Informed
Consent
for Primary Custom LASIK |
Please read the following pages carefully and initial
and sign where indicated. Please do not sign any section
that you have not read or do not understand. It is important
that you bring this informed consent with you on the
day of your procedure.
SECTION 1:
GENERAL INFORMATION ON INFORMED CONSENT
It is our hope to fully inform you concerning the side
effects, limitations and complications of Custom LASIK
surgery. We continually struggle to balance the benefits
of laser surgery with the known and unknown risks. It
is important to understand that it is impossible to
perform any form of surgery without the patient accepting
a certain degree of risk and responsibility. This consent
form, in combination with the extensive educational
materials provided and the entire consultation process,
is designed to enhance your understanding of the potential
for difficulties that may be encountered during both
the procedure and the healing process.
Many of our patients are surprised and some are upset
by the extent to which we attempt to inform them of
the potential for complications. It is not our intention
to frighten or dissuade someone from pursuing laser
surgery, as most of our patients will never encounter
any serious complications and the vast majority are
pleased with the improvement they achieve. It is our
intention, however, to accurately outline the associated
risks to all candidates so that they may either elect
not to accept the risks associated or be better prepared
to deal with any unexpected complication or side effects
which may arise. Custom LASIK is a purely elective procedure,
and you may decide not to have this operation at all.
The only way to avoid all surgical risk is by not proceeding
with surgery.
SECTION 2: LASER VISION CORRECTION BACKGROUND SUMMARY
Laser in situ Keratomileusis (LASIK), a form of laser
vision correction, reshapes the part of the eye known
as the cornea to possibly reduce or eliminate the need
for glasses or contact lenses in cases of myopia (nearsightedness),
hyperopia (farsightedness) and astigmatism (ovalness).
There are two primary techniques for reshaping the cornea
with laser surgery, PRK and LASIK. In both forms of
laser vision correction, the transparent cornea at the
front of the eye is reshaped with your prescription.
PRK, or photorefractive keratectomy, reshapes the surface
layers of the cornea, while Custom LASIK fine tunes
the inner corneal layers with the Excimer laser. The
Excimer laser produces a cool beam of ultraviolet light
energy, capable of removing very precise amounts of
corneal tissue to change the shape or curvature of the
cornea and potentially improve your vision. The LASIK
procedure is a newer, more advanced form of keratomileusis,
a procedure that has been practiced in South America
and Europe for over three decades. Both procedures are
able to treat myopia, hyperopia and astigmatism but
have benefits, limitations and risks.
Both PRK and Custom LASIK are performed on an outpatient
basis and take only 5 to 15 minutes to complete. Although
patients often feel some pressure sensation, both procedures
are painless. In both the PRK and Custom LASIK procedures,
topical anesthetic drops are used to thoroughly numb
the eye, and an eyelid holder is used to prevent blinking.
Patients focus on a red target light throughout both
procedures. In the PRK procedure, the surgeon first
removes the corneal epithelium, or protective surface
layer of the cornea. The Excimer laser then applies
computer-controlled pulses of light energy to the corneal
surface to reshape the eye. Following PRK, typically
a bandage contact lens is inserted, or the surgeon may
patch the eye closed for a few days. The epithelium
grows back over 3 or 4 days and the vision gradually
improves once the protective layer is healed. In the
Custom LASIK procedure, a protective corneal flap is
created using a very sophisticated surgical instrument
known as a microkeratome. The protective flap is about
30% of the corneal thickness and is hinged either along
the nose or beneath the upper eyelid. A suction ring
holds the eye in position while the automated microkeratome
creates the corneal flap. Patients are unable to see
the corneal flap being made, as the vision becomes gray
when the suction is applied and the red target light
disappears until the flap is completed. Most patients
sense some vibrating pressure, but the microkeratome
incision is completely painless. When the laser pulses
are completed, the corneal flap is replaced and the
natural suction within the cornea seals the corneal
flap within 1 to 5 minutes. No sutures are needed, as
the corneal flap seals rapidly. A bandage contact lens
is not typically required with Custom LASIK and a protective
eyeshield rather than a patch may be needed, but only
while sleeping. Although the vision is blurry immediately
following Custom LASIK, patients are able to blink normally
and there is rapid overnight visual improvement.
In PRK, the removal of the surface protective layer
increases the risk of pain, infection and corneal scarring
or haze. The creation of the corneal flap with Custom
LASIK allows the protective layer to be preserved and
provides for a more rapid and comfortable visual recovery.
The surface corneal layers are more sensitive than the
inner corneal layers treated with Custom LASIK; therefore
healing time is shorter compared to PRK. The intra-operative
risks however are greater with Custom LASIK than PRK,
primarily because of possible complications with the
creation of the protective corneal flap with the microkeratome.
For patients with higher degrees of myopia, hyperopia
and astigmatism, where more healing complications are
encountered, or for patients who desire a more rapid
visual recovery, Custom LASIK may be the treatment of
choice.
SECTION 3: LASIK INDICATIONS, CONTRAINDICATIONS AND
PERI-OPERATIVE CARE
| • |
Custom
LASIK is indicated for the treatment of myopia
(near-sightedness), hyperopia (farsightedness)
and astigmatism |
| • |
Candidates
must be 18 years of age or older |
| • |
Candidates
must have a stable refraction with no more than
0.50 diopter change within the previous year,
as the procedure will not change the natural growth
or aging of the eye |
| • |
Candidates
must be aware that this is an elective procedure
and that there are alternative forms of vision
correction that are either non-surgical or surgical
including eyeglasses, contact lenses, orthokeratology
(ortho-K), radial keratotomy (RK), intracorneal
ring segments (ICRS), automated lamellar keratoplasty
(ALK), holmium laser thermokeratoplasty (LTK),
refractive phakic lens implants or photorefractive
keratectomy (PRK). |
| • |
Candidates
must be free of certain eye diseases including
keratoconus, glaucoma, cataracts and certain retinal
and optic nerve diseases |
| • |
Candidates
must be free of certain eye viruses including
herpes simplex and herpes zoster · Candidates
must be free of certain health problems including
uncontrolled diabetes, autoimmune or collagen
vascular disease, any medication or condition
which renders the patient immuno-compromised |
| • |
Candidates
must make their surgeon aware of certain eye problems
including amblyopia (lazy eye), strabismus (muscle
imbalance), severe dry eyes or any recurrent,
residual or active eye condition which may affect
healing |
| • |
Candidates
must make their surgeon aware of certain general
health conditions including keloid scarring with
previous surgical healing, back problems, claustrophobia
or other psychological problems which may affect
the surgery or recovery |
| • |
Candidates
must make their surgeon aware of any implants
including a cardiac pacemaker, insulin implant
or other electronic implanted device |
| • |
Patients
must also make their surgeon aware of any medication
allergies and any medications they are taking
to avoid potential drug interactions and allergic
reactions |
| • |
The
FDA considers pregnancy and nursing to be contra-indications,
although their effects on Custom LASIK have not
been studied. Female patients agree to disclose
to their surgeon if they are pregnant, could potentially
be pregnant or plan to become pregnant within
the next 6 months. |
PRE-PROCEDURE AND
POST-PROCEDURE CARE
The screening examination performed by your TLC eye doctor is intended to assess candidacy for refractive surgery based upon the corneal shape, prescription and other ocular and visual findings, but not to identify or treat eye disease. Ocular disease may be present prior to refractive surgery or may develop after surgery. Refractive surgery will not treat ocular disease. You should have a complete eye examination with retinal evaluation prior to refractive surgery and annually thereafter to identify and treat ocular disease. In general, patients with higher degrees of myopia have a higher risk of retinal problems, and reducing the degree of myopia with laser vision correction does not lower the risk. Patients who wear contact lenses must discontinue their use prior to Custom LASIK to allow the cornea to return to its natural contour. Soft contact lenses must be removed at least 3 days prior to surgery, and overnight use requires the lenses to be discontinued one to two weeks prior to the procedure date. Candidates with rigid gas permeable lenses must discontinue their use 1 to 3 months prior to Custom LASIK. Post-operative follow-up care with an eye care professional is required for 1 year to monitor Custom LASIK healing, then yearly for routine eye care and, for those eligible, to maintain your TLC Lifetime Commitment program. If a second enhancement procedure is needed or a complication occurs, a patient may be required to return to the TLC Center or lengthen their stay at their expense. If after one year, any further enhancement procedures are required, there will be a charge of $500.00 per eye for the specialized testing required for surgical planning. If there is new technology or other techniques available at that time that you wish to take advantage of in your re-treatment there will be an additional fee. The final clinical results are dependent upon properly following your post-operative care instructions.
SECTION 4: PRESBYOPIA/THE
MONOVISION OPTION
Many people around the age of 40 begin to have trouble
reading up close due to the natural weakening of their
focusing muscles, which is known as 'presbyopia'. Custom
LASIK will not prevent the natural aging of the eyes
or the need for reading glasses as you age, even if
you do not require them now. Although farsighted patients
usually improve their reading ability with Custom LASIK,
it is possible that nearsighted patients may need reading
glasses sooner. Monovision may allow for improved reading
ability in both nearsighted and farsighted patients
after age 40. The monovision option is usually selected
only by candidates over 35 years of age, and simply
means that we leave one eye a little nearsighted after
Custom LASIK. For nearsighted patients your myopia is
under- corrected in one eye, and for farsighted patients,
your hyperopia is a little overcorrected to provide
you with some reading ability as you age. Monovision
will not eliminate your need for reading glasses for
fine print, but is useful for reading your watch, opening
your mail or reading price tags without readers. The
disadvantage is that your distance sharpness will not
be as good and you will have more difficulty with activities
such as driving at night or with sports such as golf
or tennis. Night driving glasses may be needed with
monovision to reduce night glare. If you are in monovision
contact lenses already, then the monovision option is
ideal for you. A trial of monovision contact lenses
by your own eye doctor is beneficial. In our experience,
85% of patients over age 40 still prefer the best distance
vision possible in both eyes and wear reading glasses
when needed, declining the monovision option.
I would like to have the best distance vision in both
eyes
I would like to have monovision
SECTION 5: LEGAL RESPONSIBILITIES
AND DISCLOSURES
CONFIDENTIALITY
By initialing below, you give permission for the medical
data concerning your surgery and subsequent treatment
to be submitted to TLC and its affiliates, the Excimer
laser manufacturer and the governmental regulatory authorities.
The data will be utilized for statistical analysis,
record keeping, marketing and/or quality control. Patient
identity will be strictly confidential in any dissemination
of data.
GOVERNING LAW/ JURISDICTION
By initialing below, you agree that the relationship
and resolution of any and all disputes between yourself
and the surgeon shall be governed by and construed in
accordance with the laws of the Province of Ontario.
You also acknowledge with your initials that the procedure
was performed in the Province of Ontario and that the
Courts of the Province of Ontario shall have jurisdiction
to entertain any complaint, demand, claim or cause of
action, whether based on alleged breach of contract
or alleged negligence arising out of treatment. You
hereby agree that you will commence any such legal proceedings
in the Province of Ontario and you irrevocably submit
to the exclusive jurisdiction of the Courts of the Province
of Ontario.
FINANCIAL INTEREST OF SOME
DOCTORS
By initialing below, you also acknowledge that you are
aware that some TLC doctors and/or optometric affiliates
have a financial interest in this TLC Center or in TLC
directly and they may indirectly benefit financially
from the laser vision correction services performed
at this center.
SECTION 6: RISKS AND
COMPLICATIONS
As discussed earlier, all forms of surgery carry a certain
degree of risk for adverse effects and complications.
Problems can be related to the surgical component of
Custom LASIK or the healing component. Most surgical
problems are related to the creation of the corneal
flap and most healing problems develop within the first
month following Custom LASIK. Most complications improve
or resolve within 6 to 12 months or with retreatment,
but some surgical or healing complications may result
in permanent visual blurring, glare, discomfort or need
for corrective contact lenses. The risk of a severe
complication is dependent not only upon the functioning
of the microkeratome, blade and surgical technique but
upon a number of other factors including the prescription,
orbital structure and corneal shape. In general, there
is a small risk in the range of 1 to 5% of experiencing
a complication and a very small risk, less than 1%,
of a severe sight-threatening complication. Please read
this section carefully for a better understanding and
initial below.
The risks of Custom LASIK revolve around 5 primary areas:
| 1 |
Post-operative
Side Effects, Adverse Effects and Complications |
| 2 |
Refractive
Complications |
| 3 |
Corneal
Flap Complications |
| 4 |
Corneal
Healing Complications |
| 5 |
Other
Miscellaneous Complications |
1. Post-operative Side Effects, Adverse Effects
and Complications
There are several adverse effects which may be encountered
early in the post-operative period, including foreign
body sensation, pain or discomfort, sensitivity to bright
lights, blurred vision, dryness of the eyes, tearing
and fluctuation in vision. Persistent pain is uncommon
following Custom LASIK and may indicate a disturbance
of the epithelial protective layer, displacement of
the corneal flap or possible infection and should be
evaluated promptly by your doctor. Corneal infection
following Custom LASIK is rare but very serious and
can potentially result in corneal scarring requiring
a corneal transplant and in very severe cases, infections
can even result in blindness. Corneal inflammation can
also be produced from medication or healing reactions,
which may be allergic, toxic or immune in nature. Diffuse
interface keratitis (also known as Sands of the Sahara)
is the most important inflammatory reaction and can
produce corneal hazing, blurred vision, farsightedness,
astigmatism that may result in permanent corneal irregularities.
Treatment may involve topical steroids or further surgery
and may or may not restore vision fully. The most common
long-term side effect is dryness of the eyes, which
often precedes Custom LASIK but may be exacerbated.
The most important long-term side effect is night glare,
starbursting, haloes or simply reduced visual quality
under low light conditions. It is very common to have
night glare early during the recovery course and night
glare is more common when only one eye has been treated.
Night visual disturbances are typically produced by
the pupil size exceeding the laser treatment area. It
is more common in nearsighted patients with severe prescriptions
and large pupils. Some patients benefit from night driving
glasses and most, but not all, patients improve substantially
over 6 to 12 months. In a small percentage of patients
night glare may be permanent and affect your night driving
abilities.
2. Refractive Complications
Refractive problems that may be encountered include
too much correction, too little correction, a prescription
imbalance between eyes, aggravation of muscle imbalance
problems or a loss of effect from regression. Custom
LASIK may result in overcorrections and undercorrections
due to the variability in patient healing patterns and
other surgical variables, leaving patients nearsighted,
farsighted or with astigmatism. This may or may not
require patients to wear spectacles or contact lenses
or to undergo further surgery. Further surgery entails
additional risk and is not guaranteed to provide an
ideal visual outcome, although improvement is typically
achieved. Patients may also heal differently between
eyes, based upon differences between eyes in pre-operative
prescriptions, corneal curvature, variation in healing
or other surgical variables. Differences in refraction
between eyes is termed anisometropia, which is most
severe when only one eye is treated, may result in a
loss of depth perception, eyestrain, headache, double
vision and the need for contact lenses. Both farsightedness
and anisometropia may result in worsening of muscle
balance problems, causing an eye to wander more or produce
eye fatigue. Lastly, depending upon the severity of
the original prescription, the individual healing pattern
of the patient and other surgical variables, regression
may occur, causing the eyes to return toward their original
prescription, partially or, very rarely, completely.
Further enhancement surgery may be performed when medically
stable if adequate corneal tissue is available and no
other medical contraindications are present. As stated
previously, enhancement surgery, while generally very
effective, is associated with additional risk and is
not guaranteed to achieve the ideal visual result.
3. Corneal Flap Complications
The primary benefits of Custom LASIK are related to
the creation of the protective corneal flap. The corneal
flap must be of clinically adequate quality, thickness
and size to proceed with laser treatment. Corneal flap
complications range in severity from those that simply
require the procedure to be postponed by 3 to 6 months,
to those that create permanent corneal irregularities
resulting in blurred vision. The most severe Custom
LASIK complication is that of corneal perforation which
has been reported several dozen times worldwide. Corneal
flap complications that occur after the Custom LASIK
procedure during the recovery period include displacement
and wrinkling of the corneal flap and epithelial ingrowth.
Corneal flap problems include but are not limited to:
| • |
Corneal
flaps of inadequate size, typically too short,
preventing laser treatment and requiring the Custom
LASIK procedure to be repeated in 3 to 6 months.
Typically there is no serious visual disturbance,
although glare and shadowing may occasionally
be produced. |
| • |
Corneal
flaps of inadequate thickness may or may not be
adequate for laser treatment, and may result in
the procedure being stopped and repeated after
3 to 6 months. A thin corneal flap may result
in a slow visual recovery over weeks to months
and possibly permanently blurred vision with or
without laser treatment. |
| • |
Corneal
flaps of inadequate quality or smoothness, include
a variety of corneal flap problems which may produce
serious permanent corneal irregularities and significant
visual blurring. Corneal flap irregularities may
be produced because of inadequate suction pressure,
inadequate orbital size, inadequate patient cooperation,
malfunction or problems with the microkeratome,
blade or suction apparatus. |
| • |
Corneal
flaps are routinely hinged either nasally or superiorly
beneath the upper eyelid. A corneal hinge is not
required for a good visual result, but a hinged
corneal flap is more secure and typically heals
faster and more smoothly. Depending upon the corneal
shape, the suction ring alignment and the microkeratome,
it is possible that a free corneal cap may be
produced which is not hinged to the cornea. Although
the laser treatment can still be performed, if
any irregularities in flap quality or thickness
are noted, the corneal disc is immediately replaced
and allowed to heal. If the free corneal cap is
of excellent quality, then the procedure is completed,
but special care must be taken during the first
24 to 48 hours not to displace or lose the corneal
cap. Loss of the corneal cap may result in scarring,
permanent corneal irregularity and the need for
more invasive surgery. |
| • |
Corneal
perforation is the most serious Custom LASIK complication.
Corneal perforation is prevented by the microkeratome
depth plate, which is checked before each and
every procedure. Some microkeratomes have fixed
corneal depth plates. Perforation of the cornea
requires corneal suturing and the need for an
intraocular lens implant, as the natural lens
is usually lost or damaged. It should be appreciated
that corneal perforation may also potentially
result in infection, the need for a corneal transplant
or, rarely even, blindness. |
| • |
Corneal
flap displacement, partial or complete, occurs
during the early post-operative period, typically
during the first 12 to 24 hours, but may occur
days to weeks later with trauma. Care should be
taken to protect the eyes from trauma, as well
as to avoid rubbing the eyes or forcefully closing
the eyes during the first week following Custom
LASIK. Partial displacement of the corneal flap
may result in corneal striae or wrinkles, which
blurs vision both qualitatively and quantitatively.
Most corneal striae are treatable but some may
be resistant to treatment, especially in highly
nearsighted patients. Complete displacement of
the corneal flap is often painful and requires
urgent replacement. There is a higher risk of
epithelial ingrowth and infection with corneal
flap displacement. |
| • |
Epithelial
ingrowth occurs during the first month following
Custom LASIK and is more likely to occur in patients
with an abnormal or weakly adherent protective
layer, for which age is a factor. Epithelial ingrowth
is produced when epithelial surface cells grow
underneath the corneal flap during the healing
of the corneal flap incision. Epithelial ingrowth
is more common with any trauma or breakdown of
the epithelium, which is more common in Custom
LASIK enhancement procedures and long-term contact
lens wearers. Treatment of this condition involves
lifting the flap and clearing the cells away.
Although most small areas of epithelial ingrowth
need only be monitored, untreated large areas
of epithelial ingrowth may distort vision and
may actually damage the flap integrity if severe
and progressive. |
4. Corneal Healing Complications
The protective corneal flap of Custom LASIK reduces
the healing time of Custom LASIK refractive surgery
compared to PRK, but significant healing is still required
which can affect the quality and vision of the final
result. Corneal healing problems with Custom LASIK are
more likely to be experienced by patients corrected
for higher degrees of nearsightedness, farsightedness
and astigmatism, which may potentially slow visual recovery
and increase the need for enhancement procedures for
over- and under-corrections. Corneal healing may affect
not only the speed of visual recovery but the smoothness
and may produce visual blurring. Rarely, corneal scarring
may be produced with Custom LASIK. The most important
aspect of corneal healing following Custom LASIK or
any other form of refractive surgery is the development
of corneal irregularities which may permanently affect
the quality, crispness and sharpness of the final visual
result. Corneal irregularities, or irregular astigmatism,
are produced when the cornea heals in an irregular pattern,
which may or may not follow a surgical flap complication.
Corneal irregularity may also be produced from abnormalities
and complications of the laser treatment, including
central islands and decentrations which may produce
blurring, shadowing, glare and double vision. Some corneal
irregularity is commonly expected for the first several
weeks following an uncomplicated Custom LASIK procedure.
However, if it persists beyond 6 months it is considered
abnormal and may be permanent. Most corneal irregularity
improves over 6 to 12 months. Some causes of corneal
irregularity may be surgically managed but other causes
are permanent. The greatest limitation of healing problems
is that further surgical intervention does not guarantee
better healing and may in fact result in a further reduction
of visual quality.
Irregular astigmatism from both healing and surgical
complications may result in a loss of best corrected
vision, which means that a patient may be unable to
read the bottom few lines of the eye chart even with
spectacle or contact lens correction. Specifically,
the best vision a patient measures after surgery even
with lens correction may not be as good as the patient
enjoyed before refractive surgery.
In certain cases, the vision may be severely impaired
and affect the ability of a patient to drive legally.
This is most important in patients who already have
reduced visual acuity from other causes. That is, Custom
LASIK is not intended to increase the visual potential
of a patient. Many candidates with high prescriptions
who often are unable to read 20/20 before surgery, even
when corrected with glasses or contacts, should not
expect to read 20/20 after surgery. Furthermore, a patient
who is best corrected before surgery to 20/40 is already
borderline for legal driving and any loss of best corrected
vision from healing or surgical complications may prevent
legal driving.
Corneal healing is very patient specific and plays a
critical role not only in how well a patient recovers
from a surgical flap complication but in how rapidly
and smoothly all patients recover.
5. Other Miscellaneous Complications
It is important to note that it is impossible to list
every conceivable complication that is not listed above.
Risks and complications that are considered to be unforeseeable,
remote or not commonly known are not discussed. In addition,
there may be long-term effects not yet known or anticipated
at the present time. The most severe possible complications
would necessitate more invasive or repeated corneal
surgery, including corneal transplantation, and could
potentially produce partial or complete loss of vision.
SECTION 7: EXPECTATIONS
OF THE PROCEDURE
The goal of Custom LASIK is to achieve the best visual
result the safest way. The goal is not to eliminate
glasses and contacts completely but to dramatically
reduce your dependence upon them in an attempt to help
improve your quality of life. Night driving glasses
and reading glasses may always be needed even when an
excellent visual result is achieved. It is also important
to recognize that even 90% clarity of vision is still
10% blurry and glasses may still be needed for certain
activities that require fine or detailed vision.
Enhancement procedures can be performed when the cornea
is stable unless medically unwise or unsafe. Adequate
corneal tissue must be available to proceed with an
enhancement procedure, and a repeat measurement of the
residual corneal thickness will be taken. Typically
patients considered for an enhance-ment procedure should
have at least 1.00 diopter of residual hyperopia, myopia
or astigmatism or unaided vision of 20/40 or worse.
Enhancement procedures are performed after 1 to 3 months,
once adequate corneal healing and stability is achieved.
Enhancement procedures are typically performed by lifting
the original flap during the first few months before
full healing occurs, or by creating a new corneal flap.
There are always risks which must be balanced against
the benefits of performing further surgery.
Complications are an inherent part of surgery and despite
our best efforts, training and skill, we recognize that
some patients will experience problems. It is simply
our hope to educate you as to what those problems may
be so that you can make an informed decision whether
or not to proceed. No one ever believes that they will
be in the small percentage of people that develops a
significant complication, so it is important for all
candidates to appreciate that there are truly no guarantees.
SECTION 8: TREATMENT
OF ONE OR BOTH EYES
There are both advantages and disadvantages to having
Custom LASIK on both eyes on the same day. The benefits
of surgery on both eyes during the same session begin
with the simple fact that patients often prefer this
option as it is more convenient, with respect to either
work or home life. Patients may also feel that their
vision feels more balanced, with improved depth perception,
and night glare may dissipate more rapidly. Some patients
find they have less anxiety, while others prefer the
safety of treating only one eye at a time to allow visual
recovery of the first eye prior to proceeding with the
second eye.
The primary risks of treating both eyes on the same
day are related to unrecognized surgical complications
or, more commonly, unexpected healing complications,
which can produce either temporary or permanent visual
blurring. Adequate visual recovery from laser vision
correction for activities such as driving, as well as
returning to work, may take 1 day or 1 month, or even
longer in patients who respond abnormally, whether one
or both eyes are treated. If both eyes are treated,
then visual recovery may be prolonged and there is no
way to predict who will take longer to heal. There is
also no opportunity to learn from the healing pattern
of the first eye. If there is an undercorrection or
overcorrection in one eye, this is likely to occur in
both eyes and both eyes will require retreatment. Other
healing complications may also affect both eyes. Most
importantly the risk of infection may result in severe
scarring, corneal transplantation and even complete
loss of vision in both eyes.
Please initial in the appropriate box below and indicate
on the front of the Informed Consent as well.
I would like to have BOTH EYES treated together
I would like to have only my RIGHT EYE treated today
I would like to have only my LEFT EYE treated today
SECTION 9: WRITTEN CONFIRMATION
Please write in your own handwriting the following two
statements to confirm that you have understood and accept
that Custom LASIK is an elective surgical procedure
and, as with all surgical procedures, the result cannot
be guaranteed. That you acknowledge that although vision-threatening
complications are quite rare, it is possible that partial
or complete loss of vision may be produced as a result
of a surgical or healing complication. That the procedure
may not eliminate all of your myopia, hyperopia or astigmatism
and that additional correction with glasses, contact
lenses or further surgery may be required.
I understand that "there are risks and that there are
no guarantees"
I understand that "I may still need to wear glasses"
SECTION 10: VOLUNTARY
CONSENT
Please sign below that you have carefully reviewed this
informed consent document and that you have had an opportunity
to have any questions that you may have had answered.
By signing below you also indicate that you are aware
that Custom LASIK is an elective procedure, that you
do not need to have this procedure and that you understand
your other surgical and non-surgical alternatives for
vision correction.
Custom LASIK represents a new technique utilizing wavefront
technology and corneal topographic information, which
potentially can provide patients with superior visual
results by correcting both prescription data and visual
aberrations within the eye. Custom treatments however
are early in development and therefore it must be recognized
that there can be no guarantee as to their visual outcome
compared to standard LASIK programs or that the visual
results may be worse. There are also no long-term studies
available to determine the side effects of Custom LASIK
and the implications of correcting visual aberrations.
It is believed that having superacuity at distance may
increase the need for reading glasses for near tasks
beyond age 40. While Custom LASIK is believed to be
an advanced form of Laser vision correction with greater
visual outcome potential, there are no guarantees that
this technique will not be harmful. Custom LASIK as
well is still subject to the same surgical and healing
risks associated with standard LASIK outlined in this
informed consent. Finally, it must be understood that
the final visual result with Custom LASIK is always
dependent upon the individual healing of the cornea,
the customized treatment program simply provides the
potential for superior visual results.
| Patient
Full Name: (Print) |
__________________ |
| Patient
Signature: |
__________________ |
| Witness
Full Name: (Print) |
__________________ |
| Witness
Signature: |
__________________ |
| Surgeon
Name: |
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| Surgeon
Signature: |
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| Date
of Procedure: |
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