Intended Benefits. Who Is Not Eligible For the Procedure? (Intralase Sub-Bowman s Keratomileusis)

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1 PATIENT CONSENT FORM Intralase SBK / WGA SBK (Intralase Sub-Bowman s Keratomileusis) Intralase Sub-Bowman s Keratomileusis (SBK) is a term used to describe a Laser Vision Correction procedure where a laser creates a thin flap which is used to gain advantages of both Lasik and PRK. Intended Benefits In the vast majority of cases, Intralase Sub-Bowman s Keratomileusis (SBK) results in a person s reduced dependence on glasses and contact lenses. Who Is Eligible for the Procedure? To be eligible for Intralase SBK, you must: 1. Be 18 years of age or older; 2. Not have had a significant change (one diopter) in your glasses or contact lens prescription for the last twelve (12) months. Who Is Not Eligible For the Procedure? Certain conditions may interfere with the healing process or cause additional problems, risks, or complications. These conditions include, but are not limited to: 1. Residual, recurrent or active eye disease; 2. Severe dry eyes; 3. Uncontrolled diabetes; 4. Pregnancy and nursing mothers; 5. Certain rheumatological conditions (e.g. rheumatoid arthritis, lupus or other autoimmune disorders); 6. Pacemakers; 7. Thin cornea; 8. Flat cornea. If you have or have been advised that you may have any of these conditions, you should discuss them thoroughly with your surgeon.

2 Risks and Other Considerations All surgical procedures, including Intralase SBK, involve risks. Focus Eye Centre cannot promise or guarantee that the Intralase SBK procedure will be completely effective or make your vision better than it was before the procedure. It is unlikely, but possible, that the Intralase SBK procedure or a complication arising from the procedure could make your vision worse or could injure your cornea or optic nerve. This could result in partial or total blindness, or could require a corneal transplant. Although it is not possible to list every potential risk or complication that may result from the procedure, most of the risks commonly associated with Intralase SBK are as follows: 1. FemtoSecond Laser and Flap Complications During the Intralase SBK procedure, an instrument called a femtosecond laser is used to create a flap of the epithelial and surrounding tissue of the cornea. There are some risks associated with this part of the procedure. While these risks are extremely rare, complications may occur and include the following: The flap may be incomplete, not centered properly, too thin, too thick, uneven or too short resulting in the laser surgery being cancelled and rescheduled after approximately one month of healing time. The flap may not heal well after surgery. The flap may have loose edges, wrinkles, folds or other defects or may cause irregular astigmatism all of which could result in decreased vision. The thin flap may be removed to allow new epithelial cells to recover the cornea. A small amount of debris or tissue may become trapped under the flap after surgery. The debris can result from the instruments used, the tear-film oils or from floating material in the eye. The presence of this debris is monitored after surgery and may need to be removed surgically by irrigating beneath the flap. In most cases, debris that is left behind is cleared over time by the body s own cleaning systems. 2. Infection/Drug Reaction and Other Remote Risks As with any surgical procedure, there is a remote possibility of infection. With the Intralase SBK procedure, infection on the surface of, or beneath the flap, is a rare event. Infections are managed by the use of antibiotic eye drops. It may be necessary to lift the flap to culture and treat the infection. If the infection is not treated and results in significant scarring of the cornea, a partial or complete corneal transplant may be required to restore vision. Incidence of infection: 1 in 10, Discomfort/Increased Light Sensitivity Many patients experience mild discomfort for hours following Intralase SBK, although patients reactions range from no discomfort at all to moderate pain. Patients may also experience a burning and/or scratchy sensation during this time. Some sensitivity to light may exist during the first couple of days. In rare cases, light sensitivity may persist for a couple of weeks after surgery. 4. Blurry or Fluctuating Vision Almost all patients experience blurry vision immediately following surgery. This is normal. With Intralase SBK there is considerable improvement in vision within the first 24 hours after surgery. By one to two days after surgery most patients can see at least 20/40 and are able to drive. It may take several weeks before clear, crisp vision is achieved. Small fluctuations in vision may persist up to six months after surgery. The healing varies from patient to patient.

3 5. Glare/Halos/Starbursts Even without having Laser Vision Correction, many people experience night glare (haloes, starbursts) when wearing glasses or contact lenses. Night glare is common immediately following the procedure and will typically last up to three or four months. Most patients are not affected by the glare and are still able to drive during this time. In the vast majority of cases, these effects are temporary and will disappear. Night glare is more likely to occur in patients with high prescriptions and/or large pupils. Incidence of significant glare: 1 in Decreased Night Vision Up to 25% of patients who are tested for night vision (also known as contrast sensitivity testing) after Laser Vision Correction have some reduction. Wavefront-guided Laser Vision Correction will reduce this temporary reduction to less than 5% of patients. However only 2% of patients are aware that there have been changes to the quality of their night vision and virtually all patients (99.9%) are back to their normal night vision by six months. Laser Vision Correction improves night vision in up to 15% of patients. Wavefront has a wider treatment diameter and eliminates imperfections both of which significantly reduce night driving symptoms. 7. Excessive Corneal Haze Corneal haze is part of the normal healing process and, when present, gradually subsides with little or no permanent effect on vision. Corneal haze typically has little or no effect on vision and is usually not present after six months. Some patients do experience excessive corneal haze and require enhancement with the laser. This complication is rare with Intralase SBK. Incidence of serious haze: 1 in Increased Eye Pressure The steroid eye drops used following Intralase SBK can, on rare occasions, cause increased intraocular pressure. Typically, intraocular pressure returns to normal, with no long-term effects, once the use of steroid eye drops have been discontinued. It is important for you to attend your follow-up examinations so that your eye pressure can be carefully monitored. Incidence of serious increased eye pressure: 1 in Under Correction/Over Correction Although the laser is very precise, individual healing varies considerably. As a result, there is no guarantee that Intralase SBK will be successful in providing 100% of the desired level of vision correction. The chances of being under or over corrected increases the higher the initial prescription. In most, but not all cases, under or over corrections can be treated with drops or, if necessary, with an enhancement procedure. Enhancement is performed once vision has stabilized usually a minimum of six months after the original procedure. Corrective lenses may still be required for good vision for certain activities (e.g. long distance night driving). Incidence of significant over correction: 1 in 400 Incidence of significant under correction: varies with prescription

4 10. Regression Some patients who have good vision after Laser Vision Correction will show regression some months later. This is due to thickening of the epithelial and stromal cells (keratocytes) in the cornea and is often caused by UV exposure, hormone changes (pregnancy) or a debilitating illness. Regression can be treated either with the use of eye drops or with another laser enhancement. Incidence of significant regression: 2 in Loss of Best-Corrected Vision Some patients can temporarily lose the ability to read one and very rarely two lines on the eye chart after Intralase SBK in comparison to their previous best-corrected vision. This loss of vision typically occurs as a result of microscopic corneal surface irregularities. In some circumstances, an enhancement may partially or fully restore the patient s loss of best-corrected vision. Incidence of loss of best-corrected vision: 1 in Epithelial Ingrowth Intralase SBK involves the creation of a corneal flap. During the first 24 hours after the procedure, the protective epithelial layer grows over the edge of the corneal flap. There is a small risk that some epithelial cells may grow underneath the flap. This is more common in people with weak cell layers which bond poorly to the eye surface. Any breakdown of the protective epithelial layer during surgery may increase the incidence of epithelial ingrowth. Treatment involves lifting the flap and clearing away the cells. Untreated epithelial ingrowth may distort vision and may damage the flap and underlying cornea if severe and progressive. Small ingrowths do not usually present any visual problems and need only to be monitored. Epithelial ingrowth is rare with Intralase SBK. Incidence of Epithelial Ingrowth: 1 in Diffuse Lamellar Keratitis or Sands of the Sahara In some cases, Intralase SBK patients experience a temporary condition caused by an inflammatory reaction between the flap and the corneal bed of the eye. This condition is called Sands of the Sahara or Diffuse Lamellar Keratitis (DLK). This condition is generally treated with a strict regimen of eye drops and close monitoring. However, the surgeon may feel it is necessary to irrigate underneath the corneal flap. Incidence of DLK: 1 in Corneal Ectasia With some Lasik patients, the incision to create the flap will destabilize the cornea to the point it will start to bulge i.e. in a weak car tire. This is referred to as Ectasia. It is almost unheard of with PRK, and although the SBK process does not destabilize the cornea, there is a very small chance ectasia may occur. If this happens the patient may require a corneal transplant to restore vision. Incidence of severe corneal ectasia: 1 in 100,000

5 15. Ischemic Optic Neuropathy Vascular Occlusion occurs when the suction ring is placed on the eye during the construction of the corneal flap. The pressure in the eye increases and the patient will notice that the light will dim. When the suction is off, the vision returns within a few seconds. There is a very rare risk that when the suction is applied to the eye, permanent damage to the optic nerve can occur resulting in significant and irreplaceable loss of vision. This condition is known as Ischemic Optic Neuropathy (ION). Incidence of Ischemic Optic Neuropathy: 1 in 1,000, Dry Eyes Dry eye is a common, but generally temporary, condition following Intralase SBK. This can usually be treated with lubricating eye drops and occasionally with temporary inserts or plugs that prevent the normal drainage of tears into the nose allowing tears to stay on the eye longer. Dry eye generally improves within a few months after surgery but, in rare cases, can continue for longer periods of time and may require long-term use of lubricant drops and permanent plugs. Incidence of significant dry eye: 1 in 100 Monovision As we age, the crystalline lens of the eye gradually loses its ability to accommodate to nearby objects. This condition, known as presbyopia, usually begins around the age of 42 and results in the need for bifocals or reading glasses. With monovision correction, one eye is slightly under corrected to help reading vision. A small amount of distance sharpness may be sacrificed, possibly requiring night driving glasses. Reading glasses may still be required for very fine print. However, overall dependence on glasses will be dramatically reduced. A few patients (approx 0.1%) are unable to adapt to monovision and require an enhancement to improve the under correction. I understand and agree to have monovision. o YES o NO (If yes, please complete this section) Patient: Witness: Doctor: Lifetime Commitment At Focus Eye Centre, we stand behind our results. Please read the Lifetime Commitment Form for detailed information.

6 PATIENT CONSENT TO INTRALASE SBK / WGA SBK 1. I have read this consent form. 2. I have been given the opportunity to ask questions. All of the questions I have asked have been answered to my satisfaction. I understand how Intralase SBK is performed and aware of the risks and complications. 3. I understand that: a. Intralase SBK is an elective procedure. There is no health or medical reason why I need to have Intralase SBK. b. Alternative treatments to Intralase SBK, including eye glasses and contact lenses, are available. c. The results of the Intralase SBK procedure vary from patient to patient and the desired outcome cannot be guaranteed. d. Intralase SBK is not risk free. Complications from the Intralase SBK procedure, as described in this consent form, are possible. Enhancement may be necessary but there is no guarantee that I will be a good candidate for enhancement or the enhancement will be successful. e. Adherence to recommended eye drop regimen and periodic follow-up visits with an eye doctor after Intralase SBK are required to reduce the risk of longer-term complications and increase the likelihood that the desired outcome will be achieved. 4. I confirm that I am neither pregnant nor a nursing mother and that I will notify my doctor if I become pregnant in the three month period following Intralase SBK. I understand that pregnancy may affect my healing response and that some medications may pose a risk to an unborn or nursing child. 5. I agree to accept personal financial responsibility for the payment of all fees related to my Intralase SBK procedure. These fees must be paid prior to surgery. I also agree to accept responsibility for the costs of treatment of unexpected complications if these costs are not met by public or private health insurance, including but not limited to, any additional physician fees, laboratory costs, travel and hotel expenses. 6. I understand that, if at any time prior to my procedure I decide that I do not want to go forward with the Intralase SBK procedure, I may withdraw my consent. Governing Law I hereby agree that the relationship between myself, Focus Eye Centre, and my surgeon shall be governed by and construed in accordance with the laws of the Province of Ontario. Jurisdiction I hereby acknowledge that the treatment will be performed in the Province of Ontario and that the courts of the Province of Ontario shall have jurisdiction to entertain any complaint, demand, claim or cause of action, whether based on alleged breach of contract or alleged negligence arising out of the treatment. I hereby agree that I will commence any such legal proceedings in the Province of Ontario, and only in the Province of Ontario, and hereby submit to the jurisdiction of the Courts of the Province of Ontario. My decision to undergo Intralase SBK has been my own and has not been made under duress of any kind. Patient: Witness: I am a duly licensed eye care professional in good standing. I am knowledgeable about Sub-Bowman s Keratomileusis (SBK) and its risks and benefits. I have personally discussed the risks with the patient, have given the patient the opportunity to ask questions, and have answered those questions to the best of my ability. Doctor:

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