LASIK SOS
2003-08-18 13:16:11 UTC
Health Warning ==> Injured Patients, Eye Pain, Corneal Debris,
Ultraviolet Radiation Burns, and Laser Eye Surgery
<== Introduction ==>
This is not an advertisement. This posting contains information of a
medical and technical nature, regarding the surgical procedure known as
"laser eye surgery."
<== COUNTING THE CASUALTIES ==>
I found out about the dangers involved in laser eye surgery the hard
way.
I trusted a person with an M.D., one of the "top LASIK surgeons" in San
Diego -- Michael Gordon at the Gordon-Binder Vision Institute -- to
perform bilateral LASIK on me for moderate near-sightedness in 1998.
At that time, I immediately found myself needing eyedrops to deal with
the constant feeling of a dirty contact lens on my left eye. Before the
surgery, I only had this feeling when I had a contact lens in my eye.
After the surgery, I have this feeling all the time -- and it has
increased in intensity.
I also found that I developed double-vision 3 months post-op --
literally, seeing 2 of each of my co-workers. I have subsequently been
diagnosed with 12 diopters of "strabismus" -- literally, a crossed left
eye.
In my opinion, LASIK Surgeon Michael Gordon lied -- more than once -- to
close the sale.
Since I began meeting other LASIK patients, I find that they have
experienced similar treatment at the hands of other LASIK surgeons. In
other words, what "us patients" are observing is that laser eye surgeons
frequently lie to patients during pre-op consultations.
Apparently, the FDA and FTC have similar concerns. Both agencies have
issued a number of admonitions to the LASIK industry regarding
under-stating the risks of LASIK surgery. I have records of such
statements for the 2002 time-frame -- and for the 1994-1995 time-frame.
I have described Doctor Gordon's behavior during his treatment of me at
this website:
http://users.tns.net/~equity/LASIK_Casualties_SD
Are there other laser eye surgery casualties in Southern California ?
Yes. In short, having laser eye surgery performed by a highly
experienced refractive surgeon is no guarantee of a satisfactory
outcome.
There are a number of ways to find out about laser eye surgery
casualties. One is to behold the sight of thousands of injured laser
eye surgeons asking for help. There are several on-line forums where
this is possible. (Reference 1)
Another way to find out about refractive surgery casualties is to go to
the courthouse and enter the names of experienced LASIK surgeons. As
further described below, I have done this
That these people have experienced real damage to their eyes after laser
eye surgery -- damage which would not have occurred if they hadn't had
the surgery -- becomes fairly obvious when one speaks with the patients,
their attorneys, or reads the records of the trial.
A few other things become obvious, too. Counting medical malpractice
and fraud lawsuits at the courthouse shows only the tip of the iceberg
of laser eye surgery casualties. And, laser eye surgeons frequently
out-lawyer their patients.
Lastly, one way to find out about casualties is to ask the LASIK
surgeons themselves. Based on my own experience with Doctor Michael
Gordon, and the possible falsification of clinical trial results by
Doctor Thomas Tooma, I believe that asking the LASIK surgeons themselves
is not an effective technique for obtaining the information needed to
make an educated choice about refractive surgery -- the real facts about
real people who have experience real damage to their eyes after laser
eye surgery.
Website About some of Perry Binder's casualties
http://users.tns.net/~equity/LASIK_Casualties_SD
Website About some of Robert Maloney's casualties
http://users.tns.net/~equity/LASIK_Casualties_LA
Website About some of Thomas Tooma's casualties
http://users.tns.net/~equity/LASIK_Casualties_OC
Webpage About About some of Glenn Kawesch's casualties -- the URL is
long, starting with "http" and ending with "rnum=5" --
http://groups.google.com/groups?q=CRSQA+group:sci.med.vision&hl=en&lr=&ie=UTF-8&
group=sci.med.vision&selm=55496c96.0209091939.7f672972%40posting.google.com&rnum=5
NOTE: If any of the websites listed above becomes unavailable, please
contact me via email at
***@yahoo.com
I would be quite willing to provide the URL's for mirror websites not
listed.
Note: In most cases, this is not a comprehensive list of the patients
who have experienced damage to their eyes after laser eye surgery
performed by the named doctors.
Thousands of laser eye surgery patients are asking for help with their
post-surgical complications at a number of on-line forums, as further
described in Reference 1.
Most of those patients experienced the primary manifestation of their
corneal disease at the time of, or shortly after, their laser eye
surgery.
<== Surgical Debris Left Embedded in the Cornea ==>
In fact, Ultraviolet radiation burns -- in the eye, as described below
-- are not the extent of the damage frequently associated with laser eye
surgery.
Many laser eye surgery patients are left with surgical debris embedded
in their cornea.
Following is an excerpt of an email I received from Doctor Robert
Maloney, one of the more experienced laser eye surgeons in Los Angeles.
The email is re-printed in its entirety in the 'References' section
(Reference 2)
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"Recent clinical studies show that everyone has microscopic debris, and
as you well know, most people do not have symptoms of your severity."
(email received Feb. 20, 2003)
----------------------------------------------------------------------------------------------------------
As is evident from reading the excerpted email, the debris which Doctor
Maloney says is embedded in patients' corneas after LASIK surgery is
conveniently considered to not cause pain, in the cases of patients that
do have significant post-op eye pain, such as myself.
I have spoken to another patient, who has stated affirmatively that they
have a metal sliver in their cornea, which is large enough that they can
see it themself in the bathroom mirror. A result of their own LASIK
surgery, also performed by a "top" laser eye surgeon in Southern
California.
How much eye pain does the patient with the metal sliver have ? Good
question.
Would you like to participate in the Experiment ? (Reference 3)
<== Ultraviolet Radiation Burns ==>
Would you stare at the sun ?
I hope not.
The sun sends a lot of radiation our way. 1367 watts per square foot
above the earth in outer space. On a really BRIGHT day, 63.5% of that
sunlight makes its way through the atmosphere ... perhaps landing on
your skin as you lay on the coral sand at some tropical beach resort.
(Reference 6)
It might feel good, but ... you wouldn't stare at it. 80 watts per
square foot ... 0.56 watts per square inch. Or, to use the terms of
laser science, 0.56 joules per square inch. (Reference 5)
Yet, according to the specifications that they have given to the FDA,
ophthalmic lasers -- the lasers used during laser eye surgery -- have a
"fluence", respectively, of .774 and 1.032 joules per square inch.
(References 4, 5, 7)
In other words, the radiation emitted by these ophthalmic lasers -- when
they are on, during the pulse, when the laser is firing directly into
the patient's eye -- is more intense than the sun on a very bright day,
as it warms your skin on that proverbial tropical beach.
I am referring to the Bausch & Lomb Technolas 217 and the VISX Star S2
and S3 lasers.
The Nidek and Summit/LADAR-vision ophthalmic lasers are also high-power
pulsed ultraviolet lasers.
In other words, it is typical, during laser eye surgery, to stare at a
radiation source which, when it is on, is brighter than the sun at the
beach, in terms of radiation intensity.
The sun emits "broadband radiation" -- in the infra-red, visible, and
ultraviolet spectrums. The laser used in laser eye surgery emits mostly
193 "nanometer" radiation. Ultraviolet, C Band, radiation. The kind of
radiation which the atmosphere filters out. The kind of radiation we
seek protection from when we put "SPF 30" sun-block on our skin, or
"UV-protected" sunglasses on our eyes.
Is the human cornea vulnerable to damage from Ultraviolet radiation ?
Yes it is, as described below. The first step in collecting this
information is a simple web-search using the terms "Ultraviolet
Radiation Burn Eye".
Both the Bausch & Lomb ophthalmic laser and the VISX laser are "pulsed"
ultraviolet lasers.
The Bausch & Lomb Technolas 217 is "on" for .000000225 seconds, or
.000000900 seconds, out of every second.
The VISX Star S2 is "on" for .000000100 seconds, out of every second.
In engineering terms, this relates to what is what is known as "duty
cycle".
<== How Much Material is Removed ? What if the Ophthalmic Laser wasn't
Pulsed -- What if it was Run Continuously ?? ==>
I ask this question because it sheds some light on the power and
radiation intensity of the laser used during laser eye surgery.
During a typical laser eye surgery, a section of corneal tissue 8
millimeters in diameter, 80 microns thick, is removed.
First, let's translate that into English units:
8 millimeters = 8 x .03937 inches = .315 inches -- about a third of an
inch.
80 microns = .080 x .03937 inches = .00315 inches -- about the thickness
of a piece of 20-weight Xerox paper.
And the ophthalmic laser is on, at most, .000000900 seconds out of every
second. (Reference 5)
To get an idea of the power of this laser -- it's ability to slice
through Flesh, Blood, and Bone -- let us ask a simple question: what
would happen if the patient was exposed to a radiation source of this
intensity, and it was continuous, not pulsed ?
To make the calculations easier, and more conservative, let's round the
duty cycle off, from .00000090, to .000001. A duty cycle of
one-millionth.
If this radiation source were left on continuously, for the duration of
a typical laser eye surgery performed on just one eye, it would vaporize
approximately this much soft tissue: a volume about 10 inches in
diameter. 3.15 inches deep. Tapered around the edges. In less than a
minute. (Reference 8)
That's a powerful laser. If it were left on continuously, it would
photo-ablate a volume of soft tissue (eye tissue and brain tissue, for
example) about the size of an adult human's head -- in under a minute.
To paraphrase Elvis Presley -- that's a "hunka hunka burnin' laser."
In short, the Bausch & Lomb, VISX, Nidek, and Summit/LADAR-Vision
Ophthalmic lasers used to perform laser eye surgery are not just pulsed
ultraviolet lasers.
They are high-powered, pulsed, ultraviolet lasers.
And the "doctor" is asking you to stare RIGHT AT IT for the duration of
hundreds of very short pulses. And the "doctor" is saying it "is safe".
That depends on the definition of "is safe".
I don't get paid to tell you that it "is safe" to stare at this
high-powered pulsed ultraviolet lasers. I am concerned because I have
seen many people experience significant, disabling, and crippling damage
to their eyes, because they made the mistake of trusting a "doctor" who
says that it "is safe" to stare at this laser.
In most cases, the "doctor" who is saying it "is safe" to stare at this
laser is receiving a fair few dollars as part of the deal.
In my opinion, those fair few dollars have blinded those "doctors" to
the risks involved in staring at high-powered, pulsed ultraviolet
lasers.
<== Many Laser Eye Surgery Patients Describe the Symptoms of an
Ultraviolet Radiation Burn -- in the Eye ==>
Many of the laser eye surgery patients with whom I have spoken describe
2 specific symptoms: A foreign-body sensation in the eye, and a painful
sensitivity to bright lights. Both of these are treated topically, and
temporarily, by applying eye-drops, and by wearing sunglasses.
Many laser eye surgery patients -- even patients with "positive
outcomes" -- in fact, have these 2 symptoms during the early post-op
period, and then the symptoms diminish over time, as the tissue of and
around the eye heals from the trauma of the surgery. For some, the
symptoms do not attenuate, over time.
For some, the symptoms escalate, over time. I find that my own symptoms
fall in this latter category. 4 years, and 10 months, at the time of
this writing.
Following are the symptoms described by an occupational safety health
organization in Canada - the symptoms associated with the use of an
arc-welder which emits significant amounts of Ultraviolet-C band
radiation.
"· pain - ranging from a mild feeling of pressure in the eyes to intense
pain in severe instances,
· tearing and reddening of the eye and membranes around the eye,
· sensation of "sand in the eye" or abnormal sensitivity to light, and
· inability to look at light sources (photophobia)." (Reference 9)
And, what does the occupational safety health organization in Canada
recommend for persons who have an Ultraviolet radiation burn from
operating an arc-welder ? Eye-drops.
In my own case, I have been describing a feeling like a dirty contact
lens in my eye since the time of my surgery. During the past 2 years,
since 2001, this discomfort has escalated to a condition of pain -- in
the eye. I also experience painful light sensitivity -- so that I am
more comfortable wearing sunglasses -- at 6 o'clock in the morning on
cloudy days. Something I certainly did not have to do pre-op.
These 3 symptoms -- the foreign body sensation, the eye pain, and the
painful light sensitivity -- are all described in my medical records,
going back to the time of my LASIK surgery.
In about March 2003, during a web-search, I found the data described in
Reference 9.
Here are the facts:
1. Every laser eye surgery patient experiences the pre-conditions for an
ultraviolet radiation burn, in the eye -- exposure of their corneas and
eyes to extremely intense C-band Ultraviolet radiation.
2. Many, if not most, laser eye surgery patients experience the symptoms
of a mild Ultraviolet Radiation Burn -- in the eye -- in the hours,
days, and weeks after their surgery.
3. Some patients experience the symptoms of a very bad Ultraviolet
Radiation burn -- in their eyes -- after laser eye surgery.
4. The human cornea is definitely vulnerable to damage from Ultraviolet
radiation. (References 7, 9, 10, 11, 12)
To quote the Canadian Ophthalmological Society (Reference 10),
"UV phototoxicity has been implicated in causing or accelerating the
progression of several diseases of the eye or its supporting structures,
including the eyelids. The following is a partial list of some of the
more common diseases involved.
Basal cell and squamous cell carcinoma, melanoma: skin cancer of the
eyelids.
Pingueculae, pterygia: conjunctival growths between the eyelids that may
encroach on the visual axis and obstruct or distort vision.
UV photokeratitis, snow blindness, arc welder's burn: acute superficial
"burn" of the cornea from high-intensity short-term exposure to UV
radiation."
A Google Search using the terms "ultraviolet radiation burn eye" can
shed more light on the subject of the human eye and Ultraviolet
Radiation Burns --
http://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=ultraviolet+radiation+burn+eye
<== Refractive Surgery Causes Corneal Disease ==>
Thousands of persons have now experienced a very unusual coincidence.
They have laser eye surgery, and they find themselves living with
corneal discomfort and eye pain.
Then, when they ask their laser eye surgeon about the possibility of a
causal connection between the laser eye surgery and the sudden massive
onset of the symptoms of corneal disease, those patients are frequently
told, "it's a coincidence."
For me, this is reminiscent of the situation in the tobacco industry,
before the link between tobacco and cancer was acknowledged. As we now
know, certain individuals associated with the tobacco industry worked to
hide the link between tobacco use and cancer.
In my opinion, this is exactly what is happening in the laser eye
surgery industry.
I cite two additional examples of this below. One example pertains to
advertisers objecting to television news coverage of complications from
laser eye surgery. (Reference 14) The other example pertains to the
possible falsification of clinical trial results by one of the most
experienced refractive surgeons in Southern California.
For example, I was recently contacted by San Diego television reporter
Darlynne Reyes with KSWB-TV regarding a news piece about refractive
surgery complications. We played phone tag a few times. I left a message
on her answering machine expressing my concern that her advertisers
might object to such news coverage. She subsequently left a message on
my answering machine at work. In that message, she stated that she had
met with her editor, that KSWB-TV had run a similar piece previously,
and that KSWB-TV advertisers had, indeed, objected strongly to KSWB
television coverage of complications from refractive surgery.
Below, I have placed a transcript of the telephone message that Darlynne
Reyes left on my answering machine. (Reference 14)
Somehow, I have a feeling that it wasn't a car dealer that objected to
KSWB-TV's previous news coverage of complications from laser eye
surgery. In my opinion, the advertisers that objected were "doctors"
that are trying to sell laser eye surgery. In order to sell laser eye
surgery, those advertisers need for potential customers to believe that
laser eye surgery is "safe", in the same sense that getting a tooth
filled is safe.
Well, I can tell you for sure. Laser eye surgery is NOT safe. If you
don't believe me, please read this account, my plea for help for a
patient of one of the most experienced refractive surgeons in Southern
California, Thomas Tooma in Newport Beach.
http://www.lasiksos.com/worst-case.htm
Early in the year 2001, it was discovered that the patient I have
referred to as "Julie" has large quantities of metal dust embedded in
her corneas. She was not born with metal dust in her corneas. The only
time that I can think of when metal dust could have been deposited in
her lamellar interface -- below the flap -- is at the time the flap was
cut -- at the time of her laser eye surgery. Which was performed by
TLC-affiliated Newport Beach laser eye surgeon Doctor Thomas Tooma early
in the year 1999. One of the most experienced, highly regarded laser eye
surgeons in Southern California.
This patient has lived with constant, excruciating eye pain since the
day of her laser eye surgery. This patient spends most of her time with
her eyes closed. This patient can also see a Snellen chart, without
contact lenses. What good is seeing a Snellen chart if your eyes hurt so
much you have to keep them closed all the time ?
Again and again, I am told by Tooma's defenders and salespeople that he
is "one of the best". If "one of the best" can leave a patient crippled
with constant eye pain -- then I suggest it's time to call a "Time Out."
Is there a Doctor in the House ?
Would you like to participate in the Experiment ? (Reference 3)
<== Did Doctor Thomas Tooma Alter the Results of a Clinical Trial ?? ==>
Unfortunately, the plot thickens. The patient with the metal dust
embedded in their corneas, and the constant eye-pain, was told that
their LASIK surgery was part of a clinical trial. That clinical trial
was conducted in conjunction with Loma Linda University. When we called
LLU to request a copy of the record of that patient's participation in
that clinical trial, we were told that there was NO RECORD of that
patient's participation in that clinical trial.
In my opinion, the logical explanation for this is that Doctor Tooma
removed that patient's record from the records of that clinical trial.
Subsequently, given that that patient's surgery was allegedly performed
using a Technolas 116 and that Technolas is owned by Bausch & Lomb, I
perused the Bausch & Lomb literature. Lo and behold, there's Doctor
Tooma himself in a recent Bausch & Lomb annual report.
Now, I'm a design engineer -- you know, one of those people who enjoyed
calculus classes in high school. I know that equipment manufacturers
loan expensive equipment to potential customers -- in this case, laser
eye surgeons.
I'm also a human being. And common sense tells me that you don't get
your picture in an annual report by being loaned an expensive ophthalmic
laser workstation, and using it to cripple a patient. You can, however,
get your picture in an annual report by borrowing the surgical
workstation, and reporting back that "it works great" -- even when it
most clearly doesn't.
<== The "Standard of Care" in Refractive Surgery ==>
As you may have deduced if you have read this far, it is my opinion and
observation, based on about 5 years of observing, that the "standard of
care" in refractive surgery is far below the standard of care in most
other fields of medicine. In other words, the assumption that we make
about doctors, that they would not knowingly place our health at risk,
does not, in my opinion, apply in the field of refractive surgery.
In short, in my opinion, based on 5 years of observation, many of those
who are considered to be the "best in the business" of refractive
surgery can not be trusted with the health of anyone's eyes.
<== Is All-laser Eye Surgery "Safer" ?? ==>
I am in possession of an email from a Boston-area patient who is
experiencing continued eye-pain 1 1/2 months after their initial
surgery, which was performed using the Intralase laser to cut the flap,
and an ophthalmic laser to perform the ablation.
To quote brief excerpts from that patient's recent emails, they are
experiencing a "foreign body sensation" in the eye, eye "pain", and a
feeling of "pressure" in the eye" -- the exact symptoms of an
Ultraviolet Radiation Burn. After all-laser eye surgery.
My feeling is that the laser eye surgery industry needs to mobilize
itself to help this patient, and all other injured laser eye surgery
patients.
Additionally, the experience of one of Thomas Tooma's patients is
represented online at this URL:
http://users.tns.net/~equity/LASIK_Casualties_OC/NavTooma.htm
That patient is now blind in one eye. They experienced a broken major
blood vessel in the eye -- shortly after their own LASIK surgery. The
broken blood vessel is believed to have occurred because of the tissue
trauma induced by the suction ring (the device used to immobilize the
eye) and the speculum (the device used to move the eyelid out of the
way.) During "all-laser eye surgery", both the suction ring and the
speculum are used. In other words, what happened to Tooma's patient, the
human being associated with Orange County case #01CC06832, can happen to
any all-laser eye surgery patient.
So, too, are all laser eye surgery patients vulnerable to the damaging
effects of Ultraviolet Radiation, which is known to be both carcinogenic
(causing cancer) and cataractogenic (causing cataracts) (References 7,
9, 10, 11, 12)
<== Closing Statements ==>
Is it ethical to give prospective laser eye surgery patients ALL the
information about refractive surgery casualties ? I believe so -- it
is ethical to provide prospective patients with this information.
In short, it is my request that the refractive surgery industry adopt
the following goals as its own.
1) Make the treatment of injured patients a top priority. The patients
with the most eye pain go to the front of the line.
2) Given the evident lack of mature medical solutions for patients
injured by laser eye surgery, make the development of those solutions a
top priority -- more important than selling new surgeries and recklessly
endangering the eye health of new patients.
3) Fully disclose to all prospective patients the entire depth and
breadth of all known adverse outcomes from laser eye surgery. In other
words, count the casualties, and tell prospective patients about those
casualties. Present the information not as something that COULD happen,
but as something that HAS happened, after surgery by almost all of the
"top" refractive surgeons.
Sincerely,
~ Roger ~
Roger E. Bratt
http://www.lasikSOS.com/
Copyright 2003 Roger E. Bratt -- All Rights Reserved.
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This is Not an Advertisement for any of the following persons or
organizations:
Doctor Michael Gordon
Doctor Perry Binder
Doctor Thomas Tooma
Doctor Robert Maloney
Doctor Glenn Kawesch
Bausch and Lomb
VISX
Summit Technology
Nidek
TLC Laser Eye Centers
Loma Linda University
KSWB-TV
Intralase
----------------------------------------------------------------------------------------------------------
REFERENCES.
( Reference 1 ) Counting the Casualties, in medical articles, online
forums, personal websites, Medical Foundations, and recently published
articles in the print media:
Patients with Injured Eyes, Asking for Help.
The online forum at the Surgical Eyes Foundation
http://surgicaleyes.atinfopop.com/4/OpenTopic
The "LASIK Disaster" website. This patient experienced "corneal melt" -
an inflammation that was not diagnosed in the early stages. After about
8 surgeries to deal with the messy situation, her cornea is finally
stabilized, though an extra 100 microns thinner.
http://www.lasikdisaster.com/
LASIK Info Center
http://www.lasikinfocenter.net/
The LASIK SOS Website
http://www.lasikSOS.com
The online forum, about LASIK complications, operated by Dr. Gerald Horn
at the Chicago Laser Center
http://www.lasikprk.com/VisionPlaceIII/bb/bbNOW.htm
USENET newsgroups "sci.med.vision" and "alt.lasik-eyes"
http://groups.google.com/groups?q=sci.med.vision&ie=ISO-8859-1&hl=en
http://groups.google.com/groups?hl=en&lr=&ie=ISO-8859-1&q=alt.lasik-eyes&btnG=Google+Search&meta=
Wendy Lyons Sunshine's article about LASIK casualties in Northern
California, "A Pain in the Eye That's Forever"
http://www.eastbayexpress.com/issues/2003-04-23/feature.html/1/index.html
Wendy Lyons Sunshine's article about LASIK casualties in the Dallas
Texas area, "Shattered Sight, Shattered Lives"
http://www.fwweekly.com/issues/2003-02-20/feature.html/page1.html
( Reference 2 ) Email received from Doctor Robert Maloney Regarding
Debris Embedded in the Cornea During LASIK.
NOTES ...
1. The Doctor's comments below were made in the context of a
conversation about my own post-op complications after LASIK surgery.
2. I have masked Doctor Maloney's contact information using ***
characters. I have also removed the mailing address and fax and phone
number.
3. Normally, I keep emails confidential. However, this email is of
particular interest. Doctor Maloney makes a statement which I believe
all laser eye surgery patients ought to hear BEFORE they have surgery --
that corneal debris is a frequent side effect of LASIK surgery.
4. Additionally, it is interesting to note, that because some patients
apparently do have corneal debris without eye pain, in the case of
patients that do develop eye pain after LASIK, this same debris is for
some reason considered to not be a problem -- to not be a source of
inflammation.
----------------------------------------------------------------------------------------------------------
"From: drmaloney@*************.com
To: ***@yahoo.com
Subject: RE: LASIK Date: Thu, 20 Feb 2003 06:28:47 -0800
Would you like me to help you find someone in the area to do confocal
microscopy on your cornea? To be honest I doubt very much that embedded
debris is the cause of your troubles. Recent clinical studies show that
everyone has microscopic debris, and as you well know, most people do
not
have symptoms of your severity.
I appreciate the issue of delicacy in discussing my patients, but would
you
be comfortable talking in general terms rather than discussing specific
patients?
Robert K. Maloney, M.D.
Maloney Vision Institute"
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( Reference 3 ) In this context, "Would you like to participate in the
Experiment ?" is a rhetorical construct. The most heart-felt advice I
could give you is -- laser eye surgery is one very poorly-administered
experiment that I suggest you NOT participate in.
( Reference 4 ) Bausch & Lomb FDA Filing for the Technolas 217
Ophthalmic Laser
Laser Wavelength 193 nm
Laser Pulse Duration 18 nanoseconds
Laser Head Repetition Rate 50 Hz
Effective Corneal Repetition Rate 12.5 Hz
Fluence (at the eye) 120 mJ/cm2
Range of Ablation Diameter 2.0 to 2.05 mm
http://www.accessdata2.fda.gov/Google/fda_search.pl?client=
fdagov&site=fdagov&restrict=&searchselector=&q=Technolas+217
Search yielded a document named "P990027S002b.doc" when performed June
7, 2003.
Ref.
http://www.fda.gov/search.html
These numbers give 2 options to derive peak power from average power -
does the laser fire 12.5 pulses at the patient's eye every second, or 50
pulses ? I emailed Bausch & Lomb asking for technical input; this matter
has not yet been clarified. Therefore I shall perform the calculations
for both cases.
( Reference 5 ) Translating from milli-watts per square centimeter to
milli-watts per square inch
Power for lasers is frequently expressed using an energy term (joules),
instead of a power term (watts).
120 mJ/cm^2 ==> 120 mW/cm^2
Radiation Source: ophthlamic laser which fires 12.5 pulses 18
nano-seconds long per second with a stated fluence of 120 mJ/cm^2
CW (continuous wave) or pulsed ? : Pulsed
Duty Cycle: .000000225, 12.5 pulses per second ... each pulse is 18
nanoseconds long.
"Fluence", Power Density of laser beam: 120 milli-watts per square
centimeter - 774 milli-watts per square inch - about 3/4 of a watt per
square inch.
Power Density: .774 watts per square inch, about 3/4 of a watt per
square inch.
Peak Watts per Square Inch, if the 120 milli-Joules specification is a
physical average: 3,440,000
Beam Width: 2 millimeters, about 1/ 12 of an inch
Radiation Source: ophthlamic laser which fires 50 pulses 18 nano-seconds
long per second with a stated fluence of 120 mJ/cm^2
CW (continuous wave) or pulsed ? : Pulsed
Duty Cycle: .00000090, 50 pulses per second ... each pulse is 18
nanoseconds long.
Power Density: .774 watts per square inch, about 3/4 of a watt per
square inch.
Peak Watts per Square inch, if the 120 milli-Joules specification is a
physical average: 860,000
Beam Width: 2 millimeters, about 1/ 12 of an inch
( Reference 6 ) Radiation Source: The Sun
CW (continuous wave) or pulsed ? : CW
Duty Cycle: 100%
Average Watts per square meter, in outer space: 1367
http://stratus.ssec.wisc.edu/streamer_web/userman/solar.html
Amount of radiation "absorbed at the surface": 51%
http://www.geog.ouc.bc.ca/physgeog/contents/7f.html
Average Watts per square meter, on the average beach: 697
Average Watts per square foot, on the average beach: 65
Average Watts per square foot, on the beach, at the equator: up to 90
Average Watts per square foot, at 29,000 feet elevation, at the equator:
TBD
Average Watts per square foot, term used in comparison with excimer
laser: 80
(Note: one of the goals of the analysis is to express the ratio as
conservatively as possible, that is, to not over-state the ratio when
comparing the ophthalmic excimer laser to the sun.)
Average Watts per square inch, term used in comparison with excimer
laser: .56 watts per square inch
Amount of solar radiation "absorbed at the surface" if .56 watts is
absorbed at the surface: 63.5%
Frequency Spectrum of the Sun: Broadband - Infrared, Visible,
Ultraviolet
( Reference 7 ) VISX FDA Filing for the Star S2 Ophthalmic Laser
http://www.fda.gov/cdrh/pdf/p930016s014b.doc
V. DEVICE DESCRIPTION
A. Laser System
"The device used in the clinical study was the VISX STAR S2 Excimer
Laser System for which a full description can be found in the SSED for
supplement 7. The excimer is an argon-fluoride laser that generates
pulses at 193 nm wavelength. The output of the excimer laser also has
the following characteristics: fluence of 160 mJ/cm2; 20 nanoseconds
pulse duration; and, pulse repetition rate of up to 10 Hz."
----------------------------------------------------------------------------------------------------------
Power for lasers is frequently expressed using an energy term (joules),
instead of a power term (watts).
160 mJ/cm2 ==> 160 mW/cm2
160 mW/cm2
= 1032 milli-watts per square inch
Average Watts per square inch for the sun, term used in comparison with
excimer laser:
.56 watts per square inch
= 560 milli-watts per square inch
( Reference 8 )
The area of a surface varies with the square of the radius. To increase
the area by a factor of 1000, the radius is increased 31.6 times.
( Reference 9 )
Canadian Center for Occupational Health Safety (CCOHS)
"Occupational Safety Guidelines regarding Exposure to Ultraviolet-C Band
Radiation during Arc Welding."
"Certain types of UV radiation can produce an injury to the surface and
mucous membrane (conjunctiva) of the eye called "arc eye," "welders'
eye" or "arc flash." These names are common names for "conjunctivitis" -
an inflammation of the mucous membrane of the front of the eye. The
symptoms include
· pain - ranging from a mild feeling of pressure in the eyes to intense
pain in severe instances,
· tearing and reddening of the eye and membranes around the eye,
· sensation of "sand in the eye" or abnormal sensitivity to light, and
· inability to look at light sources (photophobia)."
( Reference 10 )
Thomas Jefferson National Accelerator Facility, in Virginia --
http://www.jlab.org/ehs/manual/EHSbook-465.html
"Cornea
An important function of the cornea is to focus light. Damage to the
cornea is caused by exposure to ultraviolet and far infrared radiation.
The cornea is most susceptible to damage from ultraviolet light. Over
exposure to ultraviolet burn light can cause photokeratitus (also known
as Welder's flash, arc eye, snow blindness). Signs of photokeratitus
include redness, tearing and discharge from the mucous membrane that
lines the inner surface of the eyelid. Symptoms include an acutely
painful sensation of gritty material in the eye."
( Reference 11 )
Department of Environmental Health & Safety, at UC-Davis --
http://ehs.ucdavis.edu/sftynet/sn-106.html
"The cornea of the eye is composed of a thin layer of specialized
epithelia cells. These cells can also absorb UV radiation, resulting in
tiny lesions on the cornea that may not be felt for several hours after
exposure. The sensation is much like having sand in your eye. Known as
photokeratitis, welders flash or snow blindness, the effects can last up
to 48 hours but subsides as the cells of the cornea rebuild. Although
most UV radiation that enters the eye is absorbed in the cornea,
molecular changes can occur in the lens as photons bombard proteins and
change their configuration, resulting in cataract formation."
( Reference 12 )
The Canadian Ophthalmological Society
http://www.eyesite.ca/english/program-and-services/policy-statements-guidelines/UV-radiation-eye.htm
"UV phototoxicity has been implicated in causing or accelerating the
progression of several diseases of the eye or its supporting structures,
including the eyelids. The following is a partial list of some of the
more common diseases involved.
Basal cell and squamous cell carcinoma, melanoma: skin cancer of the
eyelids.
Pingueculae, pterygia: conjunctival growths between the eyelids that may
encroach on the visual axis and obstruct or distort vision.
UV photokeratitis, snow blindness, arc welder's burn: acute superficial
"burn" of the cornea from high-intensity short-term exposure to UV
radiation.
Spheroidal degeneration, Labrador keratopathy: loss of corneal clarity
from long-term exposure to UV radiation.
Cataracts: opacification of the crystalline lens of the eye.
Eclipse or solar retinopathy: damage to the retina from acute exposure
during an eclipse or while gazing directly at the sun.
Macular degeneration: central retinal damage in the part of the retina
responsible for the best sight.
Acceleration of the progression of the pigmentary retinopathies
(retinitis pigmentosa), iritis (intraocular inflammation) or cystoid
macular edema (central fluid accumulation in the retina)."
( Reference 14 )
The initial email from KSWB reporter Darlynne Reyes.
NOTES ...
1. 99.99% of the time, I treat incoming email as sacrosanct and
confidential. However, when the email is able to shed light on a public
health epidemic which the laser eye surgery would not like publicized, I
make exceptions to that rule.
2. I have masked Ms. Reyes' contact information using "*" characters. I
have also removed the phone number.
----------------------------------------------------------------------------------------------------------
"From: "Reyes, Darlynne" Dmreyes@*******.com
To: "'***@yahoo.com'" ***@yahoo.com
Subject: Lasik surgery
Date: Wed, 14 May 2003 22:05:02 -0500
Dear Roger,
My name is Darlynne Reyes and I am a reporter at KSWB-TV. I am currently
doing research for a possible story on LASIK eye surgery and I came
across
your website. I would like to talk to you more about this topic. Would
you please give me a call? I'm hoping you can help me out or point me
in the right direction.
My work phone number is: <excised>. Thanks for your time!!
Darlynne Reyes
KSWB-TV
Reporter"
----------------------------------------------------------------------------------------------------------
Phone message from Darlynne Reyes, message left on work phone
approximately May 22, 2003
"Hey Roger
it's Darlynne Reyes calling from KSWB
Thanks for ... uhh ... returning my call
I appreciate that
and ... uh ... actually it's kind of funny that you would leave that
message for me
as far as ... uh ... you being curious what our advertisers would say
because ... uh ... (laughter)
when you had left me that message I talked to my news director
and ... uhh ... that's actually ... uhhh ... exactly what she talked to
me about
and apparently we have done this story before I came on board here
and ... uhh ... there was actually some ... uh ... big problems with the
piece (laughter)
so unfortunately I guess I will not be doing this piece ... uhhh ... for
next month
even though i had hoped to and (in-audible)
Doesn't seem like it's in the cards ... oh well ...
thank you so much Roger
and ... uhh ... I appreciate it and ... uhh ...
maybe we'll work together on some other type o' story
in the meantime thanks for returning my call
OK talk to you later bye bye."
( Reference 15 ) Copyright Statement & Home Page for the analysis
contained in this email.
Copyright 2003 Roger E. Bratt -- All Rights Reserved.
This communication has been be re-published at the home page for LASIK
SOS.com, at this URL --
http://www.lasikSOS.com
Ultraviolet Radiation Burns, and Laser Eye Surgery
<== Introduction ==>
This is not an advertisement. This posting contains information of a
medical and technical nature, regarding the surgical procedure known as
"laser eye surgery."
<== COUNTING THE CASUALTIES ==>
I found out about the dangers involved in laser eye surgery the hard
way.
I trusted a person with an M.D., one of the "top LASIK surgeons" in San
Diego -- Michael Gordon at the Gordon-Binder Vision Institute -- to
perform bilateral LASIK on me for moderate near-sightedness in 1998.
At that time, I immediately found myself needing eyedrops to deal with
the constant feeling of a dirty contact lens on my left eye. Before the
surgery, I only had this feeling when I had a contact lens in my eye.
After the surgery, I have this feeling all the time -- and it has
increased in intensity.
I also found that I developed double-vision 3 months post-op --
literally, seeing 2 of each of my co-workers. I have subsequently been
diagnosed with 12 diopters of "strabismus" -- literally, a crossed left
eye.
In my opinion, LASIK Surgeon Michael Gordon lied -- more than once -- to
close the sale.
Since I began meeting other LASIK patients, I find that they have
experienced similar treatment at the hands of other LASIK surgeons. In
other words, what "us patients" are observing is that laser eye surgeons
frequently lie to patients during pre-op consultations.
Apparently, the FDA and FTC have similar concerns. Both agencies have
issued a number of admonitions to the LASIK industry regarding
under-stating the risks of LASIK surgery. I have records of such
statements for the 2002 time-frame -- and for the 1994-1995 time-frame.
I have described Doctor Gordon's behavior during his treatment of me at
this website:
http://users.tns.net/~equity/LASIK_Casualties_SD
Are there other laser eye surgery casualties in Southern California ?
Yes. In short, having laser eye surgery performed by a highly
experienced refractive surgeon is no guarantee of a satisfactory
outcome.
There are a number of ways to find out about laser eye surgery
casualties. One is to behold the sight of thousands of injured laser
eye surgeons asking for help. There are several on-line forums where
this is possible. (Reference 1)
Another way to find out about refractive surgery casualties is to go to
the courthouse and enter the names of experienced LASIK surgeons. As
further described below, I have done this
That these people have experienced real damage to their eyes after laser
eye surgery -- damage which would not have occurred if they hadn't had
the surgery -- becomes fairly obvious when one speaks with the patients,
their attorneys, or reads the records of the trial.
A few other things become obvious, too. Counting medical malpractice
and fraud lawsuits at the courthouse shows only the tip of the iceberg
of laser eye surgery casualties. And, laser eye surgeons frequently
out-lawyer their patients.
Lastly, one way to find out about casualties is to ask the LASIK
surgeons themselves. Based on my own experience with Doctor Michael
Gordon, and the possible falsification of clinical trial results by
Doctor Thomas Tooma, I believe that asking the LASIK surgeons themselves
is not an effective technique for obtaining the information needed to
make an educated choice about refractive surgery -- the real facts about
real people who have experience real damage to their eyes after laser
eye surgery.
Website About some of Perry Binder's casualties
http://users.tns.net/~equity/LASIK_Casualties_SD
Website About some of Robert Maloney's casualties
http://users.tns.net/~equity/LASIK_Casualties_LA
Website About some of Thomas Tooma's casualties
http://users.tns.net/~equity/LASIK_Casualties_OC
Webpage About About some of Glenn Kawesch's casualties -- the URL is
long, starting with "http" and ending with "rnum=5" --
http://groups.google.com/groups?q=CRSQA+group:sci.med.vision&hl=en&lr=&ie=UTF-8&
group=sci.med.vision&selm=55496c96.0209091939.7f672972%40posting.google.com&rnum=5
NOTE: If any of the websites listed above becomes unavailable, please
contact me via email at
***@yahoo.com
I would be quite willing to provide the URL's for mirror websites not
listed.
Note: In most cases, this is not a comprehensive list of the patients
who have experienced damage to their eyes after laser eye surgery
performed by the named doctors.
Thousands of laser eye surgery patients are asking for help with their
post-surgical complications at a number of on-line forums, as further
described in Reference 1.
Most of those patients experienced the primary manifestation of their
corneal disease at the time of, or shortly after, their laser eye
surgery.
<== Surgical Debris Left Embedded in the Cornea ==>
In fact, Ultraviolet radiation burns -- in the eye, as described below
-- are not the extent of the damage frequently associated with laser eye
surgery.
Many laser eye surgery patients are left with surgical debris embedded
in their cornea.
Following is an excerpt of an email I received from Doctor Robert
Maloney, one of the more experienced laser eye surgeons in Los Angeles.
The email is re-printed in its entirety in the 'References' section
(Reference 2)
----------------------------------------------------------------------------------------------------------
"Recent clinical studies show that everyone has microscopic debris, and
as you well know, most people do not have symptoms of your severity."
(email received Feb. 20, 2003)
----------------------------------------------------------------------------------------------------------
As is evident from reading the excerpted email, the debris which Doctor
Maloney says is embedded in patients' corneas after LASIK surgery is
conveniently considered to not cause pain, in the cases of patients that
do have significant post-op eye pain, such as myself.
I have spoken to another patient, who has stated affirmatively that they
have a metal sliver in their cornea, which is large enough that they can
see it themself in the bathroom mirror. A result of their own LASIK
surgery, also performed by a "top" laser eye surgeon in Southern
California.
How much eye pain does the patient with the metal sliver have ? Good
question.
Would you like to participate in the Experiment ? (Reference 3)
<== Ultraviolet Radiation Burns ==>
Would you stare at the sun ?
I hope not.
The sun sends a lot of radiation our way. 1367 watts per square foot
above the earth in outer space. On a really BRIGHT day, 63.5% of that
sunlight makes its way through the atmosphere ... perhaps landing on
your skin as you lay on the coral sand at some tropical beach resort.
(Reference 6)
It might feel good, but ... you wouldn't stare at it. 80 watts per
square foot ... 0.56 watts per square inch. Or, to use the terms of
laser science, 0.56 joules per square inch. (Reference 5)
Yet, according to the specifications that they have given to the FDA,
ophthalmic lasers -- the lasers used during laser eye surgery -- have a
"fluence", respectively, of .774 and 1.032 joules per square inch.
(References 4, 5, 7)
In other words, the radiation emitted by these ophthalmic lasers -- when
they are on, during the pulse, when the laser is firing directly into
the patient's eye -- is more intense than the sun on a very bright day,
as it warms your skin on that proverbial tropical beach.
I am referring to the Bausch & Lomb Technolas 217 and the VISX Star S2
and S3 lasers.
The Nidek and Summit/LADAR-vision ophthalmic lasers are also high-power
pulsed ultraviolet lasers.
In other words, it is typical, during laser eye surgery, to stare at a
radiation source which, when it is on, is brighter than the sun at the
beach, in terms of radiation intensity.
The sun emits "broadband radiation" -- in the infra-red, visible, and
ultraviolet spectrums. The laser used in laser eye surgery emits mostly
193 "nanometer" radiation. Ultraviolet, C Band, radiation. The kind of
radiation which the atmosphere filters out. The kind of radiation we
seek protection from when we put "SPF 30" sun-block on our skin, or
"UV-protected" sunglasses on our eyes.
Is the human cornea vulnerable to damage from Ultraviolet radiation ?
Yes it is, as described below. The first step in collecting this
information is a simple web-search using the terms "Ultraviolet
Radiation Burn Eye".
Both the Bausch & Lomb ophthalmic laser and the VISX laser are "pulsed"
ultraviolet lasers.
The Bausch & Lomb Technolas 217 is "on" for .000000225 seconds, or
.000000900 seconds, out of every second.
The VISX Star S2 is "on" for .000000100 seconds, out of every second.
In engineering terms, this relates to what is what is known as "duty
cycle".
<== How Much Material is Removed ? What if the Ophthalmic Laser wasn't
Pulsed -- What if it was Run Continuously ?? ==>
I ask this question because it sheds some light on the power and
radiation intensity of the laser used during laser eye surgery.
During a typical laser eye surgery, a section of corneal tissue 8
millimeters in diameter, 80 microns thick, is removed.
First, let's translate that into English units:
8 millimeters = 8 x .03937 inches = .315 inches -- about a third of an
inch.
80 microns = .080 x .03937 inches = .00315 inches -- about the thickness
of a piece of 20-weight Xerox paper.
And the ophthalmic laser is on, at most, .000000900 seconds out of every
second. (Reference 5)
To get an idea of the power of this laser -- it's ability to slice
through Flesh, Blood, and Bone -- let us ask a simple question: what
would happen if the patient was exposed to a radiation source of this
intensity, and it was continuous, not pulsed ?
To make the calculations easier, and more conservative, let's round the
duty cycle off, from .00000090, to .000001. A duty cycle of
one-millionth.
If this radiation source were left on continuously, for the duration of
a typical laser eye surgery performed on just one eye, it would vaporize
approximately this much soft tissue: a volume about 10 inches in
diameter. 3.15 inches deep. Tapered around the edges. In less than a
minute. (Reference 8)
That's a powerful laser. If it were left on continuously, it would
photo-ablate a volume of soft tissue (eye tissue and brain tissue, for
example) about the size of an adult human's head -- in under a minute.
To paraphrase Elvis Presley -- that's a "hunka hunka burnin' laser."
In short, the Bausch & Lomb, VISX, Nidek, and Summit/LADAR-Vision
Ophthalmic lasers used to perform laser eye surgery are not just pulsed
ultraviolet lasers.
They are high-powered, pulsed, ultraviolet lasers.
And the "doctor" is asking you to stare RIGHT AT IT for the duration of
hundreds of very short pulses. And the "doctor" is saying it "is safe".
That depends on the definition of "is safe".
I don't get paid to tell you that it "is safe" to stare at this
high-powered pulsed ultraviolet lasers. I am concerned because I have
seen many people experience significant, disabling, and crippling damage
to their eyes, because they made the mistake of trusting a "doctor" who
says that it "is safe" to stare at this laser.
In most cases, the "doctor" who is saying it "is safe" to stare at this
laser is receiving a fair few dollars as part of the deal.
In my opinion, those fair few dollars have blinded those "doctors" to
the risks involved in staring at high-powered, pulsed ultraviolet
lasers.
<== Many Laser Eye Surgery Patients Describe the Symptoms of an
Ultraviolet Radiation Burn -- in the Eye ==>
Many of the laser eye surgery patients with whom I have spoken describe
2 specific symptoms: A foreign-body sensation in the eye, and a painful
sensitivity to bright lights. Both of these are treated topically, and
temporarily, by applying eye-drops, and by wearing sunglasses.
Many laser eye surgery patients -- even patients with "positive
outcomes" -- in fact, have these 2 symptoms during the early post-op
period, and then the symptoms diminish over time, as the tissue of and
around the eye heals from the trauma of the surgery. For some, the
symptoms do not attenuate, over time.
For some, the symptoms escalate, over time. I find that my own symptoms
fall in this latter category. 4 years, and 10 months, at the time of
this writing.
Following are the symptoms described by an occupational safety health
organization in Canada - the symptoms associated with the use of an
arc-welder which emits significant amounts of Ultraviolet-C band
radiation.
"· pain - ranging from a mild feeling of pressure in the eyes to intense
pain in severe instances,
· tearing and reddening of the eye and membranes around the eye,
· sensation of "sand in the eye" or abnormal sensitivity to light, and
· inability to look at light sources (photophobia)." (Reference 9)
And, what does the occupational safety health organization in Canada
recommend for persons who have an Ultraviolet radiation burn from
operating an arc-welder ? Eye-drops.
In my own case, I have been describing a feeling like a dirty contact
lens in my eye since the time of my surgery. During the past 2 years,
since 2001, this discomfort has escalated to a condition of pain -- in
the eye. I also experience painful light sensitivity -- so that I am
more comfortable wearing sunglasses -- at 6 o'clock in the morning on
cloudy days. Something I certainly did not have to do pre-op.
These 3 symptoms -- the foreign body sensation, the eye pain, and the
painful light sensitivity -- are all described in my medical records,
going back to the time of my LASIK surgery.
In about March 2003, during a web-search, I found the data described in
Reference 9.
Here are the facts:
1. Every laser eye surgery patient experiences the pre-conditions for an
ultraviolet radiation burn, in the eye -- exposure of their corneas and
eyes to extremely intense C-band Ultraviolet radiation.
2. Many, if not most, laser eye surgery patients experience the symptoms
of a mild Ultraviolet Radiation Burn -- in the eye -- in the hours,
days, and weeks after their surgery.
3. Some patients experience the symptoms of a very bad Ultraviolet
Radiation burn -- in their eyes -- after laser eye surgery.
4. The human cornea is definitely vulnerable to damage from Ultraviolet
radiation. (References 7, 9, 10, 11, 12)
To quote the Canadian Ophthalmological Society (Reference 10),
"UV phototoxicity has been implicated in causing or accelerating the
progression of several diseases of the eye or its supporting structures,
including the eyelids. The following is a partial list of some of the
more common diseases involved.
Basal cell and squamous cell carcinoma, melanoma: skin cancer of the
eyelids.
Pingueculae, pterygia: conjunctival growths between the eyelids that may
encroach on the visual axis and obstruct or distort vision.
UV photokeratitis, snow blindness, arc welder's burn: acute superficial
"burn" of the cornea from high-intensity short-term exposure to UV
radiation."
A Google Search using the terms "ultraviolet radiation burn eye" can
shed more light on the subject of the human eye and Ultraviolet
Radiation Burns --
http://www.google.com/search?hl=en&ie=UTF-8&oe=UTF-8&q=ultraviolet+radiation+burn+eye
<== Refractive Surgery Causes Corneal Disease ==>
Thousands of persons have now experienced a very unusual coincidence.
They have laser eye surgery, and they find themselves living with
corneal discomfort and eye pain.
Then, when they ask their laser eye surgeon about the possibility of a
causal connection between the laser eye surgery and the sudden massive
onset of the symptoms of corneal disease, those patients are frequently
told, "it's a coincidence."
For me, this is reminiscent of the situation in the tobacco industry,
before the link between tobacco and cancer was acknowledged. As we now
know, certain individuals associated with the tobacco industry worked to
hide the link between tobacco use and cancer.
In my opinion, this is exactly what is happening in the laser eye
surgery industry.
I cite two additional examples of this below. One example pertains to
advertisers objecting to television news coverage of complications from
laser eye surgery. (Reference 14) The other example pertains to the
possible falsification of clinical trial results by one of the most
experienced refractive surgeons in Southern California.
For example, I was recently contacted by San Diego television reporter
Darlynne Reyes with KSWB-TV regarding a news piece about refractive
surgery complications. We played phone tag a few times. I left a message
on her answering machine expressing my concern that her advertisers
might object to such news coverage. She subsequently left a message on
my answering machine at work. In that message, she stated that she had
met with her editor, that KSWB-TV had run a similar piece previously,
and that KSWB-TV advertisers had, indeed, objected strongly to KSWB
television coverage of complications from refractive surgery.
Below, I have placed a transcript of the telephone message that Darlynne
Reyes left on my answering machine. (Reference 14)
Somehow, I have a feeling that it wasn't a car dealer that objected to
KSWB-TV's previous news coverage of complications from laser eye
surgery. In my opinion, the advertisers that objected were "doctors"
that are trying to sell laser eye surgery. In order to sell laser eye
surgery, those advertisers need for potential customers to believe that
laser eye surgery is "safe", in the same sense that getting a tooth
filled is safe.
Well, I can tell you for sure. Laser eye surgery is NOT safe. If you
don't believe me, please read this account, my plea for help for a
patient of one of the most experienced refractive surgeons in Southern
California, Thomas Tooma in Newport Beach.
http://www.lasiksos.com/worst-case.htm
Early in the year 2001, it was discovered that the patient I have
referred to as "Julie" has large quantities of metal dust embedded in
her corneas. She was not born with metal dust in her corneas. The only
time that I can think of when metal dust could have been deposited in
her lamellar interface -- below the flap -- is at the time the flap was
cut -- at the time of her laser eye surgery. Which was performed by
TLC-affiliated Newport Beach laser eye surgeon Doctor Thomas Tooma early
in the year 1999. One of the most experienced, highly regarded laser eye
surgeons in Southern California.
This patient has lived with constant, excruciating eye pain since the
day of her laser eye surgery. This patient spends most of her time with
her eyes closed. This patient can also see a Snellen chart, without
contact lenses. What good is seeing a Snellen chart if your eyes hurt so
much you have to keep them closed all the time ?
Again and again, I am told by Tooma's defenders and salespeople that he
is "one of the best". If "one of the best" can leave a patient crippled
with constant eye pain -- then I suggest it's time to call a "Time Out."
Is there a Doctor in the House ?
Would you like to participate in the Experiment ? (Reference 3)
<== Did Doctor Thomas Tooma Alter the Results of a Clinical Trial ?? ==>
Unfortunately, the plot thickens. The patient with the metal dust
embedded in their corneas, and the constant eye-pain, was told that
their LASIK surgery was part of a clinical trial. That clinical trial
was conducted in conjunction with Loma Linda University. When we called
LLU to request a copy of the record of that patient's participation in
that clinical trial, we were told that there was NO RECORD of that
patient's participation in that clinical trial.
In my opinion, the logical explanation for this is that Doctor Tooma
removed that patient's record from the records of that clinical trial.
Subsequently, given that that patient's surgery was allegedly performed
using a Technolas 116 and that Technolas is owned by Bausch & Lomb, I
perused the Bausch & Lomb literature. Lo and behold, there's Doctor
Tooma himself in a recent Bausch & Lomb annual report.
Now, I'm a design engineer -- you know, one of those people who enjoyed
calculus classes in high school. I know that equipment manufacturers
loan expensive equipment to potential customers -- in this case, laser
eye surgeons.
I'm also a human being. And common sense tells me that you don't get
your picture in an annual report by being loaned an expensive ophthalmic
laser workstation, and using it to cripple a patient. You can, however,
get your picture in an annual report by borrowing the surgical
workstation, and reporting back that "it works great" -- even when it
most clearly doesn't.
<== The "Standard of Care" in Refractive Surgery ==>
As you may have deduced if you have read this far, it is my opinion and
observation, based on about 5 years of observing, that the "standard of
care" in refractive surgery is far below the standard of care in most
other fields of medicine. In other words, the assumption that we make
about doctors, that they would not knowingly place our health at risk,
does not, in my opinion, apply in the field of refractive surgery.
In short, in my opinion, based on 5 years of observation, many of those
who are considered to be the "best in the business" of refractive
surgery can not be trusted with the health of anyone's eyes.
<== Is All-laser Eye Surgery "Safer" ?? ==>
I am in possession of an email from a Boston-area patient who is
experiencing continued eye-pain 1 1/2 months after their initial
surgery, which was performed using the Intralase laser to cut the flap,
and an ophthalmic laser to perform the ablation.
To quote brief excerpts from that patient's recent emails, they are
experiencing a "foreign body sensation" in the eye, eye "pain", and a
feeling of "pressure" in the eye" -- the exact symptoms of an
Ultraviolet Radiation Burn. After all-laser eye surgery.
My feeling is that the laser eye surgery industry needs to mobilize
itself to help this patient, and all other injured laser eye surgery
patients.
Additionally, the experience of one of Thomas Tooma's patients is
represented online at this URL:
http://users.tns.net/~equity/LASIK_Casualties_OC/NavTooma.htm
That patient is now blind in one eye. They experienced a broken major
blood vessel in the eye -- shortly after their own LASIK surgery. The
broken blood vessel is believed to have occurred because of the tissue
trauma induced by the suction ring (the device used to immobilize the
eye) and the speculum (the device used to move the eyelid out of the
way.) During "all-laser eye surgery", both the suction ring and the
speculum are used. In other words, what happened to Tooma's patient, the
human being associated with Orange County case #01CC06832, can happen to
any all-laser eye surgery patient.
So, too, are all laser eye surgery patients vulnerable to the damaging
effects of Ultraviolet Radiation, which is known to be both carcinogenic
(causing cancer) and cataractogenic (causing cataracts) (References 7,
9, 10, 11, 12)
<== Closing Statements ==>
Is it ethical to give prospective laser eye surgery patients ALL the
information about refractive surgery casualties ? I believe so -- it
is ethical to provide prospective patients with this information.
In short, it is my request that the refractive surgery industry adopt
the following goals as its own.
1) Make the treatment of injured patients a top priority. The patients
with the most eye pain go to the front of the line.
2) Given the evident lack of mature medical solutions for patients
injured by laser eye surgery, make the development of those solutions a
top priority -- more important than selling new surgeries and recklessly
endangering the eye health of new patients.
3) Fully disclose to all prospective patients the entire depth and
breadth of all known adverse outcomes from laser eye surgery. In other
words, count the casualties, and tell prospective patients about those
casualties. Present the information not as something that COULD happen,
but as something that HAS happened, after surgery by almost all of the
"top" refractive surgeons.
Sincerely,
~ Roger ~
Roger E. Bratt
http://www.lasikSOS.com/
Copyright 2003 Roger E. Bratt -- All Rights Reserved.
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This is Not an Advertisement for any of the following persons or
organizations:
Doctor Michael Gordon
Doctor Perry Binder
Doctor Thomas Tooma
Doctor Robert Maloney
Doctor Glenn Kawesch
Bausch and Lomb
VISX
Summit Technology
Nidek
TLC Laser Eye Centers
Loma Linda University
KSWB-TV
Intralase
----------------------------------------------------------------------------------------------------------
REFERENCES.
( Reference 1 ) Counting the Casualties, in medical articles, online
forums, personal websites, Medical Foundations, and recently published
articles in the print media:
Patients with Injured Eyes, Asking for Help.
The online forum at the Surgical Eyes Foundation
http://surgicaleyes.atinfopop.com/4/OpenTopic
The "LASIK Disaster" website. This patient experienced "corneal melt" -
an inflammation that was not diagnosed in the early stages. After about
8 surgeries to deal with the messy situation, her cornea is finally
stabilized, though an extra 100 microns thinner.
http://www.lasikdisaster.com/
LASIK Info Center
http://www.lasikinfocenter.net/
The LASIK SOS Website
http://www.lasikSOS.com
The online forum, about LASIK complications, operated by Dr. Gerald Horn
at the Chicago Laser Center
http://www.lasikprk.com/VisionPlaceIII/bb/bbNOW.htm
USENET newsgroups "sci.med.vision" and "alt.lasik-eyes"
http://groups.google.com/groups?q=sci.med.vision&ie=ISO-8859-1&hl=en
http://groups.google.com/groups?hl=en&lr=&ie=ISO-8859-1&q=alt.lasik-eyes&btnG=Google+Search&meta=
Wendy Lyons Sunshine's article about LASIK casualties in Northern
California, "A Pain in the Eye That's Forever"
http://www.eastbayexpress.com/issues/2003-04-23/feature.html/1/index.html
Wendy Lyons Sunshine's article about LASIK casualties in the Dallas
Texas area, "Shattered Sight, Shattered Lives"
http://www.fwweekly.com/issues/2003-02-20/feature.html/page1.html
( Reference 2 ) Email received from Doctor Robert Maloney Regarding
Debris Embedded in the Cornea During LASIK.
NOTES ...
1. The Doctor's comments below were made in the context of a
conversation about my own post-op complications after LASIK surgery.
2. I have masked Doctor Maloney's contact information using ***
characters. I have also removed the mailing address and fax and phone
number.
3. Normally, I keep emails confidential. However, this email is of
particular interest. Doctor Maloney makes a statement which I believe
all laser eye surgery patients ought to hear BEFORE they have surgery --
that corneal debris is a frequent side effect of LASIK surgery.
4. Additionally, it is interesting to note, that because some patients
apparently do have corneal debris without eye pain, in the case of
patients that do develop eye pain after LASIK, this same debris is for
some reason considered to not be a problem -- to not be a source of
inflammation.
----------------------------------------------------------------------------------------------------------
"From: drmaloney@*************.com
To: ***@yahoo.com
Subject: RE: LASIK Date: Thu, 20 Feb 2003 06:28:47 -0800
Would you like me to help you find someone in the area to do confocal
microscopy on your cornea? To be honest I doubt very much that embedded
debris is the cause of your troubles. Recent clinical studies show that
everyone has microscopic debris, and as you well know, most people do
not
have symptoms of your severity.
I appreciate the issue of delicacy in discussing my patients, but would
you
be comfortable talking in general terms rather than discussing specific
patients?
Robert K. Maloney, M.D.
Maloney Vision Institute"
----------------------------------------------------------------------------------------------------------
( Reference 3 ) In this context, "Would you like to participate in the
Experiment ?" is a rhetorical construct. The most heart-felt advice I
could give you is -- laser eye surgery is one very poorly-administered
experiment that I suggest you NOT participate in.
( Reference 4 ) Bausch & Lomb FDA Filing for the Technolas 217
Ophthalmic Laser
Laser Wavelength 193 nm
Laser Pulse Duration 18 nanoseconds
Laser Head Repetition Rate 50 Hz
Effective Corneal Repetition Rate 12.5 Hz
Fluence (at the eye) 120 mJ/cm2
Range of Ablation Diameter 2.0 to 2.05 mm
http://www.accessdata2.fda.gov/Google/fda_search.pl?client=
fdagov&site=fdagov&restrict=&searchselector=&q=Technolas+217
Search yielded a document named "P990027S002b.doc" when performed June
7, 2003.
Ref.
http://www.fda.gov/search.html
These numbers give 2 options to derive peak power from average power -
does the laser fire 12.5 pulses at the patient's eye every second, or 50
pulses ? I emailed Bausch & Lomb asking for technical input; this matter
has not yet been clarified. Therefore I shall perform the calculations
for both cases.
( Reference 5 ) Translating from milli-watts per square centimeter to
milli-watts per square inch
Power for lasers is frequently expressed using an energy term (joules),
instead of a power term (watts).
120 mJ/cm^2 ==> 120 mW/cm^2
Radiation Source: ophthlamic laser which fires 12.5 pulses 18
nano-seconds long per second with a stated fluence of 120 mJ/cm^2
CW (continuous wave) or pulsed ? : Pulsed
Duty Cycle: .000000225, 12.5 pulses per second ... each pulse is 18
nanoseconds long.
"Fluence", Power Density of laser beam: 120 milli-watts per square
centimeter - 774 milli-watts per square inch - about 3/4 of a watt per
square inch.
Power Density: .774 watts per square inch, about 3/4 of a watt per
square inch.
Peak Watts per Square Inch, if the 120 milli-Joules specification is a
physical average: 3,440,000
Beam Width: 2 millimeters, about 1/ 12 of an inch
Radiation Source: ophthlamic laser which fires 50 pulses 18 nano-seconds
long per second with a stated fluence of 120 mJ/cm^2
CW (continuous wave) or pulsed ? : Pulsed
Duty Cycle: .00000090, 50 pulses per second ... each pulse is 18
nanoseconds long.
Power Density: .774 watts per square inch, about 3/4 of a watt per
square inch.
Peak Watts per Square inch, if the 120 milli-Joules specification is a
physical average: 860,000
Beam Width: 2 millimeters, about 1/ 12 of an inch
( Reference 6 ) Radiation Source: The Sun
CW (continuous wave) or pulsed ? : CW
Duty Cycle: 100%
Average Watts per square meter, in outer space: 1367
http://stratus.ssec.wisc.edu/streamer_web/userman/solar.html
Amount of radiation "absorbed at the surface": 51%
http://www.geog.ouc.bc.ca/physgeog/contents/7f.html
Average Watts per square meter, on the average beach: 697
Average Watts per square foot, on the average beach: 65
Average Watts per square foot, on the beach, at the equator: up to 90
Average Watts per square foot, at 29,000 feet elevation, at the equator:
TBD
Average Watts per square foot, term used in comparison with excimer
laser: 80
(Note: one of the goals of the analysis is to express the ratio as
conservatively as possible, that is, to not over-state the ratio when
comparing the ophthalmic excimer laser to the sun.)
Average Watts per square inch, term used in comparison with excimer
laser: .56 watts per square inch
Amount of solar radiation "absorbed at the surface" if .56 watts is
absorbed at the surface: 63.5%
Frequency Spectrum of the Sun: Broadband - Infrared, Visible,
Ultraviolet
( Reference 7 ) VISX FDA Filing for the Star S2 Ophthalmic Laser
http://www.fda.gov/cdrh/pdf/p930016s014b.doc
V. DEVICE DESCRIPTION
A. Laser System
"The device used in the clinical study was the VISX STAR S2 Excimer
Laser System for which a full description can be found in the SSED for
supplement 7. The excimer is an argon-fluoride laser that generates
pulses at 193 nm wavelength. The output of the excimer laser also has
the following characteristics: fluence of 160 mJ/cm2; 20 nanoseconds
pulse duration; and, pulse repetition rate of up to 10 Hz."
----------------------------------------------------------------------------------------------------------
Power for lasers is frequently expressed using an energy term (joules),
instead of a power term (watts).
160 mJ/cm2 ==> 160 mW/cm2
160 mW/cm2
= 1032 milli-watts per square inch
Average Watts per square inch for the sun, term used in comparison with
excimer laser:
.56 watts per square inch
= 560 milli-watts per square inch
( Reference 8 )
The area of a surface varies with the square of the radius. To increase
the area by a factor of 1000, the radius is increased 31.6 times.
( Reference 9 )
Canadian Center for Occupational Health Safety (CCOHS)
"Occupational Safety Guidelines regarding Exposure to Ultraviolet-C Band
Radiation during Arc Welding."
"Certain types of UV radiation can produce an injury to the surface and
mucous membrane (conjunctiva) of the eye called "arc eye," "welders'
eye" or "arc flash." These names are common names for "conjunctivitis" -
an inflammation of the mucous membrane of the front of the eye. The
symptoms include
· pain - ranging from a mild feeling of pressure in the eyes to intense
pain in severe instances,
· tearing and reddening of the eye and membranes around the eye,
· sensation of "sand in the eye" or abnormal sensitivity to light, and
· inability to look at light sources (photophobia)."
( Reference 10 )
Thomas Jefferson National Accelerator Facility, in Virginia --
http://www.jlab.org/ehs/manual/EHSbook-465.html
"Cornea
An important function of the cornea is to focus light. Damage to the
cornea is caused by exposure to ultraviolet and far infrared radiation.
The cornea is most susceptible to damage from ultraviolet light. Over
exposure to ultraviolet burn light can cause photokeratitus (also known
as Welder's flash, arc eye, snow blindness). Signs of photokeratitus
include redness, tearing and discharge from the mucous membrane that
lines the inner surface of the eyelid. Symptoms include an acutely
painful sensation of gritty material in the eye."
( Reference 11 )
Department of Environmental Health & Safety, at UC-Davis --
http://ehs.ucdavis.edu/sftynet/sn-106.html
"The cornea of the eye is composed of a thin layer of specialized
epithelia cells. These cells can also absorb UV radiation, resulting in
tiny lesions on the cornea that may not be felt for several hours after
exposure. The sensation is much like having sand in your eye. Known as
photokeratitis, welders flash or snow blindness, the effects can last up
to 48 hours but subsides as the cells of the cornea rebuild. Although
most UV radiation that enters the eye is absorbed in the cornea,
molecular changes can occur in the lens as photons bombard proteins and
change their configuration, resulting in cataract formation."
( Reference 12 )
The Canadian Ophthalmological Society
http://www.eyesite.ca/english/program-and-services/policy-statements-guidelines/UV-radiation-eye.htm
"UV phototoxicity has been implicated in causing or accelerating the
progression of several diseases of the eye or its supporting structures,
including the eyelids. The following is a partial list of some of the
more common diseases involved.
Basal cell and squamous cell carcinoma, melanoma: skin cancer of the
eyelids.
Pingueculae, pterygia: conjunctival growths between the eyelids that may
encroach on the visual axis and obstruct or distort vision.
UV photokeratitis, snow blindness, arc welder's burn: acute superficial
"burn" of the cornea from high-intensity short-term exposure to UV
radiation.
Spheroidal degeneration, Labrador keratopathy: loss of corneal clarity
from long-term exposure to UV radiation.
Cataracts: opacification of the crystalline lens of the eye.
Eclipse or solar retinopathy: damage to the retina from acute exposure
during an eclipse or while gazing directly at the sun.
Macular degeneration: central retinal damage in the part of the retina
responsible for the best sight.
Acceleration of the progression of the pigmentary retinopathies
(retinitis pigmentosa), iritis (intraocular inflammation) or cystoid
macular edema (central fluid accumulation in the retina)."
( Reference 14 )
The initial email from KSWB reporter Darlynne Reyes.
NOTES ...
1. 99.99% of the time, I treat incoming email as sacrosanct and
confidential. However, when the email is able to shed light on a public
health epidemic which the laser eye surgery would not like publicized, I
make exceptions to that rule.
2. I have masked Ms. Reyes' contact information using "*" characters. I
have also removed the phone number.
----------------------------------------------------------------------------------------------------------
"From: "Reyes, Darlynne" Dmreyes@*******.com
To: "'***@yahoo.com'" ***@yahoo.com
Subject: Lasik surgery
Date: Wed, 14 May 2003 22:05:02 -0500
Dear Roger,
My name is Darlynne Reyes and I am a reporter at KSWB-TV. I am currently
doing research for a possible story on LASIK eye surgery and I came
across
your website. I would like to talk to you more about this topic. Would
you please give me a call? I'm hoping you can help me out or point me
in the right direction.
My work phone number is: <excised>. Thanks for your time!!
Darlynne Reyes
KSWB-TV
Reporter"
----------------------------------------------------------------------------------------------------------
Phone message from Darlynne Reyes, message left on work phone
approximately May 22, 2003
"Hey Roger
it's Darlynne Reyes calling from KSWB
Thanks for ... uhh ... returning my call
I appreciate that
and ... uh ... actually it's kind of funny that you would leave that
message for me
as far as ... uh ... you being curious what our advertisers would say
because ... uh ... (laughter)
when you had left me that message I talked to my news director
and ... uhh ... that's actually ... uhhh ... exactly what she talked to
me about
and apparently we have done this story before I came on board here
and ... uhh ... there was actually some ... uh ... big problems with the
piece (laughter)
so unfortunately I guess I will not be doing this piece ... uhhh ... for
next month
even though i had hoped to and (in-audible)
Doesn't seem like it's in the cards ... oh well ...
thank you so much Roger
and ... uhh ... I appreciate it and ... uhh ...
maybe we'll work together on some other type o' story
in the meantime thanks for returning my call
OK talk to you later bye bye."
( Reference 15 ) Copyright Statement & Home Page for the analysis
contained in this email.
Copyright 2003 Roger E. Bratt -- All Rights Reserved.
This communication has been be re-published at the home page for LASIK
SOS.com, at this URL --
http://www.lasikSOS.com