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
Recommendations for Visian ICL™ Phakic Implant Surgery
Visian ICLTM Phakic Implant Surgery:
Risk Management Recommendations
Anne M. Menke, R.N., Ph.D.
OMIC Risk Manager
PURPOSE OF RISK MANAGEMENT RECOMMENDATIONS
OMIC regularly analyzes its claims experience to determine loss prevention measures that our insured ophthalmologists can take to reduce the likelihood of professional liability lawsuits. OMIC policyholders are not required to implement these risk management recommendations. Rather, physicians should use their professional judgment in determining the applicability of a given recommendation to their particular patients and practice situation. These loss prevention documents may refer to clinical care guidelines such as the American Academy of Ophthalmology’s Preferred Practice Patterns, peer-reviewed articles, or to federal or state laws and regulations. However, our risk management recommendations do not constitute the standard of care nor do they provide legal advice. If legal advice is desired or needed, an attorney should be consulted. Information contained here is not intended to be a modification of the terms and conditions of the OMIC professional and limited office premises liability insurance policy. Please refer to the OMIC policy for these terms and conditions.
Version 2/26/07
These risk management recommendations and sample consent form (at www.omic.com) provide information on risk reduction and coverage issues related to phakic implant surgery with the Visian ICLTM
Approved uses
• The Visian ICLTM was approved by the FDA for:
o the correction of myopia ranging from -3 to -15 D with ≤ 2.5 D astigmatism at the spectacle plane
o the reduction of myopia ranging from -15 to -20 D anterior with ≤ 2.5 D astigmatism at the spectacle plane
o in adults from 21 to 45 years of age
o with an anterior chamber depth ≥ 3.00 mm, and a
o stable refractive history within 0.5D for 1 year before implantation
♣ Any use outside these parameters constitutes “off-label” use of the device. The ophthalmologist should weigh the risk/benefit ratio and inform the patient of the “off-label” status. The “off-label” status should be added to the procedure-specific consent form.
Possible contraindications
• Anterior chamber depth < 3.0 mm as determined by the eye doctor
• Anterior chamber angle < Grade II as determined by gonioscopic examination
• Patients who are pregnant or nursing
• Endothelial cell density as specified in the labeling.
OMIC coverage information
• OMIC’s standard policy excludes refractive surgery. OMIC-insured ophthalmologists must apply for, and be granted, an endorsement to their OMIC policy in order to obtain coverage for phakic IOLs. Coverage is granted for on-label use.
o Please contact the Underwriting Department at 800.562-6642, extension 639 for questions about coverage or off-label use.
o The application form and refractive requirements are available at http://www.omic.com/products/bus_products/ref_guide_remaining.cfm#phakic
Informed consent
• There is a sample consent form on the OMIC website in the refractive surgery section. Carefully review it and change it as needed to reflect your practice.
• OMIC encourages its insureds to inform their patients of their limited experience performing new surgical techniques. For additional information regarding this informed consent issue, please refer to OMIC’s Hotline article, “Informing Patients About Your Surgical Experience,” featured in the Spring 2004 Digest, and available at www.omic.com.
OMIC policyholders who have additional questions or concerns about practice changes are invited to call OMIC’s confidential Risk Management Hotline at (800) 562-6642, extension 641.
Verisyse™ Recommendations
VerisyseTM Phakic Implant Surgery
Anne M. Menke, R.N., Ph.D.
OMIC Risk Manager
DISCLAIMER Recommendations presented here should not be considered inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtain the same results. The ultimate judgment regarding the propriety of any specific procedure or treatment must be made by the ophthalmic in light of the individual circumstances presented by the patient. This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted. This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.
Version 2/22/2006
NOTICE TO PHYSICIANS
• INFORMED CONSENT
• This consent form is provided as a sample form only. Carefully review it and change it as needed to reflect your practice.
• OMIC encourages its insureds to inform their patients of their limited experience performing new surgical techniques. For additional information regarding this informed consent issue, please refer to OMIC’s Hotline article, “Informing Patients About Your Surgical Experience,” featured in the Spring 2004 Digest, and available at www.omic.com.
• APPROVED USES
• The VerisyseTM Phakic IOL was approved by the FDA to reduce or eliminate myopia in adult patients who have:
o Myopia ranging from -5 to -20D with ≤2.5D of astigmatism at the spectacle plane
o An anterior chamber depth ≥ 3.2 mm
o Stable refraction (< 0.5D change for six months)
♣ Any use outside these parameters constitutes “off-label” use of the device. The ophthalmologist should weigh the risk/benefit ratio and inform the patient of the “off-label” status. The “off-label” status should be added to the procedure-specific consent form.
• POSSIBLE CONTRAINDICATIONS
• Patients less than 21 years of age
• Anterior chamber depth < 3.2 mm as determined by the eye doctor
• Abnormal iris or cornea
• Patients who are pregnant or nursing
• Endothelial cell density less than specified in the labeling
• OMIC COVERAGE INFORMATION.
• OMIC insured ophthalmologists must apply for, and be granted, an endorsement to their OMIC policy in order to obtain coverage for phakic IOLs.
• Coverage is granted for on-label use.
• Please contact the Underwriting Department at 800.562-6642, extension 639 for questions about coverage or off-label use.
• The application form and refractive requirements are available at http://www.omic.com/products/bus_products/ref_guide_remaining.cfm#phakic
OMIC policyholders who have additional questions or concerns about this issue should call our Risk Management Department at 800-562-6642, extension 651 or 662.
