Ecstatic surgeons who become millionaires by performing thousands of fast, painless, vision-restoring operations annually. Grateful patients eager to shell out as much as $6,000 in the hope of forever shedding their eyeglasses. Sleek surgery centers adorned with recessed lighting, buttery soft leather furniture and huge plate glass observation windows. Healthy profits that have earned one laser manufacturer a place on Fortune magazine's list of America's 100 fastest-growing companies.
This is the story of how one of medicine's most staid specialties -- ophthalmology -- is being transformed by a new laser procedure known as Lasik, the acronym for laser in situ keratomileusis.
In the Washington area, advertisements for Lasik plaster the sides of Metro buses, decorate the pages of newspapers and magazines and fill the radio airwaves during morning and afternoon drive time. For the past few months shoppers at Fair Oaks Mall in Northern Virginia have been able to pick up a slice of pizza and stroll over to the Visual Freedom Center to watch patients having surgery. Patients can buy a videotape of their procedure, which takes about 10 minutes.
In less than three years Lasik, which has not yet been approved by the Food and Drug Administration, has become one of the hottest surgeries in ophthalmology--or any other field of medicine. In 1997 about 200,000 procedures were performed; this year the total is expected to approach one million.
Among those who have recently had the surgery are actress Courtney Cox, supermodel Cindy Crawford and Atlanta Braves pitcher Greg Maddux. Two days after his July 9 surgery, Maddux pitched, proclaiming the operation a great success.
"I've never seen anything that compares with this," said Jay L. Klessman, a veteran Washington optometrist, who estimates that 200 of his patients have had Lasik. "The frenzy over this surpasses even [operations for] cataracts in their heyday. Sometimes people just see a bus ad and come in and say they want the surgery. They haven't done any research, they don't know anything about it."
No Long-Term Studies
While most people would gladly dump their glasses or contact lenses if given the choice, ophthalmologists caution that not everyone sees better after laser surgery.
Researchers have found that between 1 and 2 percent of Lasik patients experienced a deterioration in their vision that could not be corrected by wearing glasses. Some had debilitating and permanent complications--including irregular astigmatism--a warping of the cornea--or double vision.
Several months ago an advisory panel of the FDA recommended that the agency approve the use of excimer lasers for Lasik. Because the devices have been approved for another laser eye surgery, doctors legally can use the laser to perform Lasik if they decide it's in the patient's interest. But the FDA panel warned that Lasik is less predictable in patients who have high levels of nearsightedness or astigmatism. The 11-member panel also recommended that doctors tell patients with large pupils that they are more likely to experience glare and halos after surgery. What's more, the stability of postoperative vision beyond six months has not been studied, the panel noted.
Unlike cataract surgery, which restores vision to eyes marred by a cloudy lens, Lasik is an elective procedure performed on healthy eyes.
Most Lasik patients suffer from myopia, or nearsightedness, which means that their eyes can't see distant objects. Lasik also corrects farsightedness, the inability to see close objects, as well as astigmatism, a visual distortion that causes blurred vision. But the procedure does not correct presbyopia, the age-related inability of the eye to focus that causes nearly everyone to need reading glasses--or bifocals--sometime after 40.
Lasik is the latest--and most doctors believe the best--of a series of operations designed to eliminate or lessen myopia. It has numerous advantages over its predecessors, radial keratotomy (RK), in which a doctor makes wagon-wheel shaped slits in the cornea, and photorefractive keratectomy (PRK), which uses an excimer laser to vaporize the top layer of the cornea. Lasik has eclipsed these procedures because it is largely painless, recovery is fast, vision stabilizes quickly and it is easy for a doctor to do a reoperation in the first year to fine-tune results.
Using a special knife called a microkeratome, the surgeon slices a microscopically thin hinged flap in the top of the cornea and then zaps the exposed tissue with a laser for a preprogrammed number of seconds. The laser sculpts the cornea according to the correction needed. The flap is then carefully replaced; the eye's natural suction enables the flap to adhere without stitches. Some patients see well enough to drive without glasses the day after surgery.
While cataract surgery is covered by Medicare and private insurance plans, Lasik is considered cosmetic and not "medically necessary" by insurers. As a result, Lasik is financed almost entirely by patients.
For laser eye surgeons and surgery chains, which have grown exponentially in recent years, the lack of involvement by insurance companies is a boon. Patients pay for surgery up front and in cash without the hassle, discounts or red tape doctors complain are routine when dealing with managed care plans. The procedure typically takes less than 15 minutes and is usually performed in an office. Expensive monitoring equipment and anesthesia services are not necessary. The only anesthesia used is numbing eye drops and the only medical garb a patient dons is a blue paper surgical cap to keep hair away from the eye.
The simplicity of the procedure enables doctors to perform dozens of operations per day. Mark Whitten, the Washington area's busiest and best-known eye surgeon, sent out a press release last summer after he performed his 10,000th laser surgery. Roy Rubinfeld, a corneal specialist who is one of the area's most experienced laser surgeons, says he routinely performs between 60 and 100 Lasiks per week; his record is 62 procedures in a single day.
"I don't get bored," said Rubinfeld, director of training at TLC The Laser Center, the nation's largest chain of eye surgery centers, which has offices in Rockville and Tysons Corner. "I love it," added Rubinfeld, who has undergone laser eye surgery himself and recently operated on his wife. "It's not that easy to do very well, and it's a lot of fun to see the smiles on people's faces. It's a gift."
Laser eye surgery "tends to be an incredibly gratifying experience," agreed Gerald D. Horn, a Chicago ophthalmologist who is medical director of LCA Vision, a chain of surgery centers. "I can't tell you how many patients have told me their surgery was a miracle."
For Horn and the nation's 3,000 refractive surgeons--ophthalmologists who specialize in laser surgery--it also can be extremely lucrative. Optometrists who receive fees for referring patients and performing pre- and postoperative care, known as "co-management," also share in the wealth.
Surgeons are loath to discuss how much of the total fee--between $2,000 and $3,000 per eye--they collect. Financial arrangements vary, but according to David Harmon, a St. Louis analyst who tracks the refractive surgery market, $900 per eye--$1,800 per patient--is not unusual. Experienced surgeons can operate on a new patient every 10 to15 minutes.
The most prolific eye surgeons, Harmon added, often are part-owners of laser centers and as a result reap additional profits.
Busy refractive surgeons "are making literally millions of dollars," said Leo Maguire, an ophthalmologist at the Mayo Clinic in Rochester, Minn. "Some of these guys are big into retail."
Eye surgeons, angry over what they regard as unwarranted intrusion by managed care plans and Medicare's sharp reductions in fees for cataract surgery, say they earn their hefty fees. "The whole managed care world was really frustrating," said Horn, who practices in suburban Chicago. "This is a breath of fresh air. It's partly monetary, but we also feel like we're doing something we were trained to do."
Medicine and Marketing
Some laser surgeons, Maguire included, worry that the marriage of medicine and marketing has fostered a disturbing casualness on the part of doctors and patients.
"It's critical that patients understand that this is surgery, that they be fully informed and comfortable with the patient-doctor relationship," said Rajesh K. Rajpal of the Washington Laser Eye Center. "I do not try to convince patients that laser surgery is right for them. They have to make that decision."
But some doctors are far more aggressive about signing up patients, consumer advocates say.
"The money is so fabulous and so many people are walking away happy" that the minority of patients who have poor results tend to be forgotten, said Ron Link, founder of a New York based group called Surgical Eyes, which maintains a Web site of patients unhappy with laser surgery. "I don't think Lasik is an inherently bad procedure, but I think people aren't being screened carefully enough. And if something goes wrong, there's no going back."
Maguire agrees that too often patients don't learn about the risks until after they have a bad result. He also has warned that surgeons may be creating "a refractive underclass": people who may see 20/20 on the eye chart, a crude measure of vision devised in the 19th century, but who have lost visual acuity in other, more subtle ways, such as a diminished ability to see contrast.
"I've done [Lasik] on neurosurgeons and on cardiac surgeons, but I tell them ahead of time, just like I tell a baseball player: Your job has extremely high visual acuity needs and you have to think long and hard whether you're willing to take the small but real risk" of a bad or mediocre result, Maguire said.
Some unhappy patients say the laser juggernaut is being fueled by aggressive promotional campaigns waged by laser manufacturers, including VISX of Santa Clara, Calif., the industry leader and the company cited by Fortune magazine.
On its Web site, VISX--which receives $250 for every procedure performed using its $525,000 machine, as does Summit, its Massachusetts-based competitor--features "VISX University." Doctors who log on can learn "how to grow your laser vision correction practice." They are invited to take a quiz that asks if they offer financing plans and whether they or any staff members have had laser surgery themselves.
Jim McCollum, vice president of marketing for VISX, said he did not think that the company's promotional efforts were responsible for the popularity of Lasik. "Word of mouth is driving this much more than VISX University or any advertising," he said. "What's driving this is happy patients telling their friends, family and co-workers."
While the marketing makes Mayo's Maguire uncomfortable, he finds other aspects of Lasik troubling. Among them are the paucity of scientific studies about the procedure and the fact that no one knows how Lasik patients will fare in 10 or 20 years. Many surgeons, he pointed out, don't know their patients' results because they see them only to perform surgery, not for postoperative follow-up, which is often done by optometrists.
"One of the problems with refractive surgery is that there's no good animal model," on which innovations could be tested and problems could be addressed, Maguire noted. "That means innovation has to occur on people."
Seeing the Clock
The area's busiest laser center, TLC, is housed on the first floor of a glossy black office tower on Rockville Pike across from White Flint Mall.
One recent morning Keith Lawson, a 34-year-old producer for Black Entertainment Television, lay on a table, his head precisely positioned under a laser operated by Roy Rubinfeld.
Lawson, who had considered having eye surgery for nine years, was severely nearsighted and had thin corneas, two conditions Rubinfeld warned might cause complications. To blunt his nervousness, Lawson had taken Xanax, an anti-anxiety drug Rubinfeld prescribes to calm patients, who are awake and must cooperate during the procedure.
Lawson's girlfriend anxiously peered through an observation window as Rubinfeld joked with the two laser technicians assigned to assist him. First he cut the flap, then peeled it back and fired the laser, its staccato bursts echoing through the room for less than a minute.
"Perfect, beautiful, perfect," Rubinfeld crooned repeatedly, as Lawson lay rigid, concentrating on not moving his eye.
Less than eight minutes after it began, surgery on both eyes was completed and Lawson blinked and sat up.
"Hey, Keith, what time is it?" Rubinfeld asked.
"9:15....oh my God," he answered, realizing he could see without glasses for the first time since the age of 8.
Ten days later, Lawson said he could see well enough to drive without glasses or contact lenses. He said his vision is still improving. Although he sees halos at night around lights, "but I saw them before, my vision was so bad. They don't bother me," Lawson said.
The best thing, he added, is being able to see the clock on the VCR in his bedroom. "A couple of times, though, I woke up in the middle of the night and panicked because I could see so well I was sure I had fallen asleep wearing contacts."
Reshaping the Cornea With Lasik
1. The eye is numbed using anesthetic drops.
2. The surgeon uses a special knife to cut a micro hinged flap in the top layer of the cornea.
3. The inner layer of the cornea is reshaped using bursts from an excimea laser.
4. The surgeon replaces the flap which adheres without stitches.
HEALTH TALK ONLINE
Got a question about laser surgery? Join us today at 2 p.m. for a discussion of this procedure on The Washington Post's Internet edition at www.washingtonpost.com. Our guest is eye specialist Roy Rubinfeld, director of training at TLC The Laser Center, which has offices in Rockville and Tysons Corner. Send in your comments and questions.
CAPTION: After treatment, some patients leave their glasses in a basket at the TLC office in Rockville.
CAPTION: Roy Rubinfeld of The Laser Center, in left photo, examines the eyes of Marco Cisneros, who is about to undergo Lasik surgery. In right photo, TLC senior technician Deborah Krempels positions patient Keith Nong in preparation for surgery.
CAPTION: Rubinfeld, in left photo, lifts back a flap of corneal tissue on Nong's eye. Nong and his wife, T.V. Nong, relax after his surgery before going home.