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
(www.USAEyes.org). "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
www.USAEyes.org website. CRSQA
also certifies U.S. doctors who complete its patient outcome evaluation
and oversight program.
