Microsoft word - 12989-lvi_cat.consent

Informed Consent for Cataract Surgery
Patient Information, Risks & Benefits; Is Cataract
Surgery Right for You ?
Dr. Wandzura and the team at the LAKELAND VISION INSTITUTE
present this information in order to educate you regarding your decision on
whether or not to have cataract surgery.
A clear understanding of the proposed surgery, including risks &
benefits, is part of the medical consent process.

This information is not meant to frighten or alarm you, but rather to educate
you so that you can make an informed decision.
Please review this information at home with your family. Keep this
information in your cataract surgery folder with your other instructions and
documents. If you have any questions or concerns, please contact Dr.
Wandzura’s office @ 306-764-2020 or by email @ [email protected].
We will have a LAKELAND VISION consent form based on this booklet &
a separate VICTORIA HOSPITAL consent form for you to sign at the office
before your surgery is booked.
Thank you for trusting Lakeland Vision, the office of Dr. Wandzura, for
your eye surgery needs. We look forward to serving you.
Section 1: Basic Eye Anatomy

Light enters the eye through the cornea and then passes through the lens.
The lens of the eye works like the lens in a camera. The lens focuses light
from your world onto the retina (the retina is like camera film). The
incoming image is then transmitted by the optic nerve to your brain where
the image is processed, allowing you to “see”.
The lens is made up of protein fibers that are optically clear. The lens fibers
are held in place by a very thin membrane, called the capsule. The capsule in
turn is attached to the eye by very thin “ropes” called the zonules. The lens
sits behind the iris (the colored part of the eye) and the black central hole in
the iris is called the pupil.
When you are young, the lens is clear and you enjoy clear, crisp vision. As
you age, the lens protein fibers harden and become progressively opaque,
which causes the image to become slowly dimmer and less clear.
Section 2: Refractive Errors

A CATARACT is the natural lens of the eye that has become cloudy and
opaque, resulting in reduced vision, clarity and brightness.
PRESBYOPIA, or “old-eye”, means that as humans get older, the natural
lens hardens and cannot focus on near objects as easily. Presbyopia
symptoms (eye strain when reading, blurry objects that are close) start to
occur to people in their mid-40’s (this is why people wear reading glasses or
have to get bifocals in their glasses).
MYOPIA, or “near-sightedness”, means that incoming light is focused too
much, in front of the retina, so that the image is blurry. Myopia is corrected
with glasses or contacts to “push the image back” onto the retina (minus
lenses do this). Incidence of myopia is estimated to be 20 – 25 % of the
world’s population.
HYPEROPIA, or “far-sightedness” means that the incoming light is not
focused enough, and creates a blurry image. Plus lenses in glasses or
contacts “pull the image forward“ onto the retina so that it can be seen.
Incidence of hyperopia is estimated to be 5 - 10 % of the world’s population.
ASTIGMATISM means that the front of the eye (the cornea) is not round in
shape (like a soccer ball or grapefruit cut in half) but rather is shaped more
like a football or watermelon cut in half. Astigmatism can be corrected with
glasses or contact lenses. Up to 70 % of the population has significant (more
than 1 diopter) of astigmatism.
The 4 types of refractive errors are myopia, hyperopia, astigmatism &
presbyopia.

Section 3: Cataract Diagnosis & Testing

Cataracts usually develop slowly in most cases. Many patients are not even
aware that they have cataract. The vision loss is generally slow & insidious.
However, sometimes cataracts can occur rapidly, usually associated with
trauma, steroid medications, diabetes or other genetic or ocular diseases.
The common cataract symptoms & signs are:
 Blurred vision; vision that is “not clear”  Difficulty with bright lights; “glare”  Trouble seeing clearly at night and/or difficulty driving at night  Rings of light around bright lights; “halo”  Multiple images of one object (double, triple or more images)  Complaints of “my glasses don’t work anymore” having to frequently change glasses that work seem to help only temporarily  Dim vision, especially in low light situations  Darkened or reduced color vision, difficulty distinguishing colors When your vision becomes reduced enough that you are having difficulty with activities of daily living, then you are usually referred to an ophthalmologist who specializes in cataract surgery. Cataracts are traditionally diagnosed after a complete eye exam, which does include measurement of visual acuity, contrast and glare acuity if applicable, intraocular pressures & dilated eye exam of the lens and retina. As in all walks of life, technology has significantly advanced the practice of ophthalmology. A complete eye exam is often enough to diagnose cataract, but far more advanced technology is now used and recommended to maximize outcomes and minimize complications. Advanced diagnosis technology includes, but is not limited to: 1. OCT imaging of the retina
a. OCT (Optical Coherent Technology) uses scanning lasers
to measure microscopic structures inside the eye that sometimes cannot be seen with a standard eye exam. OCT evaluates the retina for unsuspected or unseen retinal diseases like macular degeneration, macular holes, macular traction & macular cysts. b. This test is covered by Sask. Health.
2. Determination of intraocular lens (IOL) power
a. The cataract is actually the lens of the eye. Without a
lens, the light cannot be focused and you cannot see. Prior to IOL development, people were left without a lens after cataract removal (called aphakia) and had to suffer with very thick glasses and poor vision. Today the standard of care is a intraocular lens (IOL) in every cataract surgery case, unless unexpected complications have occurred, preventing the placement of the IOL in the eye. b. There are 2 ways to measure the eye, one way is to use
ultrasound measurements and the other way is to use laser measurements. Ultrasound measurements have been used for 30 or more years and are still considered an acceptable standard of care. c. Ultrasound measurement of the eye is covered by
Sask. Health.
d. Laser measurements are a newer & the best way to
measure the eye. The laser measuring machine is called the “ZEISS IOL-MASTER”. The IOL Master test is quicker, easier and operator independent, which means that laser measurments are 10 -20 times more precise and accurate than standard ultrasound measurements. e. LAKELAND VISION is pleased to provide the latest
IOL MASTER 500 series for the benefit of our patients and IOL calculation excellence. f. This test is not insured by SK Health and is optional
but is very HIGHLY recommended if you wish to
have the best refractive results.
g. The data from the ultrasound or IOL Master is then used
in lens calculation formulas to determine which IOL power will be used for each patient. h. Standard formulas are used in cases where IOL
selection is not as critical and are free of charge.
i. One of the world’s leading ophthalmologists has
developed a “Fourth Generation Formula” which is known to provide more accurate and precise calculations, especially in “challenging eyes”, such as very far-sighted or very near-sighted eyes. j. The 4th Generation “Halliday 2 Formula” is used in
combination with IOL Master 500 data. The cost to
use this formula is included in the IOL Master Fee,
and is not insured by SK Health.
3. OCT imaging of the front of the eye
a. This test measures the size, structure and configuration of the front of the eye where the cataract is located. This test is important to detect unsuspected weakness or disturbances in the normal tissue of the eye. b. Complications are more likely when the eye tissues are weak or abnormal in some way. If the surgeon is prepared, complications can be anticipated & risks can be minimized. c. This test is not insured by SK Health and is optional
but is recommended.
4. Corneal topography
a. This test measures the front of the eye called the cornea, in order to detect any corneal diseases or irregularities and to measure the corneal power. The topography results also help the surgeon plan the type & location of the surgical incision during the surgery. b. This test is not insured by SK Health and is optional
but is recommended.
5. Wavefront analysis
a. Wavefront analysis measures the complete optical system
of the patient’s eye. Lakeland Vision Institute is proud to offer the Tomey iTRACE system, a state-of-the–art wavefront analyzer and one of the few such systems in Canada. The wavefront analysis measures higher order aberrations of the eye and is used to optimize the intraocular lens selection for each patient. Using wavefront analysis is like buying a “tailor-made suit”. b. This test is not insured by SK Health and is optional
but is recommended.

After consultation with Dr. Wandzura, the appropriate
additional diagnostic tests will be recommended. Retina
OCT and ultrasound measurements ARE insured
services. Laser measurement of the eye & 4th generation
IOL formula calculations ARE NOT insured but BOTH
ARE highly recommended. Anterior OCT, topography,
wavefront analysis are NOT insured services and are
optional.

Section 4: Benefits of Cataract Surgery
Cataract surgery is the most commonly performed surgery in the world. In
Canada, over 250,000 cataract surgeries are performed annually. Many of
you will know friends or family that have benefitted from cataract removal
with IOL implantation. Clinical outcome studies have shown 95% of
patients experience an improvement in their vision and reported being
satisfied with their visual result.
Cataracts affect your vision and can also impair your normal everyday tasks
called “activities of daily living”. Several studies have shown that reduced
vision also means reduced quality of life. Elderly patients with visual
impairment but are otherwise well are more likely to experience functional
decline. Reduced vision is also associated with reduced independence.
Studies have also shown an association between reduced vision and falls
resulting in hip fractures. Reduced contrast sensitivity that occurs with
cataract formation is associated with decreased driving performance and an
increased risk of accidents. One study has shown reduced vision to have a
greater negative impact on elderly patients than the impact of high blood
pressure, diabetes, acid reflux and even angina.

Section 5: Risks of Cataract Surgery
Physical function, emotional well-being and overall quality of
life can be enhanced when visual function is restored after
cataract surgery. Improved visual function means less risk of
injury, less risk of accidents and reduces overall disability,
especially in the elderly “at-risk” patients.

Cataract surgery is a quick, minimally invasive and successful surgery in the
vast majority of cases.

However, ALL SURGERY HAS RISKS. The overall risk of
complications in cataract surgery is very low, reported at 1 % of all
cases. This means that cataract surgery is actually the safest surgery
that you can ever have.

HOWEVER, THE INCIDENCE OF COMPLICATIONS IS NOT
ZERO.
A guarantee of surgical results is NEVER promised. Complications are
rare, but when they do occur, they are usually unexpected.

Major complications

a. Death is not usually discussed when considering modern
cataract surgery. There is no complication of the surgery itself that would cause mortality, however there could be complications arising from general anaesthesia, for instance. b. Most cataract patients are elderly and many of these patients are
diabetic, may have high blood pressure and/or high cholesterol and other medical health issues. This means that these patients are at risk of higher morbidity & mortality rates based on their overall health status alone. c. Surgery can also invoke stress in different individuals to
different degrees. Patients could suffer heart attack or stroke if they are ill and susceptible to stressors. HOWEVER, IN THIS SITUATION, THESE PATIENTS ARE LIKLEY TO SUFFER THE SAME MORBIDITY AND MORTALITY WITH TIME EVEN IF THEY DO NOT HAVE EYE SURGERY. 2. Post-operative Infectious Endophthalmitis
a. Infectious endopthalmitis means a bacterial or fungal infection in the inside of the eye after cataract surgery. b. This is one of the most serious complications after surgery. c. The bacteria usually come from the patient’s own skin and eyelashes. The most common time for endophthalmitis is day 3 to day 5 after the cataract surgery. d. Fortunately, this complication is very rare, reported in the e. The infection can be treated if caught early and treated aggressively, but despite treatment, up to 50 % of cases have reduced vision or blindness. 3. Suprachoroidal hemorrhage
a. This complication is due to a blood vessel bursting inside the back of the eye during the surgery. This is due to hardening of the arteries combined with blood thinners in most reported cases. b. This complication almost always results in complete blindness. Fortunately, with modern cataract surgery, this complication has become even more rare, reported at 1 in 10,000 to 1 in 50,000 cases. 4. Retinal detachment
a. Eyes that are very near-sighted are at increased risk in the immediate post-operative period, which is commonly said to be the first 6 weeks after surgery. b. Overall incidence is reported to be 1 in 1000 cases, but this risk is for all patients, so the risk in near sighted patients is much higher at 1 in 50. c. Retinal detachments can be repaired with surgery in the majority of cases (75 %) but even with successful repair, some patients do not recover full visual function. 5. Cystoid Macular Edema (CME)
a. This is thought to be the most common complication after b. The incidence of clinical CME (i.e. when the patient notices some visual impairment) is reported to be 1 in 100 to 5 in 100 cases (1 – 5 %). c. The incidence of CME that is not visually significant (i.e. only seen on specialized tests) is much higher, as high as 30 %. d. CME occurs when the body produces a type of chemical (called prostaglandins) after the eye surgery as part of the healing process. Some individuals produce too much prostaglandins chemical after their eye surgery which in turn causes leakage of fluid out of the blood vessels into the center of their retina (called the macula). e. CME is much more common in diabetics or people with previous iritis or pre-existing macular disease (like epiretinal membranes). f. Most of the time, CME will resolve with treatment. However, it is always much better to prevent CME from occurring in the first place if possible. g. CME that does not resolve & becomes chronic will cause permanent central visual blurring (i.e vision that is reported by patient’s as “never sharp”) but CME does not cause complete blindness. h. The incidence of CME is greatly reduced by combining steroid & non-steroid eye drops before, during and after cataract surgery. i. All patients undergoing cataract surgery will be prescribed these drops to minimize the risk of CME. 6. Toxic Anterior Segment Syndrome (TASS)
a. This is a new complication that has just been described in the b. TASS means that the front of the eye develops excessive inflammation like it is infected, but on microbiology tests and samples, no bacteria are ever found. c. TASS tends to occur in isolated outbreaks at different hospitals d. The cause is thought to be any piece of equipment, instrument or surgical product that is contaminated with material that is toxic to the eye (examples reported include silica, metals, endotoxins, sterile contaminants). e. There have been reported outbreaks in Toronto, Vancouver, f. At Victoria Hospital in Prince Albert, as of 2013 there have been NO TASS outbreaks.
7. Dropped or retained cataract nucleus
a. In some patients, the eye tissues are weak from age, trauma or b. If the capsule or zonules are weak, the cataract may not be able to be removed with normal surgical techniques i. Additional surgery to remove the remaining cataract from the back of the eye is required from the retinal service in Saskatoon (called a posterior vitrectomy) ii. The visual results for patients are usually quite good after vitrectomy if the remaining cataract is managed & removed quickly and appropriately c. Anterior segment OCT can help predict this potential problem (see Section 3; paragraph 3a) and the surgeon can take steps to prepare and in some cases prevent this complication by altering the surgical plan i. This is why the additional diagnostic test anterior OCT is 8. Swelling of the Cornea (Corneal edema)
a. Transient swelling of the cornea is common after cataract i. Very dense cataracts, small eyes with little internal space, prolonged surgery time & poor patient co-operation all contribute to post-operative corneal edema b. Corneal edema usually resolves on its own over the first 1 week i. During this time your vision will be “milky or blurry” c. Certain patients have a genetic disease of their cornea, which predisposes them to long-lasting or even permanent corneal edema i. This condition is called Fuch’s Corneal Dystrophy 1. Patients with this condition have a separate consent to read & sign regarding this condition before they can decide and proceed with cataract surgery 9. Dislocated intraocular lens (IOL)
a. The IOL is supported by the remaining capsule & zonules (see i. If the tissues are weak, the IOL can move, tilt or displace ii. The IOL can be repositioned if it is not in the capsule in 1. Will usually occur from brisk rubbing of the eye in iii. In complicated cases, the IOL can move or dislocate 1. Sometimes the IOL can be left alone if vision is stable but extensive IOL repositioning & suture fixation is required if the IOL has moved out of position too much 10. Posterior capsule rupture and/or vitreous loss
a. The capsule of the lens is extremely thin (only 10 – 15 microns i. Surgeons want to preserve the capsule at the time of surgery so there is a place for the IOL to stay ii. A ruptured capsule means the IOL may have to be placed in a secondary location (called the sulcus) or in front of the iris (called an anterior chamber lens) 1. An anterior chamber lens is less ideal (higher risk b. Vitreous loss occurs in cases of posterior capsule rupture or i. Additional surgical steps are required (called anterior vitrectomy) to remove the vitreous from the front of the eye where it does not belong 1. If managed appropriately, visual results after anterior vitrectomy are usually good, unless there is too much tissue damage & instability a. Additional surgical procedures may be
Section 5: Alternatives to Treatment

1. Cataract surgery is almost always an ELECTIVE
procedure, which means that the patient has a choice as to
whether or not to proceed with surgery, based on a review
of the risks & benefits of surgery (the purpose of this
document)

a. Almost everyone will get a cataract if they live long
b. Every patient is different and they must make their own
c. Every eye is different and the surgical risks may be
higher or lower than the average, depending on the case d. The patient is responsible for the final decision, based on
their review of this information combined with the advice and guidance of their surgeon, Dr. Wandzura e. When the patient decides that their vision is
insufficient for their needs AND they wish to see
better, cataract removal with IOL implantation is the
treatment of choice

2. One alternative to surgery is to do nothing & stay as
a. If you have no symptoms and the cataract is early, there
is no need to do anything (“don’t worry about it”) b. However the cataract will not get better with time and
c. Some patients are content to leave things as they are and
d. Everyone has different visual requirements and
3. A second alternative to surgery is to change your
a. Sometimes, changing your glasses will provide some
i. Be aware that the improvement may last only a
short time as the cataract continues to progress ii. Your optometrist generally will not refer you to
consider surgery unless they have already determined that changing your glasses will be of limited help iii. Nevertheless, changing glasses can be an option
for some patients

You must understand that there are risks with any
operation. The only way to avoid all risk is to not have
the operation in the first place !
Section 6: Realistic Expectations
Medical studies have shown that 95 % of cataract surgery patients are happy
with their outcome. We know from the discussion above that the overall
complication rate in cataract surgery is very low at about 1 %.
How is it possible then, that 99 % of people have no operative complications
but only 95 % are satisfied with their surgical result ? This means 4 % of
cases had no complications yet the patient is unsatisfied.
This is due to what doctors call UNREALISTIC EXPECTATIONS. Patients
either have not been told or do not understand the nature and expected
results of the surgery. Dealing with unrealistic expectations prior to surgery
is an important component of the informed consent process.
UNREALISTIC EXPECTATION # 1

Standard cataract surgery is designed to eliminate glasses

a. This is FALSE. Standard cataract surgery is designed to remove the cataract and improve vision WITH new glasses. b. Surgery to eliminate glasses is called REFRACTIVE surgery (various laser types & surgeries involved in refractive surgery is a different topic & is beyond the purpose of this discussion) c. However, with new IOL technology, it is possible to correct some refractive errors at the time of cataract surgery (this is a new field in ophthalmology called cataract-refractive surgery) d. The patients who have no refractive error at all (therefore do i. The incidence of myopia is 20-25 % and hyperopia is 5 – 1. On top of myopia or hyperopia people also have astigmatism in 70 % (see section 2 refractive errors) 2. Therefore the incidence of no refractive error at all e. Therefore with standard cataract surgery, unless something extra is done, 80 – 90 % of patients should expect to wear glasses full time after surgery f. Advanced diagnostic testing with laser eye measurements (IOL Master) can significantly increase the number of eyes that have a reduced refractive error i. This is why the added expense of this test is worthwhile g. Purchasing an “Premium IOL” decided to reduce your refractive error will give you the best result and reduce your dependence on glasses Cataract surgery treats the cataract and is not
performed to eliminate the need for eyeglasses. To
reduce the need for glasses, refractive surgery is
required.
UNREALISTIC EXPECTATION # 2
Cataract surgery will make me see as well as I did when I was young.
a. There is no possible way that surgery can reverse the process of aging and the natural decline that occurs in all living tissues. i. Most people accept that they cannot run as fast, lift ii. The same is true of vision as we age
UNREALISTIC EXPECTATION # 3
I have been told that I have more than one eye disease or problem. I
have poor vision but cataract surgery will fix everything & I will see
perfectly again.

1. This expectation is completely unrealistic and is dangerous to believe. This is one of the most difficult concepts for patients to understand. a. Cataract surgery fixes the cataract only. b. If you have macular degeneration, diabetic eye disease, glaucoma, previous trauma or any other ocular disease as told to you by Dr. WANDZURA, then you cannot reasonably expect to see perfectly again. c. Removing the cataract should, in most cases, improve your i. In some cases, removing the cataract does not help the vision very much or may not even help at all ii. If your disease is severe and if the condition continues to progress, then your vision will continue to worsen despite successful cataract surgery iii. Cataract surgery generally does NOT cause other ocular d. The most common culprit to limit vision after cataract surgery is age-related macular degeneration (ARMD) i. If you have ARMD and also have cataracts, you will have to decide if cataract surgery is even worthwhile 1. Dr Wandzura will tell you how dense the cataract is and if removing the cataract is expected to help you a lot, help you somewhat or may not help at all ii. ARMD and any other eye disease (ocular co-morbidity) will be discussed with you and the separate applicable consent form signed prior to surgery Standard cataract surgery will NOT replace glasses in most
cases, will NOT make you see like you were young again &
will NOT cure all of your eye problems
Section 7: Special High Risk Situations in Cataract
Surgery

There are several important eye conditions or “ocular co-morbities” that are
associated with a higher risk for complications. These are:
a. These eyes often have denser cataracts, pupils that do not dilate well and possible weak zonule support (see complications section) a. Surgical access to the eye is more difficult a. Technically more difficult and takes longer (increased risk of a. These eyes are usually very small and difficult to work in as a. The opposite problem as (d), these eyes are unusually large and b. Highest risk of retinal detachment is found here a. Regardless of the previous surgery, there is increased risks of unexpected tissue weakness, bleeding and/or inflammation a. Very difficult to see the cataract and to remove the cataract a. Called synechiae, usually from previous iritis a. Technically more difficult as the surgeon cannot see well a. Although usually associated with pseudoexfoliation syndrome (see (a) above), weak or absent zonules can occur after trauma or in very old eyes i. May not be detectable until surgery is already underway a. This medication is called a alpha-1 antagonist medication b. Most commonly it is given to males with enlarged prostates in c. Sometimes women can be given Flomax to help pass kidney d. This medication binds the muscle inside your iris even after one e. During surgery, the iris will contract, flop around and want to i. Extra anaesthetic & a special technique (Malyugin Ring technique) is used by Dr Wandzura to manage this problem safely f. You must let us know if you have EVER taken Flomax Be sure to report any previous Flomax use and previous eye
injury or eye surgery to Dr. Wandzura BEFORE you have
cataract surgery

Section 8: Anaesthetic Choices
There are 3 ways to provide anaesthesia for cataract patients so that their
experience is reasonably comfortable and more importantly, so that the
patient can co-operate enough to allow safe, quick and successful cataract surgery. a. Also known as “just drops” (no needle) technique b. 80 % of Dr Wandzura’s cataract cases are good topical c. These patients must be able to lie on their back, relatively still and stare at a very bright light (from the operating microscope) d. These patients will feel pressure, water and intermittent sensations, but generally are reporting minimal discomfort during surgery e. No risk of eye injury; patients will feel more during and a. 25 % of cases, usually patients that are very nervous, cannot hold their eye still or have other ocular co-morbidity or other high risk situations b. Similar to a dentist freezing a tooth, an injectable anaesthetic is given in the lower eyelid which then spreads out behind the eye in the fatty tissues c. The needle is NOT in the eye d. Eye muscles are paralyzed so the eye cannot move and vision is black so the bright light is not bothersome e. Surgical co-operation is better as the patient does not have to hold eye still, just lie flat and relax f. Patient generally feels less once the freezing is done g. Intravenous sedation is usually given before the injection h. Risks of local anaesthetic are rare but the risks are also i. If the injection is given too close to the eye, the eye can be perforated with resulting blindness ii. If the injection affects the muscles around the eye, iii. If a blood vessel breaks due to the injection needle, a blood clot can form behind the eye which can compress the optic nerve and result in blindness a. The least common type, only 5 % of cases b. Usually the very young or mentally challenged cases that c. Can include patients who cannot hold their eye still but d. Most comfortable for patient, easiest for surgeon as well e. Usually BOTH eyes are done at same time to avoid 2 f. Takes more time, hosopital not as efficient g. Main risk is most serious complication of all, not waking Section 9: Conclusion

After review of this document, you should feel informed and confident about
your decision to proceed with cataract surgery. Any questions that you may
should be asked BEFORE your surgery. If you do not understand something
in this document, be sure to ASK Dr. Wandzura and his staff for an
explanation.
If you do NOT wish to proceed with cataract surgery due to your new
understanding of the procedure and associated risks, or for any other reason,
then we are also pleased to have helped you make an informed decision and
we respect the decision that is right for you. Be sure to go over this
information with your spouse and family. Educating your family will help
them be better prepared when it is their turn to consider cataract surgery in
their own lives.
Cataract surgery is very rewarding for both patients and surgeon alike. We
love hearing stories from our patients about how cataract surgery has helped
them to see better and to enjoy their lives more fully. Educated and prepared
patients are better able to accept and deal with complications appropriately if
any complications happen to occur in their case. The majority of
complications can be dealt with satisfactorily with time, medication and
additional surgical procedures.
Thank you for taking the time to read through and more importantly
understand the procedure that you are considering. If you wish to proceed,
please initial each page, indicating that you have read & understood the
contents and then we will prepare the appropriate consent forms for you to sign and book your surgery accordingly.

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