Nidek EC-5000 Excimer Laser System by wanghonghx

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									                                                                        TABLE OF CONTENTS
   PATIENT INFORMATION
         BOOKLET
                                                      1. INTRODUCTION .............................................. 1

 Photorefractive Surgery Performed                    2. HOW THE EYE FUNCTIONS ............................. 1
  as an Intrastromal Keratectomy                      3. WHAT IS LASIK? ........................................ 4
under a Keratomileusis Flap (LASIK)                   4. CONTRAINDICATIONS ..................................... 5
   for Myopia (Nearsightedness)                       5. WARNINGS .................................................... 6
          and Astigmatism
                                                      6. PRECAUTIONS ................................................ 7
                                                      7. RISKS ........................................................... 7

        Nidek EC-5000                                 8. BENEFITS .................................................... 10
                                                      9. ARE YOU A GOOD CANDIDATE FOR LASIK? ..... 10
     Excimer Laser System
                                                      10. BEFORE THE SURGERY ................................. 12
                                                      11. THE DAY OF SURGERY ................................ 13
    SURGICAL LASER TREATMENT FOR                      12. THE FIRST DAYS AFTER SURGERY ................ 15
   NEARSIGHTED PATIENTS WITH VISION
                                                      13. QUESTIONS TO ASK YOUR DOCTOR .............. 16
     CORRECTION –1.00* TO –14.00
   DIOPTERS SPHERICAL EQUIVALENT AND                  14. SELF-TEST .................................................. 17
    HAVING     ASTIGMATISM 0.00 TO –4.00              15. SUMMARY OF IMPORTANT INFORMATION ........ 18
             DIOPTERS OF CYLINDER                     16. SUMMARY TABLES ...................................... 21
    * Ask your doctor about certain limitations in    17. GLOSSARY ................................................. 22
    the lower range of correction. You may not be
    qualified for treatment with certain amounts of
    astigmatism.


       Please read this entire booklet.
       Discuss its contents with your
     doctor so that all of your questions
     are answered to your satisfaction.
      Ask any questions you may have
      before you agree to the surgery.

                     Distributed by:

               Nidek Incorporated
            47651 Westinghouse Drive
            Fremont, California 94539
                  (510) 226-5700

Document Part Number: 16006-P872A 05.01
1. Introduction                                          first enters the front of the eye, provides about
   Please read the following information if you          two thirds of the eye’s focusing power, and the
   are thinking about having a type of laser             lens inside the eye provides the other third.
   surgery, called Laser in situ Keratomileusis1         Normally, in relatively young persons (i.e., less
   (LASIK, also called laser-assisted in situ            than 50 years of age) the lens of the eye can
   keratomileusis), performed to correct                 adjust its focusing power somewhat, so you
   nearsightedness (myopia) with or without              can see objects clearly both near and far away.
   treatment for astigmatism. The options for            The eye focuses light by refracting all light
   correction of myopia and astigmatism now              rays to meet at a single point. If the focusing
   include glasses, contact lenses, and different        process works perfectly, a sharp image of the
   kinds of refractive surgery such as radial            object you are looking at will be focused
   keratotomy (RK), automated lamellar                   exactly on the retina and you will see a clear
   keratoplasty, surface treatment by                    image. However, if the light focuses either in
   photorefractive keratectomy (PRK), and                front of or behind the retina, the image on the
   LASIK using excimer lasers, including the             retina (and the image you see) will be blurred,
   Nidek EC-5000 Excimer Laser System.                   and you are said to have a refractive error.
   This information can help you make an                 Refractive errors are not diseases, but are
   informed decision when selecting a method             common variations observed in human beings
   to correct your nearsightedness. If both of           across the world.
   your eyes are nearsighted, your doctor may            There are three main types of refractive error.
   recommend LASIK surgery for both eyes to              They are called nearsightedness (myopia),
   achieve satisfactory vision. However, there           farsightedness (hyperopia) and astigmatism.
   are cases where it is better to reshape the           The amount of refractive error present in the
   cornea on only one eye. For example, one              eye is measured in units called “diopters.”
   reason for treating only one eye is that you          When your eye cannot focus correctly, it is
   may use the eye for looking close up and one          said to have one of the main refractive errors:
   eye for looking far away.                             myopia or hyperopia.
   Please read this booklet completely. Discuss          Myopia usually starts in childhood and
   any questions you may have with your                  typically stabilizes in the late teens or early
   doctor in order to decide if LASIK is the             adulthood. The tendency to develop myopia
   right choice for you. Only a trained and              also runs in families. Myopia can range from a
   certified practitioner can determine whether          very mild to a very strong nearsighted effect.
   or not you are a suitable candidate for               The range of treatment with the Nidek EC-
   LASIK. You should be aware that a small               5000 covers a large part of that range.
   percentage of patients treated with excimer           Hyperopia is also very common, and is
   lasers experience permanent vision                    especially problematic in older persons who
   reduction. The goal of LASIK is to reduce             have difficulty in focusing on objects up close.
   your need for glasses or contact lenses by            Currently, the Nidek EC-5000 is not
   changing the shape of the cornea through              approved for treating hyperopia.
   LASIK laser surgery.
                                                         Astigmatism occurs when the refractive error
                                                         is stronger in a particular direction.
2. How the Eye Functions                                 Astigmatism may occur with either myopia
   The cornea and lens of the eye focus light like       or hyperopia.
   a camera lens to form an image on the retina at
   the back of the eye. The cornea, where light
   1
       Underlined terms are contained in the Glossary.                        2
                             1
The following pictures emphasize the role of          Good focus depends on three factors, the
the cornea in determining the focusing power          overall shape and size of your eye, the shape
of the eye. They show that the more sharply           of the cornea, and your lens power. During a
the cornea is curved, the more the light rays are     regular eye examination, your doctor checks
bent. If the cornea is curved too much, the           your vision to determine where the eye
image focuses in front of the retina and the eye      focuses light relative to your retina. When
is nearsighted. If the cornea is too flat, the        your doctor adjusts your vision with
image focuses behind the retina and the eye is        different lenses, he correctly focuses light on
farsighted. When the cornea shape is just right,      the retina.
the image from a distant object is focused            Myopia affects about 25% of the population
exactly on the retina. This proper focus for          in North America. Myopic individuals see
distance vision is called emmetropia.                 near objects clearly, but distant objects are
                                                      blurry. Nearsightedness and astigmatism can
                                                      be corrected by any method that reduces the
                                                      total refractive power of the eye, and
                                                      includes the use of glasses, contact lenses
                                                      and refractive surgery. With glasses or
                                                      contacts, changes in your vision that occur
                                                      slowly over time can be corrected by simply
                                                      adjusting the lens prescription of your
                                                      glasses or contacts. Refractive surgery, on
                                                      the other hand, produces changes that are
                                                      permanent and cannot be undone or easily
                                                      modified if your vision changes or if the
                                                      initial surgery is not successful (2.9% of
                                                      initial surgeries were found to be greater
                                                      than 2.0 D from intended correction at 6
                                                      months after surgery).

                                                    3. What is LASIK?
                                                      LASIK is laser surgery to correct near-
                                                      sightedness (myopia) with or without
                                                      astigmatism. An excimer laser beam is used
                                                      to flatten the middle layer of the cornea. The
                                                      laser beam removes microscopic amounts of
                                                      tissue from the middle layer of the cornea,
                                                      precisely reshaping the cornea.
                                                      The excimer laser produces a beam of
                                                      ultraviolet light in a series of rapid pulses.
                                                      Each pulse lasts only a few billionths of a
                                                      second and removes a microscopic amount
                                                      of tissue by evaporating it. Excimer laser
                                                      light does not penetrate the eye and leaves
                                                      other eye structures (iris, lens, and retina)
                                                      undisturbed. The laser produces very little

                     3                                                     4
   heat and is controlled by the doctor during              •   You show signs of thinning of the
   the operation.                                               cornea (keratoconus) or corneal
   Prior to LASIK, some anesthetic drops are                    disease. This condition can lead to
   placed on the eye to numb it. Your doctor then               serious cornea problems that require
   begins the LASIK procedure by cutting a thin                 additional surgical repair and result
   flap on the front of the cornea using a special              in poor vision.
   cutting instrument called a micro-keratome.              •   You have a condition which would
   The doctor will then fold back this flap of                  stimulate large amounts of scar
   tissue much like opening a hinged cabinet                    tissue (keloid formation). Scarring
   door. Folding back the flap will give the doctor             can be permanent and may require
   access to the middle layer of the cornea where               surgery to repair.
   the laser treatment will be performed. This part         •   You are taking prescription
   of the procedure usually takes a couple of                   medications that affect corneal
   minutes. After that, your doctor uses the laser              healing or your refraction. You
   beam to perform the LASIK procedure. The                     should discuss all medications you
   laser treatment usually lasts only about 15-40               take, even over-the-counter
   seconds. After the laser treatment is complete,              medications, with your eye doctor.
   the doctor will carefully fold the flap of cornea            Many medications can affect the way
   tissue back into place to complete the                       your cornea is changed by the laser
   procedure.                                                   and the way it heals after LASIK
   This procedure is performed on one eye at a                  treatment. These may affect your
   time even if both are to be treated. If all goes             refractive outcome and possibly
   well with the first eye, and your vision                     result in reduced vision after LASIK
   stabilizes without complication or adverse                   treatment.
   reaction, then the second eye can be treated
   later. LASIK laser surgery on the second eye is     5. Warnings
   usually done at least one week after the first
   eye, if needed.                                       Discuss with your doctor if:
                                                            •   Your nearsightedness is changing. If
4. Contraindications                                            your vision is unstable, then you
                                                                should not be treated. Treatment of
   You should not have LASIK surgery if:                        unstable vision may affect the
       •   You have collagen vascular,                          accuracy of your refractive results.
           autoimmune or immunodeficiency                   •   You have severe allergies. Your
           diseases (for example: rheumatoid                    medications may have to change
           arthritis, lupus or AIDS). These                     before or after your eye surgery.
           conditions may result in scarring or                 These medications may change the
           poor healing after LASIK treatment                   wetness (moisture level) in your eye.
           resulting in reduced vision.                         If the medication changes the
       •   You are pregnant or nursing. These                   wetness of your eye, the accuracy of
           conditions may affect your                           your refractive results may be
           preoperative refraction making it                    affected.
           difficult to choose the correct                  •   You have been diagnosed with
           amount of LASIK treatment.                           ocular Herpes simplex or ocular
                                                                Herpes zoster. Herpes are viral

                        5                                                    6
           infections. Laser treatment may           See the information listed below for details
           reactivate the infection.                 on risks of complications and adverse
      •    You have nystagmus (uncontrolled          events.
           eye movements) or another condition           At the time of surgery, it is possible that
           that prevents a steady gaze. You              the flap will not be cut correctly. In
           need to be able to keep your eyes still       some cases, the flap of tissue may not be
           during treatment. The accuracy of             the correct size or shape or may be too
           your refractive results will be               thin (0% of cases). In these cases, the
           affected if you can not keep your             doctor may have to stop the surgery,
           eyes still during treatment.                  fold the flap into position, and allow it
                                                         to heal. In most cases, the doctor can
6. Precautions                                           complete surgery at a later date. In the
                                                         studies on LASIK, the majority of these
   The safety and effectiveness of the Nidek             cases were completed later and had a
   EC-5000 Excimer Laser has NOT been                    successful result.
   evaluated in patients with the following
   conditions or situations. Therefore, no               Although the effects of LASIK on visual
   statement regarding the safety and                    performance under poor lighting
   effectiveness can be made about the effect            conditions have not been determined, it
   these situations may have on LASIK                    is possible that you will find it more
   refractive surgery with the EC-5000:                  difficult than usual to see in conditions
                                                         such as very dim light, rain, snow, fog
      •    Eyes with disease or corneal                  or glare from bright lights at night.
           abnormality.                                  These effects have been reported as
      •    Eyes with previous surgery or injury          being more common in persons with
           to the center of the cornea where             large pupils (over 5.5 mm). It is possible
           LASIK will be performed.                      that these may be permanent effects.
      •    Patients with glaucoma or high               The first week following surgery:
           pressure in the eye.                         The following complications have been
      •    Patients taking insulin for diabetes.        reported up to several weeks following
      •    Patients over the long term (more            LASIK treatment. They are associated
           than 1 year after the surgery).              with the normal healing process after
                                                        treatment and include:
      •    Patients under 21 years of age.
                                                        •   Discomfort (including mild to
7. Risks                                                    moderate pain, pressure,
   LASIK is a laser surgical procedure involv-              scratchiness, burning sensation, and
   ing your eyes and has potentially serious                dryness) may last for up to 1 day
   risks. You should consider and discuss with              after surgery, for which your eye
   your doctor the risks that are noted in this             doctor can provide medications.
   booklet. These are based on clinical experi-         •   The feeling that something is in your
   ence with LASIK cases and the possible                   eye.
   concerns that doctors believe should be
   considered for this kind of eye surgery.             •   Swelling of the cornea.
                                                        •   A problem with healing of the
                                                            corneal flap, including damage to the
                                                            flap, loss or misalignment of the flap,
                        7                                                8
    or growth of cornea surface cells under           •   Too large a correction (causing
    the flap. If needed, the doctor may lift              farsightedness more than +2.0 D)
    the flap to clean the µιδδλε layer of the             (1.2%).
    cornea and reposition the flap to                 •   Losing a significant amount (more
    improve healing.                                      than 2 lines lost on an eye chart) of
•   Blurred vision and tearing or watery                  vision even with glasses (0.6%).
    eyes may occur as the cornea and the              If the results of the surgery are not
    flap heal.                                        satisfactory, you may need to have
•   Sensitivity to bright lights.                     additional LASIK surgery in the same
The first one to six months following                 eye.
surgery:
                                                8. Benefits
•   Your intraocular pressure may
    increase due to use of steroid or anti-            LASIK surgery, as performed with the
    inflammatory medications (0% to                    Nidek EC-5000 Excimer Laser, is
    0.1% of eyes had a significant                     effective in reducing nearsightedness
    elevation in intraocular pressure in               requiring correction from –1.00 to
    this time frame). This is usually                  –14.00 diopters spherical equivalent in
    resolved by drug therapy or by                     patients with 0.00 to –4.00 diopters of
    stopping the use of the steroid or                 astigmatism (85.2% of treated eyes were
    anti-inflammatory medication.                      within 1.0 diopter of intended correction
                                                       at 6 months).
•   Hazy or cloudy vision rarely occurs
    after LASIK surgery (<1% of eyes                   LASIK may reduce overall nearsighted-
    had mild or moderate haze with no                  ness (84.4% significantly improved
    significant loss of vision).                       uncorrected vision to the level of 20/40
                                                       or better at 6 months).
•   An increase in fluctuation of vision
    (40.0% pre-operatively vs. 64.3%                   LASIK may reduce or eliminate
    post-operatively).                                 dependency upon contact lenses or
                                                       glasses (47.4% could see 20/20 or better
•   Glare (35.7% pre-operatively vs.                   without glasses or contacts at 6 months).
    35.7% post-operatively).
                                                       LASIK should be considered a
•   Difficulty in night driving (26.2%                 permanent surgical procedure, in that
    pre-operatively vs. 69.0% post-                    the refractive result changes little after
    operatively).                                      the first few months. If your refractive
Caution: You should contact your                       result is unsatisfactory, your doctor may
   doctor if you notice any pain or                    recommend further surgical treatments,
   change or loss of vision in the eye.                or correcting your remaining refractive
   Eye pain or sudden loss of vision can               error with glasses or contacts.
   indicate a serious problem that
   requries immediate medical
   attention.                                   9. Are You a Good Candidate for LASIK?

One year after surgery:                            If you are considering LASIK, you must:

Nidek clinical studies showed that at one             •   Be at least 21 years of age.
year after LASIK surgery the following                •   Have healthy eyes which are free
vision-threatening events happened:                       from eye disease or corneal
                 9                                                     10
       abnormality (for example: scar,                    LASIK treatment is not intended to
       infection, etc.).                                  eliminate the need for reading
   •   Have nearsightedness (myopia)                      glasses. In some patients, reading
       requiring vision correction between                glasses may be required after
       –1.00 and –14.00 diopters spherical                treatment even if they were not worn
       equivalent, with 0.00 to –4.00                     before treatment. As patients get to
       diopters of astigmatism.                           age 40 and beyond, they are more
                                                          and more likely to require reading
   •   Be sure your eye doctor has                        glasses when their distance vision is
       satisfactory evidence that your                    otherwise excellent. Nearly all older
       refraction has been stable over the                patients require reading glasses if
       past year (changed by ≤ 0.5 diopters               their distance vision is fully
       in your vision correction, or by                   corrected.
       ≤ 0.5 diopters in your astigmatism
       correction).                                       If the thought of occasionally
                                                          wearing eye wear is uncomfortable,
   •   Be informed of LASIK risks and                     then LASIK may not be right for
       benefits as compared to other                      you.
       available treatments for nearsighted-
       ness (myopia) and astigmatism.                 •   If you expect an instant change in
                                                          vision. The visual results are not
   •   Be willing to sign an informed                     instant, even for patients with less
       consent form, as provided by your                  than 4 diopters of correction. It may
       eye care professional.                             take up to 3 months, sometimes
                                                          longer, for the shape of the cornea to
Why LASIK may not be right for you:                       stabilize following surgery. You
                                                          must be patient and be willing to
   •   If you expect perfect results. No                  wait until the healing process
       surgical procedure can assure you                  finishes. You may also be asked to
       perfect results or can guarantee that              temporarily wear corrective lenses.
       your expectations will be met.
                                                          Please note that various occupations
   •   If you expect perfect vision under all             may have certain restrictions
       conditions. At night, eyes that have               regarding refractive surgery.
       been reshaped by refractive procedures             Therefore, you should check with the
       such as LASIK may experience glare                 appropriate people before having
       and a variety of visual effects. The               refractive surgery.
       LASIK procedure only reshapes the
       central portion of the cornea and
       does not reshape the entire cornea.      10. Before the Surgery
       As a result, when the pupil of the eye      If you are interested in having LASIK, you
       dilates (over 5.5 mm) under low light       will need to have a pre-surgical examination
       conditions, it may open past the            to determine if your eye is healthy and
       boundaries of the treated area              suitable for LASIK. This will include a
       producing unwanted changes in               complete eye history, and a thorough
       vision, such as halos and                   examination of both eyes. In addition,
       hypersensitivity to light. You may          computerized mapping of your cornea will
       find that you will need to wear             be done to determine if it is smooth and
       corrective lenses to drive at night.        properly shaped.
                   11                                                 12
                                                         •   Next, the doctor repositions your head
                  WARNING                                    in the chair, and then carefully folds
    If you wear contact lenses, it is very                   back the flap of tissue much like
    important to stop wearing them 2-4                       opening a hinged cabinet door. This
   weeks before the evaluation. Failure to                   gives the doctor access to the middle
     do this can affect the quality of your                  layer of the cornea where the laser
  vision and the accuracy of your refractive                 treatment will be performed. The
                     result.                                 doctor then refocuses the microscope
                                                             on your cornea. You will be asked to
                                                             look directly at a blinking light. Relax
   Before the surgery, please tell your doctor               the muscles of your face and forehead
   well in advance if you take any medications               and try to keep both eyes open without
   or have any allergies. Also, talk with your               squinting. As you continue to look at
   doctor about whether you can eat or drink                 the blinking light, small amounts of
   immediately before the surgery. You should                tissue will be removed from your
   arrange for transportation for the day of                 cornea using the Nidek EC-5000
   surgery and your next doctor’s appointment,               Excimer Laser.
   since you must not drive immediately after
   the surgery. You can resume driving only
   after receiving permission from your doctor.                   PRECAUTION
                                                         It is very important that you keep
                                                      looking at the blinking light during the
11. The Day of Surgery                                  procedure, even if the light fades or
   Before the surgery, numbing (anesthetic)           becomes dim. The quality of vision and
   drops will be placed into the eye to be            accuracy of your refractive result after
   treated and you will be escorted into the           LASIK can depend upon you looking
   room with the laser. You will lie on your         straight at this blinking light throughout
   back in a reclining chair and look up at a                        the treatment.
   microscope that will deliver the laser light to
   your cornea. An instrument will be placed             •   You will be exposed to laser energy
   between your eyelids to hold them open                    for less than 1 minute. However, the
   during surgery. For protection and comfort,               entire surgical procedure takes about
   a temporary shield will cover the eye not                 10 to 15 minutes.
   having surgery.
                                                         •   After the laser surgery is complete,
      •   Your doctor may perform a brief                    the doctor will fold the flap of cornea
          practice treatment so you can hear                 tissue back into place and gently
          and smell what the laser will be like              smooth the surface. Some drops or
          during the treatment.                              ointment will be placed into your
      •   Your doctor begins the procedure by                eye. Then it will be covered and
          using a cutting instrument, called a               patched for your protection and
          microkeratome, to cut a thin flap in               comfort. The surgery itself is
          the front of the cornea. The                       painless because of the numbing
          instrument used to hold your eyelids               actions of the anesthetic drops that
          open may need to be changed                        were applied to your eye at the
          between this part of the surgery and               beginning of the procedure.
          before doing the laser treatment.

                       13                                                 14
      •   After 45 to 60 minutes, the anesthetic                    IMPORTANT
          will wear off and your eye may hurt for         Use anti-inflammatory eye drops and
          1 to 3 days. Most patients describe this     lubricants as directed by your doctor. The
          pain as moderate to severe. Do NOT           quality of your vision and the accuracy of
          rub your eyes for the first 3 to 5 days.       your refractive result can depend upon
          Rubbing your eyes can damage the               you following your doctor’s directions.
          cornea and will delay healing. Your
          doctor can prescribe pain medication
          to make you more comfortable               13. Questions to Ask Your Doctor
          during the first week after the
          surgery.                                      You may want to ask the following
                                                        questions to help you decide if LASIK is
                   WARNING                              right for you:
  Your doctor will monitor you for any side-               •   What other options are available for
  effects if topical steroids were used. The                   correcting my nearsightedness and
   possible side-effects from prolonged use                    astigmatism?
     of topical steroids are an increase of                •   Will I have to limit my activities
  pressure in the eye (ocular hypertension),                   after surgery, and for how long?
        glaucoma or cataract formation.
                                                           •   What are the benefits of LASIK for
                                                               my amount of nearsightedness and
12. The First Days After Surgery                               astigmatism?
   In your doctor’s office, your eye patch will            •   What quality of vision can I expect
   be removed the following day. You will be                   in the first few months after surgery?
   mildly sensitive to light and have the feeling
   that something is in your eye for the first few         •   If LASIK does not correct my vision,
   days. Sunglasses may make you more                          what is the possibility that my
                                                               glasses would need to be stronger
   comfortable during this time.
                                                               than before? Could my need for
      •   Your vision should become stable                     glasses increase over time?
          within the first several weeks after
                                                           •   Will I be able to wear contact lenses
          surgery. Some patients may
                                                               after LASIK if I need them?
          experience some small changes (for
          example, improvement or worsening                •   How is LASIK likely to affect my
          of their vision). These changes may                  need to wear glasses or contact
          occur up to six months or more after                 lenses as I get older?
          surgery.                                         •   Is it likely I will need reading glasses
      •   Hazy or cloudy vision rarely occurs                  sooner than later?
          after LASIK surgery (<1% of eyes                 •   Will my cornea heal differently if
          had mild or moderate haze).                          injured after having LASIK?
                                                           •   Should I have LASIK surgery in my
                                                               other eye?
                                                           •   How long will I have to wait before I
                                                               can have LASIK surgery on my other
                                                               eye?


                       15                                                  16
       •   What vision problems might I              15. Summary of Important
           experience if I have LASIK only on        Information
           one eye?
                                                       LASIK is a permanent operation to the
   Discuss the cost of surgery and follow-up care      cornea that cannot be easily changed.
   requirements with your doctor, as laser
   treatment is not covered by most health             Alternatives to LASIK include glasses,
   insurance policies.                                 contact lenses, RK, and PRK.

14. Self-Test                                          LASIK is not a laser version of radial
                                                       keratotomy (RK); they are completely
   Are you an informed and educated                    different from one another.
   patient?
                                                       Some occupations, such as pilots, do not
   Take the test below and see if you can              accept applicants who have had any
   correctly answer these questions after              refractive surgery.
   reading this booklet.
                                                       Refractive error must be stable (within
                       TRUE        FALSE               ± 0.5 diopters in your vision correction,
 1. Excimer laser refractive surgery is risk free.     or within ± 0.5 diopters in your
                          []         []                astigmatism correction) for at least one
                                                       year before surgery.
 2. Excimer laser surgery uses pulses of
    invisible light.    []          []                 The following risks of LASIK surgery
                                                       should be noted:
 3. It doesn’t matter if I wear my contact
     lenses when my doctor told me not to.             •   temporary discomfort may be
                           []        []                    expected for 24 to 72 hours after
                                                           surgery. If the discomfort persists,
 4. The laser does all the work; I just have to
                                                           please contact your doctor.
    lie on the chair and close my eyes.
                          []          []               •   problems that may last several
                                                           weeks: corneal swelling, blurred
 5. After the surgery, there is a good chance
                                                           vision, feeling something in the eye,
    that I will be less dependent on eye
                                                           shadow images, light sensitivity,
    glasses.               []         []
                                                           tearing, and pupil enlargement.
 6. I may need reading glasses after laser
                                                       •   adverse events beyond the first few
     surgery.           []           []
                                                           months: elevation of intraocular
 7. There is a risk that I may lose some vision            pressure (0% at 6 months); cloudy
    after laser surgery.                                   cornea affecting vision (0% at 6
                            []        []                   months); over-correction by more
                                                           than 2.0 diopters (1.2% at 6 months,
 8. It doesn’t matter if I am pregnant.                    1.2% at 12 months); under-correction
                            []       []                    or nearsighted by more than 2.0
 9. If I have an auto-immune disease, I am still           diopters (1.7% at 6 months, 0.6% at
     a good candidate for LASIK.                           12 months); loss of best vision that
                         []        []                      can be achieved with glasses (0.1%
                                                           at 6 months); lost or damaged
   Answers to SELF-TEST are found at the
                                                           corneal flap (0% at 6 months); and
   top of page 20.
                                                           ghost images (1.3% at 6 months).


                       17                                              18
The following benefits of LASIK surgery       Answers to Self-Test Questions:
should be noted:                           1. False (see Risks on page 7);
•   Nearsightedness with astigmatism       2. True (see What is LASIK? on page 4);
    may be reduced so that the amount of
    time contact lenses or glasses are     3. False (see Before The Surgery on page 12);
    used during the day is reduced or      4. False (see The Day of Surgery on page 13);
    eliminated.
                                           5. True (see Benefits on page 10);
•   LASIK may be an alternative to
    glasses in some patients who are       6. True (see Why LASIK may not be right for
    intolerant of contact lenses.          you on page 11);

•   LASIK may be another alternative to    7. True (see Risks on page 7);
    correct nearsightedness and            8. False (see Contraindications on page 5);
    astigmatism.                           9. False (see Contraindications on page 5).
Patients considering LASIK surgery
should:
                                           16. Summary Tables
•   Discuss fully with one or more
    ophthalmic surgeons the
                                              Summary of Key Safety and Efficacy Variables
    complications of LASIK surgery, the
                                                       at 6 months after Surgery
    risks and the time required for
    healing, and have a complete eye       Efficacy Variables
                                           Visual acuity without glasses or contacts:
    examination before making a final               20/20 or better                     47.4%
    decision.                                       20/40 or better                     84.4%
                                           Treated eyes within range of target
•   Read both the Patient Information      correction (MRSE):
    Booklet and the Informed Consent                ± 0.50 diopters                     60.3%
    Document (ICD) provided by your                 ± 1.00 diopters                     85.2%
    doctor carefully before signing the             ± 2.00 diopters                     97.1%
    ICD.
                                           Safety Variables
                                           Visual acuity with glasses being
                                                    20/40 or worse                       0.1%
                                           Loss of more than 2 lines on vision chart
                                                    with glasses on                      0.7%
                                           Visual acuity with glasses on worse than
                                                    20/25 when it was better than
                                                    20/20 before surgery                 0.7%




                                           At the point of stability (6 months), the preci-
                                           sion (accuracy of MRSE post-op to target for
                                           MRSE ±1.00 D) is significantly lower for
                                           refractive errors of ≥10.0 D of myopia (see
                                           following table).




                19                                                    20
                                                               17. Glossary
              Pre -Ope rative M R SE ≥10.0 D
            at the Point of Stability (6 months )
                                                                     Astigmatism—a refractive error that is
Diffe re nce from    -10.0 D to        -12.0 D to
    Intended          -11.99 D          -13.99 D    ≥14.0 D                 stronger in one direction than
    Outcome           n/N (%)           n/N (%)     n/N (% )                others, usually corrected by glasses
 ±0.50 diopters         39/77             3/20        0/4                   or contacts with a slight cylinder
                       (50.6%)          (15.0%)     (0.0%)                  shape.
 ±1.00 diopters         58/77            11/20        0/4            Automated lamellar keratoplasty—an older
                       (75.3%)          (55.0%)     (0.0%)                 surgical technique to remove a thin
 ±2.00 diopters         72/77            16/20        3/4                  layer of the cornea and reshape it to
                       (93.5%)          (80.0%)     (75.0%)                correct refractive error.
                                                                     Collagen vascular disease—any of several
                                                                            conditions that alter the way your
                                                                            body creates and metabolizes
           Complications and Advers Events
                                   e                                        normal connective tissue like
                                                                            collagen. The cornea is made
                                                                            mostly of collagen. Some common
                                    Immediate Post-
Description                             op to        At 6                   examples include lupus, sclero-
                                       1 Month      Months                  derma, and rheumatoid arthritis.
                                                                     Corneal edema—a swelling of the cornea,
Complications—
 Discomfort                             ------         0.0%                 common in response to eye surgery
 Haze (mild to moderate)                0.0%           0.0%                 or injury, that sometimes causes
 Foreign body sensation                 ------         0.5%                 temporary clouding of the cornea.
 Ghost/double images                    ------         1.3%
                                                                     Corneal infiltrate—an infection or inflam-
 Corneal swelling                       0.0%          -----
 Peripheral corneal                                                         matory response that penetrates into
   surface defect                        ------        0.2%                 the cornea, often more difficult to
 Flap not size and shape                                                    treat than a surface problem.
   intended or not cut
                                                                     Cylinder—describes the barrel shaped lens
   completely                            ------        0.0%
                                                                            required to fix your astigmatic
Adverse events—                                                             refractive error.
 Corneal infiltrate or ulcer             ------        0.0%
                                                                     Efficacy—how well or effectively a treat-
 Lost or misaligned flap                 ------        0.0%
 Elevated intraocular                                                        ment performs.
   pressure (relative or                                             Increase in fluctuation of vision—variations
   absolute)                             -----         0.0%                  in vision more than usual or normal
 Loss of visual acuity after
                                                                             that are easily noticed by a person
   6 months                              ------        0.5%
 Late onset haze with                                                        when lighting conditions change
   decreased vision                      ------        0.0%                  (e.g., daytime compared to night-
 Retinal accidents/detach.               -----         0.0%                  time vision).
                                                                     Intraocular pressure (IOP)—the normally
                                                                             constant fluid pressure inside the
                                                                             eye. When too high, it can cause
                                                                             glaucoma.




                               21                                                    22
Laser in situ keratomileusis (LASIK)—use
                                                INFORMATION CENTER
        of an excimer laser to treat refrac-
        tive error under a thin flap of the
        cornea. The flap is made first,
                                                Primary Eye Care Professional
        moved out of the way for laser
        treatment, then replaced to cover       [This information can be pre-printed by physician offices]
        the treatment area.
MRSE—the manifest refraction spherical
     equivalent, a measure of the overall       Name:
     lens power of the refractive correc-       Address:
     tion needed by your eye.
                                                Phone:
Radial keratotomy (RK)—a surgical treat-
        ment to correct refractive error
        using small cuts to change the shape
        of the cornea.
                                                Doctor Performing LASIK
Recurrent erosions—a repeated uncovering
       of the corneal epithelial cells that
       protect the cornea.
                                                Name:
Refractive surgery—surgery to change how
                                                Address:
        the eye focuses to correct refractive
        error. This includes the use of laser   Phone:
        surgery or cuts to alter the shape of
        the cornea, implantation of small
        lenses or rings, or surgical re-        Treatment Location
        moval of a clear lens.
Sphere—describes the round shaped lens
                                                Name:
      required to fix your refractive error
      when you do not have astigmatism.         Address:
                                                Phone:




                                                            Laser Manufacturer:
                                                                   Nidek Co., Ltd.
                                                                   Gamagori, Japan


                                                                 U.S.A. Offices:
                                                               Nidek Incorporated
                                                            47651 Westinghouse Drive
                                                            Fremont, California 94539
                                                                (510) 226-5700



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