England had them. Canada had them. America was determined to have them and, in 1981, they arrived: extended-wear contact lenses. The best thing for eyes since Helen of Troy. They were safe, comfortable, easy. You could insert and forget them for up to a month. Hardly anyone, in all the studies conducted by the Food and Drug Administration, reported any problems.
But now, doctors nationwide are reporting problems.
The most serious threat, corneal ulcers--literally holes in the eye--can result in permanent vision impairment and, if untreated, loss of the eyeball.
Estimates on the number affected varies with the information source, ranging from .1% to 6% of the roughly 4.5 million Americans wearing the lenses. Citing the higher figure, the Wisconsin Optometry Board of Examiners recently passed an emergency rule requiring optometrists in their state to have patients sign an informed consent warning of potential hazards.
The FDA quotes the lower percentage but, according to an official memo, "The agency is worried not so much by the absolute numbers of problems reported, as by what appears to be a sharp jump in the rate of problems reported."
Not coincidentally, Wisconsin is also the scene of what may be the first contact lens lawsuit in this country. The parents of a 15-year-old in Wisconsin are suing Ipco Corp. and Bausch & Lomb for $5.3 million. They claim a Sterling Optical chain store, owned by Ipco, sold him Bausch & Lomb lenses with inadequate construction. After three weeks of wear, he developed a corneal ulcer that has required corneal transplants which may or may not save the sight of his right eye.
Other serious, but less urgent, concerns are conjunctivitis, a red irritated eye caused by an excessive number of bacteria on the eye, and corneal vascularity, a condition where an oxygen deprived cornea sends hungry blood vessels scavenging into the eye. This process takes months but, unchecked, it, too, can lead to loss of vision.
Seventeen companies produce the 37 different kinds of extended-wear lenses on the market today. According to industry sources, extended-wear have been outselling all other types of lenses for the past two years.
Increasing numbers of independent research institutes, in addition to the FDA, are investigating whether the fault lies with the lenses themselves, with eye doctors who do not examine patients properly, or with patients who do not take care of their lenses.
One thing on which most experts agree is that not everyone who wants to wear extended-wear should get them.
Bad candidates include people with weakened immune systems, recurrent eye infections, diabetes, arthritis and dry eyes. In addition, people with allergies or hay fever who are forgetful or unhygienic, and women who carelessly apply eye makeup or who take oral contraceptives, may be bad risks, experts say.
Even a patient's profession can make a difference. Sanford Feldman, a San Diego ophthalmologist who has seen some ulcerous eyes removed, says he would hesitate to prescribe lenses for a short order cook who is exposed to smoke and heat all day.
Dr. Robert S. Rosen, an Escondido ophthalmologist who has had referrals of 25 cases of ulcerous eyes in six months, adds children under 21 to that list. "We don't know the long-term effects," he says. "I turn down half the people who ask me for them. I don't want hassles."
The bottom line, when it comes to lenses, is oxygen transmission.
So far, only soft lenses have been approved for extended wear, although there are now on the market some rigid gas-permeable daily lenses which may be approved for extended-wear use by the end of the year.
Soft lenses are 1 1/2 times the size of hard lenses. Like Saran Wrap, soft lenses are thin and clear. Unlike smooth hard lenses, they are constructed of highly porous hydrogelpolymers that soak up tears laden with oxygen so the cornea can "breathe."
If the lens fits too tightly or if the pores clog up with dust or debris, the eye may be deprived of oxygen, leading to a condition called hypoxia.
Hypoxia makes the eye vulnerable to cuts. Because the lens works almost like a bandage, masking the feeling of pain, the wearer with an abrasion may think he merely has a speck of dirt under his eyelid. During sleep, the closed eye gets even less oxygen and the condition worsens. The combination of the cut and the low-oxygen environment provides fertile ground for bacterial, fungal and viral infections which can enter the eye from a number of sources including contaminated cleaning solutions or an unwashed hand inserting the lens.
If the infective agent is pseudomonas, a fungus found in ordinary tap water, the organism might eat its way into the crack, causing permanent sight impairment in a matter of hours.
Jerome Leiblein, chairman of the contact lens section of the American Optometric Assn., suggests that another reason the lenses aren't for everybody is that there is no extended-wear lens at present that meets everyone's oxygen needs.
"We don't have extended-wear lenses, we have extended-wear eyes. Certain patients, because of a low metabolic rate, are better able to sleep in them because they need less oxygen."
Because of individual variation in oxygen needs, as well as other factors--the eye's natural buildup of protein and calcium/lipid deposits--many doctors agree that advertising 30-day lenses can be misleading.
"There's no such thing as a 30-day lens," Rosen says. "In my opinion, if you wear it for more than a week you can get in trouble."
Some practitioners claim their patients can wear their lenses for months without complications. The longest case in history, though, is undoubtedly the first.
In 1887, a German prosthetic eye maker fitted a patient, who had had his lid removed, with a blown glass shell which he wore day and night for 21 years. An exam in 1908 revealed that the lens had produced no ill effects.
Experts also agree on the need for patients to understand and adhere to a good lens care regimen. That means no homemade cleaning solutions, warns Dr. Perry Binder, president of the San Diego Eye Institute and director of ophthalmic surgery and research at Sharp Cabrillo Hospital. Once opened, non-preserved saline solutions should be refrigerated and the bottle discarded after one week.
Acanthamoeba, a tiny organism against which the eye has virtually no defense, can be found in standing distilled water. Experts warn patients not to put lenses in the mouth or to clean them with saliva. Sharing someone's eye drops may lead to sharing his infection. Bausch & Lomb reminds users to be especially careful when showering, washing and swimming.
Eye care practitioners also stress the importance of a thorough disinfection process, including surfactants and enzyme cleaners to remove the eye's natural calcium/lipid and protein deposits. Some doctors insist on thermal or heat cleaning. Others, because of the way heat can discolor some lenses, recommend a hydrogen peroxide solution made especially for contact lenses. Like a sponge, lenses can absorb cleaning solutions, so it is important to watch for allergic reactions which, unchecked, can lead to secondary infections.
Also like a sponge, a lens can get brittle and old. Consequently, some practitioners say lenses should be traded in every four months while others recommend six months or even a year and a half.
Binder, who helped conduct some of the initial FDA tests for extended-wear lenses, says the reason the FDA had such good results was that doctors were required to take what is called "chair time" to explain proper procedure to patients. In addition, a strict scheduling of follow-up visits helped catch problems before they became threatening.
Many doctors interviewed say they now require a 24-hour follow-up visit for their extended-wear patients, to be followed by weekly office visits for the first month, and visits every three months for the balance of the year.
Leiblein criticizes "bargain" optical shops that tell the patient to come back if he's experiencing problems. That may be too late, Leiblein says.
Many optometrists and ophthalmologists accuse low-priced stores of being more concerned about sales than about proper patient care.
Lens prices can start as low as $69 in some commercial establishments and reach a $200-$500 range in private offices.
Some ophthalmologists say privately that the war is really between commercial (those allowed to advertise) and professional optometrists (those who don't advertise) and that it is primarily an economic one. They say because of volume sales, discount places can undercut the private practitioner's prices and possibly put him out of business.
Ophthalmologists are medical doctors trained not only to fit glasses and lenses, but to diagnose and treat eye diseases. Optometrists are graduates of optometric schools, where they learn to measure refractive errors, fit glasses and lenses and detect some eye disorders. They cannot prescribe medicine in most states, including California.
Mitchell Belensky, president of the California Society of Ophthalmic Dispensers and a veteran of discount stores, says price often does determine quality.
"If a discount house sells contacts for $99 a pair, they don't have time to spend with the patient," he says.
As an optician, Belensky is licensed to fit lenses, but chooses not to, working with glasses instead.
"We need higher standards as to who is trained to fit," he says. "They (the discount places) can take anyone off the street and teach him how to do it."
Some opticians point out that ophthalmologists and optometrists can also cut corners by hiring poorly trained assistants rather than opticians to do their actual fittings.
But Thomas Chee, a fellow of the Contact Lens Society of America, who has been fitting lenses for 23 years, says, "You cannot look at a group and say, 'These people are better than those people.' You have to look at the individual . . . his training, expertise, professionalism. . . . I and my associates spend a great deal of time and money on continuing education every year to keep abreast of changes.
"The problem is with the 'quickie fit,' the people who are selling lenses rather than fitting them. There are members of all three groups who are guilty of that practice."
The Federal Trade Commission maintains that there is no substantial difference between commercial and non-commercial establishments. They are considering a rule, called Eyeglass II, that would remove restrictions on the expansion of chain stores anywhere in the country.
Only 10 states now operate without any restrictions on the growth of chain stores.
The FTC studies did not include an examination of extended-wear contact lenses.
In Sacramento, the Pearle Bill, named for Pearle Vision Centers, the largest ophthalmological chain in the country with 1,150 outlets, is also under consideration. If passed, which may happen as early as Sept. 1, it would establish an Eyeglass II-type rule for the state of California.
Most experts agree that with new vigilance in caring for extended-wear lens patients, the incidence of corneal ulcers should drop back to the very low numbers of the initial FDA study.
But just in case, contact lens manufacturers are following a twofold research strategy. According to Binder, they are "falling all over each other to make a lens that will allow the same amount of oxygen as when the eye is open." They are experimenting with silicone and other new polymers.
At the same time, they are testing certain rigid gas permeable lenses such as the Boston Lens IV for extended use. Because hard lenses are not porous, they are more easily cleaned and some doctors think they will make users less prone to infections.