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FDA Workshop on Contact Lens Care Co-Sponsored by American Academy of Ophthalmology

01/28/2009   08:51:19 AM

Two-day workshop focuses on developing guidance for contact lens care products

SAN FRANCISCO – The American Academy of Ophthalmology (Academy) was among the co-sponsors of a workshop led by the Food and Drug Administration (FDA) to develop guidance for contact lens care products. The session, called the Microbiological Testing for Contact Lens Care Products Workshop, was held on January 22 and 23 in Silver Spring, Md.

“This workshop is an important step in tightening the safety net for Americans who wear contact lenses,” said Dr. Thomas Steinemann, MD, an ophthalmologist at MetroHealth Medical Center in Cleveland and a professor of ophthalmology at Case Western Reserve University, and a clinical correspondent for the Academy. “In spite of technological advances in contact lens care products over the past 20 years, there has been little substantial improvement in reducing the rate of microbial keratitis among contact lens wearers. This workshop gave eye care professionals the opportunity to reach consensus on practical solutions to decrease that rate.”

The workshop, which was attended by nearly 100 participants from industry, government and academia addressed issues raised during a hearing of the FDA’s Ophthalmic Devices Panel in June 2008. That hearing focused on two outbreaks of contact-lens related keratitis reported by the Centers for Disease Control and Prevention in 2006 and 2007.  The 2006 outbreak was attributed to Fusarium, a fungus, while the 2007 outbreak was linked to Acanthamoeba, a protozoa.

Acanthamoeba testing poses many challenges. Among the issues discussed at the workshop was the development of standardized methodologies for evaluating the efficacy of multi-purpose solutions against Acanthamoeba. The meeting also focused on test methods designed to evaluate the efficacy of multi-purpose solutions under "real world" conditions.  The FDA will summarize proceedings from the meeting. The Academy plans to continue this collaborative effort with participants and scientists within the FDA and others to develop standardized methodologies for anti-microbial efficacy testing against Acanthamoeba and to also update current disinfection efficacy testing for bacteria and fungi. .

In addition to the FDA and the Academy, the workshop was sponsored by the Contact Lens Association of Ophthalmologists, American Optometric Association, and the American Academy of Optometry. 

For the Academy’s recently updated contact lens care guidelines, please go to www.geteyesmart.org.

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About the American Academy of Ophthalmology

AAO is the world's largest association of eye physicians and surgeons—Eye M.D.s—with more than 27,000 members worldwide.  Eye health care is provided by the three “O’s” – opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at www.aao.org

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