Optometrists and other experts sponsor workshop to investigate increase in Acanthamoeba keratitis and to develop new testing methods to improve contact lens care products and protect against infections
ST. LOUIS, Jan. 26 /PRNewswire/ -- In an effort to increase the safety and effectiveness of contact lenses and lens care products for consumers, doctors of optometry from the American Optometric Association (AOA) co-sponsored a workshop last week with the U.S. Food and Drug Administration's Center for Devices and Radiological Health (FDA/CDRH) and other ophthalmic leaders. During the two-day public event, industry leaders discussed test method parameters for evaluating the effectiveness of contact lens care products to protect against infections from the Acanthamoeba parasite, which is common to water and soil.
Current FDA testing fails to include the Acanthamoeba parasite as part of its standard testing process, despite numerous Acanthamoeba and Fusarium keratitis incidences among lens wearers in late 2006 and 2007. To help protect consumers from infections and other complications, the AOA and others leaders in the vision community have been urging the agency to expand current testing practices to include the harmful parasite. Participants also discussed improving microbiological test methods to better simulate "real world" consumer use conditions, including patient non-compliance.
"Our participation in this important workshop indicates that we strongly support the FDA in making changes to help protect the sight of Americans," said William Benjamin, O.D., and member of the AOA's Commission on Ophthalmic Standards. "We encouraged the FDA to require products be tested under more realistic conditions, when feasible, and in situations where lens wearers are not compliant with a doctor's instructions."
During the workshop, participants reached consensus on testing parameters and new criteria for disinfection efficacy test methods. Specifically, the working group found agreement on the particular Acanthamoeba parasite species and strains to test as well as an acceptable threshold for disinfection efficacy. The FDA has announced that it will release the results of the workshop on the FDA Center for Devices and Radiological Health Web site. In addition, doctors of optometry and other participants are committed to continue working with agency officials to further develop the new standards and implement needed changes to better protect contact lens patients.
In addition to the AOA and the FDA, workshop participants included representatives from the American Academy of Ophthalmology (AAO), the American Academy of Optometry (AAO), and the Contact Lens Association of Ophthalmologists (CLAO). AOA representatives Dr. William Benjamin and Dr. Christine Sindt emphasized the importance of stricter standards for contact lens solutions, including changes in current no-rub policies, pre-market testing of products, and changes in labeling of products.
The FDA regulates contact lenses and lens care products as medical devices, a classification that requires the lens and product makers to obtain the agency's approval before marketing and sales.
"Contact lenses are among the safest forms of vision correction; however, it's important to remember that contact lenses are medical devices," said Mary Beth Rhomberg, O.D. "Patients can and should take an active role in protecting themselves from eye infections by carefully following their optometrist's instructions regarding care of contact lenses."
According to the AOA, proper lens hygiene and compliance includes using fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Additionally, most solutions are approved for use without rubbing; however, optometrists are recommending that patients rub their lenses to enhance cleaning for additional safety.
Since more than 80 percent of all contact lens wearers go to an optometrist for their eye care (according to the Contact Lens Institute), AOA doctors of optometry have taken an active role in educating patients and working with federal health officials to improve lens wear and care instructions.
"We are also asking the FDA to require an expiration date on bottles of solution. Currently, the FDA does not require a mandatory discard date after opening," said Dr. Benjamin. "The only current requirement is that the solution must have a preservative or be packaged to reduce contamination. This has been confusing for both patients and doctors."
According to the AOA, there are measures contact lens wearers can and should take to reduce their risk of infection.
Recommendations for Contact Lens Wearers from the American Optometric Association
About the American Optometric Association (AOA):
The American Optometric Association represents approximately 36,000 doctors of optometry, optometry students and paraoptometric assistants and technicians. Optometrists serve patients in nearly 6,500 communities across the country, and in 3,500 of those communities are the only eye doctors. Doctors of optometry provide two-thirds of all primary eye care in the United States.
American Optometric Association doctors of optometry are highly qualified, trained doctors on the frontline of eye and vision care who examine, diagnose, treat and manage diseases and disorders of the eye. In addition to providing eye and vision care, optometrists play a major role in a patient's overall health and well-being by detecting systemic diseases such as diabetes and hypertension.
Prior to optometry school, optometrists typically complete four years of undergraduate study, culminating in a bachelor's degree. Required undergraduate coursework for pre-optometry students is extensive and covers a wide variety of advanced health, science and mathematics. Optometry school consists of four years of post-graduate, doctoral study concentrating on both the eye and systemic health. In addition to their formal training, doctors of optometry must undergo annual continuing education to stay current on the latest standards of care. For more information, visit www.aoa.org.
Media Contacts: Matt Willette O: 703-837-1001 MWillette@aoa.org Liz Torrez O: 312-255-3036 or C: 773-580-5640 email@example.com
|SOURCE American Optometric Association|
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