~ 1 ~ CLINIQUE LASERVUE. Informed Consent Form for LASIK

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Doreen Carson
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1 ~ 1 ~ CLINIQUE LASERVUE Informed Consent Form for LASIK Please read the following information and consent form very carefully. Your initials indicate that you understand all of the necessary patient information on LASIK. Please do not sign this form unless you read and understand each page. INTRODUCTION: With this consent form, which is given to you during the consultation process, we wish to fully inform you about LASIK surgery. This consent form reflects the vast experience of Laservue s surgeons (over 100,000 LASIK procedures as of July 2014). The vast majority of our patients are very pleased with the improvement they achieve. Complications are extremely rare. It is our intention to accurately explain this procedure so that you may make a truly informed choice on whether to proceed with LASIK surgery. Our clinic is constantly updating its technologies so as to offer our patients the most advanced procedures and treatments available under the regulations of Health Canada. BLADELESS LASIK: Lasik involves 2 main steps: 1) FLAP CREATION: In the first, a flap of corneal tissue is created by a femtosecond laser (bladeless lasik). 2) EXCIMER LASER TREATMENT: In the second step, once the flap has been lifted, the 2 nd laser reshapes the curvature of the underlying cornea to reduce or eliminate the need for glasses or contact lenses in cases of myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (ovalness). After surgery, the flap is held into position through an almost immediate suction (vacuum) within the cornea. The outer protective layer (epithelium) then envelops the surface within hours. The eye will feel scratchy for 4-6 hours after surgery. It may be light sensitive for 24 hours.

2 ~ 2 ~ ALTERNATIVE TREATMENTS: Patients must have rejected alternatives to LASIK, which include: 1) having no surgery 2) glasses 3) contact lenses 4) other refractive procedures if Lasik is not indicated (example PRK or intraocular lens) CONTRA-INDICATIONS: The treatment should not be performed on persons with: Residual, recurrent, or active eye disease (keratoconus, unstable glaucoma, cataract, etc ) Progressive myopia or hyperopia uncontrolled autoimmune disease (lupus, rheumatoid arthritis) unstable diabetes immunodeficiency as a result of disease (e.g. AIDS) or chemotherapy treatment for acne with Accutane (Isotretinoin) chronic pain syndrome (e.g. fibromyalgia) If you know that you have any of these conditions, you should inform your physician. COST OF THE PROCEDURE: The cost is divided into 2 components: the surgical fee, and the fees for pre- and postoperative care. The total fees due to Laservue are payable on the day of surgery. The fees for postoperative care cover all visits related to your surgery for a period of 2 years but not for subsequent routine eye exams. FOLLOW-UP EXAMINATIONS: Patients must return for follow-up at 1 day, 1 month, and 6-9 months, following LASIK. A patient may be required to return more frequently if medically necessary. All patients are to understand and accept the fact that if an enhancement is needed (2.5%), they may be required to return or stay longer in Montreal. The additional travel and hotel costs associated with enhancements are not covered by Laservue.

3 ~ 3 ~ PLANNING YOUR SURGERY: BILATERAL SURGERY: (Surgery on both eyes in the same treatment session) Bilateral surgery is convenient, and the balance between your eyes is restored more quickly. The vast majority of patients can drive their car on the following day. The only possible disadvantage of having bilateral surgery is that if a serious infection or inflammation occurs, it could occur in both eyes. A rare inflammation or infection in both eyes may cause a decrease of vision in both eyes at the same time. This has occurred in 2 cases out of 100,000 at Laservue. Both patients were successfully treated with eyedrops and had no lasting reduction of vision. Fortunately, this happens so rarely after LASIK that over 99% of our patients choose to have bilateral surgery. MONOVISION: (One eye for distance and one eye for near) Everyone after the age of 40 experiences presbyopia, resulting in the need for reading glasses or bifocals. In monovision, the aim is to have the non-dominant eye focused slightly up close to help reading vision. Monovision helps with simple near tasks such as opening mail, reading price tags, or looking at one s wristwatch. The overall dependence on glasses is dramatically reduced. The downside however is that monovision involves giving up some distance sharpness. Night driving glasses are more common, and readers may still be required for fine print or prolonged reading. Patients, who desire the best distance vision unaided, such as golfers, or patients who don t want to wear glasses for driving, should avoid monovision. Finally, not all people can adapt to monovision. In our experience, we will only attempt a monovision correction if the patient has successfully tried it in contact lenses before surgery.

4 ~ 4 ~ PATIENT EXPECTATIONS: The goal of the procedure is to achieve the best visual results in the safest way possible. Over 99% of patients are able to function without glasses or contact lenses. In other words, complete freedom from distance glasses cannot be guaranteed. Additional procedures, glasses or contact lenses may be required to achieve adequate vision in rare cases. Lasik does not correct the condition known as presbyopia (aging of the eye), which occurs in most people after the age of 40 and requires them to wear reading glasses for close-up work. If you presently need reading glasses, you will likely still need them after this treatment. If you do not need reading glasses and are over age 40, you will need them later on. Lasik surgery will not prevent you from developing naturally occurring eye problems such as glaucoma, cataracts, or retinal degeneration or detachment. For some patients with higher prescriptions (eg 5 to 10), LASIK surgery will dramatically improve their quality of life by reducing their dependence on glasses or contact lenses. However, night driving glasses may still be needed. RETREATMENTS: Enhancement LASIK surgeries are performed in 2.5% of patients. We prefer to wait 4-6 months after the first surgery. We do not usually perform retreatments before 4 months post-op. In order to perform an enhancement surgery, there must be adequate corneal tissue remaining. This is determined by measuring the thickness of your cornea before the initial Lasik surgery. In the rare case that there is inadequate tissue, you will be told in your consultation before surgery that it may not be possible to later perform an enhancement.

5 ~ 5 ~ SIDE EFFECTS: Side effects are symptoms that are commonly experienced after surgery which do not affect its outcome. 1) DISCOMFORT AFTER SURGERY: Your eyes will feel scratchy and irritated for 4-6 hours. This is why we ask you to blink your eyes often for 6 hours after surgery this helps to lubricate the eyes. 2) DRY EYES: Many patients have LASIK surgery because they have developed dry eyes and can no longer tolerate their contact lenses. This symptom is often worse after surgery and may require lubricating eye drops for several weeks. 3) NIGHT GLARE AND/OR HALOS: Most patients with high prescriptions already experience some degree of night glare, especially if they have large pupils. As the LASIK flap heals, the mild swelling may cause some halos at night or a few weeks. This symptom does not limit your functionality and will gradually clear within 2-8 weeks in almost all cases. Typically, 6 months after surgery, less than 1% of patients still experience night glare which can affect night driving. Patients with large pupils and severe myopia are more prone to experiencing night glare. The HD (High Definition) treatment significantly decreases the potential of night glare. 4) SENSITIVITY TO LIGHT is common for a few days. In less than 1/1000 cases, this sensitivity requires steroid eye drops for several weeks. 5) NEURALGIA: There have been very rare reports world-wide of a chronic neuralgia-like eye discomfort after Lasik, usually requiring pain medication. The cause is not known, but it is believed to be related to hypersensitivity of the nerves in the cornea. We have only seen one such case. COMPLICATIONS: Visual potential is the level of vision an eye can achieve with the best possible optical correction. Patients who do not see 20/20 or 100% with glasses or contact lenses before surgery cannot expect or anticipate 100% vision after surgery. On the other hand, the visual potential will improve by one or two lines in 60% of cases after HD (High Definition) Lasik. In other words, the vision may reach a better visual potential than was possible with glasses or contact lenses before surgery. A complication is an event that affects the visual potential of the eye.

6 ~ 6 ~ THE LIST BELOW COVERS THE KNOWN CAUSES FOR A LOSS OF VISUAL POTENTIAL. NO ONE HAS EVER GONE BLIND FROM LASIK SURGERY. THE FOLLOWING LIST IS DERIVED FROM LASERVUE S EXPERIENCE OF OVER 100,000 CASES OF LASIK AS OF JULY The risk of infection is extremely rare (1/20,000) with LASIK. The risk of infection is much higher with the simple use of contact lenses. 2. Inflammation in the flap interface can occur rarely. It usually resolves within 3-4 days. In 1 in 1000 of cases the inflammation is more severe and requires antiinflammatory eye drops and close follow-up. In extremely rare cases, a serious inflammation results in corneal scarring or corneal haze, this can cause a reduction of 1-2 lines of vision on the eye chart. At Laservue this has happened in 1 in 10,000 eyes that have had LASIK. No permanent reduction of vision occurred. 3. A corneal flap complication can occur at the time of surgery or during the first few days after: in 1/10,000 cases, the flap may be too thin or too small for a laser treatment, in which case the laser application may have to be delayed for at least 6 months. The visual potential is not affected by this. during the first 24 hours of healing, in 1/5,000 cases, it is possible for the flap to develop folds which can affect the visual potential. These will require a re-lifting of the flap to smooth them out. 4. Epithelial ingrowth: In rare instances (1 in 10,000) the surface epithelial cells may grow underneath the flap. This is more common in people with an epithelial layer which bonds poorly to the eye surface. Small ingrowths do not present any visual problems and do not require any treatment. 5. Progressive deformation of the cornea (ectasia) is a very rare condition seen in 1 in 10,000 cases, which can cause astigmatism and reduction of visual potential.

7 ~ 7 ~ PATIENT CONSENT: 1. I understand the basic nature, the possible side effects and risks of the LASIK procedure. All of my questions have been answered to my satisfaction, and I have been provided ample time to review and understand the contents of this informed consent document. 2. I understand that as with any form of surgery, the outcome can never be guaranteed. I specifically understand that the benefits of LASIK also cannot be guaranteed. There is no guarantee of perfect vision. I understand that the correction obtained may not eliminate all of my myopia, hyperopia and astigmatism and that additional correction with glasses, contact lenses or further surgery may be needed in rare cases. I understand that Laservue is not responsible for any costs associated with the subsequent need for glasses or contact lenses. In the case of an incomplete correction, I understand that there is a 10% risk that I will no longer be able to wear contact lenses after surgery. I understand that I may not achieve the level or quality of vision I hope for. 3. I understand that as a result of laser surgery, there is a small risk that my vision may be made worse. I understand that I may be one of the less than 1/10,000 of people that may have a complication. Examples of such include: infection, inflammation of the flap interface, corneal flap complications, epithelial ingrowth, and ectasia. 4. I understand that there are extremely rare or theoretical complications that have never yet happened at Laservue: ptosis (droopy eyelid), damage to the retina (sensory membrane at the back of the eye), or the need for a corneal transplant as a result of corneal scarring or deformation (ectasia). 5. I understand that if re-treatment is necessary it is usually performed at 4-6 months. Not all eyes can be re-treated and this decision is made on an individual basis. In certain cases my cornea at the outset may not be thick enough to perform a re-treatment. 6. I understand that in the event of any complication related to laser surgery, no financial compensation or reimbursement is available to me from my surgeon, or the Clinique Laservue. 7. I undertake to follow the pre- and post-operative instructions given to me by the personnel of Laservue.

8 ~ 8 ~ In signing this informed consent form I certify that I have read the preceding information and understand the contents. Any questions I have concerning the consent form have been answered by my referring eye Doctor, my surgeon or a Laservue patient consultant. My decision to proceed with LASIK surgery is completely voluntary. DATE: PATIENT FULL NAME (print): PATIENT SIGNATURE: WITNESS NAME (print): WITNESS SIGNATURE: SURGEON S SIGNATURE: CONSENT FOR BILATERAL SURGERY: I understand that bilateral surgery is convenient in that it allows a more rapid recovery with less visual symptoms. I understand that my ability to function could be affected in the very rare event that a reduction of visual potential occurred in both of my eyes at the same time. The main theoretical causes of such an occurrence would be an inflammation or infection in both eyes at the same time after surgery. At Laservue this has happened only twice in 100,000 cases. In both cases there was no permanent reduction of vision after appropriate treatment with eyedrops. DATE: PATIENT FULL NAME (print): PATIENT SIGNATURE: WITNESS NAME (print): WITNESS SIGNATURE: SURGEON S SIGNATURE:

CLINIQUE LASERVUE. Informed Consent Form for Photo-Refractive Keratectomy (PRK)

$CLINIQUE LASERVUE. Informed Consent Form for Photo-Refractive Keratectomy (PRK)$ CLINIQUE LASERVUE Informed Consent Form for Photo-Refractive Keratectomy (PRK) Please read the following information and consent form very carefully. Your initials indicate that you understand all of the