Download PAtIent consent forM Intralase sBK / WgA sBK

PATIENT CONSENT FORM
Intralase SBK / WGA SBK
(Intralase Sub-Bowman’s Keratomileusis)
Intralase Sub-Bowman’s Keratomileusis (SBK) is a term used to describe a Laser Vision Correction procedure
where a laser creates a thin flap which is used to gain advantages of both Lasik and PRK.
Intended Benefits
•
In the vast majority of cases, Intralase Sub-Bowman’s Keratomileusis (SBK) results in a person’s reduced
dependence on glasses and contact lenses.
Who Is Eligible for the Procedure?
To be eligible for Intralase SBK, you must:
1. Be 18 years of age or older;
2. Not have had a significant change (one diopter) in your glasses or contact lens prescription for the last
twelve (12) months.
Who Is Not Eligible For the Procedure?
Certain conditions may interfere with the healing process or cause additional problems, risks, or complications.
These conditions include, but are not limited to:
1.
2.
3.
4.
5.
6.
7.
8.
Residual, recurrent or active eye disease;
Severe dry eyes;
Uncontrolled diabetes;
Pregnancy and nursing mothers;
Certain rheumatological conditions
(e.g. rheumatoid arthritis, lupus or other autoimmune disorders);
Pacemakers;
Thin cornea;
Flat cornea.
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
If you have or have been advised that you may have any of these conditions, you should discuss them
thoroughly with your surgeon.
Risks and Other Considerations
All surgical procedures, including Intralase SBK, involve risks. Focus Eye Centre cannot promise or guarantee
that the Intralase SBK procedure will be completely effective or make your vision better than it was before
the procedure.
It is unlikely, but possible, that the Intralase SBK procedure or a complication arising from the procedure could
make your vision worse or could injure your cornea or optic nerve. This could result in partial or total blindness,
or could require a corneal transplant. Although it is not possible to list every potential risk or complication
that may result from the procedure, most of the risks commonly associated with Intralase SBK are as follows:
1.FemtoSecond Laser and Flap Complications
During the Intralase SBK procedure, an instrument called a femtosecond laser is used to create a “flap” of
the epithelial and surrounding tissue of the cornea. There are some risks associated with this part of the
procedure. While these risks are extremely rare, complications may occur and include the following:
• The flap may be incomplete, not centered properly, too thin, too thick, uneven or too short resulting
in the laser surgery being cancelled and rescheduled after approximately one month of healing time.
•The flap may not heal well after surgery. The flap may have loose edges, wrinkles, folds or other
defects or may cause irregular astigmatism all of which could result in decreased vision. The thin
flap may be removed to allow new epithelial cells to recover the cornea.
• A small amount of debris or tissue may become trapped under the flap after surgery. The debris can
result from the instruments used, the tear-film oils or from floating material in the eye. The presence of
this debris is monitored after surgery and may need to be removed surgically by irrigating beneath the
flap. In most cases, debris that is left behind is cleared over time by the body’s own cleaning systems.
2. Infection/Drug Reaction and Other Remote Risks
As with any surgical procedure, there is a remote possibility of infection. With the Intralase SBK procedure,
infection on the surface of, or beneath the flap, is a rare event. Infections are managed by the use of
antibiotic eye drops. It may be necessary to lift the flap to culture and treat the infection. If the infection
is not treated and results in significant scarring of the cornea, a partial or complete corneal transplant
may be required to restore vision.
Incidence of infection: 1 in 10,000
3.Discomfort/Increased Light Sensitivity
Many patients experience mild discomfort for 24-48 hours following Intralase SBK, although patients’
reactions range from no discomfort at all to moderate pain. Patients may also experience a burning
and/or scratchy sensation during this time. Some sensitivity to light may exist during the first couple
of days. In rare cases, light sensitivity may persist for a couple of weeks after surgery.
4. Blurry or Fluctuating Vision
Almost all patients experience blurry vision immediately following surgery. This is normal. With Intralase
SBK there is considerable improvement in vision within the first 24 hours after surgery. By one to two days
after surgery most patients can see at least 20/40 and are able to drive. It may take several weeks before
clear, crisp vision is achieved. Small fluctuations in vision may persist up to six months after surgery.
The healing varies from patient to patient.
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
5.Glare/Halos/Starbursts
Even without having Laser Vision Correction, many people experience night glare (haloes, starbursts)
when wearing glasses or contact lenses. Night glare is common immediately following the procedure and
will typically last up to three or four months. Most patients are not affected by the glare and are still able
to drive during this time. In the vast majority of cases, these effects are temporary and will disappear.
Night glare is more likely to occur in patients with high prescriptions and/or large pupils.
Incidence of significant glare: 1 in 100
6.Decreased Night Vision
Up to 25% of patients who are tested for night vision (also known as contrast sensitivity testing) after
Laser Vision Correction have some reduction. Wavefront-guided Laser Vision Correction will reduce
this temporary reduction to less than 5% of patients. However only 2% of patients are aware that there
have been changes to the quality of their night vision and virtually all patients (99.9%) are back to their
normal night vision by six months. Laser Vision Correction improves night vision in up to 15% of patients.
Wavefront has a wider treatment diameter and eliminates imperfections both of which significantly reduce
night driving symptoms.
7.Excessive Corneal Haze
Corneal haze is part of the normal healing process and, when present, gradually subsides with little or
no permanent effect on vision. Corneal haze typically has little or no effect on vision and is usually not
present after six months. Some patients do experience excessive corneal haze and require enhancement
with the laser. This complication is rare with Intralase SBK.
Incidence of serious haze: 1 in 1000
8. Increased Eye Pressure
The steroid eye drops used following Intralase SBK can, on rare occasions, cause increased intraocular
pressure. Typically, intraocular pressure returns to normal, with no long-term effects, once the use of
steroid eye drops have been discontinued. It is important for you to attend your follow-up examinations
so that your eye pressure can be carefully monitored.
Incidence of serious increased eye pressure: 1 in 1000
Although the laser is very precise, individual healing varies considerably. As a result, there is no guarantee
that Intralase SBK will be successful in providing 100% of the desired level of vision correction. The chances
of being under or over corrected increases the higher the initial prescription. In most, but not all cases,
under or over corrections can be treated with drops or, if necessary, with an enhancement procedure.
Enhancement is performed once vision has stabilized usually a minimum of six months after the original
procedure. Corrective lenses may still be required for good vision for certain activities (e.g. long distance
night driving).
Incidence of significant over correction: 1 in 400
Incidence of significant under correction: varies with prescription
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
9.Under Correction/Over Correction
10.Regression
Some patients who have good vision after Laser Vision Correction will show regression some months later.
This is due to thickening of the epithelial and stromal cells (keratocytes) in the cornea and is often caused
by UV exposure, hormone changes (pregnancy) or a debilitating illness. Regression can be treated either
with the use of eye drops or with another laser enhancement.
Incidence of significant regression: 2 in 100
11.Loss of Best-Corrected Vision
Some patients can temporarily lose the ability to read one and very rarely two lines on the eye chart after
Intralase SBK in comparison to their previous best-corrected vision. This loss of vision typically occurs as
a result of microscopic corneal surface irregularities. In some circumstances, an enhancement may partially
or fully restore the patient’s loss of best-corrected vision.
Incidence of loss of best-corrected vision: 1 in 1000
12.Epithelial Ingrowth
Intralase SBK involves the creation of a corneal flap. During the first 24 hours after the procedure, the
protective epithelial layer grows over the edge of the corneal flap. There is a small risk that some epithelial
cells may grow underneath the flap. This is more common in people with weak cell layers which bond
poorly to the eye surface. Any breakdown of the protective epithelial layer during surgery may increase the
incidence of epithelial ingrowth. Treatment involves lifting the flap and clearing away the cells. Untreated
epithelial ingrowth may distort vision and may damage the flap and underlying cornea if severe and
progressive. Small ingrowths do not usually present any visual problems and need only to be monitored.
Epithelial ingrowth is rare with Intralase SBK.
Incidence of Epithelial Ingrowth: 1 in 500
13.Diffuse Lamellar Keratitis or “Sands of the Sahara”
In some cases, Intralase SBK patients experience a temporary condition caused by an inflammatory reaction
between the flap and the corneal bed of the eye. This condition is called “Sands of the Sahara” or Diffuse
Lamellar Keratitis (DLK). This condition is generally treated with a strict regimen of eye drops and close
monitoring. However, the surgeon may feel it is necessary to irrigate underneath the corneal flap.
Incidence of DLK: 1 in 300
With some Lasik patients, the incision to create the flap will destabilize the cornea to the point it will start
to bulge i.e. in a weak car tire. This is referred to as Ectasia. It is almost unheard of with PRK, and although
the SBK process does not destabilize the cornea, there is a very small chance ectasia may occur. If this
happens the patient may require a corneal transplant to restore vision.
Incidence of severe corneal ectasia: 1 in 100,000
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
14.Corneal Ectasia
15.Ischemic Optic Neuropathy
Vascular Occlusion occurs when the suction ring is placed on the eye during the construction of the corneal
flap. The pressure in the eye increases and the patient will notice that the light will dim. When the suction
is off, the vision returns within a few seconds. There is a very rare risk that when the suction is applied to
the eye, permanent damage to the optic nerve can occur resulting in significant and irreplaceable loss of
vision. This condition is known as Ischemic Optic Neuropathy (ION).
Incidence of Ischemic Optic Neuropathy: 1 in 1,000,000
16.Dry Eyes
Dry eye is a common, but generally temporary, condition following Intralase SBK. This can usually be
treated with lubricating eye drops and occasionally with temporary inserts or “plugs” that prevent the
normal drainage of tears into the nose allowing tears to stay on the eye longer. Dry eye generally improves
within a few months after surgery but, in rare cases, can continue for longer periods of time and may
require long-term use of lubricant drops and permanent plugs.
Incidence of significant dry eye: 1 in 100
Monovision
As we age, the crystalline lens of the eye gradually loses its ability to accommodate to nearby objects.
This condition, known as presbyopia, usually begins around the age of 42 and results in the need for bifocals
or reading glasses. With monovision correction, one eye is slightly under corrected to help reading vision.
A small amount of distance sharpness may be sacrificed, possibly requiring night driving glasses. Reading
glasses may still be required for very fine print. However, overall dependence on glasses will be dramatically
reduced. A few patients (approx 0.1%) are unable to adapt to monovision and require an enhancement to
improve the under correction.
I understand and agree to have monovision.
o YES
Patient: Name (Print) o NO
(If yes, please complete this section)
Signature
Date:
Witness: Date:
Doctor: Date:
Name (Print) Name (Print) Signature
Signature
Lifetime Commitment
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
At Focus Eye Centre, we stand behind our results.
Please read the Lifetime Commitment Form for detailed information.
PATIENT CONSENT TO INTRALASE SBK / WGA SBK
1. I have read this consent form.
2. I have been given the opportunity to ask questions.
All of the questions I have asked have been answered
to my satisfaction. I understand how Intralase SBK is
performed and aware of the risks and complications.
3. I understand that:
a. Intralase SBK is an elective procedure. There is
no health or medical reason why I need to have
Intralase SBK.
b. Alternative treatments to Intralase SBK, including
eye glasses and contact lenses, are available.
c. The results of the Intralase SBK procedure vary
from patient to patient and the desired outcome
cannot be guaranteed.
d. Intralase SBK is not risk free. Complications from
the Intralase SBK procedure, as described in this
consent form, are possible. Enhancement may
be necessary but there is no guarantee that
I will be a good candidate for enhancement
or the enhancement will be successful.
e. Adherence to recommended eye drop regimen
and periodic follow-up visits with an eye doctor
after Intralase SBK are required to reduce the
risk of longer-term complications and increase
the likelihood that the desired outcome will be
achieved.
4. I confirm that I am neither pregnant nor a nursing
mother and that I will notify my doctor if I become
pregnant in the three month period following
Intralase SBK. I understand that pregnancy may
affect my healing response and that some medications may pose a risk to an unborn or nursing child.
5. I agree to accept personal financial responsibility for
the payment of all fees related to my Intralase SBK
procedure. These fees must be paid prior to surgery.
I also agree to accept responsibility for the costs of
treatment of unexpected complications if these costs
are not met by public or private health insurance,
including but not limited to, any additional physician
fees, laboratory costs, travel and hotel expenses.
6. I understand that, if at any time prior to my procedure I decide that I do not want to go forward with
the Intralase SBK procedure, I may withdraw my
consent.
Governing Law
I hereby agree that the relationship between myself,
Focus Eye Centre, and my surgeon shall be governed
by and construed in accordance with the laws of the
Province of Ontario.
Jurisdiction
I hereby acknowledge that the treatment will be
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 the treatment. I hereby
agree that I will commence any such legal proceedings
in the Province of Ontario, and only in the Province of
Ontario, and hereby submit to the jurisdiction of the
Courts of the Province of Ontario.
My decision to undergo Intralase SBK has been my
own and has not been made under duress of any kind.
Patient: Name (Print) Signature
Witness: Name (Print) Signature
Date:
Date:
I am a duly licensed eye care professional in good standing. I am knowledgeable about Sub-Bowman’s Keratomileusis (SBK) and its risks and benefits. I have personally discussed the risks with the patient, have given the patient
the opportunity to ask questions, and have answered those questions to the best of my ability.
Name (Print) Signature
Date:
1565 Carling Ave., Suite 110, Ottawa, ON K1Z 8R1 n 1-800-IN-FOCUS (1-800-463-6287) n 613-724-3937 n fax 613-724-6264 n www.focuseye.com
Hotel Dieu Hospital, 166 Brock St., Suite 325, Kingston, ON K7L 5G2 n 1-877-460-6029 n 613-542-5000 n fax 613-544-2632 n www.focuseye.com
C5-3 Rev. 05/11
Doctor: