The Promise of Refractive Surgery: A Promise Not Kept an insiders journal - Part I of III

Discussion in 'Laser Eye Surgery' started by TheTruthAboutLASIK, Nov 14, 2003.

  1. The Promise of Refractive Surgery: A Promise Not Kept
    An Insiders Journal on the Evolution and Misinformation of Refractive
    Surgery


    This is dedicated to the thousands whose quality of life has suffered
    greatly as a result of believing the professionally communicated
    promise of refractive surgery

    Table of Contents

    Section Page
    Introduction 2

    Refractive Surgery and Misinformation 3

    Fundamentals of LASIK 5
    · LASIK's surgical landscape: the Cornea
    · Asphericity and imaging of light rays on the retina
    · The loss of contrast sensitivity and quality of vision
    · Dry eye
    · DLK (diffuse lamellar keratitis)
    · Accuracy of the microkeratome
    · Enhancements and the use of misleading terms

    Informed Consent 12
    · The absence of incidence data
    · A physician's internally developed data
    · Physician use of manufacturer sales aids
    · Physician's and conflicts of interest
    · Referrals to LASIK surgeons
    · Looking through a patient's eyes
    · Websites
    · Recent FTC actions


    INTRODUCTION

    The practice of businesses selectively using information to market
    products is widespread. Selectivity is a critical tool in marketing.
    But is it ethical in the marketing of therapeutic products and/or
    services in healthcare? Isn't there more at stake when a manufacturer,
    a health system, and/or a health professional selectively uses
    information to move a medical or surgical therapy than when a business
    executive tries to move a product? Isn't the obligation to tell the
    truth heightened when something to treat and possibly alter a person's
    state of health is being proposed? Are not roles in healthcare clearly
    distinguished by their unique moral responsibility?

    Unfortunately, the selective use of information in the marketing of
    healthcare products and services is rampant and growing. When I
    entered medicine years ago, the promise was to heal. Today, the
    promise of medicine has become money – to doctors, providers, and
    suppliers. This change in focus necessitates that we, as patients,
    more than ever, must take responsibility for our health.

    But "Patient Power" in this changing landscape requires full
    knowledge, not a biased selection of facts. Knowledge that is
    unbiased, truthful, and complete. This puts the burden on the
    manufacturers, health systems, and healthcare professionals to provide
    patients with all unbiased, truthful information on expected costs,
    outcomes, and complications. Good, informed patient decisions cannot
    be made with selective information. Anything less than full disclosure
    is a disservice to the patient, the healthcare system, and society.

    I have seen refractive surgery grow to 100,000 US procedures per year
    three years after 1978 introduction of RK (radial keratotomy). As
    long-term complications became known, it dropped to 30-40,000
    procedures per year in the mid-1980's. RK was reinvented in the early
    1990's emerging as "Mini-RK," with shorter incisions and enhancements.
    It fell victim to laser based procedures in the mid-1990's with the
    FDA approval of PRK, and then, the off-label LASIK procedure. Laser
    based procedures, mainly on the strength of LASIK, topped out at 1½
    million procedures per year in 2000.

    My concern for the patient has also grown with the introduction of
    each new procedure and the increasing numbers of procedures. The
    accuracy, breadth, and depth of the information used to move patients
    to a decision have been deficient. Concerns and knowledge on both
    outcomes and complications by the medical community have not been
    fully disclosed to an unsuspecting public. This is unacceptable as
    these procedures are elective, cosmetic, and irreversible.

    Defense lawyers and doctors will point to a signed "informed consent"
    as proof that the patient's are informed. But as you will learn,
    patients have been left out in the cold on key facts, and have been
    misled by clever copy. This began with the introduction of RK and has
    continued ever since. For instance, did RK patients, or even the more
    recent mini-RK patients, know that 40% of the corneas with RK after
    ten years were unstable and experienced progressive hyperopia? While
    evidence of these untoward outcomes were known in the late 1980's,
    they were not communicated to patients.

    Refractive procedures, with one exception, are permanent and
    irreversible. While permanence, at first blush, appears to be a
    positive attribute, it has a dark side – permanent problems, permanent
    outcomes, and no upgrades. The so called permanent correction
    (outcome) will not be so pleasing as one ages since the optical system
    changes with age. The required visual correction at one point in life
    may not be the desired correction later. Upgrades to improved or newer
    ways to correct vision will be ruled out since most of the present
    procedures involve permanent changes to the corneal structure
    (permanent removal of tissue). Those opting for these procedures are
    locked-in. Imagine being locked into a clunky 1980 car phone with no
    chance to upgrade to a newer, smaller, portable, feature laden, cell
    phone.

    I, like many who are interested, wear contact lenses and would like to
    be rid of them. But the question for me has always been at what risk?
    With what I know from surgeon's private hallway conversations, I
    prefer my contact lenses, and will have them for some time. I will get
    rid of contacts when something comes along with these proven
    attributes:

    · minimal risk
    · great vision
    · no maintenance
    · allows prescription changes as my visual system changes with age
    · allows me to upgrade to newer procedures as they are introduced
    · reasonably priced
    · and allows me to undergo effective, proven therapies I may need as I
    age for glaucoma, cataracts(IOLs), and macular degeneration

    Then I will put my contact lenses aside, and become an enthusiastic
    refractive surgery supporter and patient.

    "Letters to the Editor, Re: Corneal refractive power after myopic
    LASIK," Ophthalmology," September, 2003
    (These letters refer to the difficulty of determining which IOL should
    be used in cataract surgery following LASIK. Since the cornea is now
    abnormal, there is some uncertainty on what should be done.)

    Vahid Feiz, MD, Little Rock, Arkansas; Mark J. Mannis, MD, FACS,
    Sacramento, California
    "The recent article by Hamed et al1 addresses an emerging problem
    that many ophthalmologists will be facing in the relatively near
    future. It has two main conclusions: (1) when manual keratometry and
    topography are used for intraocular lens (IOL) calculations after
    myopic LASIK, the power is underestimated, and (2) there is a direct,
    linear relationship between the degree of corneal refractive surgery
    and IOL power error as evidenced by regression analysis…What exactly
    is the source of error in determining true corneal power after
    keratorefractive surgery? The answer most commonly cited is the
    alteration in the relationship between the anterior and posterior
    corneal surface that results in a change in refractive index…In
    summary, the authors' conclusions and recommendations appear to verify
    the results of previously published studies.2,4 The most accurate
    method of calculating IOL power at this point remains use of
    refractive change induced by LASIK and a fudge factor to compensate
    for the change in refractive index of the cornea. In doing so, the
    relationship between corneal power and refraction needs to be
    considered..."
    Douglas D. Koch, MD and Li Wang, MD, PhD, Houston, Texas "We enjoyed
    reading Drs. Feiz and Mannis' letter and welcome the study of new
    approaches for calculating intraocular lens (IOL) power in patients
    who have undergone LASIK and photorefractive keratectomy. However, we
    do not feel that their letter accurately characterizes their method or
    the current state of knowledge regarding this challenging problem...We
    are surprised by their comment that the clinical history method "still
    underestimated the IOL power." As they state in their article, none of
    these methods has been tested in a clinical series...Therefore, any
    comparative evaluation of these methods is purely speculation, pending
    further clinical study…the ultimate goal is the development of
    accurate methods of measuring true corneal power."
    REFRACTIVE SURGERY AND MISINFORMATION

    Misinformation and hype in refractive surgery began with the
    introduction of RK and has followed a predictable pattern ever since.
    With the introduction of each new and/or improved procedure, the
    problems of older procedures, which were previously misrepresented or
    not even discussed, were made public. When "mini-RK," an "improved" RK
    procedure, emerged in the early 1990's, the real problems (and their
    probable incidence) of the "older RK" procedure were fully disclosed.
    The case for an improved procedure had to be made so that the new
    "mini-RK" would be adopted.

    When the FDA approved PRK, the problems of the "mini-RK," heretofore
    denied, were now openly discussed in light of an even better
    procedure. When LASIK gained momentum in the late 1990's, PRK's
    problems, again accepted privately but previously denied publicly,
    were publicly discussed to move surgeons and patients to LASIK. And
    with the introduction of laser-based procedures, new stakeholders -
    optometrists, manufacturers and emerging commercial refractive chains
    - joined the refractive surgeons in misinformation and hype. The
    "refractive surgery industrial-medical complex" was born.

    We are now moving into the era of Wavefront, IntraLASIK, LASEK, and
    various intraocular lenses. LASIK, which surgeons, optometrists,
    refractive surgery chains, and manufacturers just three short years
    ago said had "1 in 10,000 problems", "Throw your glasses away
    forever," and "100% of the outcomes are 20/20", etc., will now be
    beaten up with the unvarnished truth about its outcomes and
    complications. Unfortunately, the new and/or improved procedures will
    be marketed as LASIK was – with misinformation and hype. The truth on
    these newer procedures will emerge from the "refractive surgery
    industrial-medical complex" only when there is a need to obsolete them
    with "the next big thing". And pay close attention to the spokesperson
    surgeons for the new procedures, they are the same people who hyped,
    with selective information, the procedures being abandoned.

    Where have the Medical Societies been? Medical Societies need
    revenues to survive. They cease to exist without dues paying members
    and the financial support of industry. Industry provides financial
    support through medical journal advertising, medical meeting
    participation, and support to various causes vital to the member
    interests. Taking a stand, which can impact the revenues of an
    important member and industry group, can be difficult. One society did
    take a stand against RK in the early 1980's and suffered. A lawsuit
    was filed and was successfully litigated against this society for
    interfering with the commercialization of RK (free speech).

    More recently in 2002, some surgeons, concerned with lawsuits, have
    discussed in their doctor-to-doctor web based chatrooms the
    blackballing of those doctors who serve as expert witnesses for
    plaintiffs. At the annual meeting of the American Academy of
    Ophthalmology in 2002, a Canadian surgeon, who testified in an Arizona
    malpractice case resulting in a $4 million judgment, was accosted by
    fellow US surgeons. His mistake was testifying for the plaintiff.
    Remarkably, this doctor had changed his view saying that he mis-spoke
    under oath at the jury trial. The ruling has been set aside and the
    case is waiting to be retried.

    Fear of retribution permeates the field of ophthalmology. Patient's,
    with legitimate malpractice issues, now have difficulty finding an
    "expert" surgeon who will testify on their behalf. Rather than taking
    responsibility, refractive surgeons are shifting guilt to the patient
    and to those trying to help the patient. Misplaced guilt is not
    restricted to business and politics!

    And where has the FDA been? While the FDA can regulate manufacturers,
    they cannot regulate doctors. Physician advertising is the
    responsibility of the FTC. This complicates the communication of
    accurate, non-selective information as cross-jurisdictional
    responsibilities dilute the effort.
    "Vision Quest: Laser eye surgery has worked for millions but goes awry
    for 18,000 patients a year. A new approach aims to fix that." Mary
    Ellen Egan, Forbes, September 15, 2003, pg. 222.
    "…Two years ago Heinbockel had a new kind of eye surgery called
    wavefront, approved by the Food & Drug Administration in October
    2002…Though some 3.7 million Americans have had successful surgery
    since 1995, problems such as night vision, cloudiness, glare and halos
    occur in about 3% of patients – upwards of 18,000 per year. The new
    wavefront approach reduces flaws to just 1% of cases and fixes vision
    problems LASIK cannot…The procedure costs about $2,500 per eye, or 20%
    more than LASIK…But LASIK and wavefront are as different as ordering a
    suit off the rack and being fitted for a custom-tailored one… Thomas
    Wilson, 57, had two LASIK surgeries that left him with halos and night
    vision problems…His original LASIK doctors "thought I should be
    satisfied with my results," he fumes.
    "Lens-based refractive procedures offer advantages over LASIK,"
    William F. Maloney, MD, Ocular Surgery News Europe/Asia Edition,
    September 2003
    "The limitations of LASIK and other keratorefractive procedures are
    increasingly difficult to ignore. The aberrations inherent in corneal
    reshaping methods simply do not always allow the accuracy and
    predictability most refractive surgery patients have come to expect.
    Anatomical limitations (there is only so much cornea that can be
    ablated) combined with functional limitations (treatment zone vs.
    pupil size, etc.) have resulted in the realization that LASIK just
    cannot do it all, as many had hoped it would 5 years ago.
    The steady reduction in the amount of ametropia that can be reliably
    corrected with corneal refractive techniques has left surgeons looking
    elsewhere…the IOL has clearly emerged to fill this void…
    Lens-based refractive surgery also brings us back to basics, in the
    sense that surgical skill is a prerequisite to successful outcomes and
    satisfied patients. It seems to me that at least part of the appeal of
    LASIK and other corneal procedures was perhaps that they presented an
    opportunity to circumvent this basic issue, but this did not happen…
    "Ten-Year Results on Radial Keratotomy Released," National Eye
    Institute Information Office,
    NEI Press Release, October 13, 1994
    "…the study found that more than 40 percent of RK-operated eyes
    continued to have a gradual shift toward farsightedness. This finding
    suggests that some people who have RK may need glasses at an earlier
    age for poor close-up vision, a common problem after age 40, than if
    they had chosen not to have the surgery.
    ‘Based on these findings, it may be that some people will be pleased
    with their vision shortly after having RK, but their opinion may
    change five, ten, or fifteen years down the road,' said Peter J.
    McDonnell, M.D., of the Doheny Eye Institute at the University of
    Southern California and the study's co-chairman.
    Today's findings, published in Archives of Ophthalmology, were issued
    from the Prospective Evaluation of Radial Keratotomy (PERK). The PERK
    study is the first large, well-designed clinical study to evaluate the
    long-term effects of radial keratotomy on the eye and vision.
    RK is performed to improve poor distance vision, called myopia, which
    affects millions of Americans. For some people with myopia, RK offers
    the prospect of good distance vision without the need for glasses or
    contact lenses.
    The surgery changes the shape of the cornea, the clear, rounded tissue
    at the front of the eye. It is performed by making spoke-like,
    partial-thickness incisions into the healthy cornea. These wounds
    cause the cornea to flatten, producing clearer distance vision.
    Today, about 250,000 RK surgeries are performed annually in the United
    States, up from 30,000 operations just five years ago. However, eye
    care professionals still have little scientific information about the
    procedure's long-term effects on the cornea and vision.
    To provide these data, PERK clinicians periodically examined the eyes
    of the 435 participants since the study began in the early 1980s.
    Based on these examinations, researchers have published occasional
    reports in medical journals, including the results issued today.
    At the PERK's 10-year mark, researchers reported that RK effectively
    reduced but did not completely eliminate myopia in all patients. They
    found that 53 percent of the RK-operated eyes registered 20/20 vision,
    while 85 percent of the eyes had 20/40 uncorrected vision or better
    (required for a driver's license in most states). Approximately 70
    percent of study participants said they did not wear corrective lenses
    for distance vision at the 10-year mark.
    RK also had "a reasonable margin of safety," resulting in few
    vision-threatening complications. However, the researchers noted that
    3 percent of operated eyes had poorer distance vision with glasses one
    decade after surgery, although none had corrected vision worse than
    20/30.
    Interestingly, the PERK scientists reported that 43 percent of the
    RK-operated eyes continued to have a gradual change toward
    farsightedness, called hyperopic shift. In fact, 36 percent of the
    eyes had become farsighted at the 10-year point…According to the
    researchers, this shift was detected in some affected patients as soon
    as six months after surgery and continued to progress a decade later.
    They said they do not know when and if this change will cease in the
    future.
    The scientists noted that the shift in vision was not related to the
    patient's age or post-surgical outcome. They added that they could not
    predict based on the PERK data which patients will develop the
    hyperopic shift. They did note, however, that the shift was more
    common in those who had RK surgery using longer incisions in the
    cornea, a common technique in younger and/or more myopic patients.
    Participants (in this study) were examined before and after surgery at
    two weeks, three months, six months, annually for five years, and
    again at 10 years."

    FUNDAMENTALS OF LASIK

    LASIK has inherent problems due to the nature of the procedure. These
    problems occur whether $499 or $5000 is paid for the procedure. It
    has been frustrating to observe the "refractive surgery
    industrial-medical complex" position the higher priced procedure as
    providing better outcomes and fewer complications. There are no
    unbiased scientific studies to support this.

    LASIK's surgical landscape: the cornea
    Go to www.surgicaleyes.org for a complete description of LASIK and
    other refractive procedures.
    The cornea, the part of the eye operated on during LASIK, is the front
    most tissue of the eye. It is normally transparent and does not
    contain blood vessels. The cornea is only 0.5 to 1 mm thick, and is
    generally thinner centrally than peripherally. The cornea provides
    two-thirds of the eye's image focusing ("refracting") power. The
    other one-third is provided by the eye's internal lens, which is not
    involved in LASIK.
    The cornea has five layers, and two of these are very important in
    LASIK. The outermost layer, the epithelium, is a highly sensitive
    tissue about six cells thick. It acts as a barrier between the inner
    eye and the outside world, much as skin does for the rest of the body.
    It also provides a smooth surface allowing light rays to pass into
    the eye without being distorted. The epithelium has a basement
    membrane that helps it to adhere to the cornea's middle layer, the
    stroma. If the epithelium and/or its basement membrane are abnormal,
    the cornea may not heal properly, and an irregular surface and/or
    scarring may result.
    The cornea's middle layer, the stroma, is the layer at which most of
    the LASIK procedure is performed. The stroma accounts for about 90%
    of the cornea, and is made up mostly of water and layered narrow bands
    of collagen/protein fibers. These bands crisscross the cornea and are
    under tension, much like the rubber bands in golf balls. The stroma
    consists of about 500 layers of these bands. Scarring in this layer
    can result in loss of corneal transparency.
    LASIK makes the stromal layer thinner by removing tissue, and cuts
    through the collagen bands, severing them, to the depth of the flap.
    These bands never reconnect making the cornea both weaker and
    non-homogeneous. Enhancements make the cornea thinner and sever more
    collagen/protein bands. The severing of the bands allows a surgeon to
    lift the flap years after the procedure. The cornea is sealed around
    the periphery (minimal risk of infection) but never heals to its
    original anatomy. One of the biggest unknowns is what happens over
    time to the weakened cornea. It is under constant outward pressure
    from the intra-ocular pressure in the eye. Mechanics of materials
    would suggest that the cutting of the collagen bands would be a prime
    suspect in a serious complication called ectasia. Ectasia is the
    bulging of the cornea outward, and leads to progressive hyperopia
    and/or serious complications that may lead to a corneal transplant.
    How many LASIK's would have been done if patients were informed that
    the flap never healed, that the cornea was no longer anatomically
    homogenous, that the cornea had been weakened considerably, and that
    the cornea was under constant outward stress due to intra-ocular
    pressure? How many patients know that this could lead to ectasia, an
    unnatural and unforgiving bulging of the cornea?
    "Epithelial in-growth after laser in situ keratomileusis: a
    histopathologic study in human corneas," Naoumidi I. Et al. Archives
    of Ophthalmology, Volume 121, (7): 950-5, July 2003
    Corneal epithelial cells lose their characteristic morphologic
    features and eventually degrade in the metabolically "unusual"
    environment of the flap interface. Concurrently, a capsule of
    connective tissue similar to scar tissue forms, separating them from
    healthy cornea.
    "Histological and immunohistochemical findings after laser in situ
    keratomileusis in human corneas," Philipp WE, Speicher L, Gottinger
    W., J Cataract Refract Surgery, 2003;29(4):808-20.

    This study, conducted in Austria, described histopathological and
    immunohistochemical findings in human corneas after myopic laser in
    situ keratomileusis (LASIK), followed by iatrogenic keratectasia and
    after hyperopic LASIK…Researchers concluded that the wound-healing
    response is generally poor after LASIK, which may result in
    significant weakening of the tensile strength of the cornea after
    myopic LASIK, probably due to bio-mechanically ineffective superficial
    lamella. After LASIK in patients with high hyperopia, compensatory
    epithelial thickening in the annular mid-peripheral ablation zone
    might be partly responsible for regression.

    "Late-onset traumatic laser in situ keratomileusis (LASIK) flap
    Dehiscence," American Journal of Ophthalmology, April 2001

    " A 37-year-old male had bilateral laser in situ keratomileusis
    (LASIK) surgery performed on November 5, 1999 in Canada…On May 16,
    2000 a tree branch snapped into his left eye…He noted an immediate
    decrease in vision and went to a local emergency room. The on-call
    ophthalmologist diagnosed a corneal flap dehiscence…Visual acuity, LE,
    was count fingers (CF at 6 inches)…the patients clinical status did
    not change over the next three months.

    This case has several interesting clinical lessons. Patients often ask
    when the LASIK flap will be finally healed. Since there is minimal
    wound healing except at the edges of the flap, given enough force
    directed against he cornea, the flap may become dislodged months and
    even years after uneventful surgery. 1,2 1,2 Patients should be
    educated about this possibility and wear eye protection when
    performing potentially hazardous activities…This patient originally
    had low myopia and a photorefractive keratectomy (PRK) procedure would
    have been equally effective and obviously would not have led to this
    complication."

    "The Cornea is Not a Piece of Plastic," Cynthia Roberts, PhD, Journal
    of Refractive Surgery, Volume 16, July/August 2000
    Page 409+. A conceptual model is presented in Figure 4 that predicts
    biomechanical flattening as a direct consequence of severed corneal
    lamellae. Rather than a piece of plastic, the cornea can be conceived
    as a series of stacked rubber bands (lamellae) with sponges between
    each layer (interlamellar spaces filled with extracellular matrix).
    The rubber bands are in tension, since there is a force pushing on
    them underneath (intraocular pressure), and the ends are held tightly
    by the limbus (the peripheral edge of the cornea where the clear
    cornea merges with the white of the eye). The amount of water that
    each sponge can hold is determined by how tautly the rubber bands are
    pulled. The more they are pulled, the greater the tension each
    carries, the more water is squeezed out of the interleaving sponges,
    and the smaller the interlamellar spacing. This is analogous to the
    preoperative condition in Figure 4A. After laser refractive surgery
    for myopia, a series of lamellae are severed centrally and removed, as
    shown in Figure 4B. The remaining peripheral segments relax, just like
    the taut rubber bands would relax once cut…This allows the periphery
    of the cornea to thicken.
    Postoperative corneal shape, and thus visual performance, is a
    function of at least three factors: the ablation profile, the healing
    process, and the biomechanical response of the cornea to a change in
    structure.
    Letters, American Journal of Ophthalmology, Volume 130 Issue 2 (August
    2000) Pages 258-259

    "In the interesting article by R Lin and RK Maloney (Am J
    Ophthalmology) 127:129–136, January 1999), they confirm earlier
    reports that flap-related complications after laser in situ
    keratomileusis (LASIK) occur in 5.0% to 8.7% of cases…

    Complications continue to be reported after LASIK, including
    unexplained delayed-onset keratectasia after treatment of moderate
    myopia…These reports indicate that LASIK weakens the structural
    integrity of the cornea and that the list of complications is as yet
    incomplete.

    We feel that fast and painless recovery after LASIK and the marginally
    better UCVA of 20/20 or greater may not outweigh the risks of this
    procedure in myopia less than -6.0 diopters…"

    Letters, by Brauweiler, MD, Wehler, MD, and Busin, Ophthalmology,
    September 1999, pgs 1651-1655.

    "It is my opinion that PRK and LASIK should not have been approved
    beyond 8.00 diopters. Beyond this limit many corneas will have had too
    much stroma removed to allow long-term stable vision. …Carmen
    Barraquer responded that 100% of eyes that had undergone similar
    thinning technique, known as myopic keratomileusis lost effective
    correction (in many cases up to 50%) over a twenty year
    period…Essentially what this means is that all eyes over 8 diopters
    that have their corneas thinned by laser surgery will result in
    significant return of their myopia…the main purpose of this
    communication is to alert patients to ask their patients physicians
    how much of their cornea is being removed before it is irreversibly
    vaporized.

    "Iatrogenic Keratectasia Following Myopic LASIK of Between <4 and 7
    Dioptres," S. Percy Amoils, et al, Poster, Annual meeting of the
    American Cataract and Refractive Surgery Society, Seattle, Washington,
    April 1999

    "Results: The cases show progressive ectasia that developed from 1
    week to 27 months after LASIK…Conclusions: LASIK surgery can cause
    permanent weakening and ectasia of the cornea even in low myopia…LASIK
    has certain intrinsic problems and the combination of incisional
    surgery and laser ablation has the potential for serious short and
    long term problems. Thinning and thus weakening of the stromal bed as
    well as the minimum strength inherent in the flap are the causative
    factors for the development of keratectasia."

    Asphericity and imaging of light rays on the retina
    Think of the eye as a camera. Parallel light rays enter the eye
    through the transparent cornea. The cornea (and the eye's internal
    lens) then focus the light rays in much the same manner that the lens
    of a camera would, by bending the light rays so that they come to a
    single clear focus at a specific distance. This process of bending
    light is called refracting. In a normal eye, the cornea focuses light
    at a distance that produces a single sharp image on the retina, the
    neurosensory tissue that is akin to the film in a camera. Light rays
    that are bent too little or too much do not focus at the correct
    distance, and a blurred image results from this refractive error.
    How much or little a cornea refracts light depends on the cornea's
    curvature. That is why refractive surgery seeks to change the
    refracting power of the eye by changing the cornea's curvature.

    In nearsightedness (myopia), the cornea is too steeply curved, giving
    it too much focusing power and causing light rays to focus before they
    reach the retina. In myopia, the eyeball itself may also be
    elongated, contributing to the problem of light focusing in front of
    instead of on the retina. Conventional spectacle or contact lenses
    seek to optically decrease the focal power of the cornea, and thus
    correct the myopia, by placing a concave spherical lens (a "minus
    lens") in front of the eye. LASIK seeks to achieve the same result by
    removing tissue from the central cornea, flattening the cornea's
    overall curvature and thus reducing the cornea's focusing power.
    Exactly the reverse is true in farsightedness (hyperopia).
    Astigmatism is different from myopia and hyperopia, and it can occur
    concurrently with either condition.

    But changing the curvature of the cornea is not simplistic, as some
    make it out to be. The natural shape of the cornea is what the medical
    community calls aspheric which means that it is steeper in the center
    and flatter in the periphery. If one were to focus light rays from any
    angle outside the cornea, the aspheric shape would bend them so that
    they would fall in a small area on the back of the eye on the retina,
    called the "the center of least confusion." This small area acts like
    a data collection plate for our human computer, the brain. The more
    data (light rays) that get to this collection plate, the more data the
    brain has to process for good vision. Since laser procedures get their
    effect by flattening the center of the optical zone, the cornea does
    not end up aspheric but oblate. After the procedure, the cornea is
    flatter in the center, and steeper in the periphery, causing light
    rays to fall outside the data collection plate. While this causes few
    problems in bright sunlight, since we do not need a lot of information
    to process a good image (much like a camera), it does cause problems
    as the Iris opens up seeking more data in low light or nighttime
    situations. Vision is not as sharp and is degraded. This can be
    demonstrated by testing for the loss of contrast sensitivity. Most, if
    not all, laser procedures today work by flattening the central optical
    zone creating the oblate (reverse of aspheric) surface. For Wavefront
    Guided LASIK (discussed later), an aspheric surface can be created,
    but it requires deeper tissue removal (and weakening) in the
    periphery.

    The cornea has two surfaces that contribute to its refractive power,
    the front surface, which you see, and the back of the cornea, which
    you cannot see as it is inside the eye. It would be wonderful if these
    surfaces were uniform. If they were, then one could change the front
    curvature of the eye, in an aspheric shape, without concern for the
    back and its refractive power. Neither the front nor the back surfaces
    are uniform in their shape, which means that they are irregular.
    Therefore, cutting in the front, which is done at present, is not
    being done with the back surface taken in consideration. This can lead
    to refractive differences and/or uneven corneal thickness across the
    front of the eye. The thinner areas will be weaker than the thicker
    areas.

    The loss of contrast sensitivity and quality of vision

    Visual roblems come with the creation of an oblate surface, uneven
    thicknesses, and with the transition zone from the flap to the
    untouched cornea. The most important diagnostic test for the quality
    of vision is the test for contrast sensitivity. Arthur Ginsburg, PhD,
    developed this test for the U.S. Air Force. The AF wanted to learn
    why some pilots who tested for 20/20 (quantity of vision) were missing
    objects while others who were 20/20 were seeing them with ease. The
    Air Force learned that the Snellen Eye test (black letters on a white
    background) is not a good test for vision quality. While one may see
    20/20 after LASIK, and be counted as a LASIK success, one may actually
    have degraded vision. There can be a significant difference between
    the quantity of vision and the quality of vision.

    Years ago, hearing tests were crude and involved the movement of a
    single sound frequency towards the person being tested. When the
    person heard it, hearing ability was determined - 20/20, 20/100
    hearing etc. Researchers then realized that we heard sounds across a
    range of frequencies and this test-measured sound only at one
    frequency. The audiometer was then developed to measure hearing
    losses/gains across the full range of frequencies required for high
    quality hearing. If you were to suffer from a hearing loss, it would
    be described as a low frequency, middle frequency, high frequency or
    multi-frequency loss. And fortunately, tunable hearing aids are now
    available to amplify sounds in regions where the loss(es) exist. The
    full range of frequencies has also been translated into improving the
    listening pleasure of car radios, stereo systems, etc. Today we have
    the use of equalizers for audio sound allowing us to amplify selected
    frequencies (high, lows, middle range) for our listening pleasure.

    Vision is very similar to hearing in that the quality of vision is not
    a function of one frequency but rather a range of frequencies. In the
    case of vision, these frequencies are spatial frequencies. The Snellen
    Eye Chart is crude and tests vision at one spatial frequency,
    providing woefully incomplete data on the quality of vision. The test
    for Contrast Sensitivity test measures vision across the full range of
    frequencies needed for quality vision, like the audiometer does for
    hearing.

    We know that any hearing frequency loss can interfere with the ability
    to discriminate what is heard. And we now know that any vision
    frequency loss can interfere with the ability to discriminate what is
    seen. This becomes particularly acute in low-light and/or nighttime
    situations, and explains why so many refractive patients like the
    vision they have in bright light but have significant difficulties in
    low light or nighttime situations. Bright light produces high
    contrast. Unfortunately, we do not have tunable eyewear to make up for
    these losses.

    For a much more complete description of contrast sensitivity, go to
    either www.surgicaleyes.org or www.vsrc.com (Dr. Ginsburg's site).

    "Post-LASIK changes in Corneal Asphericity," Optometric Physician May
    2003, (SOURCE: Anera RG, Jimenez JR, Jimenez del Barco L, et al.
    Changes in corneal asphericity after laser in situ keratomileusis. J
    Cataract Refract Surg 2003;29(4):762-8)
    This Spanish study analyzed the origin of the changes in corneal
    asphericity (p-factor) after laser in situ keratomileusis (LASIK) and
    the effect of post-surgery asphericity on contrast-sensitivity
    function (CSF) under photopic conditions.

    Clinicians measured the p-factor and CSF (best corrected before
    surgery and one, three and six months after surgery) in 24 eyes. They
    noted an increase in the p-factor after LASIK; there was an 87.2
    percent change in the asphericity using the paraxial formula of
    Munnerlyn and coauthors. Other factors such as decentration, type of
    laser, optical role of the flap, wound healing, biomechanical effects,
    technical procedures and reflection losses of the laser on the cornea
    could account for the greater than expected increase (12.8 percent) in
    the p-factor. The CSF measurements deteriorated after LASIK; the
    change was significant in patients with myopia worse than -4.00D at
    frequencies of 9.2, 12, 15 and 20 cycles per degree. The increase in
    corneal asphericity after surgery, greater with a higher degree of
    myopia, and the deterioration in CSF with high myopia justify new
    ablation algorithms and further study of the variables that could
    modify the ablation unpredictably.

    "Capriati troubled by night matches," www.SportingNews.com , August 9,
    2002

    MANHATTAN BEACH, Calif. -- Jennifer Capriati is wary of playing night
    matches because the court lights affect her ability to see the ball.

    Capriati, the No. 2 seed, struggled for more than two hours before
    beating No. 16 Tamarine Tanasugarn of Thailand 6-3, 6-7 (3), 6-2 in
    the third round of the JPMorgan Chase Open on Thursday night.

    "Maybe I just started rushing a bit. I got thrown off a bit as soon as
    it was getting dark," she said. "I have problems playing at night. I
    was shanking some balls on my groundstrokes."

    Capriati, who had Lasik eye surgery two years ago, also had trouble
    picking up the ball in a night match at last week's Acura Classic,
    where she lost in the quarterfinals.

    "I feel like it's wearing off a little bit," she said of the surgery.

    At Manhattan Country Club, the light poles are low on stadium court.
    "At night, lights can start to become very bright," Capriati said,
    describing the effect on her vision. "When they're really low like
    that, it just feels like there's a flashlight on me constantly."

    She didn't react well to the glare, double-faulting numerous times in
    the second set. "In the second set, I just stopped hitting the ball
    and she started really dictating the points," said Capriati, who was
    cheered on by her
    friend, actor Matthew Perry.

    At most tournaments, the top players are required to play at least one
    night match to draw crowds. Having survived that obligation, Capriati
    said officials here know not to schedule her under the lights again.

    "I know there's going to be night matches, especially at the U.S.
    Open, so what am I going to do?" she said."

    For more on this, go to http://www.capriati.host.sk/a15_02.htm

    ASCRS, 2000 Presentation by William Jory, consultant eye surgeon at
    the London Centre for Refractive Surgery on Contrast Sensitivity.

    Dr. Jory, in his study, found that Contrast Sensitivity was impaired
    in 58% of the patients who had LASIK – to the point that these people
    were not fit to drive safely at night. The Department of Health took
    this study seriously, in conjunction with a separate study at the
    University of Ottawa, and recommended that any patient who had
    refractive surgery should have a night driving test performed before a
    driving license is granted. Jory said that nighttime vision problems
    did not seem to be related to high corrections.

    "Determining Medical Fitness to Drive," published by the Canadian
    Medical Association in 2000.

    In this booklet, laser eye surgery was added to the list of risk
    factors for unsafe driving. See Canadian Press Newswire for full press
    release, August 27, 2000. This recommendation was later overturned
    after pressure was brought to bear by the Canadian Ophthalmology
    Association.

    "Functional Vision and Corneal Changes After Laser In Situ
    Keratomileusis Determined by Contrast Sensitivity, Glare Testing, and
    Corneal Topography," Jack T. Holliday, MD, MSEE, et al, Journal of
    Cataract and Refractive Surgery, Volume 25, May 1999.

    Conclusions: Functional vision changes do occur after LASIK. The
    optical quality of the cornea is reduced and asphericity becomes
    oblate. Changes in functional vision worsen as the target contrast
    diminishes and the pupil size increases. These findings indicate that
    the oblate shape of the cornea following LASIK is the predominant
    factor in the functional vision decrease.

    Guest Editorial, Michael Mrochen, PhD, Department of Ophthalmology,
    University of Zurich, EyeWorld Week, April 2001

    "Refractive corneal surgery currently focuses on the correction of
    spherocylindrical errors as the most apparent and disturbing optical
    aberrations of the human eye. Unfortunately, a significant increase in
    higher order aberrations accompanies these corrections; thus,
    higher-order optical errors such as coma and spherical aberration have
    become more common…(this) correlates with a significant decrease in
    the quality of vision, especially under scotopic conditions.

    "Inside LASIK – Screening the keratorefractive big picture show",
    Maxine Lipner, EyeWorld, April 2001

    Quotes attributed to James T. Schweigerling, PhD, Assistant Professor,
    University of Arizona…

    "Current refractive techniques, such as PRK and LASIK, dramatically
    increase aberrations in the eye." After such procedures, a wave may
    look spherical in the center, but tends to deviate due to distortions
    in the corneal periphery. "What happens is light going through the
    edge of the pupil tends to focus in front of the retina, whereas light
    going through the center ..tends to focus on the retina. This gives
    you a multifocal effect…In areas with such spherical aberrations,
    patients can still see sharp points of light, but the contrast is
    reduced and images appeared blurred and hazy." In effect, during the
    day, the patient sees very well: however, as the pupil dilates, the
    error increases dramatically.

    Quotes attributed to Leo Maguire III, MD, Associate Professor, Mayo
    Clinic…

    "It (refractive surgery) threatens public health to the extent that
    it degrades optical performance and impairs the public's ability to
    perform visually challenging tasks." Maguire also reminds
    practitioners of refractive surgery…that changes will occur in the eye
    with aging, independent of refractive surgery, and that patients in
    the keratorefractive market of today will grow old like everyone else.
    He is concerned about how well these patients with seemingly
    insignificant higher-order aberrations today will perform when their
    visual systems are later taxed by conditions, such as, early
    lenticular opacity, macular degeneration, and a decrease in
    psychophysical compensation. "By 2025, one in four drivers in the US
    will be over the age of 65…Patients with degraded night vision and
    increased glare present a danger, not only, to themselves, but to
    others who share the roadway."

    Dry eye

    Dry eye occurs naturally with age. Temporary relief from dry eye comes
    from the use of artificial tears. For some, it means eye drops every
    few hours; for others, it means infrequent use of eye drops. Drug
    companies and the NIH (The National Institute of Health, our tax
    dollars at work) have spent millions seeking a cure, and, at the very
    least, developing possible treatments.

    It is now known that LASIK causes dry eye in a large number of
    patients. When the flap is cut, the microkeratome cuts the nerves in
    the front part of the cornea. Some believe that these nerves never
    heal completely interrupting the communication between the nerves and
    the tearing mechanism. Others believe that the unnatural post-LASIK
    oblate shape hinders proper tear flow across the cornea. Regardless of
    the cause, many feel that dry eye is the Achilles heel of LASIK.

    Many surgeons implant "punctal-plugs" in the ducts that drain the
    tears to alleviate the symptoms of dry eye. These plugs prevent the
    tears from draining. Sales of punctal-plugs have skyrocketed with the
    introduction of LASIK. For those who still need relief, artificial
    tears are prescribed. The sales of tears have also skyrocketed.

    LASIK has expanded the problem of dry eye from being a naturally
    occurring phenomenon to being a surgically induced problem.

    DLK (diffuse lamellar keratitis)

    DLK is classified as a "real" complication in the FDA classification
    system. Little is known about its cause and its incidence may be much
    higher than what is being reported.

    "Bilateral diffuse lamellar keratitis following bilateral simultaneous
    versus sequential laser in situ keratomileusis," McLeod SD, Tham VM,
    et al, British Journal of Ophthalmology, 2003;87:1086-1087

    "…A retrospective non-comparative case series of 1632 eyes that had
    undergone bilateral, simultaneous or sequential LASIK between April
    1998 and February 2001 at a university based refractive centre by
    three surgeons…The main outcome measure was the incidence of
    unilateral and bilateral isolated, non-epidemic DLK…Of 1632 eyes, 126
    eyes (7.7%) of 107 patients developed at least grade 1 DLK. In six
    operating sessions, DLK was observed in more than one patient per
    session…CONCLUSION: In isolated, non-epidemic bilateral DLK, a similar
    incidence (of DLK) was observed regardless of whether the surgery was
    simultaneous or sequential, suggesting an underlying intrinsic cause
    for DLK."

    Accuracy of the microkeratome

    Laser based refractive procedures were initially marketed to a wary
    public as space age technology with space age precision (laser
    accuracy is to the micron level). Since this was technology driven,
    not surgical skill driven, there was little to worry about. While
    surgeons today are trying to differentiate themselves by skill (to
    avoid price competition), the precision of the laser is still marketed
    as an attribute of the LASIK procedure.

    What the "refractive surgery industrial-medical complex" does not talk
    about is the inaccuracy of the microkeratome that is used to cut the
    flap. If the desired depth of cut for a flap is 200 microns, the
    actual cut may be plus or minus 16-20% of this desired depth. The
    variation of the microkeratome has been a weakness of LASIK from the
    beginning. The creation of the flap, its depth, and its thickness are
    not only important to the visual outcome, but also to the potential
    for long-term complications such as progressive hyperopia and ectasia.




    "Some foresee limitations in wavefront technology." Ocular Surgery
    News, August 1, 2002

    Noel Alpins, MD, said, "No matter how finely tuned a microkeratome is,
    it's still a gross change to the cornea as opposed to the changes
    required with wave-front guided treatments." The flap presents a
    problem.

    Enhancements and the use of misleading terms

    The term enhancement originated with the mini-RK in the early 1990's.
    The mini-RK involved making a small incision RK followed by a waiting
    period. For those who had good visual outcomes, nothing more was done.
    For those that did not, another procedure was done that involved
    slightly longer incisions. If this too failed, another procedure
    followed with even longer incisions. Rather than call these
    re-operations, ophthalmologists created a patient friendly but
    misleading term, enhancements. The term has continued with all
    subsequent refractive procedures.

    One of the problems with the term is that it sounds like the procedure
    is benign. Does enhancing make it better? This is a matter of
    semantics. For LASIK and RK outcomes that are under-corrected, more
    tissue is removed or deeper, longer incisions are made respectively.
    While in some cases, vision can be improved; permanent damage to the
    cornea is increased. For LASIK and RK outcomes that are
    over-corrected, tissue cannot be added back to the cornea nor can
    permanent incisions be reduced or eliminated. In short they cannot be
    enhanced.

    These procedures are not as flexible as some would have you believe
    nor are they upgradeable. While the cornea is further flattened, it is
    also made thinner, and weaker by the removal of more tissue.
    Enhancements are a one-way street and are irreversible.

    Additional terms that are now finding their way into the vocabulary of
    refractive surgery include "Tear Savers" for the use of punctal-plugs
    (you still have symptomatic dry eye), "Advanced Surface Ablation" for
    PRK (once trashed, some are now trying to reintroduce it), "Blended
    Vision" for mono-vision (this is not like Varilux lenses where one
    lens is blended, but rather one eye is corrected to see far objects
    and the other eye is left untouched to see near objects), and most
    recently, "HD LASIK", high definition LASIK (is it really high
    definition for all? all the time? for many years?). Each of these
    terms provides a message to the patient that is selective, and
    misleads.

    INFORMED CONSENT

    Patient informed consent while critical in all medical treatments
    takes on special importance in refractive surgery since patients are
    electing to undertake the risk of irreversibly altering an otherwise
    healthy eye. Information provided by advertising, promotional
    materials (brochures, etc), in-office staff, referring doctors, and
    the surgeon are all considered part of the legal informed consent. The
    truthful setting of expectations regarding potential outcomes and
    complications in all of these communication tools is crucial to making
    an informed decision.

    Refractive patients seeking information on refractive procedures
    should know that doctors, their staffs, and referring professionals
    have been well schooled ("in-practice marketing skills sessions") on
    how to handle difficult questions and concerns in an effort to keep
    interested candidates "in play" for the procedure. "In-practice
    marketing" covers every contact the patient has with the practice.
    Training programs have been developed and offered by manufacturers to
    be given off-site or at the practice site. Many of these
    trainers/courses provide the doctor and his associates with tools to
    overcome patient objections. One of the pioneering laser manufacturers
    created their own teaching "University" to educate surgeons and their
    staffs. The "University" goal was to increase patient throughput and
    profitability for the physician and the manufacturer (the manufacturer
    received $250 per procedure until 2000 when it was reduced to
    $100-150). The course was offered to those who purchased the company's
    laser (a $450,000 purchase).

    The absence of incidence data

    The "Informed Consent" document was developed to provide a legal
    defense for doctors in the event of a lawsuit. It was also designed so
    patients would not be discouraged from the procedure. Many Informed
    Consents list possible adverse events, complications, and/or visual
    complications, including death (even though no one knows of anyone who
    has died from a procedure). And most do not list the incidence (how
    often something occurs) specifying only that a specific complication
    "may" occur. The inclusion of a significant life-changing event,
    death, that never happens, creates, by comparison, the perception that
    many of the other complications that "may" occur" are rare and "may"
    never happen as well.

    For full disclosure, informed consents must list the incidence of
    complications to insure. There is a big difference between "may" occur
    and a 20% occurrence rate when one is making an irreversible decision.
    What would you do if you were told that a car you were considering
    "may" have a problem with the front brakes, and in the context of
    "may," you were led to believe that it was 1%? What if it were 20%?
    40%? You will see later in this document that the incidence of many
    refractive surgery problems warrant incidence percentages and not the
    word "may."

    Today, when having a refractive procedure with a FDA approved
    (excepting the first LASIK approval) Class III technology,
    manufacturers are required by law to provide booklets noting the
    incidence of each untoward effect. The doctors, in-turn, are required
    to include these booklets as part of the informed consent to
    prospective patients. Read the booklet carefully, and do not let
    anyone lead you to believe that the outcomes and incidence of problems
    will be any different. Some doctors will try to tell you that
    "his/her" patients do not seem to have these problems. Don't believe
    it for a minute!

    A hangover from the first FDA laser approvals is that many of the
    original laser machines are still being used. These approvals did not
    have great incident data when approved, nor were the manufacturers and
    doctors compelled to provide FDA reviewed booklets to the patients. As
    a result, the vast majority of LASIK patients did not receive full and
    accurate information on outcomes and complications.

    Going forward, interested parties should stick to data generated from
    FDA studies (excepting the original LASIK study) to insure that apples
    are being compared to apples. All FDA studies must follow the same
    format. Be wary of non-FDA studies that create expectations of better
    outcomes and/or fewer problems. Pay very close attention to the
    inclusion criteria (who can be considered a candidate). Data can vary
    according to the type and size of correction required. The data
    generated for the FDA approval relate to a specific, well-defined
    population of people. For those who do not fit the study population,
    extrapolation of the results is problematic.


    A physician's internally developed data (personal studies)

    Some doctors may show you his/her own data, collected from his
    practice on a refractive procedure, and say that his/her data is much
    better than the FDA data. Be cautious! Have my colleague put this in
    writing.

    The differences between a surgeon study and a FDA study are
    significant. FDA post-procedure exams take about three hours. And, a
    third party, who has no vested interest, must do post procedure
    follow-up exams. If a surgeon followed this rigor, he/she would lose
    control and money. They simply cannot afford the rigor required by the
    FDA in a commercial setting. A decision based on a physicians' data is
    speculative at best.

    Physicians' use of manufacturer sales aids

    When a doctor uses marketing materials, ask who developed the pieces,
    and ask if the FDA had approved the materials. The FDA has authority
    to insure that outcome and safety data from a manufacturer are
    provided accurately. Unfortunately, this is not true for physician
    developed marketing pieces. The FTC (Federal Trade Commission) has
    jurisdiction over physicians. Individual physicians are of little
    interest to the FTC so an interested patient must be on guard with
    non-manufacturer developed material.

    It even pays to scrutinize manufacturer materials, one well-known
    laser manufacturer created a physician sales support piece showing the
    comparison of several procedures. It was done in such a way that the
    competitive procedures were misrepresented. The FDA called them on it
    and asked them to desist. They, however, were not asked to recall the
    sales piece, so it was in use long after the FDA warned them. This
    type of marketing was done not for the benefit of the patient but for
    the benefit of the manufacturer,

    Physicians and conflicts of interest

    We have the problem of multiple conflicts of interest (payments, free
    use of lasers & equipment, travel) in the medical community. Surgeons
    are not immune. It is important for patient's to understand what a
    physician's and/or refractive surgery centers ties are. One doctor
    takes great pride in having no conflicts as he consults for all
    manufacturers, pulling in over $1 million per year. It is not what he
    does for his clients, it is what he does not do…like talk about the
    complications that beset each category of procedures. The "Informed
    Consent" should include all conflicts so those seeking opinions and/or
    procedures can discern the ties of the physician or practice to
    outside forces.

    Medical opinion Leaders, medical publication authors, optometrists,
    surgeons, and manufacturers all are suspect. Since many of these
    people are conflicted, the patient must be responsible for demanding
    full disclosure. One way to insure disclosure is to have my colleague
    state in writing that he/she has received no payments (cash,
    equipment, trips, discounts) in kind from any manufacturer.

    Referrals to LASIK surgeons

    Many LASIK surgeons, LASIK centers, and National Chains have built
    their LASIK business on referrals. Most often these come from
    Optometrists (OD). Referrals generally involve payments to the
    referring doctor. Since kickbacks are illegal, a co-management
    arrangement is generally put in place. These payments, in the good
    days of 1998-2000, approached $1000/eye. An OD could make much more
    from one referral than several contact lens or eyeglass fittings.
    Today, with the economic downturn and reduced LASIK pricing, referral
    payments have been reduced, and in some cases, eliminated. This change
    raises some serious questions - ‘how much co-management was really
    being done?' and ‘was co-management really a cover for a kickback" –
    which need to be answered.

    If you are being referred, find out what the referral arrangement is,
    and find out how much the doctor has earned from referrals over the
    past three years. You may be dealing with someone who is seriously
    conflicted.

    Looking through the patient's eyes

    The article that follows, which recently appeared in the New York
    Times (2003), addresses the issue of patient information and
    perception. It underscores the need for complete disclosure so
    patients can make an informed decision. These situations are fraught
    with misunderstanding, particularly when many sources are involved
    with providing information.

    "Seeing Risk and Reward Through a Patient's Eyes", Robert Klitzman,
    MD, New York Times, May 27, 2003

    "But more important, many doctors weigh the risks and potential
    benefits of treatments in ways different from their patients without
    realizing that wide contrasts exist. Risks, after all are relative:
    what one person considers too dangerous, another might not. The way
    risks are presented and framed shapes our perceptions of them…In
    research too, (medical) investigators are supposed to warn of possible
    dangers. Yet, at times, they minimize such hazards and promote only
    the benefits…According to research, humans do not always think
    rationally about risks…they see patterns where none exist…With a side
    effect, too, it is one thing to say that the odds of its occurring are
    30 percent. But the importance or unimportance of that symptom may
    range widely between people in ways that doctors do not take into
    account. Doctors often have trouble dealing with the inadvertent, side
    effects of their own treatments."

    Websites

    Patient information websites are sponsored by doctors, refractive
    surgery centers, independent physician groups (many who have a vested
    interest in one procedure or another), former patients, manufacturers,
    and the FDA.

    Surgical Eyes (SE) www.surgicaleyes.org is the best. Any person
    considering refractive surgery, as part of the informed consent,
    should be sent to SE during the consideration process. SE provides the
    other side of the story. It is a counterweight to the hype of the
    refractive surgery community (optometrists, surgeons, and
    manufacturers). Ron Link has done a real service for patients, and
    while some may disagree, he has done a service for the surgeons as
    well. The more the patient knows, even if it results in fewer
    procedures, the healthier the industry will be.

    Misleading information characterizes most other websites and their
    chatrooms. Some website chatrooms have permanent contributors who post
    frequently as "independent experts". Be careful, some of these are not
    independent and are deeply vested. Discernment falls squarely on the
    shoulder of the reader. An appropriate caution for all is to know whom
    the expert is, and to know what financial ties they have to refractive
    surgery. If the person is a physician that does the procedure, find
    out how many procedures he/she had done and his/her annual income
    level from refractive surgery.

    The procedure history is also important. For most, a high number would
    indicate experience and expertise. For some of us, a high number would
    indicate the physician's vulnerability as problems surface. One would
    expect the higher the number, the greater the emotional investment in
    believing he/she did the right thing, and the stronger the defense of
    his/her actions.

    "LASIK complications and the Internet: Is the Public Being Misled?"
    Fahey, Weinberg, Journal of Medical Internet Research, Vol. 5, No. 1,
    March 2003.

    Conclusion: the quality and quantity of the information on the Web on
    the complications of LASIK are poor. More work is required to
    encourage clear, accurate, up-to-date, clearly authored, and
    well-referenced, balanced ophthalmic information. "The poor quality of
    the information represents a negligent omission, as the public are
    being misled into believing that LASIK is without risk," Fahey
    concluded. "This may lead to liability cases by patients with
    complications whose decision to have LASIK was based on the
    information they read on the Web site." Dr. Fahey said he believes
    that if a surgeon is responsible for the content of the site, he or
    she bears the burden to ensure that the information "is accurate,
    well-referenced and balanced."

    "Surfer Beware: Don't Trust All Online LASIK Info: Online LASIK info
    incomplete, study finds," December 13, 2002

    NEW YORK (Reuters Health) - Consumers who turn to the Internet for
    information about LASIK eye surgery should know it's a surfer-beware
    environment, according to a team of eye specialists who evaluated
    online information and reported their results Friday at the American
    Optometric Association meeting in San Diego, California.

    Dr. James O. LaMotte, a professor of optometry at the Southern
    California College of Optometry, Fullerton, and his colleagues used 10
    search engines to find sites on LASIK…Next, using a 74-topic checklist
    derived from the Food and Drug Administration, the researchers then
    rated the sites for accuracy, awarding one point for accurate
    information on each of 74 topics related to the eye surgery.

    Only 26% of the sites were rated as "markedly informative," with 28%
    moderately and 46% minimally informative, LaMotte said. A site had to
    contain at least 67% of the total possible points to win a label of
    markedly informative. The minimally informative sites contained less
    than 33% of the possible points.

    "What the LASIK Web sites did was tend to talk about the benefits of
    LASIK and to ignore the risks and contraindications," he said.
    Misinformation on the Internet is nothing new, LaMotte told his
    colleagues. Previous studies have found misleading or even harmful
    information disseminated on the Internet about fever in children and
    vascular surgical procedures. Other sites contain misleading
    information on age-related macular degeneration, an eye condition that
    can lead to blindness, LaMotte stated.

    " Medical Ethics and the Excimer Laser", Samuel Pecker, MD, Archives
    of Ophthalmology, May 1997

    "…the marketing required to achieve economic viability (of PRK laser
    surgery, and fits LASEK as well) is something that medical
    professionals are either uncomfortable with or would rather have
    someone else do."
    "This new technology and this new partnership (with laser companies)
    have the potential to create notable ethical problems, in such areas
    such as (1) agency, (2) conflicts of interest, (3) informed consent,
    (4) marketing and advertising, and (5) social issues – the
    relationship of medicine to society.

    At the least, rule 15 of the American Academy of Ophthalmology's Code
    of Ethics would be observed. It reads, ‘Disclosure of professionally
    related commercial interests is required in communications to
    patients, the public, and colleagues.'

    The marketing and advertising of PRK will put an increased burden on
    the ophthalmologist when it comes to informed consent because the
    customer will come to the physician's office with preconceived ideas
    obtained from the media and because the physician is assumed to be a
    trusted agent for a patient."

    Recent FTC actions

    The US Federal Trade Commission (FTC) recently took action against two
    companies that were considered to be advertising unsubstantiated
    claims for LASIK. The actions, taken against The Laser Vision
    Institute and Lasik Plus, are the first of their kind.

    Despite welcoming its moves, Ron Link, Surgical Eyes, is concerned
    that the FTC can only take action against national chains. "It's a
    pragmatic position to take, but how does the local violator (your
    local doctor) get addressed? I don't have an answer."
     
    TheTruthAboutLASIK, Nov 14, 2003
    #1
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