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LASIK has a 10% "failure" rate

08 May 2003

A new study by US researchers reveals that as many as one in five LASIK patients need a second treatment.

One in ten eyes corrected with laser in situ keratomileusis (LASIK) surgery needs further treatment within a year.

That's the conclusion of a study by researchers at the New Jersey Medical School in the US (Ophthalmology 110 748). But because most only need one eye retreated, it means that about one in five patients actually undergo a second LASIK procedure.

In one of the most comprehensive retrospective studies of LASIK to date, Peter Hersh and colleagues found that patients with higher initial corrections, astigmatism and those aged over 40 had a higher risk of needing a follow-up procedure.

Although the high retreatment rate is surprising, Hersh stresses that the study does not indicate that the procedure is less safe than was thought. "Retreatment is not necessarily bad," he told Optics.org. "In fact, retreatment rates have likely increased over the years as our ability to achieve an exquisitely accurate result has improved…the safety and effectiveness of retreatments are quite good."

Hersh and colleagues studied 1306 patients who underwent surgery for short-sightedness, long-sightedness or astigmatism using equipment from the US manufacturer Alcon. The study included treatments made using the new generation of wavefront-guided excimer laser systems.

According to Hersh, the advent of wavefront-customized surgery could see more people choosing to have retreatment to further improve their vision.

Of the patients studied, 233 (18%) needed retreatment. The overall incidence of retreatment was found to be 10.5-14% of eyes in patients over the age of 40, but this fell to 5-9% for 18 to 40 year-olds.

Ron Link is the executive director of The Surgical Eyes Foundation, a support group set up for people who have had disappointing - and sometimes disastrous - experience of various corrective eye surgeries. He says that LASIK surgeons must fully inform a patient with a higher degree of risk because of their age or degree of myopia.

"This is something we have been saying for a very long time - people are not being fully appraised of their degree of risk as it applies to their own set of eyes," said Link.

Hersh agrees: "Entry criteria has a great effect on the odds of needing a retreatment. Patients should be educated regarding the results expected in their individual case - the procedure that is best for them, and the odds of complications or side effects in their individual situation."

In the US, the Federal Trade Commission (FTC) recently took action against two companies that it considered to be advertising unsubstantiated claims for LASIK. The actions, taken against The Laser Vision Insitute and LasikPlus, are the first of their kind.

LasikPlus had claimed that its procedure eliminated the risk of glare, haloing and starburst effects that many LASIK patients complain of after surgery.

Despite welcoming its moves, Link is concerned that the FTC can only take action against national chains. "It's a pragmatic position to take, but how does the local violator get addressed? I don't have an answer."

Michael Hatcher is technology editor on Opto & Laser Europe magazine.

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