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Check search engines for terms such as "Glenn Hagele", "USAEYES", and =
"CRSQA" There is a lot of good information that comes up in searches on =
the 1st page.
http://www.theglennhagelere****t.com
http://www.usaeyes.us=20
http://www.lasikpimp.com=20
http://www.lasikfraud.com=20
http://www.lasikdisaster.com=20
http://www.lifeafterlasik.com=20
http://www.lasik-flap.com/forum/viewforum.php?f=3D21
http://www.lasikscam.com/viewforum.php?f=3D21
http://www.jackholladay.com/avoid_this_doctor.html
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
The LASIK Re****t - A Call for the Discontinuation of a Harmful =
Procedure=20
=20
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.=20
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.=20
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.=20
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.=20
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.=20
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.=20
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.=20
"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."=20
LASIK patient, David Shell, testifying before the FDA Ophthalmic =
Devices Panel in August, 2002.=20
Persistent Dry Eye and Quality of Life after LASIK=20
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=20
(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=20
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.=20
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.=20
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.=20
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.".=20
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=20
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.=20
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.=20
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:=20
"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."=20
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=20
"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
=20
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=20
=20
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=20
=20
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=20
=20
1998
".after PRK, the diameter of the entrance pupil greatly =
affects the amount and character of the aberrations."15
=20
1999
"Changes in functional vision worsen as the target contrast =
diminishes and the pupil size increases."16=20
=20
2000
"The increase in ocular aberrations was significantly related =
with the virtual pupil size."17=20
"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=20
=20
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=20
=20
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.=20
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.=20
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.=20
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=20
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.=20
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.=20
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.=20
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=20
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.=20
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.=20
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.=20
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.=20
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.=20
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.=20
References
1. Sugar A, Rapuano CJ, Culbertson WW, Huang D, Varley GA, =
Agapitos PJ, de Luise VP, Koch DD. Laser in situ keratomileusis for =
myopia and astigmatism: Safety and efficacy. A re****t by the American =
Academy of Ophthlamology. Ophthalmology. 2002 Jan;109(1):175-87.
2. Hovanesian JA, Shah SS, Maloney RK. Symptoms of dry eye and =
recurrent erosion syndrome after refractive surgery. J Cataract Refract =
Surg. 2001 Apr;27(4):577-84.
3. Calvillo MP, McLaren JW, Hodge DO, Bourne WM. Corneal =
reinnervation after LASIK: prospective 3-year longitudinal study. Invest =
Ophthalmol Vis Sci. 2004 Nov;45(11):3991-6.
4. De Paiva CS, Chen Z, Koch DD, Hamill MB, Manuel FK, Hassan SS, =
Wilhelmus KR, Pflugfelder SC. The incidence and risk factors for =
developing dry eye after myopic LASIK. Am J Ophthalmol. 2006 Mar; =
141(3):438-45.
5. Schwiegerling J, Snyder RW. Corneal ablation patterns to =
correct for spherical aberration in photorefractive keratectomy. J =
Cataract Refract Surg. 2000 Feb;26(2):214-21.=20
6. Hersh PS, Fry K, Blaker JW. Spherical aberration after laser in =
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7. Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront =
optimized ablation profiles. Theoretical background. J Cataract Refract =
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8. Netto MV, Ambrosio R Jr, Wilson SE. Pupil size in refractive =
surgery candidates. J of Refract Surg. 2004 Jul-Aug;20(4):337-42.
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corneal aberrations 1 year after radial keratotomy or photorefractive =
keratectomy. J Refract Surg. 2002 Jan-Feb;18(1):23-9.=20
10. Maguire LJ. Keratorefractive surgery, success, and the public =
health. Am J Ophthalmol. 1994 Mar 15;117(3):394-8.
11. Uozato H, Guyton DL. Centering Corneal Surgical Procedures. =
Amer J Ophthal. 1987 Mar 15;103(3 Pt 1):264-75.=20
12. Roberts CW, Koester CJ. Optical zone diameters for =
photorefractive corneal surgery. Invest Ophthalmol Vis Sci. 1993 =
Jun;34(7):2275-81.
13. Alster Y, Loewenstein A, Baumwald T, Lip****s I, Lazar M. =
Dapiprazole for patients with night haloes after excimer keratectomy. =
Graefes Arch Clin Exp Ophthalmol. 1996 Aug;234 Suppl 1:S139-41.
14. Oliver KM, Hemenger RP, Corbett MC, O'Brart DP, Verma S, =
Marshall J, Tomlinson A. Corneal optical aberrations induced by =
photorefractive keratectomy. J Refract Surg. 1997 May-Jun;13(3):246-54.
15. Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina JP, =
Howland HC. Effect of pupillary dilation on corneal optical aberrations =
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16. Holladay JT, Dudeja DR, Chang J. Functional vision and corneal =
changes after laser in situ keratomileusis determined by contrast =
sensitivity, glare testing, and corneal topography. J Cataract Refract =
Surg. 1999 May;25(5):663-9.=20
17. Seiler T, Kaemmerer M, Mierdel P, Krinke HE. Ocular optical =
aberrations after photorefractive keratectomy for myopia and myopic =
astigmatism. Arch Ophthalmol. 2000 Jan;118(1):17-21.
18. Schwiegerling J, Snyder RW. Corneal ablation patterns to =
correct for spherical aberration in photorefractive keratectomy. J =
Cataract Refract Surg. 2000 Feb;26(2):214-21.
19. Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision =
disturbances after corneal refractive surgery. Surv Ophthalmol. 2002 =
Nov-Dec;47(6):533-46.=20
20. Miyata K, Tokunaga T, ****ahara M, Ohtani S, Nejima R, Kiuchi =
T, Kaji Y, O****ka T. R. Residual bed thickness and corneal forward ****ft =
after laser in situ keratomileusis. J Cataract Refract Surg. 2004 =
May;30(5):1067-72.
21. Pallikaris IG, Kymionis GD, Astyrakakis NI. Corneal ectasia =
induced by laser in situ keratomileusis. J Cataract Refract Surg. 2001 =
Nov;27(11):1796-802.
22. Flanagan GW, Binder PS. Precision of flap measurements for =
laser in situ keratomileusis in 4428 eyes. J Refract Surg. 2003 =
Mar-Apr;19(2):113-23.
23. Lif****z T, Levy J, Klemperer I, Levinger S. Late bilateral =
keratectasia after LASIK in a low myopic patient. J Refract Surg. 2005 =
Sep-Oct;21(5):494-6.
24. Kramer TR, Chuckpaiwong V, Dawson DG, L'Hernault N, =
Grossniklaus HE, Edelhauser HF. Pathologic findings in postmortem =
corneas after successful laser in situ keratomileusis. Cornea. 2005 =
Jan;24(1):92-102.=20
25. Schmack I, Dawson DG, McCarey BE, Waring GO 3rd, Grossniklaus =
HE, Edelhauser HF. Cohesive tensile strength of human LASIK wounds with =
histologic, ultrastructural, and clinical correlations.
J Refract Surg. 2005 Sep-Oct;21(5):433-45.
26. Cheng AC, Rao SK, Leung GY, Young AL, Lam DS. Late traumatic =
flap dislocations after LASIK.=20
J Refract Surg. 2006 May;22(5):500-4.
27. Schein OD, Vitale S, Cassard SD, Steinberg EP. Patient =
outcomes of refractive surgery. The refractive status and vision =
profile. J Cataract Refract Surg. 2001 May;27(5):665-73.
28. Garamendi E, Pesudovs K, Elliott DB. Changes in quality of =
life after laser in situ keratomileusis for myopia. J Cataract Refract =
Surg. 2005 Aug;31(8):1537-43.
29. Kohnen T, Buhren J, Kuhne C, Mirshahi A. Wavefront-guided =
LASIK with the Zyoptix 3.1 system for the correction of myopia and =
compound myopic astigmatism with 1-year followup: clinical outcome and =
change in higher order aberrations. Ophthalmology. 2004;111:2175-2185.
30. Brint SF. Higher order aberrations after LASIK for myopia with =
Alcon and Wavelight lasers: a prospective randomized trial. J Refract =
Surg. 2005 Nov-Dec;21(6):S799-803.
31. Netto MV, Dupps W Jr, Wilson SE. Wavefront-guided ablation: =
evidence for efficacy compared to traditional ablation. Am J Ophthalmol. =
2006 Feb;141(2):360-368.=20
32. Stonecipher KG, Dishler JG, Ignacio TS, Binder PS. Transient =
light sensitivity after femtosecond laser flap creation: clinical =
findings and management. J Cataract Refract Surg. 2006 Jan;32(1):91-4.=20
33. Luna JD, Artal MN, Reviglio VE, Pelizzari M, Diaz H, Juarez =
CP. Vitreoretinal alterations following laser in situ keratomileusis: =
clinical and experimental studies. Graefes Arch Clin Exp Ophthalmol. =
2001 Jul;239(6):416-23.=20
34. Binder PS. Flap dimensions created with the IntraLase FS =
laser. J Cataract Refract Surg. 2004 Jan;30(1):26-32.=20
35. Biser SA, Bloom AH, Donnenfeld ED, Perry HD, Solomon R, Do**** =
S. Flap folds after femtosecond LASIK. Eye Contact Lens. 2003 =
Oct;29(4):252-4.
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.=20
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.
40. Lif****z T, Levy J, Klemperer I, Levinger S. Anterior chamber =
gas bubbles after corneal flap creation with a femtosecond laser. J =
Cataract Refract Surg. 2005 Nov;31(11):2227-9.=20
=20
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<TD class=3Dcontentheading width=3D"100%">
<DIV><FONT face=3DArial size=3D2><STRONG>The LASIK Re****t - A Call =
for the=20
Discontinuation of a Harmful Procedure </STRONG></FONT></DIV>
<DIV> </DIV></TD>
<TD class=3Dbuttonheading align=3Dright width=3D"100%"><A =
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<TABLE class=3Dcontentpaneopen>
<TBODY>
<TR>
<TD vAlign=3Dtop colSpan=3D2>
<P align=3Dleft><FONT face=3DArial size=3D2>LASIK is one of the =
most commonly=20
performed elective surgeries in the United States today. The =
public=20
perception of LASIK is based largely on advertising, which is =
intended to=20
entice patients to have surgery without disclosing risks, side =
effects and=20
contraindications. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The perceived =
benefits of LASIK=20
surgery are obvious, whereas risks and adverse effects are not. It =
is=20
unwise to assume that a surgeon who has a financial interest in a=20
patient=92s decision to have LASIK will provide adequate informed =
consent.=20
</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>LASIK is =
irreversible and may=20
result in long-term, debilitating complications. There are =
permanent=20
adverse effects of LASIK in 100% of cases, even in the absence of=20
clinically significant complications. This is unacceptable in the =
context=20
of an elective surgery when safer alternatives such as gl***** or =
contact=20
lenses exist. </FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>I. =
BACKGROUND</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In 1998, when the =
first laser=20
received FDA approval for LASIK, little was known about =
complications and=20
long-term safety of the procedure. Early clinical trials did not=20
thoroughly examine adverse effects of LASIK. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Since that time, =
numerous medical=20
studies have examined the risks of LASIK. It is now widely =
re****ted in=20
ophthalmic medical journals that complications such as dry eye and =
visual=20
disturbances in low light are common, and that creation of the =
corneal=20
flap permanently compromises tensile strength and biomechanical =
integrity=20
of the cornea. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In 1999 during the =
initial boom=20
in popularity of LASIK, Marguerite B. McDonald, noted refractive =
surgeon=20
and then-Chief Medical Editor of EyeWorld magazine, stated in an=20
editorial:</FONT></P>
<BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>"We are only =
starting to ride=20
the enormous growth curve of LASIK in this country. There will =
be more=20
than enough surgeries for everyone to benefit if we keep our =
heads by=20
sharing information openly and honestly and by resisting the =
temptation=20
to criticize the work of our colleagues when we are offering a =
second=20
opinion to a patient with a suboptimal result. Who was it who =
said,=20
=91When the tide comes in, all the boats in the harbor go up?=92 =
"</FONT></P></BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>Today some =
prominent refractive=20
surgeons are finding superior outcomes and better safety profiles =
with=20
surface ablations such as PRK and LASEK, which avoid creation of a =
corneal=20
flap. Yet LASIK continues to be the most common refractive =
surgical=20
procedure performed. </FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>II. DRY =
EYE</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>A re****t by the =
American Academy=20
of Ophthalmology published in 2002 stated that dry eye is the most =
common=20
complication of LASIK surgery.1 Refractive surgeons are aware that =
LASIK=20
induces dry eye, yet patients are not receiving full informed =
consent as=20
to the etiology, chronic nature and severity of this condition.=20
</FONT></P>
<BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>"My LASIK dry eye =
is not a=20
minor problem, as downplayed by some ophthalmologists. It's a=20
disability. I estimate that I am blind approximately 10 percent =
of the=20
time due to my eyes being closed because of the pain. At the =
time of my=20
surgery, I was told only a small number of patients experience a =
complication from this procedure. There is substantial evidence =
that=20
shows this crippling side effect to be relatively common." =
<BR><BR>LASIK=20
patient, David Shell, testifying before the FDA Ophthalmic =
Devices Panel=20
in August, 2002. </FONT></P></BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>Persistent Dry Eye =
and Quality of=20
Life after LASIK </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Patients elect to =
undergo LASIK=20
surgery with the expectation of improved quality of life. Instead, =
many=20
are living with chronic pain from LASIK-induced dry eye. The FDA =
website=20
states that dry eyes after LASIK may be permanent </FONT></P>
<P align=3Djustify><FONT face=3DArial=20
size=3D2>(http://www.fda.gov/cdrh/LASIK/risks.htm).
Patients =
should be=20
informed that LASIK surgery severs corneal nerves that play a =
crucial role=20
in tear production, and that these nerves do not return to normal. =
Inability to sense and respond to dryness may lead to ocular =
surface=20
damage.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Medical Research on =
the Duration=20
and Severity of Dry Eye</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Dry eye disease is =
a painful,=20
chronic condition for some patients after LASIK surgery. In 2001,=20
Hovanesian, Shah, and Maloney found that 48% of LASIK patients =
re****ted=20
symptoms of dryness at least 6 months after surgery, including =
soreness,=20
sharp pain and eyelid sticking to the eyeball.2 </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>A Mayo Clinic study =
published in=20
2004 demonstrates that 3 years after LASIK corneal nerves are less =
than=20
60% of preoperative densities.3 </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In 2006, =
researchers at Baylor=20
College of Medicine re****ted the incidence of dry eyes six months =
after=20
LASIK at 36% overall and 41% in eyes with superior-hinges.4 These =
findings=20
were based on objective medical tests rather than patient =
questionnaires,=20
which is significant as patients with nerve damage may not be =
capable of=20
sensing dryness. </FONT></P>
<DIV><FONT face=3DArial size=3D2>The scientific literature is =
replete with=20
case re****ts and studies of LASIK-induced dry eye. This =
complication is=20
widely recognized in the industry as the most common complaint of =
LASIK=20
patients, yet the problem is downplayed in the informed consent =
process.=20
Most dry eye therapies provide only marginally effective =
symptomatic=20
relief. There is no cure for LASIK-induced dry eye. Internet =
bulletin=20
boards with forums devoted to post-LASIK dry eye are a testament =
to this=20
widespread, debilitating condition. </FONT>
<P align=3Dcenter><FONT face=3DArial size=3D2>III. Night Vision=20
Impairment</FONT></P></DIV>
<P align=3Djustify><FONT face=3DArial size=3D2>Millions of LASIK =
surgeries have=20
been performed in the United States since its approval in 1998. =
Many=20
patients now suffer from visual impairment at night. Some of these =
patients, especially those with large pupils, are unsafe to drive =
at night=20
and can no longer live normal, independent lives.</FONT></P>
<BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>"When I drive to =
work every=20
day, fighting the DC traffic I hear lots of great advertisements =
including the advertisements from the center that did my surgery =
talking=20
about 95, 98 percent, whatever the percentage is of their =
patients who=20
achieve 20/20 or 20/40 or better vision, and they consider that =
a=20
success. I am considered a success by that criteria as well. =
However, in=20
anything but extremely bright daylight I am visually impaired by =
starbursts, halos, multiple ghost images because of LASIK done =
on my=20
8-millimeter pupils=85 <BR><BR>FDA approval of devices should =
include not=20
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=20
device outside of that pupil size should be considered against =
the FDA=20
approval of that device=85". <BR><BR>LASIK patient, Mitch Ferro, =
testifying before the FDA Ophthalmic Devices Panel in July,=20
1999.</FONT></P></BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>Unfortunately the =
FDA turned a=20
deaf ear on this recommendation and did not place a pupil size =
limit on=20
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.=20
Dissemination of this labeling to patients was mandated by the FDA =
but not=20
enforced, which violated the right to full informed consent for =
many=20
patients with large pupils.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Reduced visual =
quality in dim=20
light is frequently re****ted by LASIK patients.1 Patients with =
pupils that=20
dilate larger than the effective optical zone of the LASIK =
treatment are=20
at increased risk for debilitating visual aberrations and loss of =
contrast=20
sensitivity.5 Even patients with normal pupil sizes are at risk, =
as the=20
laser loses efficiency on the slope of the cornea resulting in an=20
effective optical zone that is smaller than intended.6 Newer laser =
technologies attempt to compensate by applying more laser energy =
in the=20
periphery of the ablation, but this technique removes more corneal =
tissue,=20
increasing the risk of surgically-induced keratectasia.7 =
</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In a study =
published in 2004,=20
dark-adapted pupil sizes of candidates for refractive surgery were =
found=20
to range from 4.3 to 8.9 mm with a mean diameter of 6.5 mm.8 This =
finding=20
explains why many patients had severe nighttime visual aberrations =
in the=20
early days of photorefractive keratectomy when optical zones as =
small as 4=20
mm were used. In an attempt to overcome pupil size/optical zone =
mismatch,=20
the standard treatment zone was increased incrementally over =
several=20
years. However, even the 6.5 mm optical zone commonly used today =
does not=20
prevent aberrations in many patients with large pupils, or high=20
corrections and associated small effective optical zones. =
</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Image degradation =
and visual=20
aberrations in low light after LASIK were predictable. These =
problems had=20
been widely recognized and re****ted with previous refractive =
surgeries=20
such as radial keratotomy (RK) and photorefractive keratectomy =
(PRK), and=20
were related to pupil size.9 If refractive power is not consistent =
across=20
the entire diameter of the pupil, visual aberrations and loss of =
contrast=20
sensitivity result. After cataract surgery or refractive lens =
exchange,=20
patients also re****t poor vision at night when the pupil dilates. =
As=20
phakic IOLs begin to replace LASIK for high myopia due to safety =
concerns,=20
the pattern of patients with large pupils experiencing night =
vision=20
disturbances is consistent. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Public Health =
Concerns following=20
LASIK Surgery</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Dr. Leo Maguire =
forewarned of the=20
threat to public health posed by impaired vision following =
refractive=20
surgery.10 The following is an excerpt from an editorial published =
in the=20
March, 1994 edition of American Journal of Ophthalmology: =
</FONT></P>
<BLOCKQUOTE><FONT face=3DArial size=3D2>"I hope the reader will =
now=20
understand how a patient may have clinically acceptable 20/20 =
visual=20
acuity in the daytime and still suffer from clinically dangerous =
visual=20
aberration at night if that patient=92s visual system must cope =
with an=20
altered refractive error, increased glare, poorer contrast=20
discrimination, and preferentially degraded peripheral vision. =
People=20
die at night in motor vehicle accidents four times as frequently =
as they=20
do during the day, and these figures are adjusted for miles =
driven.=20
Night driving presents a hazardous visual experience to adults =
without=20
aberrations. When we discuss aberration at night we are =
considering a=20
possible morbid effect of refractive surgery." </FONT>
<P align=3Djustify><FONT face=3DArial size=3D2>A Brief =
Chronology of=20
Scientific Literature on Night Vision Impairment after Corneal=20
Refractive Surgery</FONT></P></BLOCKQUOTE>
<P align=3Djustify><FONT face=3DArial size=3D2>Factors responsible =
for visual=20
impairment in low light following refractive surgery have been =
discussed=20
in articles and re****ted in peer-reviewed studies for nearly two=20
decades.</FONT></P>
<DIV>
<TABLE cellSpacing=3D0 cellPadding=3D7 width=3D528 border=3D0>
<TBODY>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial size=3D2>1987 =
</FONT></P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"For a =
patient to have a=20
zone of glare-free vision centered on the point of fixation, =
the=20
optical zone of the cornea must be larger than the entrance =
pupil.=20
The larger the optical zone, the larger the field of =
glare-free=20
vision."11</FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>1993</FONT></P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"Optical zone =
diameters=20
must be at least as large as the entrance pupil diameter to =
preclude=20
glare at the fovea, and larger than the entrance pupil to =
preclude=20
parafoveal glare."12 </FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>1996</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"At =
nighttime, when the=20
pupil dilates, rays from treated and untreated areas of the =
cornea=20
reach the retina at different foci and produce haloes."13=20
</FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>1997</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"Corneal =
modulation=20
transfer function calculations suggest that a significant =
loss of=20
visual performance should be anticipated following =
photorefractive=20
keratectomy, the effect being the greatest for large pupil=20
diameters."14 </FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>1998</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"=85after =
PRK, the diameter=20
of the entrance pupil greatly affects the amount and =
character of=20
the aberrations=85"15</FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>1999</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"Changes in =
functional=20
vision worsen as the target contrast diminishes and the =
pupil size=20
increases."16 </FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>2000</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"The increase =
in ocular=20
aberrations was significantly related with the virtual pupil =
size."17 </FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P>
<P align=3Djustify><FONT face=3DArial size=3D2>"Thus, an =
optical system=20
may have no refractive error in the center of the pupil and =
an=20
increasing error in the annular zones surrounding the pupil =
center.=20
The resultant image may be sharp for small pupil diameters =
but=20
degrade as the pupil expands."18 </FONT></P></TD></TR>
<TR>
<TD vAlign=3Dtop width=3D"9%">
<P align=3Djustify><FONT face=3DArial =
size=3D2>2002</FONT></P>
<P align=3Djustify><FONT face=3DArial =
size=3D2></FONT> </P></TD>
<TD vAlign=3Dtop width=3D"91%">
<P align=3Djustify><FONT face=3DArial size=3D2>"The relation =
between pupil=20
size and the optical clear zone are most im****tant in =
minimizing=20
these disturbances in RK. In PRK and LASIK, pupil size and =
the=20
ablation diameter size and location are the major factors =
involved."=20
19 </FONT></P></TD></TR></TBODY></TABLE></DIV>
<DIV><FONT face=3DArial size=3D2>The LASIK industry failed to take =
corrective=20
action in response to scientific evidence regarding the im****tance =
of=20
matching the effective optical zone to a patient=92s pupil size. =
As a=20
result, many LASIK patients are now permanently visually impaired =
in dim=20
light. </FONT>
<P align=3Dcenter><FONT face=3DArial size=3D2>IV. IATROGENIC=20
KERATECTASIA</FONT></P></DIV>
<P align=3Djustify><FONT face=3DArial size=3D2>The cornea is under =
constant=20
stress from normal intraocular pressure pu****ng outward. The =
collagen=20
bands of the cornea provide its form and biomechanical strength. =
LASIK=20
thins the cornea and severs collagen bands, permanently weakening =
the=20
cornea. This results in forward bulging of the cornea, which may =
progress=20
to a condition known as keratectasia, characterized by loss of =
best=20
corrected vision and possible corneal failure requiring corneal=20
transplant.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The FDA, laser =
manufacturers, and=20
refractive surgeons are aware of limits on flap thickness, =
ablation depth,=20
and diameter of the optical zone imposed by corneal biomechanics. =
When the=20
FDA initially approved lasers for LASIK, it established a minimum =
of 250=20
microns of corneal tissue under the flap after LASIK surgery to =
prevent=20
corneal instability and progressive forward bulging. Subsequent =
re****ts in=20
medical literature indicate that 250 microns is not sufficient to =
ensure=20
corneal biomechanical stability.20,21 In response, some surgeons =
stopped=20
performing LASIK or raised the residual stromal thickness limit in =
their=20
practices. However, the majority of surgeons continue to observe =
the 250=20
micron rule initially established by the FDA, even though this =
limit has=20
been shown to be insufficient.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The 250 micron rule =
is often=20
violated inadvertently during surgery, as microkeratomes that cut =
the=20
LASIK flap are unpredictable and produce flaps of varying =
thickness.22 For=20
this reason, flap thickness should be measured intraoperatively. =
Most=20
surgeons have not incor****ated this im****tant measurement into the =
surgical procedure prior to ablation, which places patients with =
thicker=20
flaps at increased risk. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Keratectasia may =
develop months=20
or years following LASIK.23 Since most cases are never re****ted, =
the true=20
rate of this devastating complication may never be known. The =
safest=20
solution for patients would be to abandon LASIK altogether. It is=20
im****tant to remember that LASIK is elective surgery. There is no =
sound=20
medical reason to place patients at risk of vision loss from =
unnecessary=20
surgery.</FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>V. LIMITED HEALING =
OF THE CORNEA=20
FOLLOWING LASIK</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The human cornea is =
incapable of=20
complete wound healing after LASIK surgery. In 2005, researchers =
at Emory=20
University found permanent pathologic changes in all post-LASIK =
corneas=20
examined, including undulation of Bowman's layer, spatial =
separation of=20
the LASIK flap from the stromal bed, epithelial thickening over =
the wound=20
margin, interface debris, and severed and severely disordered =
collagen=20
fibrils.24 The study reveals that the healing response never =
completely=20
regenerates normal corneal stroma. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Another recent =
study demonstrates=20
that the LASIK flap produces a scar at the margin that is only =
28.1% of=20
the tensile strength of normal corneal stroma, and the flap itself =
heals=20
to only 2.4% of normal tensile strength.25 The article re****ts =
that one=20
author has lifted LASIK flaps out to 11 years after initial =
surgery,=20
further attesting to long-term weakness of the LASIK interface =
wound.=20
Re****ts of late flap dislocations suggest that LASIK patients are=20
vulnerable to traumatic flap injury for life. 26</FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>VI. OTHER =
COMPLICATIONS AND=20
CONCERNS</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Potential =
Complications=20
</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Other =
vision-threatening=20
complications are seen following LASIK surgery such as infection, =
retinal=20
breaks and detachment, macular holes and hemorrhage, optic nerve =
damage,=20
diffuse lamellar keratitis, irregular flaps, flap folds and =
striae,=20
slipped flaps, epithelial defects, and epithelial ingrowth. These =
and=20
other complications may have severe, lasting adverse =
effects.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Inaccurate IOP =
Measurement after=20
LASIK</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The changes in =
corneal thickness=20
and curvature following LASIK affect intraocular pressure =
measurements,=20
resulting in falsely low readings. LASIK patients face lifetime =
risk of=20
undiagnosed high intraocular pressure (glaucoma), a leading cause =
of=20
blindness. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Cataract Surgery =
after=20
LASIK</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Like the general =
population,=20
LASIK patients will develop cataracts later in life. The altered =
corneal=20
surface following LASIK prevents accurate measurement of =
intraocular lens=20
power for cataract surgery. This may result in a "refractive =
surprise" for=20
LASIK patients following cataract surgery and exposes them to =
increased=20
risk of repeat surgeries. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>LASIK Results in =
Loss of Near=20
Vision</FONT></P>
<P><FONT face=3DArial size=3D2>Patients are routinely misinformed =
that they=20
will require reading gl***** after the age of 40 whether they have =
LASIK=20
or not. Nearsighted patients who do not have refractive surgery =
actually=20
retain the ability to see up close naturally after the age of 40 =
simply by=20
removing their gl*****. LASIK increases the need for reading =
gl***** by=20
changing the eye=92s focus from near to distance. The loss of near =
vision=20
after myopic-LASIK affects many daily activities, not just =
reading. LASIK=20
patients over the age of 40 may discover they have simply traded =
one pair=20
of gl***** for another. </FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>VII. PATIENT=20
SATISFACTION</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>LASIK success is =
measured by the=20
LASIK industry as uncorrected visual acuity under bright =
illumination.=20
Patients seeking vision correction are most concerned with =
elimination of=20
gl***** or contact lenses, and are unaware what it means to lose =
visual=20
quality. Patient surveys typically show a high level of =
satisfaction with=20
LASIK. However, an alarming number of =91satisfied=92 patients =
also re****t=20
symptoms such as visual disturbances in dim light and dry eye. =
</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In May, 2001, =
results from a=20
questionnaire completed by PRK and LASIK patients revealed that =
19.5%=20
re****ted a worsening in functioning, 27.1% a worsening in =
symptoms, 34.9%=20
a worsening in optical problems, 33.7% a worsening in glare, and =
41.5% a=20
worsening in driving.27 </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>In one re****t, =
researchers=20
suggest that factors such as the Hawthorne effect and cognitive =
dissonance=20
may play a role in patient satisfaction following LASIK.28 The =
Hawthorne=20
effect favorably influences patients=92 survey responses merely =
because=20
patients are aware that they are enrolled in a study. Cognitive =
dissonance=20
is a change in one=92s attitude or beliefs to eliminate internal =
conflict=20
with negative consequences of an irreversible action. </FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>VIII. NEWER=20
TECHNOLOGIES</FONT></P>
<P><FONT face=3DArial size=3D2>Wavefront-guided and =
wavefront-optimized=20
LASIK</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Newer laser =
technologies were=20
designed to reduce induction of new aberrations and prevent night =
vision=20
disturbances. As complications from current technologies generate =
bad=20
publicity, pressure to develop and market alternative technologies =
emerge.=20
"Real" complication rates are openly discussed, not when a =
procedure is=20
popular, but rather when providers push newer, "improved" =
technology. The=20
LASIK industry and LASIK surgeons aggressively promote new =
technologies as=20
"safer and more effective", blaming older technologies for past=20
complications. Although the introduction of wavefront-LASIK was =
surrounded=20
by hype, studies have shown that wavefront-guided and =
wavefront-optimized=20
LASIK actually increase, not decrease, higher order aberrations, =
reducing=20
visual quality in previously untreated eyes.29,30 A recently =
published=20
review of literature on wavefront-guided LASIK concludes that =
evidence=20
does not sup****t claims that wavefront outperforms conventional =
LASIK.31=20
Wavefront, like previous forms of refractive surgery, fails to =
deliver on=20
its promises.</FONT></P>
<P><FONT face=3DArial size=3D2>Femtosecond laser flap creation=20
(Intralase-LASIK)</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Mechanical blade =
microkeratomes=20
have been linked to flap complications and damage to the =
epithelium. The=20
femtosecond laser keratome is currently promoted as a safer =
alternative.=20
Studies have shown that the femtosecond laser produces flaps with =
smaller=20
deviations from planned thickness than mechanical microkeratomes. =
However,=20
it does not reduce most complications associated with the LASIK =
procedure=20
and has been linked to extreme light sensitivity,32 a new =
complication of=20
this technology. Femtosecond laser flaps are more difficult to =
lift than=20
flaps created with a blade, which may result in a higher incidence =
of torn=20
flaps.</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The femtosecond =
laser keratome=20
currently requires longer suction on the eye than blade =
microkeratomes to=20
create the LASIK flap. The incidence of posterior vitreous =
detachment with=20
blade microkeratomes is high, at 13% overall and 24% for patients =
with=20
high myopia.33 Increased suction ring exposure associated with use =
of=20
femtosecond lasers likely induces posterior vitreous detachment at =
even=20
higher rates as well as other serious complications such as =
retinal=20
detachment, macular hemorrhage, retinal vein occlusion, and optic =
nerve=20
damage following LASIK. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>A search of =
peer-reviewed=20
literature reveals problems associated with the femtosecond laser =
such as=20
slipped flaps, interface inflammation, flap folds, infectious =
keratitis,=20
corneal stromal inflammation, delayed wound healing, macular =
hemorrhage,=20
and gas bubbles in the anterior chamber after surgery.34-40 The =
FDA=20
medical device adverse events database=20
(http://www.fda.gov/cdrh/maude.html)
contains numerous re****ts =
involving=20
femtosecond laser keratomes. </FONT></P>
<P align=3Dcenter><FONT face=3DArial size=3D2>IX. =
CONCLUSION</FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>Patients are denied =
the whole=20
truth about the negative effects of LASIK; therefore they are =
unable to=20
give informed consent. The LASIK industry has been unresponsive to =
results=20
of medical research, which should have resulted in a higher =
standard of=20
care. Instead, LASIK surgeons have resisted raising the standard =
of care=20
in order to maintain the potential pool of candidates and to =
protect=20
themselves from liability. </FONT></P>
<P align=3Djustify><FONT face=3DArial size=3D2>The American =
Medical Association=20
endorses certain principles of medical ethics. One principle =
states that:=20
"A physician shall uphold the standards of professionalism, be =
honest in=20
all professional interactions, and strive to re****t physicians =
deficient=20
in character or competence, or engaging in fraud or deception, to=20
appropriate entities."=20
(http://www.ama-assn.org/ama/pub/category/2512.html).
The white =
wall of=20
silence called for by Dr. McDonald in 1999 violates this =
principle.=20
</FONT></P>
<DIV><FONT face=3DArial size=3D2>There has been and continues to =
be a pattern=20
within the refractive surgery industry placing patients=92 =
interests=20
secondary to financial interests. Medical doctors are ethically =
bound to=20
put the best interests of patients first. LASIK is an unnecessary =
surgical=20
procedure that permanently damages the eyes of every patient; =
therefore it=20
is a violation of a primary principle of medicine, "First, Do No =
Harm". As=20
such, the practice of LASIK should be discontinued. </FONT>
<P align=3Djustify><FONT face=3DArial =
size=3D2>References</FONT></P></DIV>
<P><FONT face=3DArial size=3D2>1. Sugar A, Rapuano CJ, Culbertson =
WW, Huang D,=20
Varley GA, Agapitos PJ, de Luise VP, Koch DD. Laser in situ =
keratomileusis=20
for myopia and astigmatism: Safety and efficacy. A re****t by the =
American=20
Academy of Ophthlamology. Ophthalmology. 2002=20
Jan;109(1):175-87.</FONT></P>
<P><FONT face=3DArial size=3D2>2. Hovanesian JA, Shah SS, Maloney =
RK. Symptoms=20
of dry eye and recurrent erosion syndrome after refractive =
surgery. J=20
Cataract Refract Surg. 2001 Apr;27(4):577-84.</FONT></P>
<P><FONT face=3DArial size=3D2>3. Calvillo MP, McLaren JW, Hodge =
DO, Bourne=20
WM. Corneal reinnervation after LASIK: prospective 3-year =
longitudinal=20
study. Invest Ophthalmol Vis Sci. 2004 =
Nov;45(11):3991-6.</FONT></P>
<P><FONT face=3DArial size=3D2>4. De Paiva CS, Chen Z, Koch DD, =
Hamill MB,=20
Manuel FK, Hassan SS, Wilhelmus KR, Pflugfelder SC. The incidence =
and risk=20
factors for developing dry eye after myopic LASIK. Am J =
Ophthalmol. 2006=20
Mar; 141(3):438-45.</FONT></P>
<P><FONT face=3DArial size=3D2>5. Schwiegerling J, Snyder RW. =
Corneal ablation=20
patterns to correct for spherical aberration in photorefractive=20
keratectomy. J Cataract Refract Surg. 2000 Feb;26(2):214-21. =
</FONT></P>
<P><FONT face=3DArial size=3D2>6. Hersh PS, Fry K, Blaker JW. =
Spherical=20
aberration after laser in situ keratomileusis and photorefractive=20
keratectomy. Clinical results and theoretical models of etiology. =
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<P><FONT face=3DArial size=3D2>7. Mrochen M, Donitzky C, Wullner =
C, Loffler J.=20
Wavefront optimized ablation profiles. Theoretical background. J =
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<P><FONT face=3DArial size=3D2>8. Netto MV, Ambrosio R Jr, Wilson =
SE. Pupil=20
size in refractive surgery candidates. J of Refract Surg. 2004=20
Jul-Aug;20(4):337-42.</FONT></P>
<P><FONT face=3DArial size=3D2>9. Hjortdal JO, Olsen H, Ehlers N. =
Prospective=20
randomised study of corneal aberrations 1 year after radial =
keratotomy or=20
photorefractive keratectomy. J Refract Surg. 2002 =
Jan-Feb;18(1):23-9.=20
</FONT></P>
<P><FONT face=3DArial size=3D2>10. Maguire LJ. Keratorefractive =
surgery,=20
success, and the public health. Am J Ophthalmol. 1994 Mar=20
15;117(3):394-8.</FONT></P>
<P><FONT face=3DArial size=3D2>11. Uozato H, Guyton DL. Centering =
Corneal=20
Surgical Procedures. Amer J Ophthal. 1987 Mar 15;103(3 Pt =
1):264-75.=20
</FONT></P>
<P><FONT face=3DArial size=3D2>12. Roberts CW, Koester CJ. Optical =
zone=20
diameters for photorefractive corneal surgery. Invest Ophthalmol =
Vis Sci.=20
1993 Jun;34(7):2275-81.</FONT></P>
<P><FONT face=3DArial size=3D2>13. Alster Y, Loewenstein A, =
Baumwald T,=20
Lip****s I, Lazar M. Dapiprazole for patients with night haloes =
after=20
excimer keratectomy. Graefes Arch Clin Exp Ophthalmol. 1996 =
Aug;234 Suppl=20
1:S139-41.</FONT></P>
<P><FONT face=3DArial size=3D2>14. Oliver KM, Hemenger RP, Corbett =
MC, O'Brart=20
DP, Verma S, Marshall J, Tomlinson A. Corneal optical aberrations =
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<P><FONT face=3DArial size=3D2>15. Martinez CE, Applegate RA, =
Klyce SD,=20
McDonald MB, Medina JP, Howland HC. Effect of pupillary dilation =
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corneal optical aberrations after photorefractive keratectomy. =
Arch=20
Ophthalmol. 1998 Aug;116(8):1053-62.</FONT></P>
<P><FONT face=3DArial size=3D2>16. Holladay JT, Dudeja DR, Chang =
J. Functional=20
vision and corneal changes after laser in situ keratomileusis =
determined=20
by contrast sensitivity, glare testing, and corneal topography. J =
Cataract=20
Refract Surg. 1999 May;25(5):663-9. </FONT></P>
<P><FONT face=3DArial size=3D2>17. Seiler T, Kaemmerer M, Mierdel =
P, Krinke=20
HE. Ocular optical aberrations after photorefractive keratectomy =
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myopia and myopic astigmatism. Arch Ophthalmol. 2000=20
Jan;118(1):17-21.</FONT></P>
<P><FONT face=3DArial size=3D2>18. Schwiegerling J, Snyder RW. =
Corneal=20
ablation patterns to correct for spherical aberration in =
photorefractive=20
keratectomy. J Cataract Refract Surg. 2000 =
Feb;26(2):214-21.</FONT></P>
<P><FONT face=3DArial size=3D2>19. Fan-Paul NI, Li J, Miller JS, =
Florakis GJ.=20
Night vision disturbances after corneal refractive surgery. Surv=20
Ophthalmol. 2002 Nov-Dec;47(6):533-46. </FONT></P>
<P><FONT face=3DArial size=3D2>20. Miyata K, Tokunaga T, ****ahara =
M, Ohtani S,=20
Nejima R, Kiuchi T, Kaji Y, O****ka T. R. Residual bed thickness =
and=20
corneal forward ****ft after laser in situ keratomileusis. J =
Cataract=20
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<P><FONT face=3DArial size=3D2>21. Pallikaris IG, Kymionis GD, =
Astyrakakis NI.=20
Corneal ectasia induced by laser in situ keratomileusis. J =
Cataract=20
Refract Surg. 2001 Nov;27(11):1796-802.</FONT></P>
<P><FONT face=3DArial size=3D2>22. Flanagan GW, Binder PS. =
Precision of flap=20
measurements for laser in situ keratomileusis in 4428 eyes. J =
Refract=20
Surg. 2003 Mar-Apr;19(2):113-23.</FONT></P>
<P><FONT face=3DArial size=3D2>23. Lif****z T, Levy J, Klemperer =
I, Levinger=20
S. Late bilateral keratectasia after LASIK in a low myopic =
patient. J=20
Refract Surg. 2005 Sep-Oct;21(5):494-6.</FONT></P>
<P><FONT face=3DArial size=3D2>24. Kramer TR, Chuckpaiwong V, =
Dawson DG,=20
L'Hernault N, Grossniklaus HE, Edelhauser HF. Pathologic findings =
in=20
postmortem corneas after successful laser in situ keratomileusis. =
Cornea.=20
2005 Jan;24(1):92-102. </FONT></P>
<P><FONT face=3DArial size=3D2>25. Schmack I, Dawson DG, McCarey =
BE, Waring GO=20
3rd, Grossniklaus HE, Edelhauser HF. Cohesive tensile strength of =
human=20
LASIK wounds with histologic, ultrastructural, and clinical=20
correlations.</FONT></P>
<P><FONT face=3DArial size=3D2>J Refract Surg. 2005=20
Sep-Oct;21(5):433-45.</FONT></P><FONT face=3DArial size=3D2>26. =
Cheng AC, Rao=20
SK, Leung GY, Young AL, Lam DS. Late traumatic flap dislocations =
after=20
LASIK. </FONT>
<P><FONT face=3DArial size=3D2>J Refract Surg. 2006=20
May;22(5):500-4.</FONT></P>
<P><FONT face=3DArial size=3D2>27. Schein OD, Vitale S, Cassard =
SD, Steinberg=20
EP. Patient outcomes of refractive surgery. The refractive status =
and=20
vision profile. J Cataract Refract Surg. 2001 =
May;27(5):665-73.</FONT></P>
<P><FONT face=3DArial size=3D2>28. Garamendi E, Pesudovs K, =
Elliott DB.=20
Changes in quality of life after laser in situ keratomileusis for =
myopia.=20
J Cataract Refract Surg. 2005 Aug;31(8):1537-43.</FONT></P>
<P><FONT face=3DArial size=3D2>29. Kohnen T, Buhren J, Kuhne C, =
Mirshahi A.=20
Wavefront-guided LASIK with the Zyoptix 3.1 system for the =
correction of=20
myopia and compound myopic astigmatism with 1-year followup: =
clinical=20
outcome and change in higher order aberrations. Ophthalmology.=20
2004;111:2175-2185.</FONT></P>
<P><FONT face=3DArial size=3D2>30. Brint SF. Higher order =
aberrations after=20
LASIK for myopia with Alcon and Wavelight lasers: a prospective =
randomized=20
trial. J Refract Surg. 2005 Nov-Dec;21(6):S799-803.</FONT></P>
<P><FONT face=3DArial size=3D2>31. Netto MV, Dupps W Jr, Wilson =
SE.=20
Wavefront-guided ablation: evidence for efficacy compared to =
traditional=20
ablation. Am J Ophthalmol. 2006 Feb;141(2):360-368. </FONT></P>
<P><FONT face=3DArial size=3D2>32. Stonecipher KG, Dishler JG, =
Ignacio TS,=20
Binder PS. Transient light sensitivity after femtosecond laser =
flap=20
creation: clinical findings and management. J Cataract Refract =
Surg. 2006=20
Jan;32(1):91-4. </FONT></P>
<P><FONT face=3DArial size=3D2>33. Luna JD, Artal MN, Reviglio VE, =
Pelizzari=20
M, Diaz H, Juarez CP. Vitreoretinal alterations following laser in =
situ=20
keratomileusis: clinical and experimental studies. Graefes Arch =
Clin Exp=20
Ophthalmol. 2001 Jul;239(6):416-23. </FONT></P>
<P><FONT face=3DArial size=3D2>34. Binder PS. Flap dimensions =
created with the=20
IntraLase FS laser. J Cataract Refract Surg. 2004 Jan;30(1):26-32. =
</FONT></P>
<P><FONT face=3DArial size=3D2>35. Biser SA, Bloom AH, Donnenfeld =
ED, Perry=20
HD, Solomon R, Do**** S. Flap folds after femtosecond LASIK. Eye =
Contact=20
Lens. 2003 Oct;29(4):252-4.<BR></FONT></P>
<P><FONT face=3DArial size=3D2>36. Chung SH, Roh MI, Park MS, Kong =
YT, Lee HK,=20
Kim EK. Mycobacterium abscessus keratitis after LASIK with =
IntraLase=20
femtosecond laser. Ophthalmologica. 2006;220(4):277-80. =
</FONT></P>
<P><FONT face=3DArial size=3D2>37. Kim JY, Kim MJ, Kim TI, Choi =
HJ, Pak JH,=20
Tchah H. A femtosecond laser creates a stronger flap than a =
mechanical=20
microkeratome. Invest Ophthalmol Vis Sci. 2006=20
Feb;47(2):599-604.</FONT></P>
<P><FONT face=3DArial size=3D2>38. Ratkay-Traub I, Ferincz IE, =
Juhasz T, Kurtz=20
RM, Krueger RR. First clinical results with the femtosecond=20
neodynium-glass laser in refractive surgery. J Refract Surg. 2003=20
Mar-Apr;19(2):94-103.</FONT></P>
<P><FONT face=3DArial size=3D2>39. Principe AH, Lin DY, Small KW, =
Aldave AJ.=20
Macular hemorrhage after laser in situ keratomileusis (LASIK) with =
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