A Pain in the Eye That's Forever 

Lasik and its failures

Page 5 of 7

Laser eye surgery was born around the time that Medicare and insurance reimbursements for cataract operations had been squeezed to a trickle. The anticipated income from the fledgling vision procedures threw the ophthalmology industry into a feeding frenzy. One industry expert familiar with the FDA approval process claims that LASIK got hustled through the system with incomplete and even suspect clinical studies. The impact of these decisions reverberates today.

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."

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