The LASIK Report on LASIK complications and the risks of LASIK
clara...@gmail.com
THE LASIK REPORT
A Call for the Discontinuation of a Harmful Procedure
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 the
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.
Ace
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http://www.lasikflap.com/forum/viewtopic.php?t=863
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
glasses 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
glasses. LASIK increases the need for reading glasses 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 glasses 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 glasses 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 report 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% reported 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 report, 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, pressures 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 support 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 reports
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 report 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.
References
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19. Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision
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Nov-Dec;47(6):533-46.
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29. Kohnen T, Buhren J, Kuhne C, Mirshahi A. Wavefront-guided LASIK
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35. Biser SA, Bloom AH, Donnenfeld ED, Perry HD, Solomon R, Doshi S.
Flap folds after femtosecond LASIK. Eye Contact Lens. 2003
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36. Chung SH, Roh MI, Park MS, Kong YT, Lee HK, Kim EK. Mycobacterium
abscessus keratitis after LASIK with IntraLase femtosecond laser.
Ophthalmologica. 2006;220(4):277-80.
37. Kim JY, Kim MJ, Kim TI, Choi HJ, Pak JH, Tchah H. A femtosecond
laser creates a stronger flap than a mechanical microkeratome. Invest
Ophthalmol Vis Sci. 2006 Feb;47(2):599-604.
38. Ratkay-Traub I, Ferincz IE, Juhasz T, Kurtz RM, Krueger RR. First
clinical results with the femtosecond neodynium-glass laser in
refractive surgery. J Refract Surg. 2003 Mar-Apr;19(2):94-103.
39. Principe AH, Lin DY, Small KW, Aldave AJ. Macular hemorrhage after
laser in situ keratomileusis (LASIK) with femtosecond laser flap
creation. Am J Ophthalmol. 2004 Oct;138(4):657-9.
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bubbles after corneal flap creation with a femtosecond laser. J
Cataract Refract Surg. 2005 Nov;31(11):2227-9.
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LASIK Complications:
Aniseikonia (difference in image size between the two eyes)
Anisometropia
Aquarium Vision
Arcing
BCVA (loss of)
Blindness
Branch Retinal Vein Occlusion
Cataract Formation
Central Islands
Central Toxic Keratopathy
Contrast Sensitivity Loss
Corneal Abrasions
Corneal Necrosis
Corneal Perforation
Corneal Scars
Corneal Thinning
Corneal Ulcers
Decompensated Strabismus (Possibly)
Depth Perception (loss of)
Diffuse Lamellar Keratitis (DLK, Sands of Sahara)
Double vision
Drooping eyelid
Dry Eyes
Ectasia
Edema
Endothelial Cell Loss
Epithelial Ingrowth
Epithelial Sloughing
Flap Buttonhole
Flap Decentered
Flap dislocation, traumatic
Flap Unfolding
Flap Melt
Flap Striae and Wrinkles
Flap Subluxation
Fluctuating Vision
GASH
Ghosting
Glare
Haloes
Haze
Headache
Hyperopic Shift
Induced Aberrations
Induced Astigmatism
Infectious Keratitis
Interface Debris
Interface Keratitis (infectious and non-infectious, early and late
onset)
Irregular Astigmatism
Irregular Wound Healing
Light intolerance
Microperforations
Monocular Diplopia
Muscle Spasms
Nerve Fiber Damage and/or Thinning
Night Vision Loss
Nocturnal glare
Optic Nerve Infarction
Optic Nerve Neuropathy
Overcorrection
Pain (persistent)
Palebral fissures (expanding induced),
Photophobia (undesirable visual sensations produced by bright lights)
Progressive Hyperopia
Psychological Problems (induced or exacerbated)
Ptosis (droopy eyelid)
Quality of Life (loss of)
Reading Problems
Recurrent Erosion
Regression (both naturally occuring and induced via hypoxia)
Retinal breaks/tears/macular holes
Retinal Detachment
Scarring
Starbursts
Steroid Induced Glaucoma
Syneresis
Trigeminal Neuralgia
Undercorrection
Uneven Pupils Sizes
Visual Field Defects
Vitreous Detachment (Floaters)*******
Future Induced Difficulties:
IOL Calculation Difficulties
Difficulty detecting Glaucoma Onset
Induced Contact Lens Intolerance
Increased susceptibility to ocular trauma (i.e., late flap,
dislocation)
serebel
The morons who posted this flapcrap can't help but try to make people
out to be fools. They think they are smarter than everyone else.
They're not.
Clarabel is yet another alias for Burch, Well we all know the retard
will swear to it.