| FDAgoldminer 2005-04-14, 8:42 am |
| http://www.fda.gov/cdrh/LASIK/risks.htm
Excerpt:
"Even the best screened patients under the care of most skilled surgeons can
experience serious complications."
What are the risks and how can I find the right doctor for me?
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.
a.. 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.
b.. 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.
c.. 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.
d.. 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.
e.. 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.
f.. 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).
g.. 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:
a.. 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.
a.. 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:
a.. 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.
a.. 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.
a.. Be wary of eye centers that advertise, "20/20 vision or your money
back" or "package deals." There are never any guarantees in medicine.
a.. 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.
a.. 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.
a.. 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.
If you want to know more about advertising ethics, do's and don'ts, or want
to report on false advertising, explore the following websites:
a.. http://www.ftc.gov/bcp/menu-ads.htm
b.. http://www.ftc.gov/bcp/menu-health.htm
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