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30-Day Extended-Wear Contacts Await FDA Approval

April 12, 2000 (Cleveland) –The FDA is considering approval of a new breed of extended-wear contact lenses, which users would be able to wear for up to a month with less discomfort and less risk of infection than with the first-generation lenses from the early 1980s.

But will the convenience of the new 30-day lenses justify their risks? That’s the point debated in a pair of “Point-Counterpoint” articles in the March issue of Review of Ophthalmology.

In her “point” article, Penny A. Asbell, MD, argues that it does. In the accompanying “counterpoint,” William Ehlers, MD, says that although the risks of extended-wear lenses are small, simple convenience does not justify their use.

In 1981, the FDA approved lenses that could be worn for up to 30 days without removal. Studies, however, showed that some people who wore them had more eye infections, and the recommended wearing time was decreased to seven days. The cornea, the clear part of the eye on which the contact lens is placed, did not get enough oxygen when people wore these lenses overnight. That made the eye more susceptible to infections, which include everything from a simple type called conjunctivitis to more serious infections that could cause blindness.

The newer extended-wear lenses are made of very different materials, which allow more oxygen to reach the cornea. One such lens is the PureVision lens from Bausch & Lomb, which is approved for seven-day use and is under study for 30-day use, says William T. Reindel, MD, director of global professional marketing for vision care at Bausch & Lomb.

“It’s time to rethink extended-wear lenses,” Asbell tells WebMD. “Clearly this is a new era and it requires a new approach to contact lens use. For the first time, we have a soft lens that is high in oxygen permeability and therefore should provide more natural wear, while maintaining comfort and good-quality vision for the patient.” Asbell is professor of ophthalmology and director of cornea services at the Mount Sinai School of Medicine in New York.

Studies of these newer lenses show that infections are uncommon, and that the real issue is some slight drying of the eyes. Asbell argues that in light of this, the new 30-day lenses offer people a good alternative to refractive surgery to correct their vision.

Ehlers, who is in private practice in Torrington, Conn., argues that wearing these lenses overnight deprives the eyes of oxygen, which can cause the eyes to swell. Dryness, as well as infections that cause ulcers of the cornea — which have been reported to be four to 20 times greater in people using extended-wear lenses — far outweighs any benefits, he says.

Ehlers also argues that people who seek the convenience of extended-wear lenses probably won’t be happy about the more frequent visits to an eye-care specialist that these lenses require. “I believe that any wearer of 30-day lenses should visit the ophthalmologist more frequently — an idea that probably won’t appeal to patients who think themselves too busy to remove lenses daily. Refractive surgery might be a better option,” he writes.

The ideal candidates for these new lenses are people who are educated about their risks, who have normal eyes, and who produce enough tears to irrigate the eyes.

For people who want to wear extended lenses, experts say that following the recommendations about wearing, cleaning, and replacing lenses greatly reduces the chance of infection. In fact, most infections and complications in extended-wear lens users were found to be related to improper cleaning and disinfection of the lenses. In addition, the experts say, people who opt for extended-wear lenses should ‘listen’ to their eyes. If redness or irritation develops, wearers should immediately remove the lenses and consult an eye-care professional.

“People who do choose to undertake that risk have to understand it and have to be willing to use good judgment,” Ehlers tells WebMD. “They also have to be willing to be flexible if their ophthalmologist sees the red flags that their cornea is not tolerating the stress of wearing extended-wear well.”

Vital Information:

  • The FDA is considering new 30-day extended-wear contact lenses that should be an improvement over the first-generation lenses introduced in the early 1980s.
  • The new lenses allow more oxygen to reach the cornea of the eye, which is important for staving off infections.
  • Experts advise those who use extended-wear lenses to carefully follow directions for cleaning lenses, and if redness or irritation develops, remove them immediately and consult an eye doctor.

Posted by: Dr.Health

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