AOA partners with FDA, other groups, to provide guidance on contact lens risk

The FDA Contact Lens Microbiology Workshop was held September 12, 2014, at FDA Headquarters. From left: Speaker J. Angelo Green, Ph.D. (FDA); moderator Michael R. Dueñas, O.D. (AOA); panelist Michelle C. Callegan, Ph.D.; panelist Carol Lakkis, Ph.D.; speaker Scott Steffen, Ph.D. (FDA); speaker Mark Willcox, Ph.D.; panelist Suzi Fleiszig, O.D., Ph.D.; and speaker Ralph Stone, Ph.D.

Microbial eye infections among contact lens wearers are on the rise in the United States and other countries.

"The collaboration of various eye care organizations is necessary to provide maximum protection for our patients."

To respond to this problem, the AOA has been working with the federal government and other eye care organizations to update guidance on contact lenses as medical devices and the testing of contact lens disinfection systems.

On Sept. 12, the AOA, the U.S. Food and Drug Administration (FDA), and other eye care organizations co-sponsored a workshop at FDA headquarters in White Oak, Maryland. The goal was to examine current microbiological testing methods for contact lenses and accessories to see if updates were necessary.

Other co-sponsors included the FDA's Center for Devices and Radiological Health (CDRH), the American Academy of Optometry, the American Academy of Ophthalmology and the Contact Lens Association of Ophthalmologists. All sponsoring organizations play a major role in educating contact lens wearers.

"The collaboration of various eye care organizations is necessary to provide maximum protection for our patients. It was great to see the results of such cooperation, led by the FDA, to improve the efficacy of contact lens solutions," says Jeffrey J. Walline, O.D., Ph.D., vice chair of the Contact Lens and Cornea Section of the AOA.

At the workshop, three scientific panels focused on different aspects of microbiological testing:

  • Pathogens in contact-lens-related keratitis;
  • The role of soil as a model to mimic the human tear film in assessing disinfection efficacy; and
  • Acanthamoeba organism and host considerations and testing methods.

Keratitis cases on the rise
"Eye care providers and the public have always been aware that wearing contact lenses holds some degree of risk," says AOA's Chief Public Health Officer Michael Dueñas, O.D.

"Data suggests that the risk of corneal keratitis may actually be increasing over time. This may be due in part to elevated exposures to pathogens as a result of poor hygiene practices, the quality of available U.S. drinking water, and the imperfect sterilization of reusable contact lenses," says Dr. Dueñas, who moderated the panel on the role of soil in disinfection efficacy.

More than 27,000 cases of microbial keratitis occur in the United States each year, said one of the workshop's presenters Elmer Tu, M.D., a professor of clinical ophthalmology at the University of Illinois Eye and Ear Infirmary in Chicago. According to Dr. Tu, rates of microbial keratitis have not improved significantly over the past two decades.

At least a third of these cases involve contact lens wearers. When looking specifically at Acanthamoeba keratitis, 85 percent of cases are found among contact lens wearers.

AOA's role in lens care
"The workshop's presenters concluded that adding new dimensions of real-world testing could tweak the regulatory process to better protect the public," Dr. Dueñas says. It's anticipated that the agency will eventually issue additional guidance on contact lens disinfection efficacy evaluations.

Any revised guidance will affect ODs who provide advice to their patients on risks and how best to care for their contact lenses. The AOA plans to remain involved in this process to provide input and feedback.

September 18, 2014

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