Extended-Wear Contact Lenses May Be Linked to Vision-Threatening Eye Infections

NEW YORK — For Lisa Franke, it began with a sore eye.

Before long she was in the hospital, enduring eye drops around the clock and periodic injections into the eye. Eventually, a surgeon had to replace the cornea, the eye’s clear outer layer.

Franke had suffered a vision-threatening infection called a corneal ulcer--an unexpected price, she believes, for having used extended-wear contact lenses.

She is not alone.

In Wisconsin, the parents of a 15-year-old boy are suing a lens manufacturer and seller for $5.3 million because a corneal ulcer destroyed part of their son’s vision. Wisconsin state regulators have ordered optometrists to dispense written warnings about the lenses, and they are considering a ban on selling them.

In Minneapolis, the University of Minnesota Hospitals recently stopped prescribing extended-wear lenses for people with healthy eyes after treating a spate of ulcers.

New concerns about use of extended-wear lenses, which can be worn continuously for as long as 30 days rather than removed nightly, are worrying some regulators, manufacturers and eye specialists.

The main problem, experts say, is that the lenses can promote corneal ulcers if they are dispensed or used improperly.

Unsanitary Habits Blamed

“Most of us feel that there really is nothing inherently bad with the lenses--it’s just the misuse of the lenses,” said Dr. Oliver Dabezies Jr., executive vice president of the Contact Lens Assn. of Ophthalmologists.

The federal Food and Drug Administration, which began approving the lenses for the general population in 1981, is reviewing scientific data to find out more about the problem. Manufacturers have prepared new lens-care instructions for wearers.

Nobody knows just how common corneal ulcers are among the users of extended-wear lenses in the nation, estimated at 3 million to 4 million people.

Although treatment stops most infections before they do permanent damage to vision, some experts believe that hundreds, perhaps a thousand people may have lost some eyesight.

“I don’t think we’re talking about an epidemic,” said Dr. James Aquavella, director of the cornea research laboratory at the University of Rochester in New York. But, he said, lens wearers should “recognize a legitimate risk.”

A recent Associated Press survey of 42 eye specialists in 32 cities found that they treated about 300 ulcer infections in the preceding year, but comprehensive figures are lacking.

Eye Ulcers More Common

“There’s an awful lot of smoke here. How much of a fire there is underneath the smoke is almost impossible to determine,” said Dr. Michael Lemp, chairman of Georgetown University’s Center for Sight.

But with the recent rise in popularity of the continuous-wear lenses, he said, “Those of us who see these problems have seen a hell of a lot more of them in the last two years.”

Corneal ulcers occur when the protective outer layer of the cornea is invaded and germs infect the tissue within. The infection can leave scars in the transparent cornea, blocking vision. One bacterium, Pseudomonas, needs only a day or two to leave a devastating scar that can require a corneal transplant.

The lenses make the cornea more susceptible to infection by reducing its oxygen supply for long periods. Dirty lenses can harbor bacteria, and lenses trap under them stagnant pools of tears that make “a wonderful place for bacteria to grow,” Lemp said.

Unchecked, an infection can also enter the eyeball and cause loss of the eye.

Contact lenses aren’t the only cause of corneal ulcers, and no one has yet proved that lens wearers run a higher risk than the general population, said Orrin Stine, chairman of the Contact Lens Institute, which represents lens manufacturers.

Many Young Wearers

The infections are “very, very rare” in users of daily-wear hard lenses. They are slightly more common among wearers of soft lenses, and more frequent--but still uncommon--among users of extended-wear soft lenses, said Dr. Perry Binder, chief of ophthalmic surgery and research at Sharp Cabrillo Hospital in San Diego.

Some extended-wear lenses are especially prescribed for use after cataract surgery, but most users are like Franke, 20, of Horicon, Wis., who says she bought them because “a lot of friends were getting them and they looked really nice without their glasses.”

“Our major concern, really, is with the young people who really do have other alternatives,” such as daily-wear contacts or glasses, said Dr. Arthur Boruchoff, cornea specialist at the Massachusetts Eye and Ear Infirmary. “We certainly have seen . . . this type of infection in this younger patient group.”

Infections associated with extended-wear contacts are showing up at eye treatment centers around the country.

Eye Hospitals’ Reports

- The Jules Stein Eye Institute at UCLA has treated about 50 ulcers associated with the lenses in the last four years, said optometrist Dr. Barry Weissman.

- Massachusetts Eye and Ear has admitted 30 to 50 cases of ulcers a year related to contact lenses, mostly extended-wear, from 1982 to 1984, said Dr. George Garcia, associate chief of ophthalmology.

- Wills Eye Hospital in Philadelphia admitted 45 cases in extended-wear users, 26 of them non-cataract patients, from July, 1983, through 1984, Dr. Peter Laibson and colleagues will reported in a professional journal.

In the AP survey, three-quarters of the 42 specialists said they had seen at least one such case in 1985. Some who handle referrals had far more.

Dr. Michael Shapiro, cornea specialist at the University of Wisconsin, reported at least 50 such cases. The Estelle Doheny Eye Foundation in Los Angeles has been seeing one or two ulcers a month in extended-wear users, said Dr. David Schanzlin, cornea specialist.

Doctors in the survey said that few ulcer patients suffered permanent vision damage. “They were caught in time,” explained Dr. Robert Weir of Dickinson, N.D., who said he treated perhaps four cases in the last year. But Dr. Frederick Brightbill, a University of Wisconsin ophthalmology professor, said that he transplanted corneas in at least half the 20 to 25 ulcer patients he treated in the last two years.

Estimates of Blindness

Nationwide, perhaps 1,000 people have lost some vision to corneal ulcers in the last two years, said Australian researcher Dr. Brien Holden.

Aquavella said he suspects that there have been a few thousand lens-related ulcer cases since 1981, and that a few hundred of those patients suffered some vision loss. Perhaps 100 of them were left legally blind in the infected eye, he said.

Holden’s work in Sweden found some vision loss in three of every 10,000 extended-wear users studied, but some experts questioned whether that figure would be valid for American conditions. Infection rates of 4% or higher have been found among post-cataract wearers, but they are at higher risk than most wearers.

In non-cataract wearers, lens manufacturer Barnes-Hind Inc. found no ulcer infections in a study on one of its lenses. Manufacturers must submit such research results when they ask the FDA to approve a product for marketing, and a recent FDA review of 14 such reports, mostly drawn from data on non-cataract wearers, found ulcers in 0.2% of 12,000 patients.

Georgetown’s Lemp, who has advised the FDA on lens approvals, said that such figures justified approving the lenses but that “in the real world,” lenses often are not dispensed with the careful selection, monitoring and instruction of patients that characterized the preliminary studies. His “very rough guesstimate” of the real-world rate of infection was 1%.

The FDA’s other trouble-spotting program, based on voluntary reports from physicians, uncovered only 32 cases of corneal ulcer in extended-wear users through November since the lenses were approved. The FDA’s Lippman acknowledges that the number is unrealistically small, but added, “we don’t know by how much.”

The FDA is reviewing those reports, manufacturer studies and scientific journals, and monitoring efforts to teach patients about proper care to see “what, if anything, FDA needs to do in addition,” said Ralph Bunge, who heads an FDA task force researching the problem.

Apart from that, available information “does not currently lead us to the conclusion that drastic, immediate action is required,” Bunge said.