A Closer Look

Walk into eye surgeon Charles Manger’s office, and two things stand out. First, there’s the oversized waiting room with enough seating for a small army. And then there’s the large bin brimming with eyeglasses cast aside by patients who have come here for laser eye surgery.

Manger and his colleagues are performing about 75 laser eye surgeries a week, especially the procedure known as Lasik. And his is hardly the only Southern California doctor’s office filled with eager patients with bad eyesight.

Never before has there been an elective surgery procedure to match the Lasik phenomenon sweeping this country. With 1 million Americans expected to undergo the vision-correction procedure this year alone--that’s about 19,000 a week--Lasik has become the most popular elective surgery in the country.

But now, the Lasik boom is experiencing growing pains. Recently, dissatisfied patients have created several Internet sites to organize consumers who report debilitating complications from Lasik.

And some eye surgeons--motivated by concern for patients or worries that bad publicity will spoil a lucrative business--have begun criticizing colleagues for misleading patients by over-hyping Lasik’s benefits.

Meanwhile, federal regulators are developing new rules to govern how the excimer lasers used to perform the procedure are marketed and used.

But rather than muting the public clamor for Lasik surgery, doctors hope the attention will serve to reassure consumers that the procedure is adequately regulated and safe, some experts say.

“I think patients will be well-served to listen to the FDA,” says Dr. Stephen G. Slade, a Houston ophthalmologist who was one of the first U.S. doctors to perform Lasik surgery.

Simple Surgery That’s

Completed in Minutes

Lasik (short for laser in-situ keratomileusis) evolved from earlier refractive surgery techniques, including radial keratotomy (RK) and photorefractive keratectomy (PRK). Thanks to developments in laser technology, Lasik is, by all accounts, a great advance over the earlier vision-improvement surgeries.

In Lasik, a surgeon uses a knife called a microkeratome to cut a flap of the cornea. An excimer laser is used to reshape the cornea. Then the corneal flap is replaced. The procedure takes just a few minutes.

Doctors are using Lasik for patients with various vision problems, including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (distorted vision).

While the first Lasik procedure was performed in 1991, the surgery is still considered investigational by the Food and Drug Administration.

Most Lasik patients are taking one of two routes: They are treated by surgeons who are using the laser “off label,” which, although permissible, means that the device has not been approved for that particular use.

Or, patients are participating in clinical trials being sponsored by several U.S. manufacturers of excimer lasers in order to collect data to gain FDA approval. The excimer laser is already approved to perform PRK.

People who undergo Lasik in clinical trials must receive certain information about the procedure and are required to sign an informed consent document. Also, researchers are required to report any complications to the FDA. There are no such requirements for patients who have the procedure done in private doctors’ offices.

Experts expect the FDA to approve the excimer laser for Lasik use by year’s end. That approval is expected to include new protections for consumers. They may include:

* Recommendation regarding patients to whom the procedure is best suited. For example, it may discourage the surgery in people with severe myopia (nearsightedness) or severe astigmatism or who have large pupils or very dry eyes. Large pupils and dry eyes tend to elevate the risk of complications.

* Requirements for warning labels that state that poorer outcomes can be anticipated in patients with vision problems beyond the recommended limits; that the long-term stability (beyond six months) has not been established; and that complications such as glare and decreased night vision can occur.

* Information on the frequency of complications among thousands of patients who participated in the clinical trials.

* Requirements that manufacturers provide training for surgeons using the excimer laser for Lasik.

“The issues will become, ‘Who is the appropriate patient, and what is the risk?’ ” says Dr. Ralph A. Rosenthal, director of the FDA’s division of ophthalmic devices.

But the FDA is not expected to include in its approval certain other protections, such as barring the use of Lasik on patients who don’t meet the FDA’s recommendations or requirements that complications be reported to regulators.

To be sure, the vast majority of Lasik procedures are successful--and the patients happy. While complications are reported in only a tiny percentage of cases, they can sometimes be serious.

Blindness occurs in about one in 10,000 patients who undergo Lasik and infection in about one in 5,000 cases, according to the data collected in clinical trials.

Less severe complications occur in about 1% of cases, most experts say. These include decreased night vision; seeing halos or experiencing glare; irregular astigmatism, in which vision is distorted in one eye; and dry eyes.

Many of the complications eventually clear up on their own in weeks or months, says Slade, the Houston doctor who is medical director for the nation’s largest chain of Lasik centers: TLC, the Laser Center.

Even patients generally satisfied with the results sometimes report being bothered by glare, poor night vision and vision that fades in and out. But for most patients, those problems go away in several weeks.

Other complications--such as dry eyes--can be longer-lasting. People already prone to dry eyes tend to have a higher risk of experiencing that problem after Lasik surgery. The problem can range from a minor annoyance to the need to apply eye drops every 15 minutes throughout the day.

“The dry eye problem has really become a nuisance with Lasik,” says Dr. Charles Fritch, medical director of LaserCare Medical Center in Costa Mesa. “I think we underestimated how much of a problem it was.”

A Web Site for Surgery Victims

The complications can be a nightmare to those who experience them, says Ron Link, an ex-New York City firefighter who co-founded a Web site to inform consumers about refractive eye surgery.

Link, 40, had radial keratotomy in 1995 and was left with distorted vision and poor night vision. He started his Web site, Surgical Eyes, in May and reports a flood of responses from patients unhappy with the results of their vision-correction surgery.

“[Doctors] have a lack of appreciation for what a true complication is,” Link says. “So much of the success of these procedures, and the way they are marketed, is based on visual acuity--20/20 vision--and not visual quality. They use the Snellen Eye Chart, which was created in 1862, to measure visual acuity. Subjectively, the patient is experiencing a whole host of other issues.”

A patient with 20/20 vision but poor night vision or chronic dry eyes may be deemed a “success” by a Lasik surgeon--even though the patient himself is unhappy, Link says.

Visitors to Link’s Web site complain that they were not told of the risk of possible complications and did not get much help from their doctors when problems occurred, he says.

“People need to know this is eye surgery that can greatly improve your life, or if it doesn’t work, can devastate your life. You are taking a huge risk, however minimal,” he says.

Surgeons are aware that more work is needed to address Lasik complications, Slade says.

“Some of the complications we don’t have good fixes for,” he says. “There are lots of different treatments we’re working on for people with those problems.”

But as Lasik becomes more popular, surgeons with minimal experience are eager to attract patients and may gloss over the risks of surgery, Manger says.

“An experienced surgeon has done more than 1,000 eyes,” he says. “But 70% to 80% of doctors doing Lasik have done less than 1,000.”

Many problems could be avoided if surgeons used a rigorous patient-selection criteria, Slade adds.

“In some cases, doctors may be doing it where it’s not their patient’s best option. People are either excellent, good, OK or crummy candidates for Lasik. A patient needs to know his or her individual odds.”

Patients around age 40 and older, for example, should all be informed that correction of nearsightedness with Lasik will improve their long-range vision but will still leave most with the need for reading glasses.

“We may not always properly counsel our patients to have realistic expectations,” Slade says. “You should never say ‘you can get rid of your glasses or contacts.’ It’s much better that patients go into this with less expectations about what the surgery can provide.”

Struggling With Poor Results

Fred Taylor, a 25-year-old San Diego man who didn’t want his actual name used for this article, says he received only promises of a good outcome when he underwent Lasik in January.

“My doctor’s Web site said that if something went wrong, it could be corrected,” said the computer software engineer.

But Taylor is still struggling with poor results. In May, he underwent a second Lasik procedure on both eyes, which surgeons call “enhancement,” because his vision hadn’t improved enough to allow him to stop wearing his contact lenses. The second procedure improved the left eye but not the right eye.

He also has such a severe problem with dry eyes that he took a leave of absence from his job this summer to visit relatives in South America, where he hoped the humid climate would help.

Taylor’s experience points up another underpublicized aspect of Lasik: The need to have second or third surgeries to improve the outcome.

Opinions vary widely about how often patients must have Lasik repeated in order to obtain a satisfactory result. While some doctors (who typically do not charge extra for repeat surgeries) put the “enhancement” rate at 2% to 10%, others say that as many as 30% of patients in some clinics must repeat the procedure.

And neither the actual rates of complications nor enhancements are likely to emerge soon. Under the Medical Device Reporting Act, a federal law, only complications occurring in hospitals or surgical clinics must be reported to the government. Doctors in private offices need not report complications.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Lasik Eye Surgery

The popularity of Lasik eye surgery is soaring.

Number of cases in millions

* Estimate (estimated range of 1.5 million to 2 million)

1997: 0.2

1998: 0.75

1999: 1*

2000: 2*

Sources: Dr. Charles Fritch, LaserCare Medical Center, Times files