Implantable Contact Lenses Are in Sight

Los Angeles Times, May 20, 2002, page S1 (Health)

Optics • A foreign study indicates they are better than laser surgery for very nearsighted people. They may be available in the U.S. in two years.

By DIANNE PARTIE LANGE

SPECIAL TO THE TIMES

Doctors have long said that implantable contact lenses could be a better way to treat extreme nearsightedness than cornea-reshaping laser surgery, which has yielded less than perfect results for some patients

Various types of implantable lenses have been used in Europe, Mexico and the Middle East for at least a decade, but the Food and Drug Administration has not yet approved their use in the U.S. The only way to get the lenses has been to take part in one of a handful of clinical trials across the country.

Eye surgeons now say the implantable lenses may be available in two years, and with potential patients facing another option in vision correction, some might wonder which works better.

Researchers in Saudi Arabia and the United Arab Emirates say they may have the answer. Their study compared, for the first time, the two techniques (one in each eye) in the same group of people.

The 61-patient study also used a traditional measure, comparing one group who received laser surgery (commonly known as Lasik), with one who received the implantable lenses. But it was the third group that set the study apart; they volunteered to have both procedures. Overall, Lasik was performed in 41 eyes, and a lens was implanted in 43 eyes. All of the patients had severe to extreme nearsightedness.

The lens used in this study, the Artisan, floats in front of the iris and is attached to the iris with two little clips.

One year after the eye surgeries, both techniques appeared to be similarly safe and effective, but those eyes corrected with the lens had better clarity and less night glare than eyes on which Lasik was done. Twenty-one percent of the eyes with the implanted lens had 20/ 20 vision, and 12% of the Lasik eyes were improved to 20/20. The results were published in the May issue of the Journal Ophthalmology.

The fact that there was less improvement in the Lasik-treated eyes didn't surprise Earnest W Kornmehl, associate professor of ophthalmology at Harvard University's medical school. People with extreme nearsightedness aren't good candidates for Lasik, he says, and for them night glare would be an expected problem.

"There's no question that the improvement [with the implanted lens] is excellent. But two years doesn't satisfy me about safety. I'd like to see five- or six-year data on the same type of lens," says Kornmehl, who is also a spokesman for the American Academy of Ophthalmology.

Researcher Alaa Mohamed EI Danasoury, director of refractive surgery services at Magrabi Eye Hospital in Jeddah, Saudi Arabia, says, "Most of our patients preferred the Artisan, even those who had the same refractive outcome [with Lasik] because they saw better with the Artisan."

One limitation of the implanted lens, he says, is that it cannot be used on people with large pupils. On the other hand, the lens can be removed if the patient isn't satisfied.

"This is an amazing study," says Robert K. Maloney, director of the Maloney-Siebel Vision Institute in Los Angeles. "The clear message is that if you are highly nearsighted, you're more likely to get perfect vision with the implanted lens than with Lasik."

Maloney is an investigator in a U.S. study using the Artisan lens in 400 eyes. "We're seeing 20/20 vision in 40% of the eyes," says Maloney. And, he points out, if the implanted lens doesn't work, it can be removed. "For low and moderate nearsightedness, Lasik is still the best procedure. But in 10 years, half of our patients will be getting this lens," he says.

For people with more moderate nearsightedness, however, laser surgery likely will remain a better choice, eye surgeons say. Although the implanted lens doesn't produce the halos or night glare that laser surgery can cause, it does carry a threat of infection. That, in turn, could lead to catastrophic vision loss.

So far there have been no reports of such problems, says Dr. Edward E. Manche of Stanford University, who also is participating in the trial of the Artisan lens, but he acknowledges that the possibility exists.

The procedure also is expected to initially cost about $3,500 per eye, compared to about $2.250 per eye for Lasik.