Business must be pretty bad, because he's offering a $1,000 discount for
suckers:
http://www.eyesurgeryusa.com/houston-lasik-eye-surgeon-jack-holladay.htm
Learn the truth about Dr. Jack Holladay at
http://www.google.com/search?hl=en&q=Dr.+Jack+Holladay
http://www.jackholladay.com/avoid_this_doctor.html
http://www.jackholladay.com/usaeyes_false_advertising.html
http://usaeyes.us/profiles/dr.-jack-holladay.html
http://www.lasikfraud.com/news/archives/000185.html
The LASIK Re****t - A Call for the Discontinuation of a Harmful Procedure
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 gl***** 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 re****ted 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 re****t 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 re****ted 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 re****ted 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 re****ts 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.
"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 re****ted 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 re****ted 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 re****t 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:
"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 re****ted 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
im****tant 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 im****tance 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
pu****ng
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 re****ts 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 incor****ated this im****tant
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 re****ted, the true rate of this devastating complication may
never
be known. The safest solution for patients would be to abandon LASIK
altogether. It is im****tant 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 re****ts 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. Re****ts 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.
Cataract Surgery after LASIK
Like the general population, LASIK patients will develop cataracts later
in
life. The altered corneal surface following LASIK prevents accurate
measurement of intraocular lens power for cataract surgery. This may
result
in a "refractive surprise" for LASIK patients following cataract surgery
and
exposes them to increased risk of repeat surgeries.
LASIK Results in Loss of Near Vision
Patients are routinely misinformed that they will require reading gl*****
after the age of 40 whether they have LASIK or not. Nearsighted patients
who
do not have refractive surgery actually retain the ability to see up close
naturally after the age of 40 simply by removing their gl*****. LASIK
increases the need for reading gl***** by changing the eye's focus from
near
to distance. The loss of near vision after myopic-LASIK affects many daily
activities, not just reading. LASIK patients over the age of 40 may
discover
they have simply traded one pair of gl***** for another.
VII. PATIENT SATISFACTION
LASIK success is measured by the LASIK industry as uncorrected visual
acuity
under bright illumination. Patients seeking vision correction are most
concerned with elimination of gl***** or contact lenses, and are unaware
what it means to lose visual quality. Patient surveys typically show a
high
level of satisfaction with LASIK. However, an alarming number of
'satisfied'
patients also re****t symptoms such as visual disturbances in dim light and
dry eye.
In May, 2001, results from a questionnaire completed by PRK and LASIK
patients revealed that 19.5% re****ted a worsening in functioning, 27.1% a
worsening in symptoms, 34.9% a worsening in optical problems, 33.7% a
worsening in glare, and 41.5% a worsening in driving.27
In one re****t, researchers suggest that factors such as the Hawthorne
effect
and cognitive dissonance may play a role in patient satisfaction following
LASIK.28 The Hawthorne effect favorably influences patients' survey
responses merely because patients are aware that they are enrolled in a
study. Cognitive dissonance is a change in one's attitude or beliefs to
eliminate internal conflict with negative consequences of an irreversible
action.
VIII. NEWER TECHNOLOGIES
Wavefront-guided and wavefront-optimized LASIK
Newer laser technologies were designed to reduce induction of new
aberrations and prevent night vision disturbances. As complications from
current technologies generate bad publicity, pressure to develop and
market
alternative technologies emerge. "Real" complication rates are openly
discussed, not when a procedure is popular, but rather when providers push
newer, "improved" technology. The LASIK industry and LASIK surgeons
aggressively promote new technologies as "safer and more effective",
blaming
older technologies for past complications. Although the introduction of
wavefront-LASIK was surrounded by hype, studies have shown that
wavefront-guided and wavefront-optimized LASIK actually increase, not
decrease, higher order aberrations, reducing visual quality in previously
untreated eyes.29,30 A recently published review of literature on
wavefront-guided LASIK concludes that evidence does not sup****t claims
that
wavefront outperforms conventional LASIK.31 Wavefront, like previous forms
of refractive surgery, fails to deliver on its promises.
Femtosecond laser flap creation (Intralase-LASIK)
Mechanical blade microkeratomes have been linked to flap complications and
damage to the epithelium. The femtosecond laser keratome is currently
promoted as a safer alternative. Studies have shown that the femtosecond
laser produces flaps with smaller deviations from planned thickness than
mechanical microkeratomes. However, it does not reduce most complications
associated with the LASIK procedure and has been linked to extreme light
sensitivity,32 a new complication of this technology. Femtosecond laser
flaps are more difficult to lift than flaps created with a blade, which
may
result in a higher incidence of torn flaps.
The femtosecond laser keratome currently requires longer suction on the
eye
than blade microkeratomes to create the LASIK flap. The incidence of
posterior vitreous detachment with blade microkeratomes is high, at 13%
overall and 24% for patients with high myopia.33 Increased suction ring
exposure associated with use of femtosecond lasers likely induces
posterior
vitreous detachment at even higher rates as well as other serious
complications such as retinal detachment, macular hemorrhage, retinal vein
occlusion, and optic nerve damage following LASIK.
A search of peer-reviewed literature reveals problems associated with the
femtosecond laser such as slipped flaps, interface inflammation, flap
folds,
infectious keratitis, corneal stromal inflammation, delayed wound healing,
macular hemorrhage, and gas bubbles in the anterior chamber after
surgery.34-40 The FDA medical device adverse events database
(http://www.fda.gov/cdrh/maude.html)
contains numerous re****ts involving
femtosecond laser keratomes.
IX. CONCLUSION
Patients are denied the whole truth about the negative effects of LASIK;
therefore they are unable to give informed consent. The LASIK industry has
been unresponsive to results of medical research, which should have
resulted
in a higher standard of care. Instead, LASIK surgeons have resisted
raising
the standard of care in order to maintain the potential pool of candidates
and to protect themselves from liability.
The American Medical Association endorses certain principles of medical
ethics. One principle states that: "A physician shall uphold the standards
of professionalism, be honest in all professional interactions, and strive
to re****t physicians deficient in character or competence, or engaging in
fraud or deception, to appropriate entities."
(http://www.ama-assn.org/ama/pub/category/2512.html).
The white wall of
silence called for by Dr. McDonald in 1999 violates this principle.
There has been and continues to be a pattern within the refractive surgery
industry placing patients' interests secondary to financial interests.
Medical doctors are ethically bound to put the best interests of patients
first. LASIK is an unnecessary surgical procedure that permanently damages
the eyes of every patient; therefore it is a violation of a primary
principle of medicine, "First, Do No Harm". As such, the practice of LASIK
should be discontinued.
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