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THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
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Ace  
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 More options Aug 25 2006, 1:36 am
Newsgroups: alt.lasik-eyes
From: "Ace" <acema...@yahoo.com>
Date: 24 Aug 2006 22:36:46 -0700
Local: Fri, Aug 25 2006 1:36 am
Subject: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
August, 2006

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

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

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

I. BACKGROUND

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

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

In 1999 during the initial boom in popularity of LASIK, Marguerite B.
McDonald, noted refractive surgeon and then-Chief Medical Editor of
EyeWorld magazine, stated in an editorial:
Quote:
"We are only starting to ride the enormous growth curve of LASIK in
this country. There will be more than enough surgeries for everyone to
benefit if we keep our heads by sharing information openly and honestly
and by resisting the temptation to criticize the work of our colleagues
when we are offering a second opinion to a patient with a suboptimal
result. Who was it who said, 'When the tide comes in, all the boats
in the harbor go up?' "

Today some prominent refractive surgeons are finding superior outcomes
and better safety profiles with surface ablations such as PRK and
LASEK, which avoid creation of a corneal flap. Yet LASIK continues to
be the most common refractive surgical procedure performed.

II. DRY EYE

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

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

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

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

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

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

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

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

III. NIGHT VISION IMPAIRMENT

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

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

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

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

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

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

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

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

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

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

A Brief Chronology of Scientific Literature on Night Vision Impairment
after Corneal Refractive Surgery
Factors responsible for visual impairment in low light ...

read more »


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Ace  
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 More options Aug 25 2006, 1:39 am
Newsgroups: alt.lasik-eyes
From: "Ace" <acema...@yahoo.com>
Date: 24 Aug 2006 22:39:05 -0700
Local: Fri, Aug 25 2006 1:39 am
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
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, 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 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

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 report 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.

6. Hersh PS, Fry K, Blaker JW. Spherical aberration after laser in situ
keratomileusis and photorefractive keratectomy. Clinical results and
theoretical models of etiology. J Cataract Refract Surg. 2003
Nov;29(11):2096-104.

7. Mrochen M, Donitzky C, Wullner C, Loffler J. Wavefront optimized
ablation profiles. Theoretical background. J Cataract Refract Surg.
2004 Apr;30(4):775-85.

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.

9. Hjortdal JO, Olsen H, Ehlers N. Prospective randomised study of
corneal aberrations 1 year after radial keratotomy or photorefractive
keratectomy. J Refract Surg. 2002 Jan-Feb;18(1):23-9.

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.

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, Lipshits 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
after photorefractive keratectomy. Arch Ophthalmol. 1998
Aug;116(:1053-62.

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.

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. Miyata K, Tokunaga T, Nakahara M, Ohtani S, Nejima R, Kiuchi T,
Kaji Y, Oshika T. R. Residual bed thickness and corneal forward shift
after laser in ...

read more »


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trulytell...@yahoo.com  
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 More options Aug 25 2006, 5:48 pm
Newsgroups: alt.lasik-eyes
From: Trulytell...@yahoo.com
Date: 25 Aug 2006 14:48:59 -0700
Local: Fri, Aug 25 2006 5:48 pm
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006

...

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Discussion subject changed to "long winded flapcrap" by serebel
serebel  
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 More options Aug 25 2006, 8:12 pm
Newsgroups: alt.lasik-eyes
From: "serebel" <sere...@aol.com>
Date: 25 Aug 2006 17:12:22 -0700
Local: Fri, Aug 25 2006 8:12 pm
Subject: Re: long winded flapcrap

 The above posts by the retard and liar are more of the typical fiction
posted on flappie.


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Discussion subject changed to "THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006" by Ace
Ace  
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 More options Aug 26 2006, 4:05 am
Newsgroups: alt.lasik-eyes
From: "Ace" <acema...@yahoo.com>
Date: 26 Aug 2006 01:05:01 -0700
Local: Sat, Aug 26 2006 4:05 am
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006

Trulytell...@yahoo.com wrote:
> A good read for anyone considering LASIK. Egad!

That kickboxer needs to read this so he can be informed before its too
late and he permanently damages his eyes with lasik or prk.

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Glenn - USAEyes. org  
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 More options Aug 26 2006, 7:26 pm
Newsgroups: alt.lasik-eyes
From: Glenn - USAEyes.org <glenn.hageleSTOPS...@USAEyes.org>
Date: Sat, 26 Aug 2006 23:26:47 GMT
Local: Sat, Aug 26 2006 7:26 pm
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
The LASIK Report : Lauranell Burch, PhD of NIEHS Demonstrates
Dangerous Inability To Interpret Lasik Medical Studies

"Truly" aka "TrulyTelling" aka "Scientist" aka "Bill" aka "Eye" aka "R
Brown" aka "Tabby" aka "Adam" and many, many more aliases is actually
Lauranell Burch, PhD who is employed by the National
Institute of Environmental and Health Sciences (NIEHS) outside of
Durham NC.

When Lauranell Burch had Lasik she was a genetics scientist at Duke
University, yet she has claimed she was "tricked" into Lasik and "had
no idea" surgery has risks. In April of 2006 Lauranell Burch made
serious unsubstantiated public allegations against a colleague at Duke
University, claiming that an affiliated doctor there lied to a
patient, refused appropriate diagnosis, and other dreadful acts. Burch
is no longer employed at Duke University.

To get an idea of Lauranell Burch's objectivity, she drives around
with "Duke University Lasik Destroyed My Vision" or some such nonsense
on the back of her car. NIEHS actually relies on this person for
research!

The fantasy that Burch calls "The LASIK Report", fully attributed to
her, is being distributed to all doctors cited, Burch's employer the
NIEHS, her co-authors of previous studies, and most importantly the
foundations and medical companies who contribute to fund research at
the NIEHS. It seems highly doubtful to me that any medically related
firm or foundation would want to continue funding any research at a
facility that employs someone who deliberately propagates manipulated
medical studies to forward her own agenda.

Glenn Hagele
Executive Director
USAEyes.org
Patient Advocacy Surgeon Certification

"Consider and Choose With Confidence"

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.


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Ragnar  
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 More options Aug 26 2006, 8:48 pm
Newsgroups: alt.lasik-eyes
From: Ragnar <ragnarsu...@yahoo.com>
Date: Sun, 27 Aug 2006 00:48:45 GMT
Local: Sat, Aug 26 2006 8:48 pm
Subject: Re: THE LASIK REPORT, A Call for the Discontinuation of a Harmful Procedure. Aug 2006
Tiger was a -11 prior to his LASIK surgery, which is in the worst one
percent of those with nearsightedness. Tiger was considered to be
legally blind without his glasses or contacts. Prior to LASIK surgery,
without his glasses or contacts, he would not have even been able to
see the ball on the tee.

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Discussion subject changed to "Glenn Hagele Attacks Female" by br...@brenthanson.com
br...@brenthanson.com  
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 More options Aug 31 2006, 1:01 am
Newsgroups: alt.lasik-eyes, sci.med.vision
From: br...@brenthanson.com
Date: 30 Aug 2006 22:01:45 -0700
Local: Thurs, Aug 31 2006 1:01 am
Subject: Glenn Hagele Attacks Female
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