1 CLINIQUE LASERVUE Informed Consent Form for Photo-Therapeutic Keratectomy (PTK) Please read the following information and consent form very carefully. Your initials indicate that you understand all of the necessary patient information on PTK. Please do not sign this form unless you read and understand each page. INTRODUCTION: With this consent form and the entire consultation process, we wish to fully inform you about PTK excimer laser surgery, and to balance its benefits with its known risks. The goal of PTK is to smooth the irregular surface of the eye to reduce distortion of vision and/or discomfort. The vast majority of our patients achieve a significant improvement. Serious complications are extremely rare. It is not our intention to frighten or dissuade someone from pursuing laser surgery. It is our intention, however, to accurately outline the associated risks so that you may make a truly informed choice on whether to proceed with PTK surgery. It is impossible to list all of the possible risks and complications associated with this proposed surgery or any other treatment. Risks and complications that are considered to be unforeseeable, remote, or uncommonly known are not discussed. It is not possible to perform such surgery if the patient does not understand and accept that any surgery has a small component of risk. If you have any other concerns or possible conditions that might affect your decision to undertake PTK surgery, you should discuss them with your physician. THE PTK PROCEDURE: The surgery is performed using a topical anesthetic (numbing drops). PTK involves 2 main steps. In the first, the outer skin of the eye (epithelium), which is about 10% of the thickness of the cornea, is removed by the surgeon to expose the underlying tissue. In the second step, the excimer laser smoothes the underlying cornea. After surgery, the eye is protected by a bandage contact lens until the outer protective layer (epithelium) closes over in 3-4 days.
2 CONTRAINDICATIONS: The treatment should not be performed on persons with: uncontrolled autoimmune disease (e.g. lupus, rheumatoid arthritis) uncontrolled glaucoma unstable or uncontrolled diabetes disease, drugs or therapy that suppresses the immune system 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. If your pre- and post-operative care is performed by another eye doctor, this separate payment will be your responsibilty. FOLLOW-UP EXAMINATIONS: Patients must return for follow-up on 2 or 3 occasions in the first week, and then 2 or 3 times during the first six months following PTK. 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 or a significant complication occurs (less than 1 per 1,000), they may be required to return or stay longer in Montreal. Although enhancement procedures performed at the Laservue facility are covered in the initial surgical fee, the additional travel and hotel costs are not. BILATERAL SURGERY: (Surgery on both eyes in the same treatment session) The visual recovery following PTK is slow over 4-7 days. Bilateral surgery is convenient, and the balance between your eyes is restored more quickly, but your functionality is impaired during this healing period. The only added risk of having bilateral surgery is that if a serious infection or inflammation occurs, it could occur in both eyes. This could cause a permanent loss of visual potential in both eyes. For these reasons, most patients undergoing PTK have it one eye at a time.
3 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 1-3 days. 2) DRY EYES: This symptom is often worse after surgery and may require lubricating eye drops for several months 3) NIGHT GLARE AND/OR HALOS: As PTK heals, the mild swelling may cause some blurred vision and halos for a few weeks. This symptom does not limit your functionality and will clear within 2-8 weeks in almost all cases. COMPLICATIONS: Visual potential is the level of vision an eye can achieve with the best possible lens correction. A complication is an event that affects the visual potential of the eye (blurred vision). The list below covers the known causes for a loss of visual potential. No one has ever gone blind from PTK surgery at Laservue. 1. Serious INFECTION has never been seen. The risk of serious infection is much higher with the simple use of contact lenses. 2. INFLAMMATION is a normal part of the healing process. It usually resolves within 3-4 days. In very rare cases, a serious inflammation results in SCAR TISSUE or CORNEAL HAZE which can cause a loss of visual potential. 3. OTHER RISKS: Ptosis (droopy eyelid) can rarely occur as a result of any eye surgery. Elevated eye pressure caused by steroid eye drops Complications could occur requiring further corrective procedures including either partial or full-thickness corneal transplant using donor cornea (this has never happened at Laservue). Ectasia is a progressive weakening of the cornea seen in 1 in 10,000 patients and may require further surgery ( cross-linking, or a corneal transplant).
4 GOVERNING LAW: I hereby agree that the relationship and the resolution of any and all disputes arising therefrom between myself and Doctor Mullie and/or Doctor Balazsi (as well as their agents, delegates, employees, and the Clinique Laservue), including any issues related to this Agreement, shall be governed by and construed in accordance with the laws of the Province of Québec and the laws of Canada applicable therein. Patient signature JURISDICTION: I hereby acknowledge that the treatment will be performed in the Province of Québec and that the Courts of the Province of Québec shall have exclusive and preferential jurisdiction to entertain any complaint, demand, claim, proceeding or cause of action, whatsoever arising out of the treatment. I hereby agree that if I commence any such legal proceedings, I will do so only in the Province of Québec, and hereby irrevocably submit to the exclusive and preferential jurisdiction of the Courts of the Province of Québec. Patient signature
5 PATIENT CONSENT: 1. I understand the basic nature, the possible risks and benefits of the PTK procedure. All of my questions have been answered to my satisfaction. I understand that it is impossible for my surgeon to foresee and inform me in advance of every conceivable complication that may occur. 2. I understand that as with any form of surgery, the outcome can never be guaranteed. I specifically understand that the benefits of PTK also cannot be guaranteed. There is no guarantee of perfect vision or comfort. I understand that Laservue is not responsible for any costs associated with the subsequent need for glasses or contact lenses. 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 surgery using the excimer laser, there is a small risk that my vision may be made worse. I understand that I may be one of the less than 1/1,000 of people that have complications and a resulting loss of my visual potential. Examples of such complications include: infection, inflammation, ectasia, or permanent problems with night vision or with visual quality. 4. I understand that there are extremely rare or theoretical complications which might lead to the need for a corneal transplant as a result of corneal scarring, corneal swelling or deformation. This has never yet happened at Laservue. 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 excimer 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.
6 In signing this informed consent form I certify that I have read the preceding information and understand all of its contents. Any questions I have concerning the consent form have been answered by my referring eye Doctor, my surgeon or a Laservue patient consultant. I fully understand the possible risks and benefits that can result from PTK. My decision to proceed with PTK surgery is completely voluntary. PROCEDURE: DATE: PATIENT FULL NAME (print): PATIENT SIGNATURE: WITNESS NAME (print): WITNESS SIGNATURE: SURGEON S SIGNATURE: CONSENT FOR BILATERAL SURGERY: I understand that my ability to function independently could be seriously affected in the very rare event that a serious loss of visual potential occurred in both of my eyes at the same time. The main theoretical causes of such an occurrence would be a serious inflammation or infection in both eyes at the same time after surgery. DATE: PATIENT FULL NAME (print): PATIENT SIGNATURE: WITNESS NAME (print): WITNESS SIGNATURE: SURGEON S SIGNATURE: