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British Evaluation Of LASIK Falls Short, Says Patient Advocacy

An international patient advocacy organization says the National Institute for Clinical Excellence (NICE) interventional procedure guidance report of the popular laser eye surgery LASIK released today is more likely to cause confusion than to help advise.



SACRAMENTO, Calif. Dec 15 2004, / PR FREE /  -- An international patient advocacy organization says the National Institute for Clinical Excellence (NICE) interventional procedure guidance report of the popular laser eye surgery LASIK released today is more likely to cause confusion than to help advise patients and clinicians.

"The NICE report does not give the public information they need, indicates problems where they are not necessarily a concern, ignores areas of true concern, and does not reflect the current outcomes with new advanced technology," stated Glenn Hagele, Executive Director of the California-based Council for Refractive Surgery Quality Assurance ( "NICE has really performed a disservice to those wanting to use LASIK to reduce their need for glasses or contacts."

LASIK, which is short for Laser Assisted In-situ Keratomileusis, uses a laser to reshape the cornea to reduce or eliminate the need for corrective lenses. The cornea is the clear front of the eye. Local anesthetic is put into the person's eye at the start of the procedure. A cutting instrument is used to create a flap in the cornea. The flap is folded back so that the middle section of the cornea is exposed. A laser is then used to remove a small amount of this middle section. A computer controls the amount and where tissue is removed. When the laser work is completed, the flap is folded back down into its original position. It's kept in place by natural suction until it heals. Approximately 8 million LASIK or similar laser eye surgery procedures have been performed since introduction in the late 1980s, with about 100,000 performed in the UK each year. LASIK is the most often performed elective surgery in the world.

Based upon concerns raised during the yearlong investigation culminating with the NICE report, The National Health System (NHS) has declined to provide LASIK to UK citizens. Although the NHS has declined to provide LASIK under its nationalized healthcare program, the procedure is available though private clinics throughout the UK. "It would be surprising for a federal or private health insurer to provide expensive elective surgery like LASIK. LASIK treats a problem that can normally be corrected with spectacles or contacts, which are significantly less expensive and certainly less invasive than laser eye surgery," said Hagele.

"One of the problems with the NICE report is that it does not reflect current patient outcomes," said Hagele, whose organization evaluates and certifies LASIK doctors and provides patient information though its Internet website. "They didn't include wavefront technology lasers, which take a detailed and unique fingerprint of the patient's eye and customize the laser treatment to maximize the probability of a good outcome. By not including the outcomes of wavefront-guided lasers, the NICE report was outdated before it was published."

The type and rate of complications from LASIK is an area where Hagele believes the report causes substantial confusion. "Imprecise language is used that does not provide a comprehensive answer to important questions, such is the probability of having a permanent complication. The report quotes rates of a few individual complications without giving the big picture. Our organization has evaluated many medical studies and reviewed thousands of LASIK patient outcomes. About three percent of patients have some sort of unresolved complication at the end of the normal six-month healing period, with less than one-half of one percent having a serious complication that requires extensive maintenance or invasive intervention."

Even what constitutes a complication is unclear. "The NICE report specifies incidents such as when cells get under the flap and multiply, but this cell ingrowth is a problem that can be readily resolved with no long-term negative effect by lifting the flap and removing the cells," reported Hagele. "There is a big difference between a problem that is fully resolved, and a true long-term complication.

"Refractive surgery is often more of a six-month process than a 20-minute miracle," said Hagele. "There are occasions when patients are slightly over or undercorrected and this may require enhancement surgery to fine tune the result. Some patients may have a significant improvement in vision, but not perfection, and will require glasses on occasion. Patients may experience dry eye, fluctuation in vision, or similar temporary problems. In all but a relatively small, but important, minority of cases, these issues are resolved with healing or treatment.

"If to be considered a 'success' LASIK must provide instantly perfect vision with no healing time, then somebody has unreasonable expectations. This is surgery, after all, and surgery requires time for healing."

About The Council For Refractive Surgery Quality Assurance The Council for Refractive Surgery Quality Assurance (CRSQA) is a nonprofit nongovernmental patient advocacy organization formed in 1998 to provide objective information about LASIK and similar eye surgery procedures in a patient-friendly format through its website. CRSQA also certifies U.S. doctors who complete its patient outcome evaluation and oversight program.

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