Informed Consent for Refractive Surgery...
consent is a process, not just a form. Information must be presented to enable
persons to voluntarily decide whether or not to undergo the contemplated
procedures used in obtaining informed consent should be designed to educate the
patient in terms that they can understand.
informed consent language and its documentation (especially explanation of the
alternatives, risks, and benefits) must be written in "lay language", (i.e.
understandable to the people being asked to participate). The consent document
must be revised when deficiencies are noted or when additional information will
improve the consent process.
are many conditions known to negatively impact on the possible
outcome from refractive surgery. At a minimum, you should have been
screened, properly and thoroughly, for all of the below, prior to
surgery. If you were not and, as a result, you have suffered a bad
outcome, you may be able to sue your doctor for the suffering you
Presenting information in a general format (the same informed
consent document being given to each patient), when patient-specific
information is known, may well form the basis for a malpractice
DO NOT BELIEVE THAT BECAUSE YOU HAVE SIGNED AN INFORMED CONSENT
DOCUMENT THAT YOU DO NOT HAVE THE RIGHT TO SUE!
You should have been told, prior to surgery, that you were
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, or military service before undergoing
- Cost is
an issue. Most medical insurance will not pay for
refractive surgery. Although the cost is coming down, it is
required a change in your contact lens or glasses
prescription in the past year. This is called refractive
instability. Patients who are:
their early 20s or younger,
hormones are fluctuating due to disease such as
are pregnant or breastfeeding, or
are taking medications such as steroids that cause
fluctuations in vision,
likely to have refractive instability and probably should
not have a refractive procedure.
- 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
- You are not an adult. Currently, no
lasers are approved for LASIK on persons under the age
note: the FDA has now changed these to "precautions" instead
of :Contraindications as previously listed on their website.
Do not allow the lobbying power of the refractive surgery
industry to fool you into believing that they are not what
they were previously called!)
The safety and effectiveness of refractive procedures has
not been determined in patients with some diseases. Do
have LASIK surgery if you have a history of any of the
- 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) and blepharitis (inflammation of the eyelids
with crusting of the eyelashes).
- Eye injuries or previous eye surgeries.
Other Risk Factors
Your doctor should screen you for the following conditions
or indicators of risk:
- 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
- Dry Eyes. LASIK surgery tends to aggravate this
LARGE REFRACTIVE ERROR (ANY TYPE) OR SMALL
AMOUNTS OF ASTIGMATISM -
are generally not as good in patients with very small amounts of
astigmatism or 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. (FDA warning
7/01). You should have been told that glasses and/or contact lenses
may not be able to correct vision problems which can exist following
REFRACTIVE SURGERY (e.g. RK, PRK, LASIK).
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. (FDA warning 4-01). This can have
significant impact on "enhancements", the follow up surgery performed
after the initial laser surgery has failed to deliver acceptable
It is required by the FDA that a person undergoing LASIK must be at least
eighteen years old. It is, however, noted by them that
who are in their early 20s or younger are more likely to have refractive
instability and probably should not have a refractive procedure.
Also, since this procedure is
essentially elective surgery, attainment of legal age is appropriate in order to
provide fully informed consent. There is no established upper age limit for
laser surgery eligibility but age may effect the healing process and the outcome of the surgery.
HORMONAL FLUCTUATIONS: Hormonal
fluctuations can effect the shape and refractive error of a person's eye. Surgery during a
period of such instability may lead to unpredictable results. Therefore, the procedure is not
recommended for women who may be pregnant, nursing, or undergoing changes in
oral contraceptive therapy.
HEALTH: The cornea is
composed of a matrix of collagen fibers, the same material which comprises
tendons and other connective tissue. Therefore, persons who have autoimmune
disorders, e.g., rheumatoid arthritis, Sjogren's Syndrome, Systemic Lupus
Erythematosis, etc., may be at risk for healing problems and unpredictable
refractive changes following surgery.
You must determine if having refractive surgery (no matter what the outcome)
will jeopardize your career. Some jobs prohibit certain refractive procedures.
Be sure to check with your employer/professional society/military service
(see section for Military/Pilots) before undergoing any procedure.
Awareness and acceptance of less than a 'perfect' result is essential prior to
undergoing surgery. You may be under corrected or over corrected. There is no
guarantee that the operation will meet a patient's expectations. A prospective patient
will expect that LASIK will
substantially improve the uncorrected visual acuity but must be able to cope
with the possible complications and be willing to accept that glasses or contact
lenses may still be necessary
for some activities. Only a certain percent of patients achieve 20/20 vision
following surgery. You may require additional treatment, but additional
treatment may not be possible. You may still need glasses or contact lenses
after surgery (but it may not be possible to adequately correct the results of
laser surgery with either glasses or contact lenses). This may be true even if
you only required a very weak prescription before surgery. If you used reading
glasses before surgery, you will still need reading glasses after surgery. (FDA
warning 7/01). You should be told that the mere achievement of 20/20 vision in a
Snellen chart in a doctors office does not mean your surgery was a success or
that you will be happy with the results achieved. Beware the surgeon who
stresses the percentage of his patients who have achieved a given degree of
visual acuity with giving equal time to complication which can exist event where
such acuity has been achieved.
PUPIL SIZE: Most
Excimer lasers in the United States currently treat an area of the cornea that
measures 6 - 7 mm in diameter. Therefore, it is important that the pupil size be
larger than the area of treatment. Measurement of the pupil size should be
performed with distance fixation in dim illumination. It should not be estimated
by your doctor or measured by holding a calibrated card up to your eye. Much of the reported
difficulties with glare experienced by LASIK patients come from those with pupil size irregularities.
It is currently believed that
a 250 micron residual amount of corneal tissue should remain following surgery.
It follows, necessarily, that your corneal thickness must be measured,
pre-operatively, and you must be advised of the accepted standard and the
corneal thickness you will be left with after surgery.
DEGREE OF REFRACTIVE ERROR:
are generally not as good in patients with very large refractive errors of any
type. A surgeon should
specifically discuss the risk of a poor outcome with any patient with
large refractive error. Merely handing you an Informed Consent document without
advising how it applies to you is not sufficient.
Most persons are either nearsighted or farsighted with some degree of
astigmatism. After the age of about 42, people also experienced difficulties
with focusing at near – this is known as presbyopia. LASIK does not correct
presbyopia. Reading glasses will be needed by older patients following surgery.
The range of refractive errors which can currently be
(nearsightedness) : -0.75 diopters to -14.0 diopters. Dependant upon
laser used. Myopics of -10 diopters or greater are at increased risk of
experiencing a poor outcome (there are those who believe -7 diopters is
the beginning of the zone of increased risk). They should be so advised and a responsible
surgeon may well recommend against surgery.
(farsightedness) : +0.75 diopters to +6.0 diopters. Dependant upon laser
(associated with myopia) : 0 to 5.0 diopters. Dependant upon laser used
(associated with hyperopia) : 0 to 5.0 diopters. Dependant upon laser used
No treatment (currently in
development with mixed results). Some doctors involved in testing also have
a financial stake in the corporation that developed the surgery and sells
devices to perform it, raising questions about their objectivity Not FDA
REFRACTIVE INSTABILITY: You
required a change in your contact lens or glasses prescription in the past year.
This is called refractive instability.
PREGNANCY: You should
understand that pregnancy causes fluctuations in hormones
in turn, can cause fluctuations in vision
FOR ALL PATIENTS: Other medical conditions will unnecessarily expose you to risks of
complications following surgery:
Unstable or uncontrolled diabetes
Significant lagophthalmos - a condition
in which complete closure of the eyelids over the eyeball is difficult or
Severe dry eye,
or severe inflammation of the eyelid margins.
uveitis, or chronic inflammation inside the eye.
Autoimmune disease or immunocompromised or on
drug therapy suppressing the immune system
Keratoconus (patients with this
condition may have unstable corneas)
History of keloid formation (unpredictable
corneal healing response)
Herpes Simplex or Herpes Zoster Virus A history of herpes simplex infection of the eye may be a contraindication to
LASIK surgery. It is believed that the virus may permanently reside in nerve
cells outside the eye and that any trauma (such as LASIK) might reactivate an
infection. However, the relationship between prior herpes infection and
refractive surgery is currently being re-evaluated. Studies are being done to
see if treatment with antiviral medication prior and after the operation might
prevent such a recurrence.
Residual, recurrent or active ocular disease(s) or abnormality except for myopia or hyperopia in either eye
Active or residual disease(s) likely to
affect wound-healing capability
Progressive myopia or hyperopia
Amblyopia (lazy eye)
Presence of a pacemaker, insulin implant or
other implanted electronic device in the patient
CONTACT LENS WEAR: You should have been told to discontinue the use of your contact lenses prior to
your exam and prior to the surgery. Please note the following:
Hard Contacts/Rigid Gas Permeable
At least three weeks minimum prior to exam and surgery.
At least for three days prior to your exam.
"Informed Consent" document, which should be signed by all patients prior to surgery, must fully discuss all
known complications and contraindications. There are many conditions which can be identified by pre-operative testing
would eliminate a patient as a reasonable candidate for surgery (thereby
avoiding a bad outcome for the patient and potential malpractice litigation for
contraindications, listed below, as well as all known potential complications,
generally and as they
specifically apply to each individual patient, should have been made known
to the patient before surgery.
DO NOT BELIEVE THAT BECAUSE YOU HAVE
SIGNED AN INFORMED CONSENT DOCUMENT THAT YOU CANNOT SUE. THIS, SIMPLY, ISN'T THE