medical device is the source of the outbreak," said Malvina Eydelman, MD, director of the Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices at the FDA's Center for Radiological Health. "The physician registry created by the Academy is a key component in our efforts to safeguard the public from a potentially harmful condition."
Cataracts affect nearly 22 million Americans age 40 and older, and by age 80 more than half of all Americans have cataracts. It is estimated that 1 in every 6 people over age 40 in the U.S. has a cataract. Over 3 million cataract surgeries are performed in the U.S. every year, a number likely to rise as the population ages.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons — Eye M.D.s — with more than 30,000 members worldwide. Eye health care is provided by the three "O's" – ophthalmologists, optometrists, and opticians. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases, infections and injuries, and perform eye surgery. For more information, visit www.aao.org. The Academy's EyeSmart® public education program works to educate the public about the importance of eye health and to empower them to preserve their healthy vision, by providing the most trusted and medically accurate information about eye diseases, conditions and injuries. Visit www.geteyesmart.org to learn more.
About the Hoskins Center for Quality Eye Care
The H. Dunbar Hoskins Jr., M.D. Center for Quality Eye Care isan evidence-based nonprofit quality-of-care and health policy research center located in San Francisco. The Hoskins Center conducts and supports clinical studies, develops patient care guidelines, establishes national data registries, and collects and analyzes data from clinical practices to improve decision making and public health policies, evaluate the value of eye care services and provide physician education to enhance access and appropriateness of eye care for the public.More information can be found at www.hoskinscenter.org.