A before-and-after mock-up of problems patients experience with their night vision.    News Category: Health From the Week of Wednesday, April 23, 2003   City of Warts Forgetting How to Die Because hospitals treat death as a failure of modern medicine, Felicidad Gomez couldn't die with the dignity she deserved. 7 Days 7 Days Antiwar activists not permitted; Hey, why steal just one?; Emeryville caves, disabled roll on; And the liberators strike again. Letters Letters for the week of April 23-29, 2003 Your snotty vulgarity only makes competition welcome. Your inspired tribute to rugby is a credit to the profession.

Happy LASIK patients are ecstatic, noted Dr. Arthur Epstein in the January 2002 issue of Review of Optometry. "But unsuccessful patients exist in a permanently altered waking nightmare from which there is presently no escape," he wrote. Epstein warned that LASIK is still experimental surgery, and in hindsight could ultimately prove to be a physician-induced health crisis.

Despite voices of warning from Epstein and others, the money machine trudges onward. Last August the FDA gave unanimous premarket approval to a new wavefront-guided LASIK system. Wavefront has been hailed as the next big step, because it allows for more customized eye-reshaping. But study participants were no more satisfied with their surgeries than patients had been during earlier LASIK studies. A full 9 percent of participants evidently were dissatisfied with their Wavefront outcome, and the study found no functional improvement compared to older lasers. The one detectable benefit was that while wavefront still created problems with glare, halos, and starbursts, it created fewer of them than older lasers. But despite all the hoopla, only half of all patients found their vision as sharp after surgery as it had been before with glasses.

Nine months after that FDA panel meeting, the eye surgeons huddled for their big San Francisco conference two weeks ago. Among the offerings were symposia, papers, and workshops such as "Management of Serious Flap Complications," "PRK, LASEK, and LASIK Nightmares," and "Evolution of the Rate of Complications After LASIK: Increased Incidence of DLK and Microkeratome Debris." Newbies who wanted to know where to begin with all those cranky patients could attend "Classification of Complications in Dissatisfied Patients Seeking a Consultation After Refractive Surgery." And everyone could benefit from "Update: Malpractice Litigation and Refractive Surgery Complications: How Do You Reduce the Legal Risks?"

The handout for course ASCRS 2311, "Prevention, Recognition, and Treatment of PRK, LASIK, and LASEK Complications," was particularly chilling. Weighing in at 56 pages, its last few pages were devoted to malpractice prevention. Most damning, however, was something buried on page nineteen. There, at the bottom of a list itemizing more than a dozen complications of LASIK-induced dry eye, appeared a warning to watch for these complications: "depression" and "suicide."

When LASIK surgery doesn't work out as desired, suffering patients look high and low for solutions. Some turn to specially designed contact lenses, others to prescription eyedrops. Many turn to additional surgery. Some even must consider transplants.

Custom-fitted hard contacts are the only long-term option for many patients, even those, like Williams, who were originally motivated to undergo LASIK to end their reliance on such lenses. Specialty manufacturers work closely with optometrists to deliver a variety of rigid gas-permeable lenses that superimpose a smooth, correctly curved surface over surgically disrupted eyes. Sometimes a soft lens will help a patient after surgery, but most frequently a hard lens is required.

Fitting lenses after LASIK is a challenge, however, and not every optometrist will tackle it. UC Berkeley's Refractive Surgery Center gets a lot of these cases from other eye clinics. "I see complications from a lot of other centers where they have very aggressive treatment and the cornea had some kind of degeneration," said the center's Dr. Haririfar. In 99.9 percent of such cases, additional surgery is not recommended and hard contacts are the preferred approach.

Dry eyes are another common LASIK byproduct. "As high as 50 percent of patients who have undergone LASIK surgery complain of dry eyes of various severity," said Holly, the doc who invented the special eyedrops. Most people's dry eye improves within six months, he said, but approximately 10 percent of all patients never improve.

Eye lubrication is a key element of good eyesight -- and far more complex than a bottle of saline solution might suggest. Patients who shed tears over their LASIK predicament could be doing themselves harm, because thin tears may wash away other lubricating layers that protect the eye's surface. This dry-eye plague is good news for Eagle Vision, the Memphis firm that patented the "punctum plug," an almost-microscopic device designed to seal off tiny canals that drain the eye. Plugging those drains can help retain natural lubrication on the eye. Eagle Vision president Murray Beard pointed to an industry analyst's report stating that 43 percent of LASIK patients now use punctum plugs.

But for all too many patients, surgery begets more surgery. Dr. Robert Dotson, a member of the American Board of Eye Surgeons, figures that 5 percent to 15 percent of nearsighted LASIK patients will require "enhancements" -- the industry euphemism for additional surgeries. Farsighted patients typically need enhancements more often.

Although the majority of patients report improved vision within a day or two of their first LASIK procedure, such statistics are no comfort to Danville resident Frank Santos, who in July 2000 had surgery to fix his farsightedness and astigmatism. "Right after the operation, my eyesight was not good," said the 67-year-old, whose health is excellent apart from his vision. "The surgeon said he would have to do an enhancement, but it took a year for my eyes to settle down; they were changing every month."

When his vision did finally stabilize enough for the surgical redo, Santos' vision had improved from 20/50 to 20/40, but with a twist: He now saw double. "Seeing people with four eyes and two mouths is strange," said Santos, once the president of an agricultural chemical company and now a choral group manager.

He struggles today with hard contact lenses, his best choice for escaping double vision. "This cannot be corrected by glasses. It's not very desirable to have spent the money and not get something better," he said. "Before LASIK, I used soft lenses that you could leave in for a week if you wanted; they were easy to use and put in. These rigid lenses are hard, they're difficult to break in, you feel them in your eyes all the time. These give better vision but are more uncomfortable." He now forks over $400-plus per year for therapeutic eyedrops. Santos observed that before LASIK, a year's worth of contact lenses didn't cost him that much.

His surgeon has graciously paid for the new lenses and for second medical opinions, but currently Santos is at a stalemate. He says he's not "the suing type," and has considered an experimental third surgery. But because the retired grandfather's eyes change so often, experts advised him to wait. Plus, he has developed a case of dry eyes. When his eyelids blink, they don't properly rewet the contours of his surgically altered eyes. "Dry eyes has deteriorated my vision," said Santos, who applies lubricating eyedrops five times a day.

When Santos doesn't use contacts, though, there is one silver lining for his golf game. "LASIK improved my putting," he said. "I see two holes, one behind the other, and I can line them up and putt straighter as a result."

For a tiny fraction of unhappy patients, such as former Navy technician Brenda Ross, a corneal transplant operation is the best post-LASIK option. In that procedure, the damaged cornea of a living patient is replaced with that of a fresh cadaver. Many tiny stitches hold the replacement in place during the long healing period, and there always is a risk that the foreign tissue will be rejected. Although Ross is a potential candidate for corneal transplant, she is cautious after watching others struggle with the same end-game surgery. "A transplant just does not guarantee you 20/20, and it takes months before the cornea unclouds and a year before you get all the stitches out," she said.

She copes in the meantime with the help of a custom "piggyback" contact lens, a sandwich of a hard lens sitting on a soft contact lens. "I still get the superimposing images, starbursts, and haloes, but they're not as bad with the lens as they are without it," she said. The real challenge is home-schooling her four daughters. "If I just focus at the computer I'm okay, or if I just focus on my child's face I'm okay," Ross said, but it's the back and forth that gives her frequent "brain-strain" headaches. "My brain gets so tired trying to function. When I get to that point the simplest question is impossible to answer."

For some industry critics, the easiest solution to the LASIK problem lies in policing the advertising more rigorously. "The advertising should be cleaned up and toned down a bit," said Santos, who credits misleading advertising for drawing many patients into surgery. "I listened to all this advertising saying how easy LASIK was." The Federal Trade Commission apparently agrees. In March of this year, it ordered two of the largest LASIK corporations in the country, Laser Vision Institute and LCA Vision/LasikPlus, to stop making unsubstantiated promises. The fingered ads falsely claimed that LASIK poses less risk than glasses or contacts and that the procedure eliminates the need for any type of glasses or contacts for life. The companies, based in Cincinnati, Ohio, and Lake Worth, Florida, each face fines of $11,000 per occurrence for future offenses.

Some critics from within the industry itself have taken up the call. Dr. Lee Anderson, president of the Texas Board of Medical Examiners, would like to halt advertising come-ons such as the raffling of free LASIK procedures, although the First Amendment may tie his hands. He is most offended by strategies that he believes are better suited to selling cars than surgery. "It troubles me greatly to see my profession 'slouching toward Gomorrah,'" wrote Anderson, an ophthalmologist, in a February 2003 letter to the editor of the Fort Worth Star-Telegram. "I never thought I would see the day when physicians would lower the stature of our profession to the level of plaid sports coats and pointed-toe shoes. But, as always, let the buyer beware."

Meanwhile, angry patients resort to their own techniques. Sandy Keller, who still waits on the Medical Board of California, steals time from her bridal business to watchdog the industry and share her findings on LasikDisaster.com. Another, Brent Hanson, currently owns nine Internet domains -- including several named to mimic surgery providers -- that all redirect visitors to his activist site, LasikCourt.com. One angry engineer pays a pilot to fly a banner over busy Southern California beaches that reads "LASIK INJURED OUR EYES -- LASIKSOS.COM." Ron Link, who runs SurgicalEyes, spends every free hour attending FDA panels, soliciting cooperation from sympathetic doctors, and counseling LASIK casualties.

A variety of scientists also are looking for a solution. Dr. Gregg Russell of Atlanta is working on an "interwave scanner," an experimental diagnostic tool that will help pinpoint what's behind all those halos, starbursts, and multiple images. UC Berkeley researcher Brian Barsky has developed algorithms to simulate what an individual's eyesight would be like after LASIK. One day this strategy could allow people to get a truer picture of what they're buying into. For patients such as Ross, Williams, and Santos, this information might have been persuasive enough to scare them off the surgery in the first place.

Meanwhile, Ginsburg's new test may eventually end the industry's reliance on the antiquated Snellen eye chart. Experts and unhappy patients argue that an eye chart reveals only the lowest-level visual problems but is useless to measure higher-level ones such as glare, multiple vision, and starbursts -- the very conditions exacerbated by LASIK. "We know today that 20/20 is not a sensitive or comprehensive measure of everyday functional vision," Ginsburg said. "It tells you how well you see tiny black letters on a white background. It doesn't tell you how well you'll see faces across the street, pedestrians at night while you're driving, or anything that's low contrast, like stepping off a curb." Ginsburg's type of vision test goes into effect next month as a new standard of the American National Standards Institute and will be used in FDA clinical trials for lens devices affecting eyesight. His test already is holding new technologies to a higher standard, and could deliver better results to patients seeking surgical vision correction.

Ginsburg noted that vision problems caused by LASIK and other refractive surgeries are very idiosyncratic. "There's a lot to complain about, is what we find with some of these patients," he said. "Some have very debilitating losses in contrast, with glare and multiple images. ... One of the heartening things is when we create the reports and pictures, and patients take those home and can show those to husbands, wives, and friends and say 'This is what I'm seeing.' It's very helpful for them psychologically. It's not helpful when someone tells them their visual acuity is okay, therefore everything is okay."

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