Intacs. Bilateral Simultaneous Intacs for Treatment of Myopia
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
Addendum: Consent for Bilateral Simultaneous Intacs for Treatment of Myopia
If you elect to have surgery performed on both eyes at the same time, you should understand both the possible advantages and disadvantages of your decision.
Safety: The risk of infection, delayed clouding of the cornea, corneal scarring and internal bleeding or retinal damage are very rare but potentially devastating. If these serious but rare complications occur in one eye, they may also occur in the other eye. Should any of these complications happen, you could experience significant loss of vision and even legal blindness. By choosing to have surgery on separate days, you avoid the risk of having one or more of these complications in both eyes at the same time.
Accuracy: If there is an over-correction or under-correction in one eye, chances are it may happen in both eyes. If a re-operation is required in one eye, it is quite possible that your fellow eye may also require a re-operation. By having surgery on separate days, the doctor can monitor the healing process and visual recovery in the first eye and may be able to make appropriate modifications to the treatment plan for the second eye if necessary. In some patients, this might improve the accuracy of the result in the second eye. By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of the first eye before treating the second eye.
Visual Recovery: Although most Intacs patients experience a rapid recovery in their vision, some may experience symptoms such as blurred vision, night glare or ghost images that can result in prolonged recovery of normal vision. Blurred vision may continue for several weeks, which could make driving difficult or dangerous and could interfere with your ability to work if it occurs in both eyes. There is no way of predicting how long your eyes will take to heal. If the eyes are operated separately, you can generally function with your fellow eye while the first eye is healing. However, there may be a period of imbalance in vision between your two eyes, producing a form of double vision. If you are able to wear a contact lens in your unoperated eye, the corrective lens could minimize this imbalance. The balance in vision between your two eyes will usually be restored more rapidly if they are operated on the same day.
Satisfaction: Both eyes tend to experience similar side effects. If you experience undesirable side effects such as glare, ghost images, increased light sensitivity, or corneal haze in one eye, you will likely experience them in both eyes. These side effects may cause a decrease in vision or other negative effects, and some patients have elected to not have their second eye treated. By having each eye treated on separate dates, you will have the opportunity to determine whether the Intacs procedure has produced satisfactory visual results without loss of vision or other undesirable side effects. If you are over age 40, you will also have an opportunity to experience the change in your close vision that results from the correction of your nearsightedness. This could influence your decision on whether to fully correct your other eye to maintain some degree of close vision without the need for glasses (monovision).
Convenience: It may be inconvenient for you to have each eye treated at separate visits because it would necessitate two periods of recovery from the surgery and might require additional time away from work.
Cost: Professional and facility fees may be greater if the eyes are operated on different days, and the additional time off work can be costly.
Initial
Consent Statement:
“I have read and understand the above risks and benefits of bilateral simultaneous Intacs for treatment of myopia, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous Intacs. My doctor has answered all of my questions about the Intacs procedure. I wish to have both of my eyes treated during the same treatment session if my doctor determines that the treatment in the first eye appeared to be technically satisfactory.”
The reason(s) I wish to have both eyes treated at the same time are:
Greater convenience
Possible faster recovery
Less time away from work
Contact lens intolerance and/or difficulty wearing contacts
Elimination of possible vision imbalance between treated and untreated eye
Other ____________________________________________
Patient signature Date
Witness Date
Mitomycin C with Refractive Surgery
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 06/30/05
ADDENDUM
MITOMYCIN-C (MMC) WITH REFRACTIVE SURGERY
INDICATIONS AND ALTERNATIVES
The correction of high degrees of nearsightedness (or myopia) using the excimer laser is associated with a higher chance of developing corneal scarring or “haze.” This corneal haze may develop years after the original procedure and can result in decreased vision. Refractive surgeries such as Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), and Advanced Surface Ablation (ASA) have been associated with corneal haze in some individuals.
Since 1997, a medication called Mitomycin-C (MMC) has been used to treat patients who develop corneal haze. Several studies have shown that the use of MMC decreases the likelihood of developing haze after PRK, LASEK, and ASA. For this reason, ophthalmologists are also using MMC prophylactically, as a preventive measure.
MMC is an antitumor antibiotic that has been used in the medical field for a number of decades. It is used as an anti-cancer drug because it can stop the proliferation or growth of certain types of cells, such as those seen in tumors. It also stops cells in the eye which produce scarring or haze. MMC has been used in the eye since the 1980’s to prevent scarring after many types of surgical procedures, such as glaucoma filtration and pterygium surgery. The use of MMC for the treatment and prevention of corneal haze is a newer use of this medication.
COMPLICATIONS
MMC is very potent and, under certain circumstances, potentially toxic. Eye-related and vision-threatening complications that have been reported when using MMC for other conditions include, but are not limited to: secondary glaucoma, corneal edema, corneal or scleral thinning or perforation requiring corneal transplants, permanent stem cell deficiency, sudden onset mature cataract, corneal decompensation, corectopia (displacement of the pupil from its normal position), iritis, scleral calcification, scleral melt, retinal vascular occlusion, conjunctival irritation (redness of the eye), and incapacitating photophobia and pain.
Although the complications listed above have been seen in various types of eye surgeries, no significant complications have been reported using the low-dose technique described below for corneal haze removal and prevention in refractive surgery. This techniques uses a low dose (0.02%) of MMC delivered by placing a small, circular shaped sponge on the central cornea for one to two minutes. This technique minimizes, but may not eliminate, the chance of developing MMC-related complications.
Patients who received preventive MMC treatments have shown improvement in visual acuity and a decrease in corneal haze. No corneal haze developed during an average follow-up period of one year. However, there is no guarantee that you will obtain a similar result. Over long periods of time, corneal haze or unforeseen toxicity may develop, which may require additional treatment.
PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING
My surgeon has indicated to me that I either have corneal haze, or that I may be more likely to develop corneal haze following PRK, LASEK, or ASA. I have read and understood the information presented above about the risks, benefits, and alternatives to using MMC for both treatment and prevention of corneal haze. I have had the opportunity to ask questions and have them answered to my satisfaction.
I understand that administering MMC for treatment and prevention of corneal haze is considered an “off-label” use of an FDA-approved medication. When a drug or device is approved for medical use by the Food and Drug Administration (FDA), the manufacturer produces a “label” to explain its use. Once a medication is approved by the FDA, physicians may use it “off-label” for other purposes if they are well-informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects.
I understand that there are no guarantees as to the success of the procedure for removing or preventing haze and that toxic side effects may develop.
I give my informed consent to my surgeon (indicated below) and/or his or her assistants to use MMC on my ________ eye (patient should write in right, left, or both).
____________________________ __________________________ ____
Patient’s name (printed) Patient’s Signature Date
____________________________ __________________________ ____
Witness name (printed) Witness’s Signature Date
Version 6/30/05
PRK. “Off-label”
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. IT DOES NOT CONTAIN INFORMATION ABOUT LIMBAL RELAXING INCISION (LRI). PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
All off-label uses of the excimer laser must be properly documented in your consent form, which can be accomplished by modification of your consent form or by addendum.
Check the label for the laser periodically so you know the current labeled indications. This information is current as of 12/01/02.
SUGGESTED INFORMED CONSENT CLAUSES FOR
DOCUMENTING “OFF-LABEL” PRK
PRK in eyes with more than 4 D of astigmatism:
I understand that the FDA approval of the excimer laser for PRK was based on attempting to correct eyes with no more than 4 D of astigmatism and that the amount of my astigmatism is greater than the amount approved for correction. Nevertheless, I wish to have PRK performed on my eye, and I am willing to accept a residual amount of astigmatism, which my doctor has demonstrated to me. I also understand that patients with more than 4 D of astigmatism have an increased likelihood of experiencing glare and halos.
I understand that my astigmatism may also be reduced if I undergo astigmatic keratotomy (microscopic incisions performed by my doctor with a special diamond scalpel) either before, during, or after my PRK procedure. I also understand that these incisions may not completely correct my astigmatism and additional incisions may be required at a later date. It is also possible that these incisions could over-correct my astigmatism, leaving me with astigmatism in a different direction. This could require suturing of the incisions or possibly additional incisions. Incisions in the cornea can also result in irregular healing, causing a distortion in vision that cannot be completely corrected with spectacle glasses.
Myopia greater than the amount approved for correction by the FDA:
I understand that the amount of my myopia is greater than the amount approved for correction by the FDA. Nevertheless, I wish to have PRK performed on my eye, and I am willing to accept a residual amount of myopia, which my doctor has demonstrated to me. I also understand that I may not obtain the full amount of correction attempted, and this has been demonstrated to me. Following PRK, I may elect to wear glasses or contact lenses to correct my remaining myopia so that I may have better distance vision. If I am not happy with my final result after PRK, I understand that I may have radial keratotomy surgery or repeat PRK surgery once my eye is stable, in an attempt to further correct my eye for distance vision.
PRK: Bilateral Simultaneous
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
Addendum: Consent for Bilateral Simultaneous PRK
While many patients choose to have both eyes treated at the same surgical setting, there may be risks associated with simultaneous treatment that are not present when the eyes are treated on different days. If you elect to have PRK surgery performed on both eyes at the same time, you should understand both the possible advantages and disadvantages of your decision.
Safety: The risk of infection and other healing complications is applicable to both eyes simultaneously. Therefore, if an infection occurs in one eye, it may also occur in the other eye. Although rare, a serious infection in both eyes can cause significant loss of vision and even legal blindness. By choosing to have PRK performed on separate days, you will avoid the risk of having one or more of these complications in both eyes at the same time.
Accuracy: If there is an over-correction or under-correction in one eye, chances are it may happen in both eyes. If a retreatment is required in one eye, it is quite possible that your fellow eye may also require a retreatment. By having surgery on separate days, the doctor can monitor the healing process and visual recovery in the first eye and may be able to make appropriate modifications to the treatment plan for the second eye if necessary. In some patients, this may improve the accuracy of the result in the second eye. By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of the first eye before treating the second eye.
Visual Recovery: Some patients may experience symptoms such as blurred vision, night glare or ghost images that may delay recovery of normal vision. Blurred vision may continue for several weeks, which could make driving difficult or dangerous and could interfere with your ability to work if it occurs in both eyes. There is no way of predicting how long your eyes will take to heal. If the eyes are operated separately, you can generally function with your fellow eye while the first eye is healing. However, there may be a period of imbalance in vision between your two eyes, producing a form of double vision. If you are able to wear a contact lens in your unoperated eye, the corrective lens could minimize this imbalance. The balance in vision between your two eyes may be restored more rapidly if they are operated on the same day.
Satisfaction: Both eyes tend to experience similar side effects. If you experience undesirable side effects such as glare, ghost images, increased light sensitivity, or corneal haze in one eye, you will likely experience them in both eyes. These side effects may cause a decrease in vision or other negative effects, and some patients have elected to not have their second eye treated.
By having each eye treated on separate dates, you will have the opportunity to determine whether the PRK procedure has produced satisfactory visual results without loss of vision or other undesirable side effects. If you are over age 40, you will also have an opportunity to experience the change in your close vision that results from the correction of your nearsightedness or farsightedness. This could influence your decision on whether or not to fully correct your other eye to maintain some degree of close vision without the need for glasses (monovision).
Convenience: It may be inconvenient for you to have each eye treated at separate visits because it would necessitate two periods of recovery from the laser surgery and might require additional time away from work.
Cost: Professional and facility fees may be greater if the eyes are operated on different days, and the additional time off work can be costly.
____________
Initial
Consent Statement:
“I have read and understand the above risks and benefits of bilateral simultaneous PRK, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous PRK. My doctor has answered all of my questions about the PRK procedure. I wish to have both of my eyes treated during the same treatment session if my doctor determines that the treatment in the first eye appeared to be technically satisfactory.
The reason(s) I wish to have both eyes treated at the same time are:
Greater convenience
Possible faster recovery
Less time away from work
Contact lens intolerance and/or difficulty wearing contacts
Elimination of possible vision imbalance between treated and untreated eyes
Other:
Patient signature Date
Witness Date
LASIK: Assumption of post-op care
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/06
MODEL FORM
This form assumes that if you have to do any specific procedure, you will have a discussion with the patient regarding the risks, benefits and alternatives related to that particular surgery or treatment e.g. an enhancement. This “informed consent” is simply setting forth an understanding between the patient and the practice on certain issues of overall care.
ASSUMPTION OF LASIK POST-OP CARE
I understand (practice/physician name) will treat the current condition of my eye/eyes secondary to previous refractive procedure performed by a surgeon at a facility which was not associated with the (practice/physician name). (practice/physician name) informed me of my option to return to the surgeon who performed the procedure but it is my choice to be treated at (practice/physician name). My reason(s) for choosing to be treated at (practice/physician name) instead of returning to the refractive surgeon is(are)
(In patient’s own handwriting to show that she had her own reasons to stay with you.)
I understand that the (practice/physician name) in no way guaranteeing any cure of my current condition which includes
(In patient’s own handwriting to document in her own words the complaints/reasons for being at your practice. If simple, uncomplicated post-op follow-up then let her state that).
I also understand that the (practice/physician name) is not accepting any liability or responsibility for the loss of vision or diminished quality of vision associated with the prior surgery.
I have had possible associated risks and consequences of treatment versus no treatment explained to me. As with all types of treatment, I understand there is the possibility of complications and an unsuccessful resolution of the current condition.
I understand that I will be charged at normal (practice/physician name) fees for service. Payment for those services will be made on the day of the exam or subsequent treatment. (practice/physician name) has answered all my questions about my proposed course of treatment at this time.
Patient Signature Date
Witness Signature Date
