buat yang butuh [http://www.fda.gov/cdrh/LASIK/default.htm]
Learning About LASIK
LASIK is a surgical procedure intended to reduce a person's dependency
on glasses or contact lenses. The goal of this Web site is to provide
objective information to the public about LASIK surgery. See other
sections of this site to learn about what you should know before
surgery, what will happen during the surgery, and what you should
expect after surgery. There is a glossary of terms and a checklist of
issues for you to consider, practices to follow, and questions to ask
your doctor before undergoing LASIK surgery.
LASIK stands for Laser-Assisted In Situ Keratomileusis and is a
procedure that permanently changes the shape of the cornea, the clear
covering of the front of the eye, using an excimer laser. A knife,
called a microkeratome, is used to cut a flap in the cornea. A hinge
is left at one end of this flap. The flap is folded back revealing the
stroma, the middlesection of the cornea. Pulses from a
computer-controlled laser vaporize a portion of the stroma and the
flap is replaced. There are other techniques and many new terms
related to LASIK that you may hear about.
What is LASIK?
The eye and vision errors
The parts of the eye The cornea is a part of the eye that helps focus
light to create an image on the retina. It works in much the same way
that the lens of a camera focuses light to create an image on film.
The bending and focusing of light is also known as refraction. Usually
the shape of the cornea and the eye are not perfect and the image on
the retina is out-of-focus (blurred) or distorted. These imperfections
in the focusing power of the eye are called refractive errors. There
are three primary types of refractive errors: myopia, hyperopia and
astigmatism. Persons with myopia, or nearsightedness, have more
difficulty seeing distant objects as clearly as near objects. Persons
with hyperopia, or farsightedness, have more difficulty seeing near
objects as clearly as distant objects. Astigmatism is a distortion of
the image on the retina caused by irregularities in the cornea or lens
of the eye. Combinations of myopia and astigmatism or hyperopia and
astigmatism are common. Glasses or contact lenses are designed to
compensate for the eye's imperfections. Surgical procedures aimed at
improving the focusing power of the eye are called refractive surgery.
In LASIK surgery, precise and controlled removal of corneal tissue by
a special laser reshapes the cornea changing its focusing power.
Other types of refractive surgery
Radial Keratotomy or RK and Photorefractive Keratectomy or PRK are
other refractive surgeries used to reshape the cornea. In RK, a very
sharp knife is used to cut slits in the cornea changing its shape. PRK
was the first surgical procedure developed to reshape the cornea, by
sculpting, using a laser. Later, LASIK was developed. The same type of
laser is used for LASIK and PRK. Often the exact same laser is used
for the two types of surgery. The major difference between the two
surgeries is the way that the stroma, the middle layer of the cornea,
is exposed before it is vaporized with the laser. In PRK, the top
layer of the cornea, called the epithelium, is scraped away to expose
the stromal layer underneath. In LASIK, a flap is cut in the stromal
layer and the flap is folded back.
Another type of refractive surgery is thermokeratoplasty in which heat
is used to reshape the cornea. The source of the heat can be a laser,
but it is a different kind of laser than is used for LASIK and PRK.
Other refractive devices include corneal ring segments that are
inserted into the stroma and special contact lenses that temporarily
reshape the cornea (orthokeratology).
What the FDA regulates
In the United States, the Food and Drug Administration (FDA) regulates
the sale of medical devices such as the lasers used for LASIK. Before
a medical device can be legally sold in the U.S., the person or
company that wants to sell the device must seek approval from the FDA.
To gain approval, they must present evidence that the device is
reasonably safe and effective for a particular use, the "indication."
Once the FDA has approved a medical device, a doctor may decide to use
that device for other indications if the doctor feels it is in the
best interest of a patient. The use of an approved device for other
than its FDA-approved indication is called "off-label use." The FDA
does not regulate off-label use or the practice of medicine.
The FDA does not have the authority to:
* Regulate a doctor's practice. In other words, FDA does not tell
doctors what to do when running their business or what they can or
cannot tell their patients.
* Set the amount a doctor can charge for LASIK eye surgery.
* "Insist" the patient information booklet from the laser
manufacturer be provided to the potential patient.
* Make recommendations for individual doctors, clinics, or eye
centers. FDA does not maintain nor have access to any such list of
doctors performing LASIK eye surgery.
* Conduct or provide a rating system on any medical device it regulates.
The first refractive laser systems approved by FDA were excimer lasers
for use in PRK to treat myopia and later to treat astigmatism.
However, doctors began using these lasers for LASIK (not just PRK),
and to treat other refractive errors (not just myopia). Over the last
several years, LASIK has become the main surgery doctors use to treat
myopia in the United States. More recently, some laser manufacturers
have gained FDA approval for laser systems for LASIK to treat myopia,
hyperopia and astigmatism and for PRK to treat hyperopia and
astigmatism.
When is LASIK not for me?
You are probably NOT a good candidate for refractive surgery if:
* You are not a risk taker. Certain complications are unavoidable
in a percentage of patients, and there are no long-term data available
for current procedures.
* It will jeopardize your career. Some jobs prohibit certain
refractive procedures. Be sure to check with your
employer/professional society/military service before undergoing any
procedure.
* Cost is an issue. Most medical insurance will not pay for
refractive surgery. Although the cost is coming down, it is still
significant.
* You required a change in your contact lens or glasses
prescription in the past year. This is called refractive instability.
Patients who are:
* In their early 20s or younger,
* Whose hormones are fluctuating due to disease such as diabetes,
* Who are pregnant or breastfeeding, or
* Who are taking medications that may cause fluctuations in vision,
are more likely to have refractive instability and should discuss
the possible additional risks with their doctor.
* You have a disease or are on medications that may affect wound
healing. Certain conditions, such as autoimmune diseases (e.g., lupus,
rheumatoid arthritis), immunodeficiency states (e.g., HIV) and
diabetes, and some medications (e.g., retinoic acid and steroids) may
prevent proper healing after a refractive procedure.
* You actively participate in contact sports. You participate in
boxing, wrestling, martial arts or other activities in which blows to
the face and eyes are a normal occurrence.
* You are not an adult. Currently, no lasers are approved for
LASIK on persons under the age of 18.
Precautions
The safety and effectiveness of refractive procedures has not been
determined in patients with some diseases. Discuss with your doctor if
you have a history of any of the following:
* Herpes simplex or Herpes zoster (shingles) involving the eye area.
* Glaucoma, glaucoma suspect, or ocular hypertension.
* Eye diseases, such as uveitis/iritis (inflammations of the eye)
* Eye injuries or previous eye surgeries.
* Keratoconus
Other Risk Factors
Your doctor should screen you for the following conditions or
indicators of risk:
* Blepharitis. Inflammation of the eyelids with crusting of the
eyelashes, that may increase the risk of infection or inflammation of
the cornea after LASIK.
* Large pupils. Make sure this evaluation is done in a dark room.
Younger patients and patients on certain medications may be prone to
having large pupils under dim lighting conditions. This can cause
symptoms such as glare, halos, starbursts, and ghost images (double
vision) after surgery. In some patients these symptoms may be
debilitating. For example, a patient may no longer be able to drive a
car at night or in certain weather conditions, such as fog.
* Thin Corneas. The cornea is the thin clear covering of the eye
that is over the iris, the colored part of the eye. Most refractive
procedures change the eye's focusing power by reshaping the cornea
(for example, by removing tissue). Performing a refractive procedure
on a cornea that is too thin may result in blinding complications.
* Previous refractive surgery (e.g., RK, PRK, LASIK). Additional
refractive surgery may not be recommended. The decision to have
additional refractive surgery must be made in consultation with your
doctor after careful consideration of your unique situation.
* Dry Eyes. LASIK surgery tends to aggravate this condition.
What are the risks and how can I find the right doctor for me?
Most patients are very pleased with the results of their refractive
surgery. However, like any other medical procedure, there are risks
involved. That's why it is important for you to understand the
limitations and possible complications of refractive surgery.
Before undergoing a refractive procedure, you should carefully weigh
the risks and benefits based on your own personal value system, and
try to avoid being influenced by friends that have had the procedure
or doctors encouraging you to do so.
* Some patients lose vision. Some patients lose lines of vision on
the vision chart that cannot be corrected with glasses, contact
lenses, or surgery as a result of treatment.
* Some patients develop debilitating visual symptoms. Some
patients develop glare, halos, and/or double vision that can seriously
affect nighttime vision. Even with good vision on the vision chart,
some patients do not see as well in situations of low contrast, such
as at night or in fog, after treatment as compared to before
treatment.
* You may be under treated or over treated. Only a certain percent
of patients achieve 20/20 vision without glasses or contacts. You may
require additional treatment, but additional treatment may not be
possible. You may still need glasses or contact lenses after surgery.
This may be true even if you only required a very weak prescription
before surgery. If you used reading glasses before surgery, you may
still need reading glasses after surgery.
* Some patients may develop severe dry eye syndrome. As a result
of surgery, your eye may not be able to produce enough tears to keep
the eye moist and comfortable. Dry eye not only causes discomfort, but
can reduce visual quality due to intermittent blurring and other
visual symptoms. This condition may be permanent. Intensive drop
therapy and use of plugs or other procedures may be required.
* Results are generally not as good in patients with very large
refractive errors of any type. You should discuss your expectations
with your doctor and realize that you may still require glasses or
contacts after the surgery.
* For some farsighted patients, results may diminish with age. If
you are farsighted, the level of improved vision you experience after
surgery may decrease with age. This can occur if your manifest
refraction (a vision exam with lenses before dilating drops) is very
different from your cycloplegic refraction (a vision exam with lenses
after dilating drops).
* Long-term data is not available. LASIK is a relatively new
technology. The first laser was approved for LASIK eye surgery in
1998. Therefore, the long-term safety and effectiveness of LASIK
surgery is not known.
Additional Risks if you are Considering the Following:
* Monovision
Monovision is one clinical technique used to deal with the correction
of presbyopia, the gradual loss of the ability of the eye to change
focus for close-up tasks that progresses with age. The intent of
monovision is for the presbyopic patient to use one eye for distance
viewing and one eye for near viewing. This practice was first applied
to fit contact lens wearers and more recently to LASIK and other
refractive surgeries. With contact lenses, a presbyopic patient has
one eye fit with a contact lens to correct distance vision, and the
other eye fit with a contact lens to correct near vision. In the same
way, with LASIK, a presbyopic patient has one eye operated on to
correct the distance vision, and the other operated on to correct the
near vision. In other words, the goal of the surgery is for one eye to
have vision worse than 20/20, the commonly referred to goal for LASIK
surgical correction of distance vision. Since one eye is corrected for
distance viewing and the other eye is corrected for near viewing, the
two eyes no longer work together. This results in poorer quality
vision and a decrease in depth perception. These effects of monovision
are most noticeable in low lighting conditions and when performing
tasks requiring very sharp vision. Therefore, you may need to wear
glasses or contact lenses to fully correct both eyes for distance or
near when performing visually demanding tasks, such as driving at
night, operating dangerous equipment, or performing occupational tasks
requiring very sharp close vision (e.g., reading small print for long
periods of time).
Many patients cannot get used to having one eye blurred at all times.
Therefore, if you are considering monovision with LASIK, make sure you
go through a trial period with contact lenses to see if you can
tolerate monovision, before having the surgery performed on your eyes.
Find out if you pass your state's driver's license requirements with
monovision.
In addition, you should consider how much your presbyopia is expected
to increase in the future. Ask your doctor when you should expect the
results of your monovision surgery to no longer be enough for you to
see near-by objects clearly without the aid of glasses or contacts, or
when a second surgery might be required to further correct your near
vision.
* Bilateral Simultaneous Treatment
You may choose to have LASIK surgery on both eyes at the same time or
to have surgery on one eye at a time. Although the convenience of
having surgery on both eyes on the same day is attractive, this
practice is riskier than having two separate surgeries.
If you decide to have one eye done at a time, you and your doctor will
decide how long to wait before having surgery on the other eye. If
both eyes are treated at the same time or before one eye has a chance
to fully heal, you and your doctor do not have the advantage of being
able to see how the first eye responds to surgery before the second
eye is treated.
Another disadvantage to having surgery on both eyes at the same time
is that the vision in both eyes may be blurred after surgery until the
initial healing process is over, rather than being able to rely on
clear vision in at least one eye at all times.
Finding the Right Doctor
If you are considering refractive surgery, make sure you:
* Compare. The levels of risk and benefit vary slightly not only
from procedure to procedure, but from device to device depending on
the manufacturer, and from surgeon to surgeon depending on their level
of experience with a particular procedure.
* Don't base your decision simply on cost and don't settle for the
first eye center, doctor, or procedure you investigate. Remember that
the decisions you make about your eyes and refractive surgery will
affect you for the rest of your life.
* Be wary of eye centers that advertise, "20/20 vision or your
money back" or "package deals." There are never any guarantees in
medicine.
* Read. It is important for you to read the patient handbook
provided to your doctor by the manufacturer of the device used to
perform the refractive procedure. Your doctor should provide you with
this handbook and be willing to discuss his/her outcomes (successes as
well as complications) compared to the results of studies outlined in
the handbook.
Even the best screened patients under the care of most skilled
surgeons can experience serious complications.
* During surgery. Malfunction of a device or other error, such as
cutting a flap of cornea through and through instead of making a hinge
during LASIK surgery, may lead to discontinuation of the procedure or
irreversible damage to the eye.
* After surgery. Some complications, such as migration of the
flap, inflammation or infection, may require another procedure and/or
intensive treatment with drops. Even with aggressive therapy, such
complications may lead to temporary loss of vision or even
irreversible blindness.
Under the care of an experienced doctor, carefully screened candidates
with reasonable expectations and a clear understanding of the risks
and alternatives are likely to be happy with the results of their
refractive procedure.
Advertising
Be cautious about "slick" advertising and/or deals that sound "too
good to be true." Remember, they usually are. There is a lot of
competition resulting in a great deal of advertising and bidding for
your business. Do your homework.
What should I expect before, during, and after surgery?
What to expect before, during, and after surgery will vary from doctor
to doctor and patient to patient. This section is a compilation of
patient information developed by manufacturers and healthcare
professionals, but cannot replace the dialogue you should have with
your doctor. Read this information carefully and with the checklist,
discuss your expectations with your doctor.
Before Surgery
If you decide to go ahead with LASIK surgery, you will need an initial
or baseline evaluation by your eye doctor to determine if you are a
good candidate. This is what you need to know to prepare for the exam
and what you should expect:
If you wear contact lenses, it is a good idea to stop wearing them
before your baseline evaluation and switch to wearing your glasses
full-time. Contact lenses change the shape of your cornea for up to
several weeks after you have stopped using them depending on the type
of contact lenses you wear. Not leaving your contact lenses out long
enough for your cornea to assume its natural shape before surgery can
have negative consequences. These consequences include inaccurate
measurements and a poor surgical plan, resulting in poor vision after
surgery. These measurements, which determine how much corneal tissue
to remove, may need to be repeated at least a week after your initial
evaluation and before surgery to make sure they have not changed,
especially if you wear RGP or hard lenses. If you wear:
* soft contact lenses, you should stop wearing them for 2 weeks
before your initial evaluation.
* toric soft lenses or rigid gas permeable (RGP) lenses, you
should stop wearing them for at least 3 weeks before your initial
evaluation.
* hard lenses, you should stop wearing them for at least 4 weeks
before your initial evaluation.
Before your initial exam, stop wearing contact lenses.
You should tell your doctor:
* about your past and present medical and eye conditions
* about all the medications you are taking, including
over-the-counter medications and any medications you may be allergic
to
Your doctor should perform a thorough eye exam and discuss:
* whether you are a good candidate
* what the risks, benefits, and alternatives of the surgery are
* what you should expect before, during, and after surgery
* what your responsibilities will be before, during, and after surgery
You should have the opportunity to ask your doctor questions during
this discussion. Give yourself plenty of time to think about the
risk/benefit discussion, to review any informational literature
provided by your doctor, and to have any additional questions answered
by your doctor before deciding to go through with surgery and before
signing the informed consent form.
You should not feel pressured by your doctor, family, friends, or
anyone else to make a decision about having surgery. Carefully
consider the pros and cons.
The day before surgery, you should stop using:
* creams
* lotions
* makeup
* perfumes
These products as well as debris along the eyelashes may increase the
risk of infection during and after surgery. Your doctor may ask you to
scrub your eyelashes for a period of time before surgery to get rid of
residues and debris along the lashes.
Also before surgery, arrange for transportation to and from your
surgery and your first follow-up visit. On the day of surgery, your
doctor may give you some medicine to make you relax. Because this
medicine impairs your ability to drive and because your vision may be
blurry, even if you don't drive make sure someone can bring you home
after surgery.
During Surgery
The surgery should take less than 30 minutes. You will lie on your
back in a reclining chair in an exam room containing the laser system.
The laser system includes a large machine with a microscope attached
to it and a computer screen.
A numbing drop will be placed in your eye, the area around your eye
will be cleaned, and an instrument called a lid speculum will be used
to hold your eyelids open. A ring will be placed on your eye and very
high pressures will be applied to create suction to the cornea. Your
vision will dim while the suction ring is on and you may feel the
pressure and experience some discomfort during this part of the
procedure. The microkeratome, a cutting instrument, is attached to the
suction ring. Your doctor will use the blade of the microkeratome to
cut a flap in your cornea.
The microkeratome and the suction ring are then removed. You will be
able to see, but you will experience fluctuating degrees of blurred
vision during the rest of the procedure. The doctor will then lift the
flap and fold it back on its hinge, and dry the exposed tissue.
The laser will be positioned over your eye and you will be asked to
stare at a light. This is not the laser used to remove tissue from the
cornea. This light is to help you keep your eye fixed on one spot once
the laser comes on. NOTE: If you cannot stare at a fixed object for at
least 60 seconds, you may not be a good candidate for this surgery.
When your eye is in the correct position, your doctor will start the
laser. At this point in the surgery, you may become aware of new
sounds and smells. The pulse of the laser makes a ticking sound. As
the laser removes corneal tissue, some people have reported a smell
similar to burning hair. A computer controls the amount of laser
energy delivered to your eye. Before the start of surgery, your doctor
will have programmed the computer to vaporize a particular amount of
tissue based on the measurements taken at your initial evaluation.
After the pulses of laser energy vaporize the corneal tissue, the flap
is put back into position.
A shield should be placed over your eye at the end of the procedure as
protection, since no stitches are used to hold the flap in place. It
is important for you to wear this shield to prevent you from rubbing
your eye and putting pressure on your eye while you sleep, and to
protect your eye from accidentally being hit or poked until the flap
has healed.
Good practices to follow before and after surgery
After Surgery
Immediately after the procedure, your eye may burn, itch, or feel like
there is something in it. You may experience some discomfort, or in
some cases, mild pain and your doctor may suggest you take a mild pain
reliever. Both your eyes may tear or water. Your vision will probably
be hazy or blurry. You will instinctively want to rub your eye, but
don't! Rubbing your eye could dislodge the flap, requiring further
treatment. In addition, you may experience sensitivity to light,
glare, starbursts or haloes around lights, or the whites of your eye
may look red or bloodshot. These symptoms should improve considerably
within the first few days after surgery. You should plan on taking a
few days off from work until these symptoms subside. You should
contact your doctor immediately and not wait for your scheduled visit,
if you experience severe pain, or if your vision or other symptoms get
worse instead of better.
You should see your doctor within the first 24 to 48 hours after
surgery and at regular intervals after that for at least the first six
months. At the first postoperative visit, your doctor will remove the
eye shield, test your vision, and examine your eye. Your doctor may
give you one or more types of eye drops to take at home to help
prevent infection and/or inflammation. You may also be advised to use
artificial tears to help lubricate the eye. Do not resume wearing a
contact lens in the operated eye, even if your vision is blurry.
What to expect after surgery
You should wait one to three days following surgery before beginning
any non-contact sports, depending on the amount of activity required,
how you feel, and your doctor's instructions.
To help prevent infection, you may need to wait for up to two weeks
after surgery or until your doctor advises you otherwise before using
lotions, creams, or make-up around the eye. Your doctor may advise you
to continue scrubbing your eyelashes for a period of time after
surgery. You should also avoid swimming and using hot tubs or
whirlpools for 1-2 months.
Strenuous contact sports such as boxing, football, karate, etc. should
not be attempted for at least four weeks after surgery. It is
important to protect your eyes from anything that might get in them
and from being hit or bumped.
During the first few months after surgery, your vision may fluctuate.
* It may take up to three to six months for your vision to
stabilize after surgery.
* Glare, haloes, difficulty driving at night, and other visual
symptoms may also persist during this stabilization period. If further
correction or enhancement is necessary, you should wait until your eye
measurements are consistent for two consecutive visits at least 3
months apart before re-operation.
* It is important to realize that although distance vision may
improve after re-operation, it is unlikely that other visual symptoms
such as glare or haloes will improve.
* It is also important to note that no laser company has presented
enough evidence for the FDA to make conclusions about the safety or
effectiveness of enhancement surgery.
Contact your eye doctor immediately, if you develop any new, unusual
or worsening symptoms at any point after surgery. Such symptoms could
signal a problem that, if not treated early enough, may lead to a loss
of vision.
LASIK Surgery Checklist
Print this document in PDF format
Know what makes you a poor candidate
Career impact - does your job prohibit refractive surgery?
Cost - can you really afford this procedure?
Medical conditions - e.g., do you have an autoimmune disease or
other major illness? Do you have a chronic illness that might slow or
alter healing?
Eye conditions - do you have or have you ever had any problems
with your eyes other than needing glasses or contacts?
Medications - do you take steroids or other drugs that might
prevent healing?
Stable refraction - has your prescription changed in the last year?
High or Low refractive error - do you use glasses/contacts only
some of the time? Do you need an unusually strong prescription?
Pupil size - are your pupils extra large in dim conditions?
Corneal thickness - do you have thin corneas?
Tear production - do you have dry eyes?
Know all the risks and procedure limitations
Overtreatment or undertreatment - are you willing and able to have
more than one surgery to get the desired result?
May still need reading glasses - do you have presbyopia?
Results may not be lasting - do you think this is the last
correction you will ever need? Do you realize that long-term results
are not known?
May permanently lose vision - do you know some patients may lose
some vision or experience blindness?
Dry eyes – do you know that if you have dry eyes they could become
worse, or if you don't have dry eyes before you could develop chronic
dry eyes as a result of surgery?
Development of visual symptoms - do you know about glare, halos,
starbursts, etc. and that night driving might be difficult?
Contrast sensitivity - do you know your vision could be
significantly reduced in dim light conditions?
Bilateral treatment - do you know the additional risks of having
both eyes treated at the same time?
Patient information - have you read the patient information
booklet about the laser being used for your procedure?
Know how to find the right doctor
Experienced - how many eyes has your doctor performed LASIK
surgery on with the same laser?
Equipment - does your doctor use an FDA-approved laser for the
procedure you need?
Informative - is your doctor willing to spend the time to answer
all your questions?
Long-term Care - does your doctor encourage follow-up and
management of you as a patient? Your preop and postop care may be
provided by a doctor other than the surgeon.
Be Comfortable - do you feel you know your doctor and are
comfortable with an equal exchange of information?
Know preoperative, operative, and postoperative expectations
No contact lenses prior to evaluation and surgery - can you go for
an extended period of time without wearing contact lenses?
Have a thorough exam - have you arranged not to drive or work
after the exam?
Read and understand the informed consent - has your doctor given
you an informed consent form to take home and answered all your
questions?
No makeup before surgery - can you go 24-36 hours without makeup
prior to surgery?
Arrange for transportation - can someone drive you home after surgery?
Plan to take a few days to recover - can you take time off to take
it easy for a couple of days if necessary?
Expect not to see clearly for a few days - do you know you will
not see clearly immediately?
Know sights, smells, sounds of surgery - has your doctor made you
feel comfortable with the actual steps of the procedure?
Be prepared to take drops/medications- are you willing and able to
put drops in your eyes at regular intervals?
Be prepared to wear an eye shield - do you know you need to
protect the eye for a period of time after surgery to avoid injury?
Expect some pain/discomfort - do you know how much pain to expect?
Know when to seek help - do you understand what problems could
occur and when to seek medical intervention?
Know when to expect your vision to stop changing - are you aware
that final results could take months?
Make sure your refraction is stable before any further surgery -
if you don't get the desired result, do you know not to have an
enhancement until the prescription stops changing?
Q: Can you refer me to a good LASIK surgeon in my area?
A: Refer to the Other Resources section of this site. You may want to
contact the organizations listed there for additional information.
While FDA regulates medical devices and drugs, FDA does not regulate
the practice of medicine and does not have a registry of doctors. FDA
does not know of any government agency that can provide a referral for
any medical procedure. You may want to go to your library and see if
there is a local community services magazine that may provide
comparison information of services for doctors in your area.
Q: How do I report a bad experience or who do I notify about a 'bad' doctor?
A: If you had a bad experience or sustained an injury, you should file
a voluntary MedWatch report (1-800-FDA-1088) to the FDA. Also, you
could contact your state medical licensing board and file a complaint
with them. In addition, you could contact your state health department
or consumer complaint organization (e.g., Better Business Bureau).
Q: How much does LASIK cost?
A: The FDA regulates the safety and effectiveness of medical devices
for their intended use. The FDA does not regulate the marketing of or
any fees associated with the use of that product. Again, you may want
to go to your library and see if there is a local community services
magazine that may provide comparison information of services for
doctors in your area.
Q: How can I find out if a particular laser has been approved to treat
my refractive error (nearsightedness, farsightedness and/or
astigmastism)?
A: You can find approved devices, their approval date, and a synopsis
of the approved indications on the FDA-APPROVED LASERS page.
Q: If the laser I am interested in has not yet been approved for a
particular indication, how can I find out when it will be approved?
A: Confidentiality restrictions prohibit FDA from commenting on the
status of a device under regulatory review, but you can try asking the
laser company for this information.
Q: Which laser is the best for treating my refractive error?
A: FDA does not provide comparisons between refractive lasers. FDA
approves the safety and effectiveness of a device independent of any
other product. However, you are encouraged to review the approval
documents to assess the capabilities of specific laser systems and
make your own comparisons. The approval number for each laser on the
FDA-APPROVED LASERS page is linked to these documents, which provide
additional, detailed information about the clinical trial results and
indications for use. Discuss any concerns you may have with your
doctor.
Q: How does wavefront LASIK compare to conventional LASIK?
A: Wavefront adds an automatic measurement of more subtle distortions
(called higher order aberrations) than just nearsightedness,
farsightedness, and astigmatism corrected by conventional LASIK.
However, these "higher order aberrations" account for only a small
amount (probably no more than 10%) of the total refractive error of
the average person's eye. Conventional LASIK increases higher order
aberrations. Although wavefront-guided treatments attempt to eliminate
higher order aberrations, results from the clinical studies have shown
that the average aberrations still increase, but less than they do
after conventional LASIK. In a few studies comparing wavefront-guided
LASIK to conventional LASIK, a slightly larger percentage of subjects
treated with wavefront LASIK achieved 20/20 vision without glasses or
contact lenses compared to subjects treated with conventional LASIK.
Patient selection ("When is LASIK not for me?") and the experience and
competence of the surgeon are still the most important considerations.
Q: What percentage of patients attain 20/20 vision or better without
glasses or contacts?
A: Data in the Approval Orders and related documents summarizes the
outcomes from the clinical trials submitted to the FDA for each
approved device. Links to these documents are included on the
FDA-APPROVED LASERS page.
Q: Can you send me more information or respond to my concern?
A: No. The most current information we have about LASIK is on this
website and we update it routinely. We do not have the resources to
respond directly to patient concerns or questions. We encourage you to
discuss these matters with your doctor.
Q: Can I use information from the FDA LASIK website?
A: Yes. Information on this website can be used freely by the public.
Any use on other websites or in publications should be properly cited.
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