FDA, a Petition?, and One injury is one too many
lasik advocate with flap melt
petition is this? It includes the question about what "rare" means to
the general person who reads a consent form that sounds like legalize.
What's it mean to you?
I'm not sure if I agree with everything in here or not, but it seems
to have some studies to back it up. I would have included that the
true complication rates are unknown, and that it is now known that at
least one person became blind in BOTH eyes. 5% complications would
fill a large stadium with people. Wearing RGPs isn't safe either due
to the risk of subsequent DLK (as I understand from reading the
discussions on this message board). I didn't see anything in it about
people going blind from LASIK. We know it happens because the FDA
includes "irreversible blindness" as a "risk".
"One patient became blind in both eyes, one became blind in one eye,
and the other two patients lost their visual ability in both their
eyes to varying degrees"
http://spirit.dos.uci.edu/useeeyes/cnews.html#04/26/2002:%20Rare%20LASIK%20Complication%20Can%20Damage%20Vision
"The newly discovered protocols pioneered at LASIK Eye Centres allowed
for the actuarial statistical analysis of more than 100,000
procedures. This was the basis for the largest controlled cohort
studies that have ever been generated in the field."
http://www.lasikeyecentres.com/Content/Default.aspx?pg=1014
xxxxxxxxxxx
from http://www.lasiksucks4u.com/petit1.htm
The following petition was sent to the FDA in an effort to stop the
increasing number of Lasik casualties. Although many doctors have
abided by the regulations set by the FDA, and have had successful
surgeries, there are many based on the reported number of casualties
who have not. Actual counts of those casualties are not known due to
non-reported cases. Since the FDA cannot totally enforce what they
mandate, why should these doctors be allowed to put people at such
high risk.
--------------------------------------------------------------------------------
Petition to the Food and Drug Administration regarding Medical Devices
used for Elective Refractive Eye Surgery with Premarket Approvals
(PMAs)
If additional information, separate comments or any other modification
to this submission is required to comply with the FDA's procedures,
please contact the Petitioner as soon as possible. We the undersigned
hereby petition the FDA to change or cancel a regulation, or to take
other action as outlined in the FDA's published procedures
(http://www.fda.gov/opacom/backgrounders/voice.html). The scope of
this petition involves ALL lasers and other instruments that currently
have FDA PreMarket Approvals (PMAs) for elective refractive eye
surgery (excluding those solely used for surgeries considered to be
either medically necessary or humanitarian and do Not have PMAs.).
Table of Contents
1. Statement of grounds
1.1 Examples of Devices included in the Scope of the Petition
1.2 Consistency with FDA's Goals
1.3 Legal Basis of this Petition
1.4 Additional legal basis of this Petition
2. Reasons for this Petition
3. Synopsis of Actions requested for the FDA (See section 3 below for
further Details).
3.1 ACTION 1. Develop a national agenda for the prevention of
injuries from elective refractive eye surgery and implement it through
coordination of federal efforts across a variety of private and public
agencies including the Department of Health and Human Services.
Uniform legislation should be required by law, enacted and enforced in
every state to mandate specific minimal safety practices. Gather
better data on the quality of care available. There are precedents in
other areas of medicine.
(http://www.hsph.harvard.edu/qcare/schneider.html). In the interest
of Public Health, insist that the FDA's PMA approvals and labeling
include the requirement that all physicians performing this surgery
are either properly trained and equipped to handle every possible
complication of refractive eye surgery OR that they refer patients
with any complication they are Not properly equipped to treat to
another physician who is available to treat all complications at the
referring physicians expense.
3.2 ACTION 2. Collect Information on the cost effectiveness of
strategies to reduce injuries caused by non-medically necessary
elective Refractive Eye Surgery to better inform public debate on the
merits of injury interventions. Many public health safety issues
regarding Refractive Eye Surgery have Not been adequately researched.
Create a comprehensive analysis of spending on the magnitude of the
total costs of elective eye surgery injuries, and the effectiveness of
prevention efforts.
3.3 ACTION 3. Conduct a retrospective comprehensive study of the
incidence and prevalence of injuries to track ALL the relevant risks.
Gather and collect all surveillance and monitoring data to allow
proper education and targeting of interventions. Could the Medical
Device Surveillance Network, MedSuN program be used for this purpose?
The United Sates Eye Injury Registry (USEIR;
http://www.useironline.org/Index2.html), a federation of state eye
registries, uses a standardized form to obtain voluntarily reported
data on eye injuries.
3.4 ACTION 4. Draft an enforcement policy for implementation of the
Federal Food, Drug, and Cosmetic Act regarding these devices along
with a document of comprehensive guidance for industry (or update any
existing documents to reflect the current state of knowledge). There
is a precedence for the FDA providing guidance on other things
regulated by the FDA
(http://www.fda.gov/OHRMS/DOCKETS/98fr/060702c.htm).
3.5 ACTION 5. Create national training programs and career
development awards for a multidisciplinary group of professionals to
monitor and implement elective eye surgery injury controls with
funding from federal agencies.
3.6 ACTION 6. Implement of the final FDA ruling should involve,
among other things, package redesign, redesign of websites and
promotional literature, and sometimes, new packaging for equipment,
and an update of the labeling requirements for all devices for any and
all then currently known risks. Remove any wording that the Public
could potentially misinterpret as an endorsement by the FDA including,
but not limited to the words Approved, Safe, etc. The American
Society of Cataract and Refractive Surgery (ASCRS) endorses the Lasik
Institute as their educational website. And the Lasik Institute under
Suggestions for Further Reading includes links to four consent forms
in http://www.lasikinstitute.org/RisksnComplications.html. Rather
than write a consent form based on what the ASCRS believes would be
good informed consent, why are these consent forms written by an
insurance company (Ophthalmic Mutual Insurance Company)?
Are these (www.omic.com) ASCRS endorsed informed consent consistent
with the labeling requirements of the PMAs for these Class III
devices?
Consent for LASIK for the Correction of Myopia (Nearsightedness).
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Informed Consent for LASIK for the Correction of Hyperopia
(Farsightedness)
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Consent for Bilateral Simultaneous LASIK
http://www.omic.com/resources/risk_man/forms/consent/LASIKbilatsim-myopia.rtf
Consent for LASIK on the Second Eye in an Interval of Less than One
Week (myopia)
http://www.omic.com/resources/risk_man/forms/consent/LASIKsecondeye.rtf
"ASCRS Mission: The mission of the American Society of Cataract and
Refractive Surgery is to raise the standards and skills of anterior
segment surgeons through clinical and practice management education
and to work with patients, government and the medical community to
promote delivery of quality eye care."
3.7 ACTION 7. Oversee the entire life cycle of these devices--from
production through distribution, and consumption/use of these class
III devices to assess whether the products are as safe as labeled and
safe period as stipulated in their PMA approvals.
3.8 ACTION 8.Hold an Ophthalmologic advisory panel meeting to
consider the surveillance data for each PMA of all manufacturers and
decide whether there is now sufficient data on safety and
effectiveness for these class III devices to continue to serve a
public health need and whether they should continue to be approved by
the FDA. At what point are the risks of certain types of procedures,
equipment or procedures significantly higher such that they should
banned? The Petitioner believe that the potential risks versus
possible benefits assessment favor a withdrawal of FDA approval of all
PMAs for the lasers listed in this petition in the interest of
protecting the Public Health (except for humanitarian purposes only).
3.9 ACTION 9. Place a moratorium on any further non-medically
necessary elective Refractive Eye Surgeries other than for strict
humanitarian purposes If:
the severity, totality of the risks (and their likelihood) of actual
injuries to the public that have occurred from the actual practice
(including non-research centers) of non-medically necessary elective
Refractive Eye Surgeries are a larger risk to the public health than
identified in previous research OR
Prudent injury intervention strategies are Not feasible to adequately
protect the Public from injury
4. Certification.
Statement of grounds
1.1 Examples of Devices included in the Scope of the Petition
Any humanitarian or medically necessary procedures for cataracts or
other eye conditions are Not the subject of this petition.
From http://www.fda.gov/cdrh/LASIK/lasers.htm
Company and model
Approval number and date
Approved indications
(D = diopters)
Alcon
- LADARVision
P970043/S10
10/18/02
Wavefront-guided LASIK: Myopia up to -7.0D with or without
astigmatism less than 0.5D
Autonomous Technology
- LADARVision
P970043/S5
5/9/00
Myopia less than -9.0D with or without astigmatism from -0.5 to -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027
2/23/00
Myopia from -1.0 to -7.0D with or without astigmatism less than -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027/S2
5/15/02
Myopia less than -11D with or without astigmatism less than -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027/S4
2/25/03
Hyperopia between 1.0 and 4.0D with or without astigmatism up to 2.0D
Dishler
P970049
12/16/99
Myopia from -0.5 to -13.0D with or without astigmatism between -0.5
to -4.0D
Kremer
P970005
7/30/98
Myopia from -1.0 to -15.0D with or without astigmatism up to -5.0D
LaserSight
- LaserScan LSX
P980008/S5
9/28/01
Myopia from -0.5 to -6.0D with or without astigmatism up to 4.5D
Nidek
- EC5000
P970053/S2
4/14/00
Myopia from -1.0 to -14.0D with or without astigmatism less than 4.0D
Summit
- Apex Plus
P930034/S13
10/21/99
Myopia less than -14.0D with or without astigmatism from 0.5 to 5.0D
Summit Autonomous
- LADARVision
P970043/S7
9/22/00
Hyperopia less than 6.0D with or without astigmatism less than -6.0D
VISX
- Star S2 & S3
P930016/S12
4/27/01
Hyperopia between +0.5 and +5.0D with or without astigmatism up to
+3.0D
VISX
- Star S2 & S3
P930016/S14
11/16/01
Mixed astigmatism up to 6.0D; cylinder is greater than sphere and of
opposite sign
VISX
- Star S2
P990010
11/19/99
Myopia less than -14.0D with or without astigmatism between -0.5 and
-5.0D
VISX
- Star S3 (EyeTracker)
P990010/S1
4/20/00
Same as S2, except with eye tracker
FDA-Approved lasers for PRK and other refractive surgeries
Company and model
Approval number and date
Approved indications
(D = diopters)
Autonomous Technology
- LADARVision
P970043
11/2/98
PRK; Myopia from -1.0 to -10.0D with or without astigmatism less than
-4.0D
Bausch & Lomb Surgical
- KERACOR 116
P970056
9/28/99
PRK; Myopia from -1.5 to -7.0D with or without astigmatism less than
-4.5D
LaserSight
- LaserScan LSX
P980008
11/12/99
PRK; Myopia from -1.0 to -6.0D with or without astigmatism less than
1.0D
Nidek
- EC5000
P970053
12/17/98
PRK; Myopia from -0.75 to -13.0D
Nidek
- EC5000
P970053/S1
9/29/99
PRK; Myopia from -1.0 to -8.0D with or without astigmatism from -0.5
to -4.0D
Refractec
- ViewPoint CK System
P010018
4 /11/02
Conductive keratoplasty; Hyperopia from +0.75 to +3.25D with or
without astigmatism up to 0.75D
Summit
- Apex & Apex Plus
P930034
10/25/95
PRK; Myopia from -1.5 to -7.0D
Summit
- Apex Plus
P930034/S9
3/11/98
PRK; Myopia from -1.0 to -6.0D with or without astigmatism from -1.0
to -4.0D
Summit
- Apex Plus
P930034/S12
10/21/99
PRK; Hyperopia from +1.5 to +4.0D with or without astigmatism less
than -1.0D
Summit Autonomous
- LADARVision
P970043/S8
7/11/00
Name Change Only
Sunrise
- Hyperion
P990078
6/30/00
Laser Thermokeratoplasty (LTK); Hyperopia from +0.75 to +2.5D with or
without astigmatism less than 0.75D
VISX
- Model B & C (Star & Star S2)
P930016
3/27/96
PRK; Myopia from 0 to -6.0D
VISX
- Model B & C (Star & Star S2)
P930016/S3
4/24/97
PRK; Myopia from 0 to -6.0D with or without astigmatism from -0.75 to
-4.0D
VISX
- Model B & C (Star & Star S2)
P930016/S5
1/29/98
PRK; Myopia from 0 to -12.0D with or without astigmatism from 0 to
-4.0D
VISX
- Star S2
P930016/S7
11/2/98
PRK; Hyperopia from +1.0 to +6.0D
VISX
- Star S2 & S3
P930016/S10
10/18/00
PRK; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to
+4.0D
VISX
- Star S2 & S3
P930016/S13
3/19/01
Add myopia blend zone; increase overall ablation zone from 6.5 to
8.0mm
1.2 Consistency with FDA's Goals.
The benefits of this petition outweigh the costs by effectively
utilizing the limited FDA resources in an area where they are most
needed to meet the goals of the FDA, Assuring Medical Product Safety,
and protecting the Public Health.
(http://www.fda.gov/ope/FY03plan/default.htm). The following
statements provide the basis for the benefits of this petition. The
costs would be based on which agencies and what specific actions are
taken based on this petition.
"Consumers spend $326 billion annually in the U.S. on medical
products. An estimated 1.3 million people are accidentally injured by
medical therapy in the U.S. each year, and as many as 100,000 die as a
result of preventable medical errors. FDA must be vigilant in
monitoring the production, distribution and use of these products
because FDA's presence raises the likelihood that public health and
safety problems associated with these products will be addressed and
because it is critical to citizen safety."
"To ensure that these products are safe the Agency must oversee their
entire life cycle--from production through distribution, and
consumption/use. "
"FDA's three primary strategies for ensuring medical product safety
are to: a) enhance global vigilance over product manufacturing and
distribution; b) strengthen and focus domestic industry monitoring;
and, c) expand and automate the systems which report on adverse events
associated with the use of medical products. "
The FDA's goals are consistent with preventing injury and protecting
the Public Health. Has the FDA ignored or even endorsed another
potential Public Health Crisis (e.g., breast implants)?
"A weakened FDA can only move slowly and with uncertainty. Consumer
confidence in the Agency suffers, and real health and safety risks may
grow."
http://www.fda.gov/ope/fy03plan/goals3.html
"* Human Subject Protection--FDA, in cooperation with other health
and safety overseers, must ensure that human subjects are adequately
protected during clinical trials. There is heightened concern for the
rights and welfare of volunteers, given the rapidly changing research
environment has led to a proliferation of multi-site clinical trials,
an increase in clinical trials using vulnerable populations. . ."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=9
"Although FDA does place emphasis on expedited review of new products,
it is also responsible for overseeing all of the activities that span
new product development--from initial research to final market
approval."
* New technologies -- FDA must have a state-of-the-art understanding
of the new science and technology that fuels these new
products—particularly developments in the biotechnology field--so that
review decisions on such products can be based on rigorous
science-based standards; "
http://www.fda.gov/ope/fy03plan/goals4.html
(http://www.fda.gov/ope/fy03plan/goals2.html)
"Radiological health resources dropped from 400 FTEs in FY 1978 to
less than 50 FTEs in FY 2001. We are seeing a resurgence of problems
in both the medical and consumer product area."
"Provide inspection coverage for Class II and Class III foreign
medical device manufacturers at 9 percent in FY 2003. (15005.02)"
"FDA's premarket functions support the Department's Prevention
Priorities, and the postmarket functions support the Department's
Medical Errors/Healthcare Quality Priorities."
Strategic Goal 1:
Provide the medical community with faster access to important,
life-saving and health-enhancing medical devices, while assuring their
safety and effectiveness.
Medical devices vary widely in their complexity and their degree of
risk or benefits, and do not all need the same degree of regulation.
Strategic Goal 2:
Reduce the risk of medical devices and radiation-emitting products on
the market by assuring product quality and correcting problems
associated with their production and use.
2) Targeted Inspections-for approval to market high risk devices;
inspections triggered by adverse reaction incidents; or product
recalls
http://www.fda.gov/ope/fy03plan/part2_med.html
"FDA's Center for Devices and Radiological Health (CDRH) has developed
key strategies to more directly promote and protect the public health
through the total life cycle of a product. This will allow CDRH to
focus regulatory resources on products in a least burdensome way no
matter what their stage of development; from concept development to
active marketing or modification."
* Total Product Life Cycle (TPLC) -- Apply TPLC model in
coordination with stakeholders;
* Meaningful Metrics -- Measure and communicate our impact on the
public health; and
* Knowledge Management -- Manage knowledge to support TPLC in the
information age.
"Two key strategic goals have been established for the 21st Century:
* Provide the medical community with faster access to important,
life-saving and health-enhancing medical devices, while assuring
safety and
effectiveness.
* Reduce the risk of medical devices and radiation-emitting products
on the market by assuring product quality and correcting problems
associated with their production and use."
(http://www.fda.gov/ope/fy03plan/goals.html)
1.3 Legal Basis for this Petition
The Petitioner make a public demand that the Food and Drug
Administration--the leading U.S. public health regulatory
agency--assert its authority and supremacy in protecting the Public
Health.
There are multiple legal bases for this petition as the lasers have
PMAs that place them within the FDA's and the CDRH division's
jurisdiction as Class III medical devices.
First, The Petitioner believe that the potential risks versus possible
benefits assessment favor the Actions proposed in this petition and
are consistent with the FDAs own objectives including Healthy People
2010. "The PHS is committed to achieving the health promotion and
disease prevention objectives of Healthy People 2010, a PHS-led
national activity announced in January 2000 to eliminate health
disparities and improve years and quality of life."
(http://www.fda.gov/OHRMS/DOCKETS/98fr/062502c.pdf).
Second, FDA regulations state that the FDA may require the submission
of the adverse safety and effectiveness data, as described in the
Class III summary or citation under title 21 Parts 800 to 898, Sec.
807.94, Sec. 807.100, section 515, and other Acts
(http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm).
Currently all of the adverse events are Not reported to the FDA
because the FDA does Not enforce reporting by all distributors and
medical providers (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).
Also, adverse events related to the procedure the laser is used for,
but Not related to the laser itself are Not necessarily reported.
Third, the Petitioner requested actions that the Federal government
develop a comprehensive surveillance plan and initiate other measures
to protect the Public from injury and the Public Health in general is
based on section 522 (21 U.S.C. 360l). The CDRH has recorded that the
failure of these devices has caused serious adverse health
consequences and further research proposed in this petition or planned
surveillance will result in the collection of useful data that can
reveal unforeseen adverse events or other information necessary to
protect the Public Health under Sec 522 (a) and (b).
Fourth, Section 522(a) states that " In General.--The Secretary may by
order require a manufacturer to conduct postmarket surveillance for
any device of the manufacturer which is a class II or class III device
the failure of which would be reasonably likely to have serious
adverse health consequences"
(http://www.fda.gov/cder/guidance/105-115.htm#SEC.%20212).
Fifth, under the FDA's authority with the Federal Food Drug and
Cosmetic Act and all rules and regulations promulgated or annexed
therein, including, but not limited to section 515(d) (g), 520(e) (q)
and (r), 21 CFR 801.109, 21 CFR 803.5, 21 CFR 803.10, 21 CFR 814.82,
21 CFR 814.84, 21 CFR 814.39, and the FOOD AND DRUG ADMINISTRATION
MODERIZATION ACT OF 1997, the Petitioner ask the FDA to act and to
implement the enclosed Actions.
1.4 Additional Legal Basis of this Petition
The FDA is mandated to assure Medical Product Safety. "To ensure that
these products are safe the Agency must oversee their entire life
cycle--from production through distribution, and consumption/use"
(http://www.fda.gov/ope/fy03plan/goals3.html). Even if these PMA
approved lasers were safe in the best of hands used for FDA clinical
trials, would the FDA meet it's goals and objectives if it was allowed
to be used significantly LESS safely or highly risky ways by medical
practitioners and their independent contracts or "technicians" on
thousand or millions of United States citizens?
The FDA does consider petitions
(http://www.fda.gov/opacom/backgrounders/voice.html) and comments for
the development of future policy
(http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm) and
has authority to change that policy under Title 21 Parts 800 to 898,
Sec. 807.94, Sec. 807.100, section 515, and other Acts
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=807.100).
According to the World Medical Association Declaration of Helsinki
that the FDA has endorsed, "It is the mission of the physician to
safeguard the health of the people. His or her knowledge and
conscience are dedicated to the fulfillment of this mission." The
Declaration of Geneva of the World Medical Association binds the
physician with the words, "The health of my patient will be my first
consideration," and the International Code of Medical Ethics declares
that, "A physician shall act only in the patient's interest when
providing medical care which might have the effect of weakening the
physical and mental condition of the patient"
(http://www.fda.gov/oc/health/helsinki89.html). And finally, "the
Purpose of biomedical research involving human subjects must be to
improve diagnostic, therapeutic and prophylactic procedures and the
understanding of the aetiology and pathogenesis of disease."
The FDA also supports the The Belmont Report, Ethical Principles and
Guidelines for the Protection of Human Subjects of Research.
Are the Basic Ethical Principles being followed to protect the patient
including informed consent,information, comprehension, risk/benefit
assessment, and the selection of subjects for research?
(http://www.fda.gov/oc/ohrt/irbs/belmont.html;
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm). Are
the risks and complications done for patients, accurate, and complete?
(http://www.eyesurgeryeducation.org/RisksnComplications.html)
"Domestic Industry Monitoring -- The law requires that FDA inspect
certain biologics, human and animal drug and feed, and medical device
manufacturers at least once every 2 years. Although at least 50
percent of statutory establishments should be inspected annually, only
22 percent of human drug, and 13 percent of medical device statutory
establishments were inspected in FY 2000. FDA will still fall far
short of its statutory inspection requirements given current funding
levels."
(http://www.fda.gov/ope/fy03plan/goals2.html)
"The Agency must allocate a significant proportion of its inspections
to high risk situations, such as firms who are producing high risk
medical devices, or where the technology is rapidly evolving and must
be more closely monitored."
Based on the percentage of adverse events reported in the trials used
to approve the PMAs for the lasers, the simple fact that the number of
serious eye injuries caused by non-medically necessary elective eye
surgery far exceeds the number and likelihood of serious eye injuries
from ALL other causes provides a legal basis for this petition.
"LASIK is currently the most common type of laser eye surgery in the
U.S., performed an estimated 1.5 million times each year."
(http://www.lasikinstitute.org/Newsroom_trialsshow.html).
Furthermore, the American Academy of Ophthalmology has supported
banning a device (bottle rockets) that since 1995 due to it causing
eye injuries similar to those caused by elective refractive eye
surgery. From July 1990 to December 1994, for instance the total
number of serious eye injuries from all causes reported to the United
States Eye Injury Registry (USEIR) was 4,575 cases (Serious Eye
Injuries Associated With Fireworks- United States, 1990-1994 MMWR Vol.
44/No. 24, June 23, 1995, pp. 449-52; Center for Disease Control MMWR
journal). On average over that 4 ½ year time period, that amounts to
~1,017 eye injuries per annum. Based on public information that over a
million LASIK operations alone are performed every year and the
percentage of those operations causing serious eye problems, the
number of serious eye injuries per annum of elective eye surgery far
exceeds all other causes.
The Petitioner believe that non-medically necessary elective eye
surgery has Not been studied well enough to determine whether it is
too risky to the Public Health and the true costs of the FDA
continuing to approve the use of any lasers or equipment for this
purpose. Several states have prohibited bottle rocket sales, and such
bans are supported by the American Academy of Ophthalmology (AAO; Eye
Safety and Sports Ophthalmology Committee. Fireworks remain serious
health hazard and cause of blindness. San Francisco: American Academy
of Ophthalmology, May 1995). Bottle Rockets were banned by the AAO in
part because they cause many of the fireworks related serious eye
injuries. From 1990-1994, there were 274 fireworks-related serious eye
injuries reported to the United States Eye Injury Registry (USEIR) and
approximately 160 of those were caused by bottle rockets (58% of the
fireworks injuries; Serious Eye Injuries Associated With Fireworks-
United States, 1990-1994 MMWR Vol. 44/No. 24, June 23, 1995, pp.
449-52; Center for Disease Control MMWR journal;
http://wonder.cdc.gov/wonder/prevguid/m0037986/m0037986.asp).
The FDA has experienced problems before with silicone breast implants
(http://www.fda.gov/cdrh/breastimplants/indexbip.html). Years after
the FDA allowed it to proceed, the Institute of Medicine (IOM)
completed its independent, unbiased review of all past and ongoing
scientific research study of silicone breast implant safety in June
1999 and concluded "First, reoperations and local and perioperative
[right after surgery] complications are frequent enough to be a cause
for concern and to justify the conclusion that they are the primary
safety issue with silicone breast implants. Complications may have
risks themselves, such as pain, disfigurement, and serious infection
and they may lead to medical and surgical interventions, such as
reoperations, that have risks. Second, risks accumulate over the
lifetime of the implant, but quantitative data on this point are
lacking for modern implants and deficient historically. Third,
information concerning the nature and the relative high frequency of
local complications and reoperations is an essential element of
adequate informed consent for women undergoing breast implantation."
(http://www.fda.gov/cdrh/breastimplants/birisk.html)
Thousands injured is too many.....We are talking about eyes. not warts
lasered off of toes.
2. Reasons for This Petition
The risks of using these PMA approved medical devices referred to in
this petition may far outweigh the potential benefits and present a
risk to Public Health. Are the Cumulative Risks Worth the Benefits of
Elective Refractive Eye Surgery? A permanent loss of eyesight, dry
eyes, chronic pain, and/or other "complications of LASIK is a high
price to pay when glasses and contacts could provide better vision (in
most cases) with a much lower risk. Taken together, the Petitioner
believe the actual sum of the risks for the non-medically necessary
use of the Class III devices referred to in this petition far outweigh
the potential benefits.
What is the total cost of elective eye surgery both to the individual
and to the Public Health at large? You can take each and every one of
the risks and costs, isolate them and ask the question, "Does each
outcome standing alone tell you how big the risk is"? And the answer
is no. That one standing alone will not tell you that. Examining each
brick and saying "This brick does not make a wall" ignores the wall.
And studies are important and all of these individual pieces of
information are important. But when we want to see the total picture,
the whole picture, we have to examine the pieces and put the picture
together. For instance, is the cornea ever again quite as strong as a
virgin, untouched cornea?
We the Petitioner is simply asking you to look at the entire wall and
see the entire picture. What is the total effect on patients quality
of life and the ultimate economic costs of any losses? Wouldn't
outcomes research be useful? (Quality of Life and Pharmacoeconomics:
An Introduction by Joyce A. Cramer, Bert, Ph.D. Spilker; Lippincott
Williams & Wilkins Publishers; 2nd edition, January 1998). For
additional recommendations on research that could be conducted and
why, see Appendix B.
Some of the more specific reasons for this petition include:
Also See Appendices A, B, C for additional risks necessitating further
research.
· Why would any sane person knowingly consent to taking these
risks? Is it ethical to allow anyone who is healthy to even take
these risks, and to only take them for cosmetic reasons when glasses
work as well or better?
· Many medical errors and unintentional injuries from elective
corneal eye surgeries can be prevented and are costly. The risks of
using these PMA approved medical devices referred to in this petition
may far outweigh the potential benefits and present a risk to Public
Health. Many Substantive Risks and the full scope of the risks have
Not been Addressed.
· Use of the Terms "Safe" and "Approved" in Connection with
Elective Refractive Surgery are Not accurate. The risks and costs
have NOT been studied adequately for the FDA to use the word "safe" or
"approved" when referring to eye surgery on formerly normal, healthy
eyes.
· Is comanagement as it is practiced commonly with Elective Eye
Surgery where the Optometrists frequently don't consult with the
Opthalmologists about complications safe? The ASCRS endorses the
practice- see their informed consent form:
http://www.ascrs.org/advocacy/comanageconsent2.doc. Here's how one
company uses it for "affordability" in the real world,
http://www.lasikvisioninstitute.com/html/bg_affordability.html. Is
this right?
· Further research is needed to know the full extent of the
risks of Elective Refractive Eye Surgery. The clinical studies upon
which the were approved did not provide the FDA with information
necessary to judge the full scope of risk. Many Substantive Risks and
the full scope of the risks have Not been Addressed including
Psychiatric and Psychological Effects. Psychiatry is a branch of
medicine and psychiatric variables tell the story of the real effects
of complications on people's lives. Is a high satisfaction rate
equivalent to an improved quality life? If patients are delighted
when RS succeeds, is it not logical to believe that they will be
miserable when it fails? Should patients know they may be
"consenting" to the possibility of being miserable for life? What
about the quality of life for those who are Not satisfied? Subjects
experiencing complications from refractive surgery in the original
clinical trials should have been questioned as to the effect of
complications on their mood, level of cognitive functioning, and other
relevant psychological variables. Instead, the clinical trials report
only ophthalmic and optometric variables and many of those were left
out too. With millions of people having refractive surgery every year
in the US alone, shouldn't the real risks be clear? Patients have a
right to know that if refractive surgery fails, it is likely that they
will become severely depressed or even experience suicidal ideation.
Patients also need to know that if they do experience severe
depression and suicidal ideation, treatment with the modern and
effective antidepressant drugs may be impossible because they often
aggravate another complication- dry eyes.
· Are there more risks of a bad outcome, problems or
complications at "discount" Lasik providers
(http://www.canolaservision.com/info/News.htm)? Whereas it is common
in other sciences to study such constructs as interrater reliability
and the generalizability of clinical interventions across practioners,
the extent to which the clinical outcomes presented in the FDA
clinical trials for the above mentioned Class III medical devices is
unclear. Thus, respected sources of laser surgery carry information
report that "We see a lot of problems from the discount places." (By
Julia Malone c.2001 Cox News Service
http://www.emoryvision.com/ajc3_2001.html). Previous research has
shown that glare, halos, starbursts, diplopia and other vision
problems (including in ordinary indoor lighting conditions) are more
common in other studies done than in those used for the PMA approvals
(http://jrs.slackinc.com/vol142s/abs-l.pdf).
· No research was submitted to the FDA regarding patterns of
comorbidity of complications. Yet, it is well known that certain
complications tend to occur together. Ophthalmology and comanaging
optometrist frequently refer to glare, astigmatism, starbursting, and
halos under the acronym "GASH". These patterns of comorbidity has vast
implications for FDA labeling and informed consent that have been
neither recognized nor appreciated. If the complications of refractive
surgery are not independent, but tend to occur together, then patients
must be advised that if they experience one complication, for example,
they are likely to experience two or more. In general, the more
complications experienced by a patient, the more likely it is that he
or she will experience depression, suicidal ideation, or one of the
syndromes listed above.
· Often, final vision quality is inferior to pre-surgical
vision and night vision is ". . . significantly impaired"
(http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf)? "The
Canadian Medical Association has added laser eye surgery to a list of
risk factors for unsafe driving, and recommends doctors test the night
vision of patients who may be experiencing visual difficulty following
surgery." (Louise Elliott, Canadian Medical Association Says Laser Eye
Surgery Can Pose Driving Risk, Canadian Press, 8/27/00) "58 percent
failed a night vision test, said ophthalmologist Dr. William Jory of
the London Centre for Refractive Surgery in London, England." (Night
Blindness Rising in Laser Eye Surgery Patients, London Free Press,
7/17/00). "Although high contrast visual acuity recovers by 1 year
after PRK, low contrast visual acuity and glare deteriorate
significantly and do not recover, even after 1 year." (J Refract Surg.
1996;12:S267-S268.)
· Wavefront is Not the answer to the problems. "These
wavefront things are two or three orders of magnitude better than we
can get with the lasers, and the healing response and the
environmental conditions also influence our surgery results". .
."Until we control the variables so we can get the standard of error
of the laser down to 0.1 D, all these little measurements we do are
not very important". . ."The standard of error in lasers usually
averages about 0.5 D at best, he said."
(http://www.aao.org/aao/news/eyenet/archive/05_00/feature2.html)
· These laser devices with PMAs, contrary to their PMAs, May
Not be as safe or substantially equivalent to the legally marketed
devices that were or are currently on the U.S. market and DO in fact
raise different questions of safety and effectiveness than the
predicate device (http://www.fda.gov/cdrh/dsma/pmaman/sec04a.html#P1821_105059).
· Adverse Events listed in the Approval orders are Not reported
in some cases to the FDA. The following adverse events are frequently
Not reported to the FDA: loss of best spectacle corrected visual
acuity (based on acuity prior to surgery), worsening of patient
complaints such as double vision, sensitivity to bright lights,
increased difficulty with night vision, fluctuations in vision,
increase in intraocular pressure, corneal haze, secondary surgical
intervention, corneal infiltrate or ulcer, corneal epithelial defect,
corneal edema, problems associated with the flap, retinal detachment,
and retinal vascular accidents. As a result, both the FDA and the
medical professionals charged with the use of these devices listed
herein have failed to acknowledge the extent and severity of
complications created by these devices, both to patients and to the
public. Please see supportive material listed in Appendix B of this
petition.
· The surveillance system already in place (USEIR) for tracking
Serious Eye Injuries is Not being utilized to track the injuries
resulting from Elective Refractive Eye Surgery and there is No
national registry or database where the data can be shared across
centers for further research.
· True Outcomes and Complication rates of Refractive Eye
Surgery are Not being provided to patients when they ask. The actual
outcomes from the standard use of these devices may actually be much
higher than those done in the studies evaluated by the FDA to provide
the PMAs for these Class III devices.
· It just makes common sense Not to do something that is Not
medically necessary and that may cause "irreversible blindness", an
inability to work, or an inability to read comfortably even if many
people like their vision initially.
· Cutting a flap or doing anything to a healthy cornea is Not
good for the eye or for vision. "The average dioptric difference in
the central region is -1.08 D (flattening), and the average dioptric
dif-ference in the outer region is +10.20 D (steepening), all induced
just by cutting the flap."
(http://www.slackinc.com/eye/jrs/vol164/edit.pdf)
· Elective Refractive Eye Surgery with Lasers may cause early
cataracts. (PRK and LASIK--their potential risk of cataractogenesis:
lipid peroxidation changes in the aqueous humor and crystalline lens
of rabbits, Wachtlin J, Blasig IE, Schrunder S, Langenbeck K, Hoffmann
F., Cornea. 2000 Jan;19(1):75-9; Photorefractive keratectomy and
cataract, Costagliola C, Di Giovanni A, Rinaldi M, Scibelli G,
Fioretti F., Surv Ophthalmol. 1997 Nov;42 Suppl 1:S133-40; ArF 193 nm
excimer laser corneal surgery as a possible risk factor in
cataractogenesis, Costagliola C, Balestrieri P, Fioretti F, Frunzio S,
Rinaldi M, Scibelli G, Sebastiani A, Rinaldi E., Exp Eye Res. 1994
Apr;58(4):453-7)
· The full risks and costs of injuries from these Class III
devices have NOT been studied adequately for the FDA to use the word
"safe" or "approved" when referring to the use of these devices for
eye surgery on formerly normal, healthy eyes. Please see supportive
material listed in Appendix B and C of this petition. Where is the
independent research for elective eye surgeries like there was for
breast implants? Has anyone bothered looking at the risks of
re-operations? Are the risks higher and the satisfaction rate lower
for re-operations? Do the risks accumulate over the lifetime of the
individual or does it stop shortly after surgery? What is the risk of
irreversible blindness, difficulty reading, or difficulty working?
Are patients adequately informed about the actual risks and the
likelihood of those risks occurring in the real world (outside of a
controlled study submitted to the FDA)?
· How likely is LASIK to cause dry eye? "Dry Eye Syndrome, is
the most frequent patient complaint to eye doctors. About 33 million
Americans in all groups experience varying degrees of dry eye
syndromes." (http://www.visionworksusa.com/disease.asp?d_num=5;
http://www.ohiovalleyeye.com/eyeinfo_blepharitis.html). "There is a
theory that by cutting across the cornea, you cut the corneal nerves,
and it decreases the stimulus of the eye, the feedback mechanism from
the eye to the brain. Therefore, you have a reduction in the
production of tears." Other theories involve goblet cell disruption
caused by the suction ring that is placed at the limbus ― a site
that boasts a high concentration of goblet cells ― as well as
the idea that an alteration of the tear flow has been brought about by
LASIK. "My hunch is that it's probably a combination of those three as
opposed to just one specifically.". . . "Not all patients are
affected, but a very high percentage are." (Diane M. Watson, Patient
Education, Proactive Approach Crucial When Treating Lasik-Induced Dry
Eye, Primary Care Optom. News, 5/00
· Patients have experienced medical complications from the use
of these devices that are devastating from a psychiatric and
psychological perspective, including the development of Acute Stress
and Posttraumatic Stress Disorder (accompanied by Dissociative
symptoms), Generalized Anxiety Disorder, Panic Disorder,
Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major
Depression. Additionally, patients experiencing these syndromes
sometimes describe suicidal ideation.
· Are there more risks of a bad outcome, problems or
complications at the discount places
(http://www.canolaservision.com/info/News.htm)? "We see a lot of
problems from the discount places." (By Julia Malone c.2001 Cox News
Service; http://www.emoryvision.com/ajc3_2001.html)
· Vision quality is usually Not as good afterwards as it was
before when corrected with glasses or contacts. "There is not a
single laser on the US market today that delivers the appropriate
overall energy for the ablations we perform". "Our data show that the
lasers are actually undertreating in the periphery—at 6.0 mm, it is
about 25% reduced from its designated calculation—and in doing so,
they make the cornea more oblate, rather than preserve its natural
prolate shape" (http://www.crstoday.com/02_current/crst0103_11.html).
"The problem with all excimer lasers on the market today is twofold.
First, the engineers assumed that the cornea is spherical rather than
prolate. Second, they assumed that their job was to reshape a
relatively steep sphere into a relatively flat sphere, rather than to
reshape a steep prolate into a flatter prolate. As a result, excimer
lasers actually reshape prolate corneas into what is known as
oblate…This shape is actually optically worse than a sphere, because
now the peripheral rays are bent even more powerfully than in the
periphery of a sphere, causing even more pronounced spherical
aberration when the pupil dilates…This problem affects every patient
who undergoes an excimer laser procedure to some extent." (Dr. Jack
Holladay, MD, What We Should Really Tell LASIK Patients, Rev. Ophth.,
5/99). "We need to think in detail about corneal optics after
refractive surgery because the normal cornea is relatively
trouble-free. The cornea after refractive surgery is not
trouble-free. It frequently has a more aberrated optical performance
than its preoperative counterpart. (Dr. Leo J. Maguire,
Keratorefractive Surgery, Success, and the Public Health, Am. J.
Ophth., Vol. 117, No. 3, 3/94). "We are actually ruining the optics
of the eye when we perform LASIK," Holladay said. "That's fine when
the pupil is small, but as it gets larger, such as in nighttime
conditions, this becomes a problem. For the last five years, I have
been preaching that we should not be doing this."
(http://jordan.fortwayne.com/ns/projects/lasik/lasik5.php).
· The shape of the eye is permanently changed from concave to
convex- it's well documented. Is the Public informed that eye surgery
causes increased higher order aberrations and what happens when the
cornea shape changes from the way it evolved (concave) to a more
flattened convex shape? "There is not a single laser on the US market
today that delivers the appropriate overall energy for the ablations
we perform". "Our data show that the lasers are actually undertreating
in the periphery—at 6.0 mm, it is about 25% reduced from its
designated calculation—and in doing so, they make the cornea more
oblate, rather than preserve its natural prolate shape"
(http://www.crstoday.com/02_current/crst0103_11.html). "Conventional
laser surgery typically treats the central portion of the eye"
(http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html).
· Some eye surgery causes a permanent wound (a flap) that never
heals. Is this safe? "The most common cause of an incomplete pass is
mechanical interference by the lids, speculum, or drapes."
(http://jrs.slackinc.com/vol162s/Gim2.pdf). LASIK has a unique safety
issue not present with other refractive surgical procedures, which
stems from the structural weakness of the corneal flap and its poor
adhesion to the underlying corneal stroma. In some ways it is
remarkable that the flap can "reattach" so easily without sutures.". .
."There is also the problem of accurately realigning the flap and
replacing it in the correct location. Flap decentration has been
reported. As with flap wrinkling, it will lead to reduced optical
quality." (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf).
· What happens to the cornea and the eye after Elective
Refractive Eye Surgery is Not healthy
(http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102;
http://www.icare4u.com/surgery.htm).
· Ecstasia and endothelial problems may be far more common than
is being currently reported. Is it safe to leave 230um after LASIK?
"Eyes were not operated if the anticipated thickness of the cornea
after surgery was 230 µm or less. There were no limits to baseline
visual acuity," (http://jrs.slackinc.com/vol183/pay.pdf). "LASIK
surgery can cause permanent weakening and ectasia of the cornea even
in low myopia. This necessitated the wearing of hard contact lenses
or penetrating keratoplasty." (S. Percy Amoils, Iatrogenic
Keratectasia Following Myopic Lasik of Between <4 and 7 Dioptres, Am.
Soc. Cataract & Refract. Surg. Meeting, Seattle, WA, 4/99). "we are
quite unaware of the actual thickness of flaps when we make them..."
(Bob Kronemyer, Predictability of Residual Stromal Thickness Hinges on
Precision of Instrumentation, Ocular Surg. News, 1/1/01). "...some
are beginning to believe that the excimer may not be as innocuous to
the endothelium as most think." (Maxine Lipner, First on the
Endothelial Cell Block, Eyeworld, 9/00). Other references include:
http://www.journalofrefractivesurgery.com/showAbst.asp?thing=5084
· Elective Refractive Eye Surgery may cause permanent problems
with the epithelial layer. "Raised epithelium within the visual axis
(figure 3) can affect visual quality"
(http://www.revoptom.com/body/articles/10_2001/ro257.htm). "The
prevalence of epithelial ingrowth after LASIK varies from 2 to
10%.2,4,5" "and can result in Peripheral Melt of Flap and other
problems." (http://jrs.slackinc.com/vol141/castill.pdf). "Recurrent
corneal erosions are some-what common following PRK or LASIK due to
epithelial injury during scraping of the epithelium or formation of
the flap. as a larger number of eyes are included"
(http://jrs.slackinc.com/vol181/abs.pdf) "How is the corneal surface
affected by LASIK? Fine lines in a lattice pattern are commonly seen
and may represent folds in the epithelium or Bowman's layer. They can
be demonstrated within the flap after LASIK and so adversely affect
visual acuity" (http://www.ascrs.org/publications/jcrs/editjun02.html;
Carpel E.F., Carlson K.H., Shannon S. Fine lattice lines on the
corneal surface after laser in situ keratomileusis (LASIK). Am J
Ophthalmol 2000; 129:379–380)
· "The newly formed corneal surface is often irregularly
aspheric, probably the cumulative results of imperfect surgery,
equipment, and unpredictable healing." "Central processing of the
visual image in the brain is able to pull out the sharp image from the
surrounding blurred images. However, the limit of resolution of such
a process is probably not better than 20/40 if the emmetropic corneal
area is small. I think that the asphericity effect is not only due to
a variable corneal surface but also due to fluctuations in refractive
index in the subepithelial and/or superficial stroma (ie., the little
island lenses)." (http://jrs.slackinc.com/vol142/bkrev.pdf).
· Glare, Halos, Starbursts, diplopia and other vision problems
(including in ordinary indoor lighting conditions) are more common in
other studies done than in those used for the PMA approvals
(http://jrs.slackinc.com/vol142s/abs-l.pdf).
· Are proper steps always filed to protect the public health
from microkeratome induced DLK?
(http://jrs.slackinc.com/vol162s/Gim2.pdf;
http://jrs.slackinc.com/vol173/amb.pdf; ). "Another serious, but more
frequent complication, is inflammation under the flap or Diffuse
Lamellar Keratitis (DLK). This is reported nationally as high as
3-10%". http://www.arizonalaservision.com/laservisioncorrection/sideeffects.html.
· "Incidence of DLK ranges from 3-9% depending on brand of
microkeratome used (http://www.moria-surgical.com/publications/fichier/Microkeratome_comparison_Iacobucci.pdf).
· "Epithelial defect may increase incidence of DLK from 2% to
approximately 56%; epidemic DLK usually means something wrong with,
eg, sterilizing system or cannulas; stages—clumping of cells (stage 2
entering stage 3; lift flap and irrigate); stage 4 presentation"
"despite intense steroid regimen; central toxic keratopathy;
characteristic mud-crack changes in Bowman's membrane and central
haze; stroma melts from toxic effects of inflammation; caveat—even if
patient looks good on first day, he or she not "out of woods" for
DLK." (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102).
· Researchers of injury prevention have concluded that
"Legislation and regulation are among the most powerful tools to
reduce . . . injuries, and most environment and product design changes
require legal action. Many existing laws, however, are not fully
enforced or have loopholes that limit their effectiveness, and some
effective laws have not been adopted in every state" (Unintentional
Injuries in Childhood, VOLUME 10, NUMBER 1 - SPRING/SUMMER 2000;
http://www.futureofchildren.org/information3134/information_show.htm?doc_id=78948)
· The medical care costs for people with chronic diseases
account for more than 70% of the nation's total medical care costs.
Calling Elective Refractive Eye Surgery safe is like raising the
interstate speed limit to 120 mph so that gunshot victims can get to
the hospital faster. A permanent loss of eyesight, dry eyes, chronic
pain (http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299§ion=pe_pmc5),
and/or other "complications of LASIK is a high price to pay when
glasses and contacts could provide better vision (in most cases) with
a much lower risk.
· Patient's experiencing the complications from use of these
devices suffer medical complications that are devastating from a
psychiatric and psychological perspective, including the development
of Acute Stress and Posttraumatic Stress Disorder (accompanied by
Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder,
Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major
Depression. Additionally, patients experiencing these syndromes
frequently describe suicidal ideation.
· Many people are persuaded that if they listen only to
impartial advice, research it thoroughly, and spend a lot of money,
lasik will be a wonderful experience and be the best thing they ever
do. There's a common belief in the illusion that we can control
outcomes through rationality and that doctors can do no harm. If a
highly educated person does thorough due diligence, takes the risks
they are told about seriously, and chooses their surgeon carefully,
and still ends up in a position where they require a procedure
approved only for humanitarian reasons, then how can the general
public make a truly informed decision?
Current FDA guidelines regarding the use of these devices to inform
patients about risk are not being followed.
3. Actions Requested of the FDA.
Action requested--What rule, order, or other administrative action
does the petitioner want FDA to issue, amend or revoke?
The Petitioner is willing to work with the FDA and any other Federal
agencies in assisting with further development of the implementation
of any injury prevention efforts including, but not limited to the
following actions.
3.1 ACTION 1. Develop a national agenda for the prevention of
injuries from elective refractive eye surgery and implement it through
coordination of federal efforts across a variety of private and public
agencies including the Department of Health and Human Services.
Uniform legislation should be required by law, enacted and enforced in
every state to mandate specific minimal safety practices. Gather
better data on the quality of care available. There are precedents in
other areas of medicine.
(http://www.hsph.harvard.edu/qcare/schneider.html). In the interest
of Public Health, insist that the FDA's PMA approvals and labeling
include the requirement that all physicians performing this surgery
are either properly trained and equipped to handle every possible
complication of refractive eye surgery OR that they refer patients
with any complication they are Not properly equipped to treat to
another physician who is available to treat all complications at the
referring physicians expense.
Without the most advanced equipment available at some of the centers
approved to conduct FDA studies, other medical practitioners
performing elective refractive surgery cannot reliably identify
complications caused by laser eye surgery. Accordingly, comprehensive
national research is needed to identify the numbers of people who have
experienced complications, so that they can get help. Patients should
be immediately informed of any complications from the procedure
regardless of whether the Medical practitioner considers the
complications clinically or non-clinically significant at the time.
Note that many of these complications can result in further
complications and irreversible consequences if Not treated as early as
possible.
1. A minimal cornea depth (preferably 300um) Not including other parts
of the eye that do not immediately contribute to corneal strength
(e.g., the flap created by LASIK) must be left after surgery. "It is
important to realize that cutting corneal tissue requires much greater
precision and better quality cut surfaces than cutting tissue in other
parts of the body." (http://jrs.slackinc.com/vol183/pay.pdf)
2. Standardized equipment preparation and cleaning procedures should
be identified and addressed. For instance, other instruments used with
these PMA devices could be evaluated to minimize bacteria and other
problems (that can cause DLK or the transmission of diseases between
patients such as CJD).
3. Medical providers must be required to follow strict minimal
standardized procedures (a cockpit checklist) including giving
patients proper instructions (e.g., which specific light they are
supposed to look at), and ensuring that any suction devices are
properly used (pressurized within the specified tolerance for the
human eye and without interference from the eyelids or instruments).
4. Improper use of equipment or procedures, or product malfunctions
must be reported to CDRH. The FDA must enforce penalties that require
accurate reporting.
5. Other requirements to be determined by future research.
3.2 ACTION 2. Collect Information on the cost effectiveness of
strategies to reduce injuries caused by non-medically necessary
elective Refractive Eye Surgery to better inform public debate on the
merits of injury interventions. Many public health safety issues
regarding Refractive Eye Surgery have Not been adequately researched.
Create a comprehensive analysis of spending on the magnitude of the
total costs of elective eye surgery injuries, and the effectiveness of
prevention efforts.
The FDA asked for research to include pupil size. Now that millions
of people have already had elective Refractive Eye Surgery, is it time
to do some research on how that might effect the results?
http://www.fda.gov/cdrh/ode/2093.html
This document clearly calls for pupil measurement, but Clinical
Research (CRS) and other applicants for the Premarket Approvals (PMA)
did not control for pupil size (or for dry eyes). In one study used
to approve a PMA, the study was split into two groups. Group 1 (723
eyes) had 90% follow up at 3 months and 76% at 6 months. Group 2 (553
eyes) had a much worse follow up (accountability) rate, 57.5 percent
at 3 months. Effectively 43 percent of the data was excluded by
splitting the groups and reporting only the better group of follow-up
for the PMA.
This research does Not appear to be independently done. From July
22-23, 1999 FDA Ophthalmic Devices Panel Meeting,
http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3528t1.pdf. One
comment was "clearly one of the frontiers in LASIK is to actually try
to improve quality of vision... we aren't there yet with that" (p.55).
"I have a question about visual quality.... Specifically regarding
halo, we know that clinically the halo experience after LASIK tends to
be more visually significant and affecting the quality of vision than
halos that occur naturally in patients without ever having surgery....
the pre op halo comes from asphericity of corneal lens combined optics
where post-op comes from this artificial excavation of cornea just
like volcano on surface of the cornea, but off sharply at 6
millimeters. Have you attempted to assess the degree of halo because
from my clinical experience those halos that occur after LASIK tend to
be more significant". (p.129).
Many comments were made about flaws in the study being badly
presented: "... and I think that is the concern that the bigger that
portion is that we are missing if we are looking for balancing a small
negative effect or at least trying to allow the patients to know what
the degree of negative effect is, when there is a lot of missing data
it is very difficult to assess that. (page 71)". Another comment was
"... the only comment I would have is that my concern is that I don't
know what the complication rate truly is lurking out there. (page
104)." And "of the three physicians who made presentations to the
Panel, one of them wasn't included in the PMA cohort and a second
actually just made the cut. So this is a constant source of concern
for me..." "Overall the accountability is less than 75% at 3 months
and less than 63% at 6 months". "... there is still need for a
standardized questionnaire or instrument to be used for the assessment
of patient satisfaction following these procedures" (p.82). "I have
strong concerns regarding accepting the study as a whole because of
the data set and if the FDA accepts this kind of study where
accountability is only 57 percent..... The doctors should be chided
for bad science, and if they enroll patients into a study, they should
be ethically bound to follow up on these patients" (p.89). "The loss
to follow-up typically should not exceed 10 percent at one year, and I
have a great deal of difficulty with an accountability of 50 to 76
percent at 6 months". (p.98)
Part of this agenda should be the adoption of new diagnostic criteria.
The Petitioner proposes including Blepharitis, Dry Eye,
Anisokeratometropia (Unequal cornea measure of vision) in studies of
vision loss involving cornea irregularities and other potential causes
of aberrations. Research should include information concerning the
nature and the relative high frequency of cumulative local
complications and reoperations and other essential elements of
adequate informed consent including making sure that patients
understand what loss of best-corrected vision (BCVA) and vision
quality really means to them and their quality of life.
Does this support this research as being independent of any conflicts
of interest? "... we are dealing with a procedure here which has
probably been performed on 100, 200, maybe 300 or more thousand
Americans and then performed by many people sitting around this table.
So, it is with that that I am sort of coloring my perspective on this
PMA" (p. 182).
3.3 ACTION 3. Conduct a retrospective comprehensive study of the
incidence and prevalence of injuries to track ALL the relevant risks.
Gather and collect all surveillance and monitoring data to allow
proper education and targeting of interventions. Could the Medical
Device Surveillance Network, MedSuN program be used for this purpose?
The United Sates Eye Injury Registry (USEIR;
http://www.useironline.org/Index2.html), a federation of state eye
registries, uses a standardized form to obtain voluntarily reported
data on eye injuries.
Many public health safety issues have Not been adequately researched.
For example: What are the benefits or costs of studying additional
positive or negative outcomes such as changes in the quality of life
or incidence or prevalence of chronic pain, cancer, apathy,
depression, and/or suicidal ideation? What are the differences in risk
of dry eyes from different types of surgeries?
At what point are the risks of certain types of procedures, equipment
or procedures significantly higher such that they should banned? What
pre-existing physical and mental conditions might increase the risks
of elective eye surgery including diabetes, autoimmune or related
problems (e.g., Hyperthyroidism and hypothyroidism), other eye
problems, depression or anxiety? By how much would improving safety
reduce the incidence or prevalence of the risk factors? Are there
studies to know how much risk patients are assuming from elective eye
surgery (e.g., what are the chances of a loss in the quality of life)
including knowing if they have a pre-existing condition that makes
them at a higher risk prior to surgery? What is the total effect on
patients quality of life and the ultimate economic costs of any
losses? Wouldn't outcomes research be useful? (Quality of Life and
Pharmacoeconomics: An Introduction by Joyce A. Cramer, Bert, Ph.D.
Spilker; Lippincott Williams & Wilkins Publishers; 2nd edition,
January 1998)
The United Sates Eye Injury Registry (USEIR;
http://www.useironline.org/Index2.html), a federation of state eye
registries, uses a standardized form to obtain voluntarily reported
data on eye injuries. A comparably mandatory recording of any elective
eye surgery injury along with a standardized coding of each injury
should be required for all 50 states. Medical providers and other
information system staff should be trained to use these codes for all
instances of elective eye surgery injuries.
Now that LASIK has been used long enough to track long term risks, a
retrospective comprehensive study of the incidence and prevalence of a
number injuries should be conducting to track ALL the risks. For
instance, we know have information that elective eye surgery can lead
to depression, suicidal ideation and even some actual suicides (first
hand witnesses provided on request;
http://www.cdc.gov/ncipc/factsheets/suifacts.htm). The age group most
likely to have elective eye surgery (over 40 yrs old) are also those
most likely to commit suicide
(http://www.cdc.gov/ncipc/fact_book/04_Introduction.htm). Possible
instruments that could be used to track qualitative vision problems
include the VF-14 (see Cataract Patient Outcomes Research Team (PORT)
Study, Steinberg, EP) and the RSVP (refractive status and vision
profile) to asses Patient outcomes of refractive surgery
(http://www.ascrs.org/publications/jcrs/absmay01.html).
How do these risks vary as the stronger the original prescription the
more likely (and more of it) that vision quality will be lost? Are
patients informed of the likelihood that this elective surgery is
ultimately going to trade off vision quality for a reduction of
refractive error that can actually hasten the onset of symptoms of
presbyopia. How risky is it to fix undesirable outcomes (meaning, poor
ablations) and how likely is it to end up getting "fixed"? Other risks
such as blindness, reduced visual acuity and vision quality (even in
ordinary indoor lighting conditions), corneal stroma problems
(scarring, bowmans membrane), visual aberrations (diplopia, higher
order aberrations, striae), epithelial problems, pain and chronic
pain, dry eyes, rejection of own tissue (restasis is prescribed after
elective eye surgery), glare, starbursts, halos, (GASH), discomfort,
loss of quality of life, psychological symptoms (suicidal ideation,
depression, anxiety and PTSD), effects on the immediate and extended
families of those who are not satisfied, additional risks of further
medical or surgical interventions, such as reoperations later or
perioperative [right after surgery] (additional surgeries can increase
risks including chronic pain;
http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299§ion=pe_pmc5;
and elective eye surgeries have resulted in 8 or more surgeries on an
eye), corneal transplantation, subcorneal damage, self or foreign
tissue rejection (the use of restasis even when no transplants were
used), disfigurement, serious infection, other comorbid conditions,
and the likelihood of these and other risks occurring independently or
in combination.
Are patients with dry eyes excluded as candidates for surgery per the
FDA's new guidance? Why wasn't dry eye tracked in the original studies
used for the PreMarket approvals of the lasers? IT has been well known
for many years that dry eye was a serious problem with elective eye
surgeries. "The lurking LASIK complication Dry eye after LASIK can be
your most serious refractive complication. Understanding and
addressing the problem is key to keeping patients happy. . . it has
significant implications on patient satisfaction, and, at times,
clinical outcomes. Learning about the incidence, etiology, prevention,
and treatment of this problem is critical for a successful refractive
practice." (http://www.escrs.org/eurotimes/May2001/lurking.asp).
Can elective eye surgery cause progressive keratoconus? "Recent data
have suggested that perturbation of the keratocyte apoptosis/mitosis
balance could underlie the development of keratoconus in a proportion
of patients" (The Wound Healing Response After Laser In Situ
Keratomileusis and Photorefractive Keratectomy. Elusive Control of
Biological Variability and Effect on Custom Laser Vision Correction;
Steven E. Wilson, MD; Rahul R. Mohan, PhD; Jong-Wook Hong, MD;
Jong-Soo Lee, MD; Rosan Choi, MD; Rajiv R. Mohan, PhD; Arch
Ophthalmol. 2001;119:889-896.)
What are the risks of using UV light from a laser directly on the
human eye?
"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)."
(http://www.eyesite.ca/english/program-and-services/policy-statements-guidelines/UV-radiation-eye.htm).
Is there an increased risk of cancer? "A number of studies have been
performed and have shown that the 193 nanometer excimer laser is
neither mutagenic nor carcinogenic(16,17)."
(http://www.vision-institute.com/director/article-elpk.html). "The
International Agency for Research in Cancer (IARC) has concluded that
solar radiation, broad spectrum UVR, and UVA, UVB or UVC radiation are
all carcinogenic to experimental animals (IARC, 1992). The main
tissues of the human body affected are those of the skin and the eye."
(http://www.nrpb.org/publications/documents_of_nrpb/abstracts/absd13-1.htm).
We know that UV light does cause melanoma and that UVC light is the
most dangerous UV frequency. Excimer lasers deliver high energy UVC
light in a localized area. We know that excessive exposure to UVC
light causes Acute kerato-conjunctivitis which is an inflammation of
the cornea and conjunctiva
(http://www-nehc.med.navy.mil/downloads/ih/IHFOM_CH11.pdf), and we
know that a similar inflammation occurs after these laser procedures.
We also know that Conjunctival malignant melanoma occurs in that same
tissue including the epithelium and stroma
(http://www.nova.edu/~kimreed/CONJUNTV.html). We also know that the
transformation of a normal cell to a cancer cell can be caused by a
variety injuries and harmful agents like cigarette smoke or toxic
chemicals or radiation including UV and UVC wavelength radiation
(http://www.drmcdougall.com/science/cancer.html).
There are indications that Excimer lasers are mutagenic (Gebhard, E.,
Lang G.K., Tittelbach, H., Rau, D., Naumann, G.O. (Institut fur
Humangenetik, Universitat Erlangen-Nurnberg) "Chromosome mutageniticy
of a 193 nm Excimer laser" Fortchr Ophthalmol 1990; (3):229-33;
Seiler, T., Bende, T., Wincker, K., Wollensak, J. "Side effects in
excimer corneal surgery. DNA damage as a result of 193 nm excimer
radiation" Graefes Arch Clin Exp Ophthalmol, 1988; 226(3): 273-6;
Trentacost, J., Thompson, K., Parrish, R.K., Hajek, A., Berman, M.R.,
Ganjei, P. "Mutagenic potential of a 193 nm excimer laser on
fibroblasts in tissue culture: Ophthalmology; 94(2): 125-9 1987;
"Cytotoxicity and mutagenicity of low intensity, 248 and 193 nm
excimer laser radiation in mammalian cells." Cancer Res. 1987 Jan. 15,
47 (2) : 410-3 ; Kochevar, I.E. (Wellman Laboratories, Mass. General
Hosp., Boston) "Cytotoxicity and mutagenicity of excimer laser
radiation." Laser Surg. Med 1989; 9(5): 440-5).
Other wavelengths of radiation can be produced and that this secondary
(UVB) radiation could also potentially cause cancer ("In situ
measurements via a quartz fiber introduced into the eye to the lens
surface showed that secondary radiation in the cataractogenic range
between 295 and 320 nm is transmitted by the cornea and reaches the
lens. The potential adverse effects of this secondary radiation should
be considered when applying 193 nm excimer laser radiation to the
cornea."; Muller-Stolzenburg N., Schrunder S., Helfmann, J., Buchwald,
H.J., Muller, G.I. "Fluorescence behavior of the cornea with 193 nm
excimer laser irradiation." Fortschr Ophthalmo; 87(6): 653-8 1990).
Should we know the answer to this question before we do this to a
million more people? The R of the acronym LASER sounds that much more
perilous and dangerous. Melanoma does occur in the eye and it occurs
on a variety of different types of epithelial cells. We also know
there is No cure for melanoma at the present time.
3.4 ACTION 4. Draft an enforcement policy for implementation of
the Federal Food, Drug, and Cosmetic Act regarding these devices along
with a document of comprehensive guidance for industry (or update any
existing documents to reflect the current state of knowledge). There
is a precedence for the FDA providing guidance on other things
regulated by the FDA
(http://www.fda.gov/OHRMS/DOCKETS/98fr/060702c.htm).
3.5 ACTION 5. Create national training programs and career
development awards for a multidisciplinary group of professionals to
monitor and implement elective eye surgery injury controls with
funding from federal agencies.
3.6 ACTION 6. Implement of the final FDA ruling should involve,
among other things, package redesign, redesign of websites and
promotional literature, and sometimes, new packaging for equipment,
and an update of the labeling requirements for all devices for any and
all then currently known risks. Remove any wording that the Public
could potentially misinterpret as an endorsement by the FDA including,
but not limited to the words Approved, Safe, etc. The American
Society of Cataract and Refractive Surgery (ASCRS) endorses the Lasik
Institute as their educational website. And the Lasik Institute under
Suggestions for Further Reading includes links to four consent forms
in http://www.lasikinstitute.org/RisksnComplications.html. Rather
than write a consent form based on what the ASCRS believes would be
good informed consent, why are these consent forms written by an
insurance company (Ophthalmic Mutual Insurance Company)?
Are these (www.omic.com) ASCRS endorsed informed consent consistent
with the labeling requirements of the PMAs for these Class III
devices?
Consent for LASIK for the Correction of Myopia (Nearsightedness).
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Informed Consent for LASIK for the Correction of Hyperopia
(Farsightedness)
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Consent for Bilateral Simultaneous LASIK
http://www.omic.com/resources/risk_man/forms/consent/LASIKbilatsim-myopia.rtf
Consent for LASIK on the Second Eye in an Interval of Less than One
Week (myopia)
http://www.omic.com/resources/risk_man/forms/consent/LASIKsecondeye.rtf
"ASCRS Mission: The mission of the American Society of Cataract and
Refractive Surgery is to raise the standards and skills of anterior
segment surgeons through clinical and practice management education
and to work with patients, government and the medical community to
promote delivery of quality eye care."
Can elective eye surgery result in optical disturbances such as
monocular double vision which cannot be corrected with spectacles or
soft contact lenses, and that in case of such an outcome, rigid gas
permeable contact lenses will be their only non-surgical (in fact,
their only full stop) means of restoring their pre-operative vision
quality even without visible intra-operative or post-operative
mishaps? For a contact-lens-intolerant patient, this information is
critically relevant to their ability to assess the risk/reward
equation on a truly informed basis.
Do the consent forms indicate the true level of risk? Include all the
individual risks themselves as well as the cumulative risks of
multiple problems and comorbid conditions. For instance, why does the
FDA warn only about problems with a correctable condition due to
blurry vision when there is a significant risk that ONE or BOTH eyes
will be permanently blurred after elective eye surgery even if
monovision isn't the intended outcome? "Many patients cannot get used
to having one eye blurred at all times. Therefore, if you are
considering monovision with LASIK, make sure you go through a trial
period with contact lenses to see if you can tolerate monovision,
before having the surgery performed on your eyes.
(http://www.fda.gov/cdrh/LASIK/risks.htm)".
3.7 ACTION 7. Oversee the entire life cycle of these devices--from
production through distribution, and consumption/use of these class
III devices to assess whether the products are as safe as labeled and
safe period as stipulated in their PMA approvals.
The Petitioner challenges you to review suggestive findings regularly
to identify how some modifications to the potential "candidates" might
be safer for the Public Health. Isn't the first priority to "first do
no harm"?
For the Agency to oversee their entire life cycle--from production
through distribution, and consumption/use of these class III devices
to assess whether the products are as safe as labeled and safe period
as stipulated in their PMA approvals. Along with this after market
surveillance process, the Petitioner also ask the FDA to reconsider
whether the potential risks versus possible benefits assessment favor
this action, whether SSED documents provide a reasonable assurance of
safety and effectiveness for the device as labeled based on the
nonclinical and clinical studies described in the PMA, and whether the
SSED accurately summarizes both the positive and negative aspects of
the scientific evidence as required for each PMA
(http://www.fda.gov/cdrh/dsma/pmaman/sec03.html#P784_26552). The
Petitioner also ask the FDA to consider whether the manufacturers
certification that "a reasonable search of all information known or
otherwise available about the class III device and other similar
legally marketed devices has been conducted (class III certification)
(k), and whether all data and information submitted in the premarket
notification are truthful and accurate and that no material fact has
been omitted and was reasonable based on the available evidence at
that time" (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).
3.8 ACTION 8.Hold an Ophthalmologic advisory panel meeting to
consider the surveillance data for each PMA of all manufacturers and
decide whether there is now sufficient data on safety and
effectiveness for these class III devices to continue to serve a
public health need and whether they should continue to be approved by
the FDA. At what point are the risks of certain types of procedures,
equipment or procedures significantly higher such that they should
banned? The Petitioner believe that the potential risks versus
possible benefits assessment favor a withdrawal of FDA approval of all
PMAs for the lasers listed in this petition in the interest of
protecting the Public Health (except for humanitarian purposes only).
There is a precedent for this recommendation: "The FDA brings together
its General and Plastic Surgery Devices Panel to review all of the
safety data from the manufacturers' PMA's. The purpose of the panel is
to advise FDA as to what they could tell the public about the safety
and effectiveness of the silicone breast implants based on the PMA's.
The panel is composed of a broad range of experts, including
representatives from the fields of plastic surgery, oncology,
epidemiology, internal medicine, immunology, radiology, pathology,
gynecology, toxicology, sociology, biomaterials and psychology, as
well as industry and consumer groups. The panel hearing rejects the
data from Dow Corning, Mentor, McGhan, and Bioplasty, concluding there
is not sufficient data about the risks and benefits of the devices.
The panel recommends the devices stay on the market temporarily and
with limited access. The need for more safety data is stressed."
(http://www.pbs.org/wgbh/pages/frontline/implants/cron.html)
Review each of these class III devices to assess whether the device is
EITHER as safe or substantially equivalent to the legally marketed
devices that were or are currently on the U.S. market that the
manufacturers used for comparison purposes in their 510(k) submissions
for their PMA approvals
(http://www.fda.gov/cdrh/dsma/pmaman/front.html;
http://www.fda.gov/cdrh/dsma/pmaman/Table%20of%20Contents.html#TopOfPage).
As part of this surveillance process, the Petitioner also ask the FDA
to consider whether the manufacturers certification that "a reasonable
search of all information known or otherwise available about the class
III device and other similar legally marketed devices has been
conducted (class III certification) (k) A statement that the submitter
believes, to the best of his or her knowledge, that all data and
information submitted in the premarket notification are truthful and
accurate and that no material fact has been omitted." Is reasonable
based on the available evidence at this time.
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).
See Appendix B and C for further discussion and consideration of this
action.
3.9 ACTION 9. Place a moratorium on any further non-medically
necessary elective Refractive Eye Surgeries other than for strict
humanitarian purposes If: the severity, totality of the risks (and
their likelihood) of actual injuries to the public that have occurred
from the actual practice (including non-research centers) of
non-medically necessary elective Refractive Eye Surgeries are a larger
risk to the public health than identified in previous research OR
Prudent injury intervention strategies are Not feasible to adequately
protect the Public from injury
If the severity and/or the risk (likelihood) of the actual injuries to
the public that have occurred from the actual practice (including
non-research centers) of non-medically necessary elective eye
surgeries are a larger risk to the public health than identified in
previous research or prudent injury intervention strategies are Not
feasible to adequately protect the Public from injury, then the
Petitioner request a moratorium on any further non-medically necessary
elective eye surgeries other than for strict humanitarian purposes.
There is a precedent for this recommendation: "The Food and Drug
Administration today called for a moratorium on the use of silicone
gel breast implants until new information on their safety can be
thoroughly reviewed by an independent advisory panel and the agency
can make a final decision in light of the panel's review."
(http://www.fda.gov//bbs/topics/NEWS/NEW00263.html).
4. Certification
To the best of the Petitioner' knowledge, the petition includes all
information relevant to the petition, favorable or not (see links and
references for details).
Name and Full address of petitioner
PHONE of petitioner here.
Appendix A.
"FDA's adverse event reporting strategies are intended to: develop a
comprehensive adverse event reporting capability; analyze problems
surfaced by these reports so that appropriate interventions can be
designed; and educate both health professionals and patients about
problems and solutions associated with appropriate product use. Two
examples of strategies designed to develop more complete reporting are
the Medical Device Surveillance Network (MeDSuN) System and the HHS
Patient Safety Task Force."
http://www.fda.gov/ope/fy03plan/goals3.html
How accurate is the adverse event reporting?
Appendix B: Risks of Elective Refractive Eye Surgery.
As is common practice, Is it accurate to tell anyone "you are a good
candidate"? No-one is a good candidate if the risks are unreasonable.
Is a 50% chance of something happening a calculated "risk" or a coin
toss? How many people should take these risks? "LASIK is currently
the most common type of laser eye surgery in the U.S., performed an
estimated 1.5 million times each year."
(http://www.lasikinstitute.org/Newsroom_trialsshow.html).
How much is the risk of decrease in his best-corrected visual acuity?
What are the possible mechanisms for this risk? Retinal damage, optic
nerve damage, a combination of both; optical problems related to
positive angle kappa, an ablation decentered over the pupil, and early
cataract changes induced by Elective Refractive Eye surgery?
What about the risk of causing or increasing cataracts or floaters?
What about the risk of Dry eyes relative to all LASIK patients? An
"iatrogenic dry eye" . . ." state is a disease of complex etiology
where the biophysical and surface chemical factors play a major role.
It is not well understood, it is not easy to diagnose, and even harder
to manage. So it was an unpleasant surprise that a considerable
number, now estimated as high as 50% of the patients undergone LASIK
surgery complained of dry eyes of various severity." About 20% of
those are Not better in 3 to 6 months.
(http://silver.he.net/~fjholly/lectures.htm).
In one unpublished study, Dry Eye was most associated with Suicidal
Ideation after LASIK. Aren't ALL patients told to use eye drops after
surgery due to the possibility of dry eyes? Why weren't patients
warned in the past about a "risk" as common as dry eye (Ang R.T.,
Dartt D.A., Tsubota K. Dry eye after refractive surgery. Curr Opin
Ophthalmol 2001; 12:318–322) and why has the FDA only recently added
on the FDA's own website that "Some patients may develop severe dry
eye syndrome. As a result of surgery, your eye may not be able to
produce enough tears to keep the eye moist and comfortable. Dry eye
not only causes discomfort, but can reduce visual quality due to
intermittent blurring and other visual symptoms. This condition may be
permanent. Intensive drop therapy and use of plugs or other procedures
may be required." (http://www.fda.gov/cdrh/LASIK/risks.htm). Dry eyes
was recently added to "Know all the risks and procedure limitations"
(http://www.fda.gov/cdrh/LASIK/reduce.htm). Are Nasal hinges
superior? "As a result, it takes longer for nerves to regenerate in
corneas with superior-hinged flaps.". . ."This is a good study that
persuasively argues the role of hinge position in the occurrence of
dry eye after LASIK"
(http://www.docguide.com/news/content.nsf/news/8525697700573E1885256D3200456654;
Hinge Position In LASIK Flaps Affects Corneal Sensation And Dry Eye.
May issue of Ophthalmology, Eric D. Donnenfeld).
"DR. GRIMMETT: I would recommend including a comment about the one in
four rate of dryness, worse or significantly worse, happened in one in
four.
CHAIRMAN McCULLEY: Those are both symptoms and signs.
DR. ROSENTHAL: May I just ask, what about in precaution? This issue of
dryness--
CHAIRMAN McCULLEY: It's common after LASIK.
DR. ROSENTHAL: In everybody?
CHAIRMAN McCULLEY: Yes.
DR. ROSENTHAL: So what about people who preoperatively have dry eyes?
CHAIRMAN McCULLEY: They're going to be in worse shape.
DR. MACSAI: Treat them.
DR. ROSENTHAL: What?
DR. MACSAI: They should be screened and treated.
DR. ROSENTHAL: Well, I mean, you know, mild dry eyes. I don't know how
we've dealt--I mean, I don't think it's relative to this LASIK
procedure, but--
CHAIRMAN McCULLEY: It's not, and we're learning more as time goes on.
Now we know, so we don't want to ignore it. It's real. And it's
probably important from a patient's information and informed consent
to be certain that they're aware, because it can lead to sufficient
dissatisfaction to seek attorney help."
(http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3598t1c.pdf, p.
203).
Many people are persuaded that if they listen only to impartial
advice, research it thoroughly, and spend a lot of money, lasik will
be a wonderful experience and be the best thing they ever do. There's
a common belief in the illusion that we can control outcomes through
rationality and that doctors can do no harm. If a highly educated
person does thorough due diligence, takes the risks they are told
about seriously, and chooses their surgeon carefully, and still ends
up in a position where they require a procedure approved only for
humanitarian reasons, then how can the general public make a truly
informed decision?
Why would any sane person knowingly consent to taking these risks?
Is it ethical to allow anyone who is healthy to even take these risks,
and to only take them for cosmetic reasons when glasses work as well
or better? What other risks are there on top of these listed below:
· Many medical errors and unintentional injuries from elective
corneal eye surgeries can be prevented and are costly. The risks of
using these PMA approved medical devices referred to in this petition
may far outweigh the potential benefits and present a risk to Public
Health. Many Substantive Risks and the full scope of the risks have
Not been Addressed.
· Use of the Terms "Safe" and "Approved" in Connection with
Elective Refractive Surgery are Not accurate. The risks and costs
have NOT been studied adequately for the FDA to use the word "safe" or
"approved" when referring to eye surgery on formerly normal, healthy
eyes.
· Is comanagement as it is practiced commonly with Elective Eye
Surgery where the Optometrists frequently don't consult with the
Opthalmologists about complications safe? The ASCRS endorses the
practice- see their informed consent form:
http://www.ascrs.org/advocacy/comanageconsent2.doc. Here's how one
company uses it for "affordability" in the real world,
http://www.lasikvisioninstitute.com/html/bg_affordability.html. Is
this right?
· Further research is needed to know the full extent of the
risks of Elective Refractive Eye Surgery. The clinical studies upon
which the were approved did not provide the FDA with information
necessary to judge the full scope of risk. Many Substantive Risks and
the full scope of the risks have Not been Addressed including
Psychiatric and Psychological Effects. Psychiatry is a branch of
medicine and psychiatric variables tell the story of the real effects
of complications on people's lives. Is a high satisfaction rate
equivalent to an improved quality life? If patients are delighted
when RS succeeds, is it not logical to believe that they will be
miserable when it fails? Should patients know they may be
"consenting" to the possibility of being miserable for life? What
about the quality of life for those who are Not satisfied? Subjects
experiencing complications from refractive surgery in the original
clinical trials should have been questioned as to the effect of
complications on their mood, level of cognitive functioning, and other
relevant psychological variables. Instead, the clinical trials report
only ophthalmic and optometric variables and many of those were left
out too. With millions of people having refractive surgery every year
in the US alone, shouldn't the real risks be clear? Patients have a
right to know that if refractive surgery fails, it is likely that they
will become severely depressed or even experience suicidal ideation.
Patients also need to know that if they do experience severe
depression and suicidal ideation, treatment with the modern and
effective antidepressant drugs may be impossible because they often
aggravate another complication- dry eyes.
· Are there more risks of a bad outcome, problems or
complications at "discount" Lasik providers
(http://www.canolaservision.com/info/News.htm)? Whereas it is common
in other sciences to study such constructs as interrater reliability
and the generalizability of clinical interventions across practioners,
the extent to which the clinical outcomes presented in the FDA
clinical trials for the above mentioned Class III medical devices is
unclear. Thus, respected sources of laser surgery carry information
report that "We see a lot of problems from the discount places." (By
Julia Malone c.2001 Cox News Service
http://www.emoryvision.com/ajc3_2001.html). Previous research has
shown that glare, halos, starbursts, diplopia and other vision
problems (including in ordinary indoor lighting conditions) are more
common in other studies done than in those used for the PMA approvals
(http://jrs.slackinc.com/vol142s/abs-l.pdf).
· No research was submitted to the FDA regarding patterns of
comorbidity of complications. Yet, it is well known that certain
complications tend to occur together. Ophthalmology and comanaging
optometrist frequently refer to glare, astigmatism, starbursting, and
halos under the acronym "GASH". These patterns of comorbidity has vast
implications for FDA labeling and informed consent that have been
neither recognized nor appreciated. If the complications of refractive
surgery are not independent, but tend to occur together, then patients
must be advised that if they experience one complication, for example,
they are likely to experience two or more. In general, the more
complications experienced by a patient, the more likely it is that he
or she will experience depression, suicidal ideation, or one of the
syndromes listed above.
· Often, final vision quality is inferior to pre-surgical
vision and night vision is ". . . significantly impaired"
(http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf)? "The
Canadian Medical Association has added laser eye surgery to a list of
risk factors for unsafe driving, and recommends doctors test the night
vision of patients who may be experiencing visual difficulty following
surgery." (Louise Elliott, Canadian Medical Association Says Laser Eye
Surgery Can Pose Driving Risk, Canadian Press, 8/27/00) "58 percent
failed a night vision test, said ophthalmologist Dr. William Jory of
the London Centre for Refractive Surgery in London, England." (Night
Blindness Rising in Laser Eye Surgery Patients, London Free Press,
7/17/00). "Although high contrast visual acuity recovers by 1 year
after PRK, low contrast visual acuity and glare deteriorate
significantly and do not recover, even after 1 year." (J Refract Surg.
1996;12:S267-S268.)
· Wavefront is Not the answer to the problems. "These
wavefront things are two or three orders of magnitude better than we
can get with the lasers, and the healing response and the
environmental conditions also influence our surgery results". .
."Until we control the variables so we can get the standard of error
of the laser down to 0.1 D, all these little measurements we do are
not very important". . ."The standard of error in lasers usually
averages about 0.5 D at best, he said."
(http://www.aao.org/aao/news/eyenet/archive/05_00/feature2.html)
· These laser devices with PMAs, contrary to their PMAs, May
Not be as safe or substantially equivalent to the legally marketed
devices that were or are currently on the U.S. market and DO in fact
raise different questions of safety and effectiveness than the
predicate device (http://www.fda.gov/cdrh/dsma/pmaman/sec04a.html#P1821_105059).
· Adverse Events listed in the Approval orders are Not reported
in some cases to the FDA. The following adverse events are frequently
Not reported to the FDA: loss of best spectacle corrected visual
acuity (based on acuity prior to surgery), worsening of patient
complaints such as double vision, sensitivity to bright lights,
increased difficulty with night vision, fluctuations in vision,
increase in intraocular pressure, corneal haze, secondary surgical
intervention, corneal infiltrate or ulcer, corneal epithelial defect,
corneal edema, problems associated with the flap, retinal detachment,
and retinal vascular accidents. As a result, both the FDA and the
medical professionals charged with the use of these devices listed
herein have failed to acknowledge the extent and severity of
complications created by these devices, both to patients and to the
public. Please see supportive material listed in Appendix B of this
petition.
· The surveillance system already in place (USEIR) for tracking
Serious Eye Injuries is Not being utilized to track the injuries
resulting from Elective Refractive Eye Surgery and there is No
national registry or database where the data can be shared across
centers for further research.
· True Outcomes and Complication rates of Refractive Eye
Surgery are Not being provided to patients when they ask. The actual
outcomes from the standard use of these devices may actually be much
higher than those done in the studies evaluated by the FDA to provide
the PMAs for these Class III devices.
· It just makes common sense Not to do something that is Not
medically necessary and that may cause "irreversible blindness", an
inability to work, or an inability to read comfortably even if many
people like their vision initially.
· Cutting a flap or doing anything to a healthy cornea is Not
good for the eye or for vision. "The average dioptric difference in
the central region is -1.08 D (flattening), and the average dioptric
dif-ference in the outer region is +10.20 D (steepening), all induced
just by cutting the flap."
(http://www.slackinc.com/eye/jrs/vol164/edit.pdf)
· Elective Refractive Eye Surgery with Lasers may cause early
cataracts. (PRK and LASIK--their potential risk of cataractogenesis:
lipid peroxidation changes in the aqueous humor and crystalline lens
of rabbits, Wachtlin J, Blasig IE, Schrunder S, Langenbeck K, Hoffmann
F., Cornea. 2000 Jan;19(1):75-9; Photorefractive keratectomy and
cataract, Costagliola C, Di Giovanni A, Rinaldi M, Scibelli G,
Fioretti F., Surv Ophthalmol. 1997 Nov;42 Suppl 1:S133-40; ArF 193 nm
excimer laser corneal surgery as a possible risk factor in
cataractogenesis, Costagliola C, Balestrieri P, Fioretti F, Frunzio S,
Rinaldi M, Scibelli G, Sebastiani A, Rinaldi E., Exp Eye Res. 1994
Apr;58(4):453-7)
· The full risks and costs of injuries from these Class III
devices have NOT been studied adequately for the FDA to use the word
"safe" or "approved" when referring to the use of these devices for
eye surgery on formerly normal, healthy eyes. Please see supportive
material listed in Appendix B and C of this petition. Where is the
independent research for elective eye surgeries like there was for
breast implants? Has anyone bothered looking at the risks of
re-operations? Are the risks higher and the satisfaction rate lower
for re-operations? Do the risks accumulate over the lifetime of the
individual or does it stop shortly after surgery? What is the risk of
irreversible blindness, difficulty reading, or difficulty working?
Are patients adequately informed about the actual risks and the
likelihood of those risks occurring in the real world (outside of a
controlled study submitted to the FDA)?
· How likely is LASIK to cause dry eye? "Dry Eye Syndrome, is
the most frequent patient complaint to eye doctors. About 33 million
Americans in all groups experience varying degrees of dry eye
syndromes." (http://www.visionworksusa.com/disease.asp?d_num=5;
http://www.ohiovalleyeye.com/eyeinfo_blepharitis.html). "There is a
theory that by cutting across the cornea, you cut the corneal nerves,
and it decreases the stimulus of the eye, the feedback mechanism from
the eye to the brain. Therefore, you have a reduction in the
production of tears." Other theories involve goblet cell disruption
caused by the suction ring that is placed at the limbus ― a site
that boasts a high concentration of goblet cells ― as well as
the idea that an alteration of the tear flow has been brought about by
LASIK. "My hunch is that it's probably a combination of those three as
opposed to just one specifically.". . . "Not all patients are
affected, but a very high percentage are." (Diane M. Watson, Patient
Education, Proactive Approach Crucial When Treating Lasik-Induced Dry
Eye, Primary Care Optom. News, 5/00
· Patients have experienced medical complications from the use
of these devices that are devastating from a psychiatric and
psychological perspective, including the development of Acute Stress
and Posttraumatic Stress Disorder (accompanied by Dissociative
symptoms), Generalized Anxiety Disorder, Panic Disorder,
Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major
Depression. Additionally, patients experiencing these syndromes
sometimes describe suicidal ideation.
· Are there more risks of a bad outcome, problems or
complications at the discount places
(http://www.canolaservision.com/info/News.htm)? "We see a lot of
problems from the discount places." (By Julia Malone c.2001 Cox News
Service; http://www.emoryvision.com/ajc3_2001.html)
· Vision quality is usually Not as good afterwards as it was
before when corrected with glasses or contacts. "There is not a
single laser on the US market today that delivers the appropriate
overall energy for the ablations we perform". "Our data show that the
lasers are actually undertreating in the periphery—at 6.0 mm, it is
about 25% reduced from its designated calculation—and in doing so,
they make the cornea more oblate, rather than preserve its natural
prolate shape" (http://www.crstoday.com/02_current/crst0103_11.html).
"The problem with all excimer lasers on the market today is twofold.
First, the engineers assumed that the cornea is spherical rather than
prolate. Second, they assumed that their job was to reshape a
relatively steep sphere into a relatively flat sphere, rather than to
reshape a steep prolate into a flatter prolate. As a result, excimer
lasers actually reshape prolate corneas into what is known as
oblate…This shape is actually optically worse than a sphere, because
now the peripheral rays are bent even more powerfully than in the
periphery of a sphere, causing even more pronounced spherical
aberration when the pupil dilates…This problem affects every patient
who undergoes an excimer laser procedure to some extent." (Dr. Jack
Holladay, MD, What We Should Really Tell LASIK Patients, Rev. Ophth.,
5/99). "We need to think in detail about corneal optics after
refractive surgery because the normal cornea is relatively
trouble-free. The cornea after refractive surgery is not
trouble-free. It frequently has a more aberrated optical performance
than its preoperative counterpart. (Dr. Leo J. Maguire,
Keratorefractive Surgery, Success, and the Public Health, Am. J.
Ophth., Vol. 117, No. 3, 3/94). "We are actually ruining the optics
of the eye when we perform LASIK," Holladay said. "That's fine when
the pupil is small, but as it gets larger, such as in nighttime
conditions, this becomes a problem. For the last five years, I have
been preaching that we should not be doing this."
(http://jordan.fortwayne.com/ns/projects/lasik/lasik5.php).
· The shape of the eye is permanently changed from concave to
convex- it's well documented. Is the Public informed that eye surgery
causes increased higher order aberrations and what happens when the
cornea shape changes from the way it evolved (concave) to a more
flattened convex shape? "There is not a single laser on the US market
today that delivers the appropriate overall energy for the ablations
we perform". "Our data show that the lasers are actually undertreating
in the periphery—at 6.0 mm, it is about 25% reduced from its
designated calculation—and in doing so, they make the cornea more
oblate, rather than preserve its natural prolate shape"
(http://www.crstoday.com/02_current/crst0103_11.html). "Conventional
laser surgery typically treats the central portion of the eye"
(http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html).
· Some eye surgery causes a permanent wound (a flap) that never
heals. Is this safe? "The most common cause of an incomplete pass is
mechanical interference by the lids, speculum, or drapes."
(http://jrs.slackinc.com/vol162s/Gim2.pdf). LASIK has a unique safety
issue not present with other refractive surgical procedures, which
stems from the structural weakness of the corneal flap and its poor
adhesion to the underlying corneal stroma. In some ways it is
remarkable that the flap can "reattach" so easily without sutures.". .
."There is also the problem of accurately realigning the flap and
replacing it in the correct location. Flap decentration has been
reported. As with flap wrinkling, it will lead to reduced optical
quality." (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf).
· What happens to the cornea and the eye after Elective
Refractive Eye Surgery is Not healthy
(http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102;
http://www.icare4u.com/surgery.htm).
· Ecstasia and endothelial problems may be far more common than
is being currently reported. Is it safe to leave 230um after LASIK?
"Eyes were not operated if the anticipated thickness of the cornea
after surgery was 230 µm or less. There were no limits to baseline
visual acuity," (http://jrs.slackinc.com/vol183/pay.pdf). "LASIK
surgery can cause permanent weakening and ectasia of the cornea even
in low myopia. This necessitated the wearing of hard contact lenses
or penetrating keratoplasty." (S. Percy Amoils, Iatrogenic
Keratectasia Following Myopic Lasik of Between <4 and 7 Dioptres, Am.
Soc. Cataract & Refract. Surg. Meeting, Seattle, WA, 4/99). "we are
quite unaware of the actual thickness of flaps when we make them..."
(Bob Kronemyer, Predictability of Residual Stromal Thickness Hinges on
Precision of Instrumentation, Ocular Surg. News, 1/1/01). "...some
are beginning to believe that the excimer may not be as innocuous to
the endothelium as most think." (Maxine Lipner, First on the
Endothelial Cell Block, Eyeworld, 9/00). Other references include:
http://www.journalofrefractivesurgery.com/showAbst.asp?thing=5084
· Elective Refractive Eye Surgery may cause permanent problems
with the epithelial layer. "Raised epithelium within the visual axis
(figure 3) can affect visual quality"
(http://www.revoptom.com/body/articles/10_2001/ro257.htm). "The
prevalence of epithelial ingrowth after LASIK varies from 2 to
10%.2,4,5" "and can result in Peripheral Melt of Flap and other
problems." (http://jrs.slackinc.com/vol141/castill.pdf). "Recurrent
corneal erosions are some-what common following PRK or LASIK due to
epithelial injury during scraping of the epithelium or formation of
the flap. as a larger number of eyes are included"
(http://jrs.slackinc.com/vol181/abs.pdf) "How is the corneal surface
affected by LASIK? Fine lines in a lattice pattern are commonly seen
and may represent folds in the epithelium or Bowman's layer. They can
be demonstrated within the flap after LASIK and so adversely affect
visual acuity" (http://www.ascrs.org/publications/jcrs/editjun02.html;
Carpel E.F., Carlson K.H., Shannon S. Fine lattice lines on the
corneal surface after laser in situ keratomileusis (LASIK). Am J
Ophthalmol 2000; 129:379–380)
· "The newly formed corneal surface is often irregularly
aspheric, probably the cumulative results of imperfect surgery,
equipment, and unpredictable healing." "Central processing of the
visual image in the brain is able to pull out the sharp image from the
surrounding blurred images. However, the limit of resolution of such
a process is probably not better than 20/40 if the emmetropic corneal
area is small. I think that the asphericity effect is not only due to
a variable corneal surface but also due to fluctuations in refractive
index in the subepithelial and/or superficial stroma (ie., the little
island lenses)." (http://jrs.slackinc.com/vol142/bkrev.pdf).
· Glare, Halos, Starbursts, diplopia and other vision problems
(including in ordinary indoor lighting conditions) are more common in
other studies done than in those used for the PMA approvals
(http://jrs.slackinc.com/vol142s/abs-l.pdf).
· Are proper steps always filed to protect the public health
from microkeratome induced DLK?
(http://jrs.slackinc.com/vol162s/Gim2.pdf;
http://jrs.slackinc.com/vol173/amb.pdf; ). "Another serious, but more
frequent complication, is inflammation under the flap or Diffuse
Lamellar Keratitis (DLK). This is reported nationally as high as
3-10%". http://www.arizonalaservision.com/laservisioncorrection/sideeffects.html.
· "Incidence of DLK ranges from 3-9% depending on brand of
microkeratome used (http://www.moria-surgical.com/publications/fichier/Microkeratome_comparison_Iacobucci.pdf).
· "Epithelial defect may increase incidence of DLK from 2% to
approximately 56%; epidemic DLK usually means something wrong with,
eg, sterilizing system or cannulas; stages—clumping of cells (stage 2
entering stage 3; lift flap and irrigate); stage 4 presentation"
"despite intense steroid regimen; central toxic keratopathy;
characteristic mud-crack changes in Bowman's membrane and central
haze; stroma melts from toxic effects of inflammation; caveat—even if
patient looks good on first day, he or she not "out of woods" for
DLK." (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102).
· Researchers of injury prevention have concluded that
"Legislation and regulation are among the most powerful tools to
reduce . . . injuries, and most environment and product design changes
require legal action. Many existing laws, however, are not fully
enforced or have loopholes that limit their effectiveness, and some
effective laws have not been adopted in every state" (Unintentional
Injuries in Childhood, VOLUME 10, NUMBER 1 - SPRING/SUMMER 2000;
http://www.futureofchildren.org/information3134/information_show.htm?doc_id=78948)
· The medical care costs for people with chronic diseases
account for more than 70% of the nation's total medical care costs.
Calling Elective Refractive Eye Surgery safe is like raising the
interstate speed limit to 120 mph so that gunshot victims can get to
the hospital faster. A permanent loss of eyesight, dry eyes, chronic
pain (http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299§ion=pe_pmc5),
and/or other "complications of LASIK is a high price to pay when
glasses and contacts could provide better vision (in most cases) with
a much lower risk.
· Patient's experiencing the complications from use of these
devices suffer medical complications that are devastating from a
psychiatric and psychological perspective, including the development
of Acute Stress and Posttraumatic Stress Disorder (accompanied by
Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder,
Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major
Depression. Additionally, patients experiencing these syndromes
frequently describe suicidal ideation.
Appendix C. Informed Consent
Ethically, should anyone even be allowed to consent to taking a risk
of seriously damaging their physical and mental health for life? Are
patients informed prior to surgery that a second procedure is
typically done months AFTER the eye has healed and there are specific
risks incurred in a second surgery so they can include that in their
initial decision to have it?
We believe in ethics, we believe in integrity and we believe in
justice being done. If you can do that, as I know you will, you will
have done your task, and to all of them who suffer and to all of them
who might be saved from suffering; and most importantly, perhaps, to
yourselves and to those who will follow you. Please do the right
thing. Please do not let this opportunity pass you by.
In a very real sense, reading the FDA transcripts prior to the
Premarket Approvals (PMAs) of these lasers for unnecessary medical
procedures, we have a glimpse of the Ophthalmology University. It is
a fervor that dismisses and rejects all evidence that is not
supportive of it. No one said we were going to have all the evidence
going one way. The evidence there is has been dismissed poorly studied
so let's consider science and research today. Time out. Wait a second.
You're Not doing this stuff to people's bodies without testing all
four tires and everything else about the automobile first are you?
You may disagree with us, which is your right. You may say it's safe
enough, but you decide that when this is finished you know two or
three things. You have fully considered what has been done before. And
you have rendered a decision that makes it real clear that people are
not to be treated as cattle or misled. Their damages are not to be
limited to their physical losses. Rather they are to include the pain,
the mental anguish, economic losses, and the loss of the enjoyment of
their life. There's more to life than working. There's more to life
than going to the doctor and paying doctor bills. Let us Not forget
about all those individuals whose fine, fine life was ruined by this
or all those who will be ruined if this is allowed to continue the way
it is practiced now.
Just one of the other bricks of this wall of suffering and increase
risk of future injuries includes the risk of falls and hip fractures.
In 1994, the estimated cost of fall-related injuries alone was $20.2
billion. Older adults' low light vision decreases by 30% by 60 on
average anyway as people age
(http://www.universityhospital.org/geriatric_education/sensory.html).
What about the potential increase in hip fractures in the elderly when
the vision problems caused by elective eye surgery are combined with
the degradation of vision that occurs naturally? Many hip fractures
are due to vision or balance problems, and "Of all fall-related
fractures, hip fractures cause the greatest number of deaths and lead
to the most severe health problems and reduced quality of life
(Wolinsky 1997; Hall 2000)"
(http://www.cdc.gov/ncipc/factsheets/falls.htm). If elective eye
surgery increases the rate of falls (a major risk in and of itself
given that 300,000 older adults suffer fall-related hip fractures some
of which result in death) by even 1%, then there's an additional cost
of over $200 million to the public. How much of the wall of increased
risks include the permanent weakening of the cornea (the flap never
heals fully), changes in lifestyles, increasing the risks of falls and
driving accidents (http://www.biopticdriving.org/DKelleher.htm; do you
want to share the road with large numbers of people who have
additional iatrogenically induced night driving problems;
http://www.icare4u.com/surgery.htm), mental health problems (including
the fear of surgery and pain;
http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6152§ion=pe_pmc5),
and other "unknown" long term effects of a permanently wounded cornea
caused by it?
Examining another brick in the wall, what about the total cost of
chronic pain resulting from this surgery? Trauma and postoperative
pain are commonly studied by the government
(http://grants1.nih.gov/grants/guide/pa-files/PA-01-115.html). One of
the FDA's main objectives is HEALTHY PEOPLE 2010
(http://www.fda.gov/OHRMS/DOCKETS/98fr/062502c.pdf) which includes
managing chronic pain. "The Public Health Service (PHS) is committed
to achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS led national activity for setting
priority areas. This Program Announcement (PA), The Management of
Chronic Pain, is related to one or more of the priority areas."
(http://www.health.gov/healthypeople/). "The prevalence of pain and
inadequate pain relief is common. Surveys show that approximately 34
million adults suffer from some form of chronic pain"
(http://www.nidr.nih.gov/news/analgesicDevWorkshop.htm). ". . . one in
every five Americans reports suffering from some form of chronic pain,
and seven in 10 say it interferes with their daily lives."
(http://www.aascif.org/public/archive/summer02/3.2.5_summer02.htm).
"Chronic pain disables more people than cancer or heart disease and
costs more than both combined. It is estimated that five million
Americans are partially disabled by back problems, and two million are
so severely disabled that they cannot work. For many people with such
chronic conditions as back pain and arthritis, the pain from the
condition may interfere with the quality of their lives more than the
actual disease or injury.". . . "With an estimated cost exceeding $125
billion annually in health care, disability compensation, lost
productivity, and lost tax revenue."
(http://www.upress.state.ms.us/catalog/spring2002/understanding_chronic_pain.html).
A common estimate is that $95 billion is lost annually due to sick
time, reduced productivity, and direct medical and other benefit costs
(Not including direct costs to the government such as lost tax
revenues and disability costs). How much does the chronic pain induced
by these elective surgeries add to the cost for the Public Health? Has
anyone bothered to ask?
Why are some people so upset that they have suicidal ideation (58 and
counting) after elective eye surgery? "About 3,000 patients a year
experience an off-center treatment, or asymmetrical healing, which the
Custom-CAP is designed to treat."
(http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html)
And the FDA considers this a "humanitarian" treatment with unknown
effectiveness (zzzzzzzzz Is there a connection that can be made
between Tinnitus and elective eye surgery? Like many elective eye
surgery patients, "tinnitus patients often are advised to ‘learn to
live with it.' (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10407886&dopt=Abstract).
Both result in depression (http://www.ata.org/about_ata/contact.html;
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?). Both are chronic,
largely untreatable conditions that cause distress leading to
increased medical and indirect costs
(http://www.flinders.edu.au/research/Reports/1997/SSPsy97.html). Much
more of the brain is involved in processing vision than hearing. What
would it be like to have something that is constantly annoying and in
many cases constantly, chronically painful ALL the time? Thousand or
millions of people know the answer to that question well. Why isn't
there any psychosocial treatment offered to assist patients in the
identification of aggravating factors and teaching them various coping
skills (if possible)? Are the complications of elective eye surgery
treated regularly or ignored even when the patient pays for the best
medical care possible to get (from centers conducting FDA studies
even)?
What about the unknown scientific certainty whether or Not it
transmits or causes diseases like cancer or CJD? We cannot justify
performing experiments on millions of people and just waiting to see
what happens! We can't implant a TV screen in the eyes of these people
and actually trace the cells in their damaged corneas. There is so
much that is beyond our control. All of us have said at one time or
another or we've seen something on TV or we've read something in the
newspaper when we've said, "I just wish I could do something about
that," whether it's crime, drugs, a problem at school or a problem
with disease. There's so much that we have no control over. But you
right now have an opportunity that comes to very, very few of us in a
lifetime. You have an opportunity now to make a difference. You have
an opportunity to sift through the evidence, to gather new evidence
and to carefully weight the consequences of either leaving the wall,
rebuilding the wall, or tearing it down entirely.
Stop this scientifically and professionally unjustifiable practice of
telling patients that because their corneas "look fine" and they can
see the 20/20 or 20/30 line on the chart that they should be happy
with their outcome. Does those who practice Ophthalmology honestly
believe Snellen acuity is the beginning and the end of the vision
equation? Isn't it well known that there can be a huge amount of
spherical aberrations with 20/20 central acuity? Why aren't statistics
kept for all intra-operative complications, post-operative
complications, low light uncorrected and best-corrected refractive
outcomes, and other induced undesirable optical phenomena? The
Petitioner challenge you to gather this data and present it to the FDA
Ophthalmic panel and to the laser manufacturers. Does the public have
a right to demand that they respond to these questions and concerns?
If science today has proven this product to be safe -- if the science
proves this product was so safe, then those hired by the FDA to help
the FDA come up with the answer would have given a thumbs up instead
of hemming that the long term risks are unknown. We know now that the
FDA has also given approval (http://www.fda.gov/cdrh/ode/annrp299.pdf)
for humanitarian treatment of up to 4,000 people known to be seriously
injured by it. The Custom-CAP was approved by the FDA under a special
"Humanitarian Use Device" exemption and is designed to treat the
"about 3,000 patients a year [who] experience an off-center treatment"
and can result in "It can result in worsened vision, corneal scarring,
corneal irregularities or corneal thinning. Moreover, its long-term
impacts are not known"
(http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html).
Humanitarian Devices Exemption (HDE) applications are similar in both
form and content to PMAs but are exempt from the effectiveness
requirements of PMAs (http://www.fda.gov/cdrh/ode/annrp299.pdf). Do we
know the true effectiveness and safety of conventional LASIK and other
eye surgeries?
Is eye tracking as good as it is supposed to be? "Eye tracking
improves accuracy, but still has limitations. Current systems cannot
compensate for eye movements exceeding 10°, a physicist said"
(http://www.pconsupersite.com/default.asp?ID=5619). "The eye tracker
pauses treatment when an eye movement >0.2 mm occurs between two
sampled positions, or when it detects significant non-circularity of
the pupil. The operator can turn the tracker on or off at any time.
The delay between the tracker acquisition of a positional signal and
the beam positional response is about 67 msec, less than the
interpulse interval of the laser beam."
(http://www.fda.gov/cdrh/pdf/H000002b.doc)
Regarding LASIK, it is well known that most of the "complications" and
risks are due to problems with the flap. If LASIK is even .1% less
safe (and the real figures may be as much as 50 times that number)
than other elective eye surgeries and one million surgeries are done
per year, then what do we tell the extra thousand people and their
families who are injured by LASIK- potentially for life? Even a
nominal increase in safety will effect thousands of people and
thousands more of their families, and the public. Let's determine the
impact of legislation, litigation, and regulation in preventing
injuries to our shared community and many of those we know and hold
dear to us, as well as a very serious danger to our great Nations
Public Health in general.
Wouldn't we want to answer these questions thoroughly before
concluding that "PRK and LASIK are safe, effective, and permanent
cures for certain vision problems" and "A LOW-RISK ALTERNATIVE TO
GLASSES"? (http://www.casad.org/English113/example%20Fall_2000.htm).
How was this impenetrable wall of horror and suffering created in the
first place? Has anyone asked simply what is going on here? For
many, they are Not so severely effected that the result is acceptable
to them, but for a significant minority they simply have to make do
with their vision whatever it is. After you know that there is no real
way to get help safely and that there are real risks of irreversible
blindness, not being able to read, not being able to work, etc., what
would you do next? What if it was you?
Thank you very much.
Appendix E. What makes you a "good candidate" for elective Refractive
Eye Surgery?
According to the FDA,
"You may be a good candidate for laser eye surgery if you:"
"have a way to pay for the treatment since laser procedures are costly
and probably not covered by health insurance policies
are fully informed about the risks and benefits of laser surgery
compared with other available treatments."
(http://www.fda.gov/fdac/features/1998/498_eye.html)
What does the cost have to do with whether or Not a permanently vision
threatening procedure is done on healthy eyes?
What are the advantages of doing surgeries known to have less
predictable results on vision, worse complications and poorer effects
on vision quality? Isn't RK Not done anymore because it weakens the
cornea? Does the AAO care about the medical advantages of one eye
surgery over another?
According to the American Academy of Ophthalmology (copied 6/24/2003),
http://www.aao.org/vp/edu/refractdemo/v1m1/incisional.cfm
"However, RK has some distinct advantages over modern forms of
refractive surgery, including"
"incisions that do not directly involve the optical zone"
"more long-term data on this procedure than on other refractive
surgical options"
"equipment that is less expensive than that used in laser surgery"
Given the long-term data that's available on these incisions and how
they do effect the optics, and as all the long-term data indicates
that RK damages the structural integrity of the eye, then that only
leaves the third reason. RK is less expensive and is Not widely used
any longer except "Surgeons in communities that do not have access to
laser technology may continue to offer RK as a method of correcting
mild to moderate myopia." With medically necessary procedures, it's
understandable that rural communities have to accept care that isn't
as good as that available in urban areas, but is it right to subject
them to blindly accept elective medical care that is known to be
inferior simply because it is cheaper and easier for the surgeon Not
to travel for a few hundred miles? What if the patient is willing to
travel? Is that the standard of care you would like for your mother
or your children?
Why aren't the following medical reasons mentioned instead of the
Ophthalmologists' costs? "Higher-order wavefront aberrations were
almost twice as high after RK than after PRK at pupil sizes of 4 and 6
mm. Spherical aberration and coma were slightly higher after PRK than
after RK." (http://www.journalofrefractivesurgery.com/showAbst.asp?thing=1885)
"RK is still performed on patients who have low to moderate degrees of
nearsightedness and simply cannot afford the more expensive laser and
surgical correction procedures."
"After RK, almost everyone experiences some visual side effects. These
visual side effects are usually mild and most often diminish over a
few days to a few weeks. But there is a slight chance that some of
these side effects won't go away completely, including light
sensitivity, glare and halos. Serious complications to RK are
extremely rare. Infection is the most worrisome complication and
fortunately it can usually be eliminated with antibiotic medications."
(http://www.joneseyecenters.com/index.cfm/procedures/radialkeratotomy)
"Without proper education, some patients mistakenly equate residual
refractive error to a surgical complication instead of a nuisance. "
(http://www.revoptom.com/body/articles/10_2001/ro257.htm)
"The clinical study of CK indicated that most patients continue to not
need glasses" and "is considered a less invasive alternative to
LASIK". "We should be able to correct most cases of hyperopia, and
our initial studies indicate ultimately, presbyopia."
Are the chances really "slight" or "small"? What does "rare" mean to
you, to me, to your neighbor? 1 in 1,000,000? 1 in 100,000, 1 in 10?
Does this type of vague explanation of the likelihood of having
permanently damaged vision fully inform anyone "about the risks and
benefits of laser surgery compared with other available treatments"?
How long is the FDA and AAO going to allow this to continue? Have you
thought about it? This is bad for the patient, but this is worse for
you. Enough said.
Dr. Leukoma
news:b0866067.0309...@posting.google.com...
> I'm not sure if I agree with everything in here or not, but it seems
> to have some studies to back it up. I would have included that the
> true complication rates are unknown, and that it is now known that at
> least one person became blind in BOTH eyes. 5% complications would
> fill a large stadium with people. Wearing RGPs isn't safe either due
> to the risk of subsequent DLK (as I understand from reading the
> discussions on this message board). I didn't see anything in it about
> people going blind from LASIK. We know it happens because the FDA
> includes "irreversible blindness" as a "risk".
Please let me know when you run across a case of contact lens-induced DLK.
I read this board as well as other boards, skim the literature, and believe
it or not, have actually fit many LASIK eyes with contact lenses. I have
yet to run across a case of contact lens-induced DLK.
DrG
Ragnar Suomi
Mr. Melt has too much time on his hands and not enough rationale to
research anything credibly.
Simpledog
I'm going to use it tomorrow at work.
"Ragnar Suomi" <ragna...@yahoo.com> wrote in message
news:vuovlvcq9id9219di...@4ax.com...
lasik advocate with flap melt
heard the cost is $250 per hour for some Doctors plus the cost of the
lenses.
The reason I'm asking these questions is because I don't know- I'm not
a Doctor and I only know 1- what happened to me, 2-what I read or 3-
what I hear from other people. I'm putting 2+2 together and getting
4. Didn't you write that RGPs can "compromise" the epithelium? And
that compromised epithelium can lead to DLK well after surgery?
By the way, I developed worse eye pain and a red eye AFTER wearing a
Focus night and day lens for a while. A few months after I stopped
wearing the lens, I developed severe eye pain and was told I had an
epithelial defect (~20 months post-op). Then a while later I was told
about flap melt. Seems logical to me that wearing the contacts CAN
cause DLK and/or flap melt in addition to epithelial problems.
I'm well educated and I've been researching the eye and visual
problems for years now. If I can't ask a simple question well enough
for you to answer it in general terms (not specific to a given case)
OR for you to come up with a specific case, then how can most people
be expected to ask the questions just the right way either to get the
information they're looking for? I'll try one more time. What is the
absolute safest contact to wear in terms of cornea health if you have
dry eyes. If you want to put a caveat on it that there should be no
prior history of x,y,z, or whatever caveat you want then that's fine.
If you don't know, then that's fine too.
you wrote,
> Dr. G, do you have any idea why rgp lenses would exacerbate dry eye
> more than soft lenses? Is it poor wettability of the rgp surface or
> something else? How do macrolenses perform in these cases?
For lack of a good technical explanation, I would just say "increased
friction" with the smaller diameter RGP.
If the epithelium has been
compromised, then the eye can be uncomfortable.
In a tear deficient situation, Macrolenses tend to suffer from lack of
tear
exchange, or at least it would appear so from the fluorescein pattern
under
the slit-lamp. After awhile, the patient reports foggy or hazy
vision, but
rarely discomfort until the lens is removed. If the epithelium has
been
compromised, then the eye can be uncomfortable.
Very recently - within the past year or so - research is showing that
the
rate of mitosis in the epithelium markedly slows under the influence
of the
contact lens, more so in the case of low Dk lenses, and it takes
awhile to
recover. Perhaps this is somehow related to long-term intolerance in
some
way, but that is only pure speculation at this point.
It seems to me that Glenn was trying to differntiate an infectious
etiology
from a non-infectious etiology. DLK has also been linked to cell
fragments
from the contamination of the microkeratome by dead bacteria in the
autoclave. Basically, DLK is probably caused by anything that can
incite
an immune reaction in an individual patient. It is an immune reaction
and
not an infection, per se.
'Tis true that DLK has been known to occur following iritis. However,
I
wonder if mild SPK is really enough to incite DLK. Dr. Wu describes a
post-operative patient who had dry eye and punctate epitheliopathy at
one
month post-op. She goes on to state that this patient developed DLK
at the
two month mark following an acute episode of red eye and foreign body
sensation.
To me, this indicates that the "little surface erosion" probably
degenerated into something more significant.
http://groups.google.com/groups?hl=en&lr=&ie=UTF-8&safe=off&threadm=Xns93F1DF808B62Edrgleukomacom%40204.127.204.17&rnum=3&prev=/groups%3Fq%3Depithelial%2Bauthor:drgNOSPAM%2540leukoma.com%26hl%3Den%26lr%3D%26ie%3DUTF-8%26safe%3Doff%26selm%3DXns93F1DF808B62Edrgleukomacom%2540204.127.204.17%26rnum%3D3
Also, the dryness following LASIK is
correlated to a degree with the amount of correction.
Also, a good tear film is necessary for successful contact lens wear.
CRT
requires that you wear a rigid lens, at least part of the time.
Patients
with dry eyes are typically intolerant of contact lenses.
Personally, and I have been saying this
for a long time, if any test for dry eye determines that you have dry
eye,
then avoid refractive surgery. Dry eye tests are notorious for giving
false negatives, i.e. indicating you have good tears when in fact you
do
not. However, when they are positive, then the chances are
overwhelming
that you have dry eye.
There are a handful of people for whom I
haven't found a solution. I believe that most of them are people who
had
contact lens intolerance prior to LASIK.
NO contact lens is safer than nothing following refractive surgery -
UNLESS
the cornea is suffering from severe keratitis, in which case a soft
lens
will help provide a moisture barrier and assist in the healing
process.
Absolutely contact lenses can cause/reduce/change astigmatism via
changing
the anterior surface of the eye. Several articles have been published
regarding the effect of stiff soft lenses - such as Focus N&D - on the
corneal shape. These are side-effects, often unintended, and do not
always
occur.
In other words, patients are "misinformed" about the dangers of
contact
lenses.
http://groups.google.com/groups?q=contact+author:drgNOSPAM%40leukoma.com&hl=en&lr=&ie=UTF-8&safe=off&selm=Xns93BB4E43693EFdrgleukomacom%4063.240.76.16&rnum=2
However, if I may
generalize a bit, soft lenses do not provide the visual quality of an
RGP
lens for MOST post-refractive patients.
with silicone-hydrogels than I have seen with daily disposables.
The major problem is that Ciba has a monopoly with their Focus N&D
that
precludes any advancement of the technology.
http://groups.google.com/groups?q=contact+author:drgNOSPAM%40leukoma.com&hl=en&lr=&ie=UTF-8&safe=off&selm=Xns93D9DB35244A8drgleukomacom%40204.127.204.17&rnum=8
I got to have the final say which was: "If you can wear glasses or
contact
lenses, I say stick with 'em." The series received high viewership,
at
least judging by the feedback I got from my patients and friends. It
was
aired during a winter storm which forced everybody to stay in front of
their TV sets.
http://groups.google.com/groups?q=epithelial+author:drgNOSPAM%40leukoma.com&hl=en&lr=&ie=UTF-8&safe=off&selm=Xns93C94F29AB38Edrgleukomacom%40204.127.204.17&rnum=6
"Dr. Leukoma" <gre...@ix.netcom.com> wrote in message news:<xQQ7b.7436$Yt....@newsread4.news.pas.earthlink.net>...
Ragnar Suomi
You claim you already had LASIK done. Enough with the contact lens
questions. Your pattern of stirring up chaos with mindless, pointless
spam in this newsgroup is established.
For someone who is well educated and has been researching visual
problems for years and who posts voluminous quantities of useless
babble, you sure don't seem to have a clue.
On 11 Sep 2003 18:38:30 -0700, kpat...@hotmail.com (lasik advocate
Dr. Leukoma
news:b0866067.03091...@posting.google.com:
> How much do you charge per hour for fitting contact lenses? I've
> heard the cost is $250 per hour for some Doctors plus the cost of the
> lenses.
My charge for a post-refractive surgery case is in that range. It was the
most rational fee scale that I could devise. For lenses, I charge exactly
what the lab charges me with absolutely no mark-up, which means lenses can
cost you as little as $20 each for custom reverse geometry RGP's. In this
manner, if we get it right the first visit, you get a cheap pair of contact
lenses. Patients who fly-in on Monday can expect to leave with a pair of
contacts on Friday. However, during that week, patients can expect to have
multiple, intensive, one-on-one sessions, with multiple sets of lenses
delivered daily by courier. A few cases have taken only a few days. In
return for this level of service, you can expect to pay what most people
would consider a very reasonable fee.
>
> The reason I'm asking these questions is because I don't know- I'm not
> a Doctor and I only know 1- what happened to me, 2-what I read or 3-
> what I hear from other people. I'm putting 2+2 together and getting
> 4. Didn't you write that RGPs can "compromise" the epithelium? And
> that compromised epithelium can lead to DLK well after surgery?
I am not aware that any of my post-LASIK patients has had DLK induced by
their contact lenses. Severely compromised epithelium in a predisposed
patient could induce DLK, but a properly fit contact lens should not be
capable of damaging the epithelium to that degree. People who engage in
fear mongering are sometimes missing their intended targets and doing a
disservice to the very people who need help.
>
> By the way, I developed worse eye pain and a red eye AFTER wearing a
> Focus night and day lens for a while. A few months after I stopped
> wearing the lens, I developed severe eye pain and was told I had an
> epithelial defect (~20 months post-op). Then a while later I was told
> about flap melt. Seems logical to me that wearing the contacts CAN
> cause DLK and/or flap melt in addition to epithelial problems.
Did you have any epithelial ingrowth? Where did the flap melt occur? Do
YOU think that the epithelial defect led to the flap melt based upon your
visual experience? Why don't you start by giving me some specifics about
YOUR situation for a change?
>
> I'm well educated and I've been researching the eye and visual
> problems for years now. If I can't ask a simple question well enough
> for you to answer it in general terms (not specific to a given case)
> OR for you to come up with a specific case, then how can most people
> be expected to ask the questions just the right way either to get the
> information they're looking for? I'll try one more time. What is the
> absolute safest contact to wear in terms of cornea health if you have
> dry eyes. If you want to put a caveat on it that there should be no
> prior history of x,y,z, or whatever caveat you want then that's fine.
> If you don't know, then that's fine too.
Some doctors would say that any contact lens is contra-indicated in a dry
eye. However, if you are saying that it is your stated objective to wear a
contact lens, then I would ask what is your objective? Do you want to wear
it as a bandage lens to prevent further epithelial damage, do you wish to
regain lost vision...what are your objectives? Most people I see need
desperately to regain some function, in which case we often need to use
some type of RGP lens. In terms of protective function, I would choose the
Proclear Compatible hands down over any soft contact lens. With RGPs,
there are only a handful of materials I work with, and most are in the same
class.
There really is no purpose in engaging in any more generalization, because
it doesn't help me and it doesn't help you. Every case is unique. I had a
patient who was several months out from surgery and a nest of epithelial
beneath the flap became active. However, it eventually burned itself out
without inciting DLK, and the patient is still wearing the contact lens.
DrG
lasik advocate with flap melt
> without inciting DLK, and the patient is still wearing the contact lens.
Did it become active while they were wearing lenses? RGP lenses? How
dry are his/her eyes?
"Dr. Leukoma" <drgN...@leukoma.com> wrote in message news:<Xns93F3DB48728...@204.127.204.17>...
Dr. Leukoma
news:b0866067.03091...@posting.google.com:
>> However, it eventually burned itself out
>> without inciting DLK, and the patient is still wearing the contact
>> lens.
>
> Did it become active while they were wearing lenses? RGP lenses? How
> dry are his/her eyes?
>
The nest of epithelial cells, introduced during a flap lift and re-
operation, did become active during the period when the patient was wearing
an RGP lens. The patient was fit with an RGP lens approximately 4 months
post-op. There was some short term discomfort with the lens during that
time, but the cells subsequently underwent apoptosis and for the most part
went away. The patient continues to wear the lens. The patient does have
some problems with film and buildup, due to the local environment, but the
lens provides clear vision and can be tolerated for most of the day. When
in Dallas, the tear film is quite good. The vision remains good for
several days without the lens, and therefore does not need to be worn every
day.
DrG
lasik advocate with flap melt
It's good to know that it hasn't come back.
What is the mechanism where the RGP helps the vision for a few days
afterwards so the contact isn't needed- the epithelial remodelling or
the actual eye shape itself changing? Can it increase the functional
size of the ablation zone if it's too small? Do any soft lenses have
this effect too?
How long does a given epithelial cell live before it's replaced? I
thought the epithelial cells didn't live long and divided often.
How do you know whether the epithelial cell got under the flap due to
the surgery or the contact lens? Couldn't the contact lens kind of
"scrape" a cell under the flap since the flap never heals fully?
Don't contacts effect the epithelium around the flap edges?
"Dr. Leukoma" <d...@leukoma.com> wrote in message news:<Xns93F4C03F8...@207.217.77.201>...
Dr. Leukoma
news:b0866067.03091...@posting.google.com:
> How long has it been since the flap melt occured for that patient?
There was no "melt" in this case. In fact, the epithelial nest could be
seen on topography as a small elevation. The flap is fully intact.
> It's good to know that it hasn't come back.
>
> What is the mechanism where the RGP helps the vision for a few days
> afterwards so the contact isn't needed- the epithelial remodelling or
> the actual eye shape itself changing? Can it increase the functional
> size of the ablation zone if it's too small? Do any soft lenses have
> this effect too?
Epithelial remodeling. The functional size of the zone can be increased or
decreased via an RGP lens. I will be presenting this information at the
CLES 2004 meeting in Orlando in January. Soft lenses have no effect.
>
> How long does a given epithelial cell live before it's replaced? I
> thought the epithelial cells didn't live long and divided often.
>
> How do you know whether the epithelial cell got under the flap due to
> the surgery or the contact lens? Couldn't the contact lens kind of
> "scrape" a cell under the flap since the flap never heals fully?
> Don't contacts effect the epithelium around the flap edges?
I know because the cells were there before the patient was fit with the
contact lens. The cells were located supero-temporally, away from the edge
of the flap. The flap edges were comfortably sealed by the epithelium.
The contact lens was never observed to have caused an epithelial defect. I
have never observed a contact lens pushing cells under a flap.
Mechanically, this is unlikely.
lasik advocate with flap melt
untouched area of the cornea outside of the flap? Don't epithelial
cells divide all the time? How did they stay "inactive" for 4 months?
By burn themselves out, do you mean that the stroma was untouched and
the cornea in that area healed 100% normally? Did the stroma get
scarred or adversely effected? Was there any piece of cornea missing
or any low spot (indentation) left in the cornea?
I live in fear of DLK and flap melt. I was told I was doing very
well. I asked why there was piece of my cornea missing since my last
visit. I was told if I'd seen you in March. . . I asked for an
educated guess. If I'd seen you in March. . . Epithelial defect was
written in March (or so I was told). I was told the flap was fine in
March (not written). The problem is I don't know what happened. All
I know is what I'm told. Why don't I know more? I know I had an
epithelial defect, overturned flap and scar tissue in July of 2001. I
asked explicitly if I should be concerned about it. Now I'm told that
the flap melt won't progress. How do they know? If they knew it
could progress in July of 2001, then why didn't they tell me then? If
it happened almost 2 years post-op, then can't it happen again? Now I
have 1 divit in my cornea (so I'm told). What happens after I have
50?
"Dr. Leukoma" <d...@leukoma.com> wrote in message news:<Xns93F56CD15...@207.217.77.201>...
Dr. Leukoma
the edge. Who says they were ever completely dormant or were incapable of
reproducing even four months after surgery? They clearly grew, as
evidenced by the elevation on topography, then they died as evidenced by
their disappearance. They are gone, kaput, dead, expired. Since they are
well outside the visual axis, it is a moot point whether there is an
elevation or a depression. The patient needed a contact lens to function,
and continues to function with the contact lens. Are you going to suggest
to this patient that they undergo yet another flap lift?
DrG