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Introduction Photorefractive Keratectorny (PRK) and Laser Assisted In Situ Keratomileusis (LASIK) are surgical laser procedures to correct myopia, hyperopia and astigmatism. This consent form describes tile various surgical procedures available, as well as the possible risks and benefits. The material is provided to help you make an informed decision on whether to proceed with refractive surgery. This information accompanies, but does not replace discussions with the doctors and staff of Lasik Vision Canada Inc. You are encouraged to ask questions about the procedure itself tiile risks, possible side effects and benefits as well as alternative treatments. The Normal eye, Myopia, Hyperopia and Astigmatism The cornea is the clear, dome-shaped window that forms the front wall of the eye. It acts as a lens to focus incoming light rays on to the retina, the lightsensitive tissue in the back of the eye. In the normal eye light rays are brought to a single sharp focus directly on the retina, resulting in clear vision without glasses or contact lenses. Any deviation from this normal focusing is called a refractive error. Myopia, hyperopia and astigmatism are common refractive errors In myopia, or nearsightedness, the eye is longer than normal. The light rays come together at a point in front of the retina, and thus are out of focus on the retina. Distant objects appear blurry, whereas near objects may be seen clearly. In hyperopia, or farsightedness, the eye is shorter than normal The light rays come together at a point behind the retinal and thus are out of focus on the retina. Near objects may appear blurry whereas distant objects may be seen more clearly. In astigmatism the curvature of the cornea (and therefore its focusing power) is not the same in the horizontal and vertical directions. Light rays entering the eye do not focus at a single point caugnp distorted vision. Many people with myopia or hyperopia have some degree of astigmatism. Traditional Correction of Refractive Errors Eyeglasses remain the most common method of correcting vision, Glasses are safe, relatively inexpensive, and usually well tolerated. To correct large refractive errors, glasses must be thick and may reduce or increase the size of the visual image by up to 25%. Contact lenses rest directly on the cornea. If fitted and used properly, they are effective and relatively safe. However, complications such as allergic reactions, infections, and mechanical injury to the cornea can sometimes occur with the use of hard or soft contact lenses. Radial Keratotomy (RK) was pioneered in Russia and brought to North America in 1979. Deep radial cuts like the spokes of a wheel, (90% of corneal thickness), are made in the cornea. These incisions cause the peripheral cornea to bulge and the central cornea to flatten thus correcting myopia and astigmatism. The Excimer Laser The Excimer laser reshapes the front surface of the cornea. This laser was developed by IBM in the early I980's to etch silicone chips. It was subsequently discovered that the laser could be used to cleanly and precisely remove Uving tissue. The laser's high-energy ultraviolet light pulses break molecular bonds, but do not heat or damage the surrounding tissue. A thin layer of tissue is removed with each pulse. A computerized shutter controls the distribution of laser pulses on the cornea. With multiple laser pulses, the central cornea can be sculpted, changing its curvature and power. Clinical treatment of sighted eyes was initiated in 1988 Clinical excimer lasers are very complicated and sensitive instruments requiring careful calibration, monitoring of energy output and regular maintenance. Photorefractive Kerrtectomy (PRK) After the eye has been anesthetized with eye drops, the surgeon removes the front surface of the cornea (the epithelium). The excimer laser is then used to sculpt a new shape onto the front surface of the cornea. It is this new surface that corrects the refractive error. Following PRK, the epithelium repairs itself growing back from the edges until it surfaces the front of the cornea. Over a period of months following the procedure the epithelium attempts to "remodel" itself. Therefore, eye drops are used for a period of approximately three months following PRK in an effort to control the remodeling process. Laser Assisted In Situ Keratomlleuds (LASIK) LASIK uses a microkeratome to create an incisional flap on the front surface of the cornea. This flap is then raised and the excimer laser is applied to the exposed cornea to create a new refractive surface. The flap is then repositioned to its original site, covering the previously exposed cornea. Mechanical, biological, and hydrostatic forces hold the flap in place without the use of stitches. Patient Selection Laser refractive surgery is appropriate for patients with myopia, hyperopia and/or astigmatism who wish to have less dependence on glasses or contact lenses, and are willing to assume the risks associated with the procedure. Minimum age is 18 years. There should be no significant change in the glasses or contact lens prescription for the previous twelve months. Patients pay for refractive surgery, as insurance or Medicare does not cover it. Some reasons for not proceeding with refractive surgery are: 1. 2. 3. 4. 5. 6. Eye inflammation or infection Excessive corneal scarring Degenerative disease of the cornea Uncontrolled diabetes Use of drugs, which may interfere with the healing process Pregnancy Patients with presbyopia (the need for reading glasses) should understand that refractive surgery would not affect this age-related process. The Operation Soft contact lenses must not be worn for at least 7 days prior to the surgery (a minimum of 3 weeks for hard or gas permeable lenses). The operation is performed as an outpatient procedure by fully qualified eye surgeons licensed to practice in British Columbia at Lasik Vision Canada Inc. Eye drops are given before treatment; this provides suitable anesthesia. The patient is positioned under the operating microscope. The eyelids are gently held open with a lid speculum. PRK: The doctor will use a sterile instrument or the laser to gently remove the surface layer (epithelium) of the cornea. Laser energy is then delivered to reshape the cornea while the patient fixates on a light within the microscope. LASIK: The doctor applies a sterile suction ring to the eye. This is not painful, but some pressure may be felt. An instrument, known as a microkeratome, is then used to create a flap in the outer layer of cornea tissue. After removing the microkeratome and suction ring, the doctor positions the flap to one side - it remains attached to the eye. The excimer laser is used to reshape the cornea while the patient fixates on a light within the microscope. Following Surgery: PRK: A soft contact lens is placed on the cornea in order to protect the eye and keep it comfortable while promoting surface healing. Over the next three to five days, until the contact lens is removed, eye drops will be used on a regular basis. Vision will be blurry during this period. Once the contact lens has been removed, different eye drops are to be used over the net few months. Vision will gradually improve. Stable vision is usually achieved within one to three months. LASIK: The flap is repositioned and holds itself in place through natural forces. No contact lens is used Eye drops me applied on a regular basis and clear plastic eye shields are worn at night only to prevent the patient from rubbing their eyes. Drops are used for one to two weeks after surgery. Stable vision is usually achieved in two to four weeks. Benefits of Refractive Surgery In most cases, vision improves enough to allow a person to function without eyeglasses or contact lenses. Corrective lenses may still be required for activities such as driving and reading. In addition to the visual improvement, you may also experience psychological and functional benefits Risks of Refractive Surgery No surgical procedure is completely free of risk. It is not possible to list every complication that can occur, and there may be adverse reactions, which are unknown at this time. Since glasses or contact Ienses are currently available and are generally safe, you need to thoroughly consider the risks versus the potential benefits of having PRK or LASIK. Risks Specific to PRK 1. Delayed epithelial healing and infection. The surface epithelium is removed just prior to the laser surgery. This layer of the cornea usually heals within three to four days, but there may be a delay in the process - associated with more pain and increased risk of infection. 2. Microscopic corneal surface irregularities. PRK can cause microscopic corneal surface irregularities and slight loss of best-corrected vision 1 to 2% of patients may loose up to two lines of vision on the eye chart. 3. Excessive corneal haze. Corneal haze occurs as part of the normal healing process. The haze peaks at six to ten weeks and then gradually subsides over several months. In most cases, it has little or no effect on the final vision and can only be seen with a microscope. However, there have been reported cases of excessive haze, which ultimately require the patient to be retreated. Retreatments for haze have been successful, but on rare occasions this risk factor has caused some permanent decreased vision. 4. Regression. In some patients, the effect of surgery is gradually lost over several months. Such regression is more common in patients who are very nearsighted (-6 diopters). In virtually all cases, this can be retreated. Risks Specific to LASIK 1. Faulty or improperly created flap. The flap may be too thin, too thick or uneven There is a small risk of the 'hinge' of the flap being cut. The flap may move or wrinkle post-operatively. Rubbing the eye may cause the flap to move or wrinkle after surgery. This may result in some permanent reduction in bestcorrected vision. 3. Epithelium or debris under the flap. A small amount of debris under the flap does not affect your vision. If necessary, the flap can be lifted and the debris removed. 4. lnfection under the flap. This is very rare. Medications treat this complication. However, scarring may occur. Risks Associated with PRK and LASIK 1. Under or over correction. If the desired corrections not achieved, glasses may still be necessary for good vision. Significant over or under corrections can be retreated. 2. Halo effect. Halo is an optical effect that is noticed in dim light. As the pupil enlarges the untreated peripheral cornea produces a second faded image. Some patients who have undergone refractive surgery notice this effect while driving at night. Halos occur less frequently with the larger treatment zones being used today. 3. Decentration. Significant Decentration of the zone of treatment (the laser beam not centered on the pupil) can occur. Halo and blurry vision can result. 4. Inconvenience between surgeries. In the time between surgery on the first and second eye, the two eyes may not work well together because of their temporary difference in refraction (spectacle correction). If a contact lens is not tolerated on the un-operated eye, work and driving may be difficult until the second eye has had refractive surgery. 5. Presbyopia and reading glasses. As a person grows older, the lens of the eye is less able to focus and near vision becomes more difficult. This is a normal aging process called presbyopia, a condition that can be alleviated with reading glasses or bifocal lenses. An advantage of being myopic (nearsighted) is that it generally takes longer to be affected by presbyopia. After laser surgery, a patient over the age of 40 may require reading glasses to see find print. 6. Remote risks. As with any eye surgery, there is a remote possibility of severe infection, corneal perforation, drug reaction, or other rare complications that could cause eye problems. 7. Raised eye pressure. Transient elevation of intraocular pressure. However, monitoring eye pressure is a routine part of the follow-up care. 8. Delayed recovery of best-corrected visual acuity (BCVA). It may take several months for full recovery of BCVA to occur following refractive surgery. This is due to healing and/or haze of the cornea. With the passage of time, the BCVA gradually improves and returns to its original pre-operative level. However, further treatment may be necessary if the best- corrected vision is not fully restored. Frequently Asked Questions Regarding PRK & LASIK How many patients have you treated at your clinic in Vancouver? The Vancouver clinic has been responsible for the treatment of over 8,000 eyes to date. These outcomes have been presented at all major Canadian and US Ophthalmology seminars for peer review. How is the surgery performed? The Excimer laser performs the treatment n7e cool light 6 the laser beam vaporizes corneal tissue, reshaping the surface and enabling the patient to see clearly without the need for glasses or contact lenses. The anesthetic is administered by eye drops; there are no needles involved. What kind of laser is it? LASIK and PRK are performed with a Nidek Excimer laser, 3" generation, It is state oft he art equipment. How long does the Procedure take? The actual surgery takes only minutes, but the amount of time the laser is active on the eye is just seconds. Preoperative examination and preparation for surgery is done in the clinic on the day of treatment and takes approximately I hour prior to surgery time. Can I drive immediately after surgery? On the day of your surgery, we recommend that you have someone with you or make alternate transportation plans, as you will not be driving for the first few days. It is recommended that you wait four days to one week before driving, longer if you are still experiencing blurred vision. Does it hurt? The procedure itself is painless. With LASIK, there may be some discomfort or irritation for up to 24 hours after surgery. With PRK you may experience irritation for one week or more after surgery. We provide pain relief medication in drop form to help eliminate any discomfort. What are the risks? No surgical procedure is completely free of risk it is not possible to list every complication that can occur, and there may be adverse reactions, which are unknown at this time. You as the patient need to thoroughly consider the risks versus the potential benefits of having PRK or LASIK. Infection: Light Sensitivity: Visual Acuity: others. Post-op drops reduce risk. This may occur in the first month (if at all) after surgery and can be alleviated by wearing sunglasses. Vision might be clearer at certain times of the day than at This is not a permanent condition, Undercorrection: Your eye may retain some degree of myopia during the healing process. This can be treated with an additional laser procedure (free of charge to the patient). Corneal Haze: Haze is uncommon with our new scanning laser. Unlike RK, there are no cut made in the cornea therefore scarring is minimal. If one is vigilant using the medication in the drop regimen, the risk is even less. If a small amount of haze were to occur, it can be treated with an additional laser procedure some months later. Delayed Epithelial Healing: With PRK, the surface epithelium is removed prior to surgery. This layer of the cornea usually heals within three to four days, but there may be a delay in the process - associated with irritation and risk of infection, which can be alleviated with medication. How long will it take to return to normal activity level (work)? The patient will have functional vision within the first 24 to 48 hours after the operation (with LASIK), however temporary blurred vision is common. We suggest that the patient take four to five days off work and will be unable to drive for approximately 3 days after surgery. Functional vision with the PRK procedure is normally present within a one to two week period What are the difference between LASIK and PRK? LASIK heals much quicker and usually provides comfort and vision within a 12 to 24 hour period after surgery. It is a more intense procedure for the patient, as a suction ring is applied to the eye creating pressure for a few seconds. The complication rate is probably lower than that of PRK. Less medication, virtually no haze, less down time for the patient), but if a complication were to occur with the flap it may be more serious than the complications of PRK alone. PRK is a less intense surgical procedure and has been very widely carried out for more than 9 years and is therefore clinically proven It requires a contact bandage lens on the eye for approximately five days while the corneal layer heals. Healing time with PRK can be 3 months or more and a drop regimen of 3 months is required If retreatment is needed the whole process is repeated. Is it guaranteed? No surgical procedure can be guaranteed, but our patients have achieved excellent results. The outcome depends on the degree of nearsightedness preoperativeiy. Initially most patients achieve 20/40 vision or better with one treatment, even with the greatest refractive error. Should you need an additional treatment, it will be covered by the clinic at no extra cost. Can I correct both eyes at once? Yes, the surgery performed in our clinic is a bi-lateral (both eyes) procedure. Having your eyes done at different times only extends the healing time and more post-op appointments are required. Most patients find it more convenient to have both eyes treated at the same time, however, if a patient requests to have them done separately that certainly can be accommodated. What happens after surgery? We see each patient the day after surgery. There are then 3 post-operative examinations starting with 1 week from their surgery date, 1-month and 3 months. The purpose of these appointments is to check the healing process of the eyes. Should any complications arise, they can be quickly addressed. What if am travelling from out of town? One of our counselors will have booked your surgery date and your surgical confirmation package will be forwarded to you. This package includes important information regarding your surgery as well as hotel referrals and a map. You may have your pre eye-exam in our clinic or you may choose to have that with your own optometrist (if you choose to do that, you or your optometrist will have to fax the results of your eye exam to the clinic). You will be required to be in our clinic on the day of your surgery, as well as the following morning for the first post-op exam, after that you are free to travel home. What will happen to my eyesight in the future? Will it get worse again? PRK and LASIK do correct myopia and astigmatism permanently. However some patients need a retreatment due to individual healing and initial corrections. For those with high prescriptions the chance of needing a retreatment is greater. Studies over the past ten years show that the result of the surgery will not lose its effectiveness over time. One thing we cannot correct is the need for reading glasses (presbyopia), as this condition affects the lens inside the eye and is part of the natural aging process. This procedure does not change the normal course of nature. Should you be genetically predisposed to cataracts or glaucoma, this procedure neither promotes nor deters when this would normally happen. The same applies should your eye physically change (nothing to do With the surgery), leaving you somewhat more myopic. How do I choose a surgeon and a facility? The more experienced the surgeon, the more knowledgeable he/she will be about preventing and managing any complications. Generally, the complication rate of a large volume surgical practice is lower than the complication rate of a low volume clinic. At this facility more than 8,000 laser refractive procedures and over 10,000 cataract surgical procedures have been completed. Staff at LASIK Vision Canada are highly trained professionals and are experienced in all aspects of these surgeries. They will be able to answer all your questions and concerns before, during, and after your procedure. We are available for emergency calls post-operatively if required. What is the cost of PRK and LASIK procedures? The regular cost these procedures is $2,950.00 (CDN) and $1,950.00 (US) for a bilateral procedure. There is no tax on this amount procedure and it may be tax deductible for some patients. Travel and accommodations for "out of town" patients are their own responsibility, however the clinic can supply you with hotel referrals at corporate rates. Thank you for your recent inquiry regarding laser vision correction with LASIK Vision Canada. We are delighted that you are seeking further information regarding this life changing procedure! Our Fees: Canadian Patients $2,950.00 both eyes US Patients $1,950.00 US both eyes Canadian Corporate rate $2,450.00 both eyes US Corporate rate $1,450.0qUS botheyes Services Included: A free-screening consultation, complete pre-eye examination to deem candidacy for the procedure, the surgical procedure and post-operative visits at 24 hours, 1 week, 1 month, and 3 months. Should the patient choose to have their pre and/or post-operative exams with their own optometrist, they would have to incur the cost of those visits. The 24-hour post-op appointment is mandatory at LASIK Vision Canada. If an enhancement procedure is required, LASIK Vision Canada honors a lifetime warranty for services performed. Enhancement procedures are provided at no extra charge. Payment Options: We offer the following payment options: 1. Cash, certified cheque or bank draft 2. Debit card: Interac bank machine card 3. Major credit cards: Visa, MasterCard, American Express 4. Financing - Payment Plan (Canadian Citizens only). This is available through Citizens Bank or Toronto Dominion Bank. The patient must call to request a financing packet be sent to them. Prior approval is required. Authorization for financing must be received in the clinic one WPPk nnnr tn surgery day. PN day "--~- r'--~ ~- --' --i. day · ~`75~' Please note a non-refundable deposit of $300 is required at the time of booking each surgery. This deposit is only refundable if tl_l~l`fie~~PStdcSm~i~ not a good candidate for medical reasons.