This information is being provided to you so that you can make an informed decision about IntraLASIK, also known as iLASIK, “all-laser” LASIK or “blade-free” LASIK.
The iLASIK surgery involves two procedures. First, the FDA-approved IntraLase™ laser is used to create a flap with laser energy. The IntraLase laser is capable of creating extremely precise flaps by producing tiny bubbles inside the cornea that are 1/10,000 of an inch in diameter. The laser beam cannot penetrate into the eye beyond the cornea. After the flap is created, an excimer laser is used to reshape the eye by removing ultra-thin layers from the cornea in order to reduce nearsightedness, farsightedness, or astigmatism. The flap is returned to its original position, without sutures.
Alternatives
iLASIK is an elective procedure. There is no emergency condition or other reason that requires or demands that you have it performed. There are alternatives to this surgery. You can continue wearing contact lenses or glasses and have adequate visual acuity. There are also other types of refractive surgery, including LASIK with a microkeratome, PRK, implantable contact lenses, and clear lens exchange.
Risk & Complications
This procedure, like all surgery, presents some risks, many of which are listed below. You should also understand that there may be other risks not known to your doctor, which may become known later. Despite the best of care, complications and side effects may occur; should this happen in your case the result might be a worsening of your vision.
In giving my consent for iLASIK, I understand the following: The surgeon will use the FDA-approved IntraLase™ laser to create a flap, and then the FDA-approved VISX Star S4 IR excimer laser to reshape the eye. The long-term risks and effects of iLASIK are unknown. I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:
A.
Vision-threatening Complications
1.
I understand that the IntraLase™ laser or the excimer laser could malfunction, requiring the procedure to be stopped before completion. Depending on the type of malfunction, this may or may not be accompanied by visual loss.
2.
I understand that irregular healing of the flap could result in a distorted cornea. This would mean that glasses or contact lenses may not correct my vision to the level possible before undergoing iLASIK. If this distortion in vision is severe, a partial or complete corneal transplant might be necessary to repair the cornea.
Initial
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
Page 1
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
3.
I understand that mild or severe infection is possible. Mild infection can usually be treated with antibiotics and usually does not lead to permanent visual loss. Severe infection, even if successfully treated with antibiotics, could lead to permanent scarring and loss of vision that may require corrective laser surgery or, if very severe, corneal transplantation or even loss of the eye.
4.
I understand that I could develop keratoconus or corneal ectasia. Keratoconus is a degenerative corneal disease affecting vision that occurs in approximately 1/2000 in the general population. Corneal ectasia is a condition very similar to keratoconus seen after refractive surgery. While there are several tests that suggest which patients might be at risk, this condition can develop in patients who have normal pre-operative testing. Since keratoconus may occur on its own, there is no absolute test that will ensure a patient will not develop keratoconus following laser vision correction. Mild keratoconus or ectasia may cause vision problems that can be corrected by glasses or contact lenses. Severe keratoconus or ectasia may require a corneal transplant.
5.
I understand that other very rare complications threatening vision include, but are not limited to, corneal swelling, corneal thinning, retinal tears or detachment, hemorrhage, venous and arterial blockage, cataract formation, total blindness, and even loss of my eye.
B.
Non-Vision-threatening side effects
1.
I understand that there is a greater chance that the whites of my eyes may temporarily appear pink or red for several days to several weeks after surgery. This redness is more common with IntraLase-created flaps than with microkeratome-created flaps.
2.
I understand that my vision after surgery using the IntraLase technology may not be clear immediately and that I might not notice improvement for several days to several weeks.
3.
I understand that there may be increased sensitivity to light, glare, and fluctuations in the sharpness of vision. I understand these conditions usually occur during the normal stabilization period, which lasts between three to six months, but they may also be permanent.
4.
I understand that there is an increased risk of eye irritation related to drying of the corneal surface following the iLASIK procedure. These symptoms may be temporary or, on rare occasions, permanent, and may require frequent application of artificial tears and/or closure of the tear duct openings in the eyelid.
5.
I understand that an under-correction or over-correction could occur, causing me to become farsighted or nearsighted or increase my astigmatism; and that this could be either permanent or treatable. If permanent, I may need to use glasses or contact lenses. I understand an over-correction or under-correction is more likely in people over the age of 40 years and may require the use of glasses for reading or for distance vision some or all of the time.
Initial
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
Page 2
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
6.
After refractive surgery, a certain number of patients experience glare, a “starbursting” or halo effect around lights, or other low-light vision problems that may interfere with the ability to drive at night or see well in dim light. Although there are several possible causes for these difficulties, the risk may be increased in patients with large pupils or high degrees of correction. For most patients, this is a temporary condition that diminishes with time or is correctable by wearing glasses at night or using eye drops. For some patients, however, these visual problems are permanent. I understand that my vision may not seem as sharp at night as during the day and that I may need to wear glasses at night or use eye drops. I understand that it is not possible to predict whether I will experience these night vision or low-light problems, and that I may permanently lose the ability to drive at night or function in dim light because of them. I understand that I should not drive unless my vision is adequate.
7.
I understand that I may not get a full correction from my iLASIK procedure and this may require future refractive surgery procedures or the use of glasses or contact lenses.
8.
I understand that there may be a “balance” problem between my two eyes if iLASIK is performed on one eye but not the other. This phenomenon is called anisometropia. I understand this would cause eye strain and make judging distance or depth perception more difficult.
9.
I understand that, after iLASIK, the eye may be more fragile to trauma from impact. Evidence has shown that, as with any scar, the corneal incision will not be as strong as the cornea originally was at that site. I understand that the treated eye, therefore, is somewhat more vulnerable to all varieties of injuries, at least for the first year following iLASIK. I understand it would be advisable for me to wear protective eyewear when engaging in sports or other activities in which the possibility of a ball, projectile, elbow, fist, or other traumatizing object contacting the eye may be high.
10.
I understand that there is a natural tendency of the eyelids to droop with age and that eye surgery may hasten this process.
11.
I understand that there may be pain, irritation, or a foreign body sensation, particularly during the first 48 hours after surgery. I also understand that pain may be associated with complications such as infection.
12.
I understand that temporary glasses either for distance or reading may be necessary while healing occurs and that more than one pair of glasses may be needed.
13.
I understand that the long-term effects of iLASIK are unknown and that unforeseen complications or side-effects could possibly occur.
14.
I understand that visual acuity I initially gain from iLASIK could regress, and that my vision may go partially back to a level that may require additional surgery, or require glasses or contact lens use to see clearly.
Initial
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
Page 3
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
15.
I understand that the correction that I can expect to gain from iLASIK may not be perfect. I understand that it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life. I understand I may need glasses to refine my vision for some activities at some point in my life, and that this might occur soon after the surgery or years later.
16.
I understand that I may be given medication in conjunction with the procedure and that my eye may be covered with a clear plastic shield afterward. I, therefore, understand that I must not drive the day of surgery and should not drive until I am certain that my vision is adequate for driving.
17.
I understand that if I currently need reading glasses, I will still likely need reading glasses after this procedure. It is possible that dependence on reading glasses may increase or that reading glasses may be required at an earlier age if I have this surgery.
18.
I understand that if I already have presbyopia (a natural condition usually seen in individuals over 40 years of age in which magnifying lenses are often necessary for near vision tasks) and have both eyes corrected for clear distance vision, I will need reading glasses for many near-vision tasks. The strength of readers I will need may vary over the course of my healing. It is possible that my dependence on near correction may increase or decrease after surgery.
19.
Retreatment surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. Retreatments can be performed no sooner than three months after surgery. Generally, the original flap can be re-lifted without creating a new flap. Rarely, a new flap may need to be created. Retreatment will only be considered if there is adequate corneal tissue. If there is inadequate tissue, it may not be possible to perform a retreatment. If necessary, an assessment and consultation will be held with the surgeon, at which time the benefits and risks of a retreatment surgery will be discussed.
20.
I understand that, as with all types of surgery, there is a possibility of complications due to drug reactions, or damage to other parts of my body. I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.
Bilateral Procedures
In approving the use of the excimer laser for the Photorefractive Keratectomy (PRK) procedure in 1995, the Federal Food and Drug Administration (FDA) set guidelines which state that if PRK is performed on one eye, PRK should not be performed on the other eye for a period of at least 90 days. The apparent rationale for this guideline is to permit the doctor an extended period of time to review the outcome of the first PRK procedure. However, this guideline does create inconvenience for many patients and their doctors, while providing no assurance that unsatisfactory outcomes can be avoided by waiting. Later, the FDA approved LASIK without changing those guidelines. One of the advantages of having LASIK on both eyes the same day is cost savings. There is additional cost to do bilateral surgery on separate days.
Initial
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
Other advantages include greater convenience, less time away from work, and faster overall recovery.
It is a generally accepted practice for doctors to exercise their own professional judgment when treating patients with approved medical devices or medications. In your doctor’s opinion, it is appropriate to perform iLASIK surgery on both of your eyes on the same day, or within a period shorter than the FDA-sanctioned 90-day waiting period.
By your signature below, you acknowledge your desire to have the iLASIK procedure performed on both of your eyes on the same day, outside the FDA guidelines, and that you accept such additional risks.
Patient Signature
Date
Monovision Correction & Presbyopia
After the age of 40, many people begin to notice a decrease in their ability to read or focus on close-up objects. This condition, called presbyopia, is a natural consequence of the aging of the eye and usually requires that affected individuals begin to use reading glasses for close-up vision. Monovision correction is a way to help compensate for this condition. iLASIK candidates over the age of 40 may want to consider monovision correction as a way to compensate for presbyopia. In monovision, one eye, usually the dominant eye, is corrected for distance viewing. The non-dominant eye is corrected for near vision tasks such as reading. While monovision correction may be helpful for situations like reading a menu at a restaurant or looking at one’s wrist watch, individuals may still require glasses for night driving or reading a phonebook (fine print). Many individuals cannot tolerate monovision. Some individuals who try monovision feel unbalanced, and others say that their near and distance vision both seem unclear. Monovision can interfere with depth perception. People who require the best distance vision possible may want to avoid monovision and recognize that they will need to wear reading glasses for near vision tasks.
I wish to have monovision correction:
By your signature below, you acknowledge that you understand the above-stated monovision and
presbyopia information.
Patient Signature
Date
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
iLASIK Retreatment (Enhacement) Information
In the event that you would need, and are found to be a candidate for, a retreatment within the first year following the initial iLASIK procedure, there will be no additional charge for the retreatment procedure.
By your signature below, you acknowledge that you understand and accept the policies for retreatment surgery.
Patient Signature
Date
Patient’s Statement of Acceptance & Understanding
By signing this document, I affirm that I have been given, have read, and understand this Informed Consent for iLASIK Refractive Surgery. My questions concerning the procedure and the associated risks have been answered to my satisfaction. To assure that you have understood the information presented, please copy the following statement in your handwriting EXACTLY as you see it (no abbreviations):
I understand the information presented and am willing to accept all risks of IntraLASIK surgery complications and the fact that I may need glasses or contact lenses or further procedures following IntraLASIK to achieve my best possible level of vision.
Patient Signature
Date
Medical Center Eye Clinic
655 Medical Center Drive NE
Salem, OR. 97301
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Board-Certified Ophthalmologist
Phone 503.581.5287 Fax 503.386.1377
Informed Consent for iLASIK Refractive Surgery
I therefore consent to iLASIK surgery on my:
I understand that preoperative and postoperative care could be performed by optometric physicians under the supervision of John G. Dodd, D.O.
Signature of Patient
Date
Signature of Clinic Staff
Date
Signature of Surgeon
Date
***Additional questions and/or concerns were addressed by Dr. Dodd, and consent for surgery reconfirmed during the final preoperative exam on the day of surgery.
