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:
Quote:
"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.

Quote:
"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

Millions of LASIK surgeries have been performed in the United States
since its approval in 1998. Many patients now suffer from visual
impairment at night. Some of these patients, especially those with
large pupils, are unsafe to drive at night and can no longer live
normal, independent lives.

Quote:
"When I drive to work every day, fighting the DC traffic I hear lots
of great advertisements including the advertisements from the center
that did my surgery talking about 95, 98 percent, whatever the
percentage is of their patients who achieve 20/20 or 20/40 or better
vision, and they consider that a success. I am considered a success by
that criteria as well. However, in anything but extremely bright
daylight I am visually impaired by starbursts, halos, multiple ghost
images because of LASIK done on my 8-millimeter pupils...

FDA approval of devices should include not only approval within a
certain range of myopia or astigmatism or hyperopia but within a range
of pupil sizes such that any use of that device outside of that pupil
size should be considered against the FDA approval of that
device...".


LASIK patient, Mitch Ferro, testifying before the FDA Ophthalmic
Devices Panel in July, 1999.

Unfortunately the FDA turned a deaf ear on this recommendation and did
not place a pupil size limit on the approval, nor did it include large
pupils in the list of LASIK contraindications. Instead, the FDA
approved lasers for LASIK with watered-down cautionary language in the
labeling regarding large pupils. Dissemination of this labeling to
patients was mandated by the FDA but not enforced, which violated the
right to full informed consent for many patients with large pupils.

Reduced visual quality in dim light is frequently reported by LASIK
patients.1 Patients with pupils that dilate larger than the effective
optical zone of the LASIK treatment are at increased risk for
debilitating visual aberrations and loss of contrast sensitivity.5 Even
patients with normal pupil sizes are at risk, as the laser loses
efficiency on the slope of the cornea resulting in an effective optical
zone that is smaller than intended.6 Newer laser technologies attempt
to compensate by applying more laser energy in the periphery of the
ablation, but this technique removes more corneal tissue, increasing
the risk of surgically-induced keratectasia.7

In a study published in 2004, dark-adapted pupil sizes of candidates
for refractive surgery were found to range from 4.3 to 8.9 mm with a
mean diameter of 6.5 mm.8 This finding explains why many patients had
severe nighttime visual aberrations in the early days of
photorefractive keratectomy when optical zones as small as 4 mm were
used. In an attempt to overcome pupil size/optical zone mismatch, the
standard treatment zone was increased incrementally over several years.
However, even the 6.5 mm optical zone commonly used today does not
prevent aberrations in many patients with large pupils, or high
corrections and associated small effective optical zones.

Image degradation and visual aberrations in low light after LASIK were
predictable. These problems had been widely recognized and reported
with previous refractive surgeries such as radial keratotomy (RK) and
photorefractive keratectomy (PRK), and were related to pupil size.9 If
refractive power is not consistent across the entire diameter of the
pupil, visual aberrations and loss of contrast sensitivity result.
After cataract surgery or refractive lens exchange, patients also
report poor vision at night when the pupil dilates. As phakic IOLs
begin to replace LASIK for high myopia due to safety concerns, the
pattern of patients with large pupils experiencing night vision
disturbances is consistent.

Public Health Concerns following LASIK Surgery
Dr. Leo Maguire forewarned of the threat to public health posed by
impaired vision following refractive surgery.10 The following is an
excerpt from an editorial published in the March, 1994 edition of
American Journal of Ophthalmology:

Quote:
"I hope the reader will now understand how a patient may have
clinically acceptable 20/20 visual acuity in the daytime and still
suffer from clinically dangerous visual aberration at night if that
patient's visual system must cope with an altered refractive error,
increased glare, poorer contrast discrimination, and preferentially
degraded peripheral vision. People die at night in motor vehicle
accidents four times as frequently as they do during the day, and these
figures are adjusted for miles driven. Night driving presents a
hazardous visual experience to adults without aberrations. When we
discuss aberration at night we are considering a possible morbid effect
of refractive surgery."


A Brief Chronology of Scientific Literature on Night Vision Impairment
after Corneal Refractive Surgery
Factors responsible for visual impairment in low light following
refractive surgery have been discussed in articles and reported in
peer-reviewed studies for nearly two decades.

1987
"For a patient to have a zone of glare-free vision centered on the
point of fixation, the optical zone of the cornea must be larger than
the entrance pupil. The larger the optical zone, the larger the field
of glare-free vision."11

1993
"Optical zone diameters must be at least as large as the entrance
pupil diameter to preclude glare at the fovea, and larger than the
entrance pupil to preclude parafoveal glare."12

1996
"At nighttime, when the pupil dilates, rays from treated and
untreated areas of the cornea reach the retina at different foci and
produce haloes."13

1997
"Corneal modulation transfer function calculations suggest that a
significant loss of visual performance should be anticipated following
photorefractive keratectomy, the effect being the greatest for large
pupil diameters."14

1998
"...after PRK, the diameter of the entrance pupil greatly affects the
amount and character of the aberrations..."15

1999
"Changes in functional vision worsen as the target contrast
diminishes and the pupil size increases."16

2000
"The increase in ocular aberrations was significantly related with
the virtual pupil size."17

"Thus, an optical system may have no refractive error in the center
of the pupil and an increasing error in the annular zones surrounding
the pupil center. The resultant image may be sharp for small pupil
diameters but degrade as the pupil expands."18

2002
"The relation between pupil size and the optical clear zone are most
important in minimizing these disturbances in RK. In PRK and LASIK,
pupil size and the ablation diameter size and location are the major
factors involved." 19

The LASIK industry failed to take corrective action in response to
scientific evidence regarding the importance of matching the effective
optical zone to a patient's pupil size. As a result, many LASIK
patients are now permanently visually impaired in dim light.

IV. IATROGENIC KERATECTASIA

The cornea is under constant stress from normal intraocular pressure
pushing outward. The collagen bands of the cornea provide its form and
biomechanical strength. LASIK thins the cornea and severs collagen
bands, permanently weakening the cornea. This results in forward
bulging of the cornea, which may progress to a condition known as
keratectasia, characterized by loss of best corrected vision and
possible corneal failure requiring corneal transplant.

The FDA, laser manufacturers, and refractive surgeons are aware of
limits on flap thickness, ablation depth, and diameter of the optical
zone imposed by corneal biomechanics. When the FDA initially approved
lasers for LASIK, it established a minimum of 250 microns of corneal
tissue under the flap after LASIK surgery to prevent corneal
instability and progressive forward bulging. Subsequent reports in
medical literature indicate that 250 microns is not sufficient to
ensure corneal biomechanical stability.20,21 In response, some surgeons
stopped performing LASIK or raised the residual stromal thickness limit
in their practices. However, the majority of surgeons continue to
observe the 250 micron rule initially established by the FDA, even
though this limit has been shown to be insufficient.

The 250 micron rule is often violated inadvertently during surgery, as
microkeratomes that cut the LASIK flap are unpredictable and produce
flaps of varying thickness.22 For this reason, flap thickness should be
measured intraoperatively. Most surgeons have not incorporated this
important measurement into the surgical procedure prior to ablation,
which places patients with thicker flaps at increased risk.

Keratectasia may develop months or years following LASIK.23 Since most
cases are never reported, the true rate of this devastating
complication may never be known. The safest solution for patients would
be to abandon LASIK altogether. It is important to remember that LASIK
is elective surgery. There is no sound medical reason to place patients
at risk of vision loss from unnecessary surgery.

V. LIMITED HEALING OF THE CORNEA FOLLOWING LASIK

The human cornea is incapable of complete wound healing after LASIK
surgery. In 2005, researchers at Emory University found permanent
pathologic changes in all post-LASIK corneas examined, including
undulation of Bowman's layer, spatial separation of the LASIK flap from
the stromal bed, epithelial thickening over the wound margin, interface
debris, and severed and severely disordered collagen fibrils.24 The
study reveals that the healing response never completely regenerates
normal corneal stroma.

Another recent study demonstrates that the LASIK flap produces a scar
at the margin that is only 28.1% of the tensile strength of normal
corneal stroma, and the flap itself heals to only 2.4% of normal
tensile strength.25 The article reports that one author has lifted
LASIK flaps out to 11 years after initial surgery, further attesting to
long-term weakness of the LASIK interface wound. Reports of late flap
dislocations suggest that LASIK patients are vulnerable to traumatic
flap injury for life. 26

VI. OTHER COMPLICATIONS AND CONCERNS

Potential Complications
Other vision-threatening complications are seen following LASIK surgery
such as infection, retinal breaks and detachment, macular holes and
hemorrhage, optic nerve damage, diffuse lamellar keratitis, irregular
flaps, flap folds and striae, slipped flaps, epithelial defects, and
epithelial ingrowth. These and other complications may have severe,
lasting adverse effects.

Inaccurate IOP Measurement after LASIK
The changes in corneal thickness and curvature following LASIK affect
intraocular pressure measurements, resulting in falsely low readings.
LASIK patients face lifetime risk of undiagnosed high intraocular
pressure (glaucoma), a leading cause of blindness.

End part 1.