01/19/2012 0 Comments

The American Academy of Ophthalmology will team with the Food and Drug Administration on a program to help ophthalmologists reduce Toxic Anterior Segment Syndrome, a rare, but potentially sight-stealing complication of cataract surgery. As a part of the FDA’s Proactive TASS Program, the AAO 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.

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 AAO-sponsored registry for Physician Quality Reporting System, a system that ophthalmologists use regularly, making reporting more convenient.

The AAO 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 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.

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