INFORMED CONSENT FOR LASER IN-SITU KERATOMILEUSIS (LASIK)
INTRODUCTION
This information is being provided to you so that you can make an informed
decision about the use of a device known as a microkeratome, combined with the
use of a device known as an excimer laser, to perform LASIK. LASIK is one of a
number of alternatives for correcting nearsightedness, farsightedness and
astigmatism. In LASIK, the microkeratome is used to shave the cornea to create a
flap. The flap then is opened like the page of a book to expose tissue just
below the cornea’s surface. Next, the excimer laser is used to remove ultra-thin
layers from the cornea to reshape it to reduce nearsightedness. Finally, the
flap is returned to its original position, without sutures.
LASIK is an elective procedure: There is no emergency condition or other reason
that requires or demands that you have it performed. You could continue wearing
contact lenses or glasses and have adequate visual acuity. This procedure, like
all surgery, presents some risks, many of which are listed below. You should
also understand that there may be other risks not known to your doctor, which
may become known later. Despite the best of care, complications and side effects
may occur; should this happen in your case, the result might be affected even to
the extent of making your vision worse.
ALTERNATIVES TO LASIK
If you decide not to have LASIK, there are other methods of correcting your
nearsightedness, farsightedness or astigmatism. These alternatives include,
among others, eyeglasses, contact lenses and other refractive surgical
procedures.
PATIENT CONSENT
In giving my permission for LASIK, I understand the following: The long-term
risks and effects of LASIK are unknown. I have received no guarantee as to the
success of my particular case. I understand that the following risks are
associated with the procedure:
VISION THREATENING COMPLICATIONS
1. I understand that the microkeratome or the excimer laser could malfunction,
requiring the procedure to be stopped before completion. Depending on the type
of malfunction, this may or may not be accompanied by visual loss.
2. I understand that, in using the microkeratome, instead of making a flap, an
entire portion of the central cornea could be cut off, and very rarely could be
lost. If preserved, I understand that my doctor would put this tissue back on
the eye after the laser treatment, using sutures, according to the ALK procedure
method. It is also possible that the flap incision could result in an incomplete
flap, or a flap that is too thin. If this happens, it is likely that the laser
part of the procedure will have to be postponed until the cornea has a chance to
heal sufficiently to try to create the flap again.
3. I understand that irregular healing of the flap could result in a distorted
cornea. This would mean that glasses or contact lenses may not correct my vision
to the level possible before undergoing LASIK. If this distortion in vision is
severe, a partial or complete corneal transplant might be necessary to repair
the cornea.
4. I understand that it is possible a perforation of the cornea could occur,
causing devastating complications, including loss of some or all of my vision.
This could also be caused by an internal or external eye infection that could
not be controlled with antibiotics or other means.
5. I understand that mild or severe infection is possible. Mild infection can
usually be treated with antibiotics and usually does not lead to permanent
visual loss. Severe infection, even if successfully treated with antibiotics,
could lead to permanent scarring and loss of vision that may require corrective
laser surgery or, if very severe, corneal transplantation or even loss of the
eye.
I understand that other very rare complications threatening vision include, but
are not limited to, corneal swelling, corneal thinning (ectasia), retinal
detachment, hemorrhage, venous and arterial blockage, cataract formation, total
blindness, and even loss of my eye.
NON-VISION THREATENING SIDE EFFECTS
1. I understand that there may be increased sensitivity to light, glare, and
fluctuations in the sharpness of vision. I understand these conditions usually
occur during the normal stabilization period of from one to three months, but
they may also be permanent.
2. I understand that there is an increased risk of eye irritation related to
drying of the corneal surface following the LASIK procedure. These symptoms may
be temporary or, on rare occasions, permanent, and may require frequent
application of artificial tears and/or closure of the tear duct openings in the
eyelid.
3. I understand that an overcorrection or undercorrection could occur, causing
me to become farsighted or nearsighted or increase my astigmatism and that this
could be either permanent or treatable. I understand an overcorrection or
undercorrection is more likely in people over the age of 40 years and may
require the use of glasses for reading or for distance vision some or all of the
time.
4. I understand that at night there may be a “starbursting” or halo effect
around lights. I understand that this condition usually diminishes with time,
but could be permanent. I understand that my vision may not seem as sharp at
night as during the day and that I may need to wear glasses at night. I
understand that I should not drive until my vision is adequate both during the
day and at night.
5. I understand that I may not get a full correction from my LASIK procedure and
this may require future enhancement procedures, such as more laser treatment or
the use of glasses or contact lenses.
6. I understand that there may be a “balance” problem between my two eyes after
LASIK has been performed on one eye, but not the other. This phenomenon is
called anisometropia. I understand this would cause eyestrain and make judging
distance or depth perception more difficult. I understand that my first eye may
take longer to heal than is usual, prolonging the time I could experience
anisometropia.
7. I understand that, after LASIK, the eye may be more fragile to trauma from
impact. Evidence has shown that, as with any scar, the corneal incision will not
be as strong as the cornea originally was at that site. I understand that the
treated eye, therefore, is somewhat more vulnerable to all varieties of
injuries, at least for the first year following LASIK. I understand it would be
advisable for me to wear protective eyewear when engaging in sports or other
activities in which the possibility of a ball, projectile, elbow, fist, or other
traumatizing object contacting the eye may be high.
8. I understand that there is a natural tendency of the eyelids to droop with
age and that eye surgery may hasten this process.
9. I understand that there may be pain or a foreign body sensation, particularly
during the first 48 hours after surgery.
10. I understand that temporary glasses either for distance or reading may be
necessary while healing occurs and that more than one pair of glasses may be
needed.
11. I understand that the long-term effects of LASIK are unknown and that
unforeseen complications or side effects could possibly occur.
12. I understand that visual acuity I initially gain from LASIK could regress,
and that my vision may go partially back to a level that may require glasses or
contact lens use to see clearly.
13. I understand that the correction that I can expect to gain from LASIK may
not be perfect. I understand that it is not realistic to expect that this
procedure will result in perfect vision, at all times, under all circumstances,
for the rest of my life. I understand I may need glasses to refine my vision for
some purposes requiring fine detailed vision after some point in my life, and
that this might occur soon after surgery or years later.
14. I understand that I may be given medication in conjunction with the
procedure and that my eye may be patched afterward. I therefore, understand that
I must not drive the day of surgery and not until I am certain that my vision is
adequate for driving.
15. I understand that if I currently need reading glasses, I will still likely
need reading glasses after this treatment. It is possible that dependence on
reading glasses may increase or that reading glasses may be required at an
earlier age if I have this surgery.
16. Even 90% clarity of vision is still slightly blurry. Enhancement surgeries
can be performed when vision is stable UNLESS it is unwise or unsafe. If the
enhancement is performed within the first six months following surgery, there
generally is no need to make another cut with the microkeratome. The original
flap can usually be lifted with specialized techniques. After 6 months of
healing, a new LASIK incision may be required, incurring greater risk. In order
to perform an enhancement surgery, there must be adequate tissue remaining. If
there is inadequate tissue, it may not be possible to perform an enhancement. An
assessment and consultation will be held with the surgeon at which time the
benefits and risks of an enhancement surgery will be discussed.
17. I understand that, as with all types of surgery, there is a possibility of
complications due to anesthesia, drug reactions, or other factors that may
involve other parts of my body. I understand that, since it is impossible to
state every complication that may occur as a result of any surgery, the list of
complications in this form may not be complete.
PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING
The details of the procedure known as LASIK have been presented to me in detail
in this document and explained to me by my ophthalmologist. My ophthalmologist
has answered all my questions to my satisfaction. I therefore consent to LASIK
surgery.
I give permission for my ophthalmologist to record on video or photographic
equipment my procedure, for purposes of education, research, or training of
other health care professionals. I also give my permission for my
ophthalmologist to use data about my procedure and subsequent treatment to
further understand LASIK. I understand that my name will remain confidential,
unless I give subsequent written permission for it to be disclosed outside my
ophthalmologist’s office or the center where my LASIK procedure will be
performed.
Patient Name Date Witness Name Date
I have been offered a copy of this consent form (please initial) _____
From:
The Lasik Institute on the web