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 necessary patient information on PRK. 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 PRK excimer laser surgery, and to balance its benefits with its known risks. This consent form outlines not only theoretical risks, but reflects the vast experience of Laservue s surgeons (over 5,000 PRK procedures since from 1992). The vast majority of our patients are very pleased with the improvement they achieve. 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 PRK 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. PRK surgery is elective. The only way to avoid any potential complication is to not undergo surgery. 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 PRK surgery, you should discuss them with your physician. THE PRK PROCEDURE: The surgery is performed using a topical anesthetic (numbing drops). PRK 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 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). 1
After surgery, the eye is protected by a bandage contact lens until the outer protective layer (epithelium) closes over in 3-4 days. ALTERNATIVE TREATMENTS: Patients must have rejected alternatives to PRK, which include: 1) having no surgery, 2) glasses, 3) contact lenses, 4) other refractive procedures such as LASIK. CONTRAINDICATIONS: The treatment should not be performed on persons with: A corneal disease called keratoconus uncontrolled autoimmune disease (e.g. lupus, rheumatoid arthritis) uncontrolled glaucoma unstable or uncontrolled diabetes residual, recurrent or active eye disease or abnormality progressive myopia or hyperopia 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 PRK. 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 (4%) 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. 2
PLANNING YOUR SURGERY: BILATERAL SURGERY: (Surgery on both eyes in the same treatment session) The visual recovery following PRK 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 PRK have it one eye at a time, usually with an interval of at least 5 days. 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 myopia less than -5 diopters and has successfully tried it in contact lenses before surgery. 3
PATIENT EXPECTATIONS: The goal of the procedure is to achieve the best visual result the safest way. Over 98% of patients are able to function without glasses or contact lenses. In other words, complete freedom from distance glasses cannot be guaranteed. Additional procedures, spectacles or contact lenses may be required to achieve adequate vision for some patients. PRK does not correct the condition known as presbyopia (aging of the eye) which occurs in most people around 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 at a later age. PRK surgery will not prevent you from developing naturally occurring eye problems such as glaucoma, cataracts, or retinal degeneration or detachment. The PRK procedure should not complicate treating these conditions. The degree of correction required determines both the rate of recovery and the accuracy of the procedure. Lower prescriptions recover the quickest and are the most accurate. Strong prescriptions may require at least two procedures. Patient differences in healing will also greatly affect visual recovery and final visual outcome, and are impossible to predict in each individual case. For some patients with higher prescriptions, PRK 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 for these patients. If you are part of this group of higher prescriptions and are unwilling to entertain the possibility of still having to wear a very thin prescription for driving, PRK surgery may not be for you. Enhancement PRK surgeries are performed in 4% of patients in whom an incomplete result is obtained, typically 4-6 months after the first surgery. In order to perform an enhancement surgery, there must be adequate tissue remaining. This is determined by measuring the thickness of your cornea before the initial PRK surgery. In the rare case that there is inadequate tissue, you will be told before surgery that it may not be possible to later perform an enhancement. 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 2-3 days. 2) DRY EYES: Many patients have PRK surgery because they have developed dry eyes and can no longer tolerate their contact lenses. This symptom is often worse after 4
surgery and requires lubricating eye drops for several months, and then usually returns back to the level of symptoms that the eye would have experienced without surgery. 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 PRK heals, the mild swelling may cause some blurred vision and halos for 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 significant night glare which can interfere with their night driving. Patients with large pupils and severe myopia are at greatest risk for permanent night glare. COMPLICATIONS: Visual potential is the level of vision an eye can achieve with the best possible lens correction. Patients who do not see 20/20 or 100% with glasses or contact lenses before surgery cannot expect or anticipate 100% after surgery. On the other hand, the visual potential will improve by one or two lines in 60% of cases after HD PRK. 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 (blurred vision), and occurs in less than 1 in 1000 cases at Laservue. The list below covers the known causes for a loss of visual potential. No one has ever gone blind from PRK surgery at Laservue. The following list is derived from the experience at Laservue with over 5,000 cases of PRK as of 2011. 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). 5
PATIENT CONSENT: 1. I understand the basic nature, the possible risks and benefits of the PRK 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 PRK 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. 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 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 at 4-6 months. In certain cases my cornea at the outset may not be thick enough to perform a retreatment. 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 PRK. My decision to proceed with PRK 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 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. PROCEDURE: DATE: PATIENT FULL NAME (print): PATIENT SIGNATURE: WITNESS NAME (print): WITNESS SIGNATURE: SURGEON S SIGNATURE: 7