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http://thelasikreport.com/TheLasikReport_Aug2006.pdf

THE LASIK REPORT
A Scientist Investigates LASIK eye surgery.

August, 2006


LASIK is one of the most commonly performed elective surgeries in the
United States today.  The public perception of LASIK is based largely
on advertising, which is intended to entice patients to have surgery
without disclosing risks, side effects and contraindications.

The perceived benefits of LASIK surgery are obvious, whereas risks and
adverse effects are not.  It is unwise to assume that a surgeon who
has a financial interest in a patient's decision to have LASIK will
provide adequate informed consent.

LASIK is irreversible and may result in long-term, debilitating
complications.  There are permanent adverse effects of LASIK in 100%
of cases, even in the absence of clinically significant
complications.  This is unacceptable in the context of an elective
surgery when safer alternatives such as glasses or contact lenses
exist.

I.  BACKGROUND

In 1998, when the first laser received FDA approval for LASIK, little
was known about complications and long-term safety of the procedure.
Early clinical trials did not thoroughly examine adverse effects of
LASIK.

Since that time, numerous medical studies have examined the risks of
LASIK.  It is now widely reported in ophthalmic medical journals that
complications such as dry eye and visual disturbances in low light are
common, and that creation of the corneal flap permanently compromises
tensile strength and biomechanical integrity of the cornea.

In 1999 during the initial boom in popularity of LASIK, Marguerite B.
McDonald, noted refractive surgeon and then-Chief Medical Editor of
EyeWorld magazine, stated in an editorial:
"We are only starting to ride the enormous growth curve of LASIK in
this country. There will be more than enough surgeries for everyone to
benefit if we keep our heads by sharing information openly and
honestly and by resisting the temptation to criticize the work of our
colleagues when we are offering a second opinion to a patient with a
suboptimal result. Who was it who said, 'When the tide comes in, all
the boats in the harbor go up?' "
Today some prominent refractive surgeons are finding superior outcomes
and better safety profiles with surface ablations such as PRK and
LASEK, which avoid creation of a corneal flap.  Yet LASIK continues to
be the most common refractive surgical procedure performed.

II.  DRY EYE

A report by the American Academy of Ophthalmology published in 2002
stated that dry eye is the most common complication of LASIK surgery.1
Refractive surgeons are aware that LASIK induces dry eye, yet patients
are not receiving full informed consent as to the etiology, chronic
nature and severity of this condition.

"My LASIK dry eye is  not a minor problem, as  downplayed by some
ophthalmologists. It's a disability.  I  estimate that I am blind
approximately 10  percent  of the time due to my eyes being  closed
because of the pain.  At the time of my surgery, I  was  told only a
small number  of patients experience a complication  from  this
procedure.  There  is substantial  evidence  that shows this crippling
side effect to be relatively common."

LASIK patient, David Shell, testifying before the FDA Ophthalmic
Devices Panel in August, 2002.

Persistent Dry Eye and Quality of Life after LASIK
Patients elect to undergo LASIK surgery with the expectation of
improved quality of life. Instead, many are living with chronic pain
from LASIK-induced dry eye.
The FDA website states that dry eyes after LASIK may be permanent
(http://www.fda.gov/cdrh/LASIK/risks.htm). Patients should be informed
that LASIK surgery severs corneal nerves that play a crucial role in
tear production, and that these nerves do not return to normal.
Inability to sense and respond to dryness may lead to ocular surface
damage.

Medical Research on the Duration and Severity of Dry Eye
Dry eye disease is a painful, chronic condition for some patients
after LASIK surgery.  In 2001, Hovanesian, Shah, and Maloney found
that 48% of LASIK patients reported symptoms of dryness at least 6
months after surgery, including soreness, sharp pain and eyelid
sticking to the eyeball.2

A Mayo Clinic study published in 2004 demonstrates that 3 years after
LASIK corneal nerves are less than 60% of preoperative densities.3

In 2006, researchers at Baylor College of Medicine reported the
incidence of dry eyes six months after LASIK at 36% overall and 41% in
eyes with superior-hinges.4  These findings were based on objective
medical tests rather than patient questionnaires, which is significant
as patients with nerve damage may not be capable of sensing dryness.

The scientific literature is replete with case reports and studies of
LASIK-induced dry eye.  This complication is widely recognized in the
industry as the most common complaint of LASIK patients, yet the
problem is downplayed in the informed consent process.  Most dry eye
therapies provide only marginally effective symptomatic relief. There
is no cure for LASIK-induced dry eye. Internet bulletin boards with
forums devoted to post-LASIK dry eye are a testament to this
widespread, debilitating condition.

III.  Night Vision Impairment


continued at
http://thelasikreport.com/TheLasikReport_Aug2006.pdf