Informed Consent for Corneal Cross-Linking Experimental Treatment for Keratoconus & Ectasia This consent may contain words that you do not understand. Please ask your doctor to explain any words or information that you do not clearly understand. You may take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.
YOUR CONDITION AND PROPOSED TREATMENT You have been diagnosed with a disorder of the cornea known as progressive keratoconus or your medical history indicates that you have corneal ectasia. In keratoconus and ectasia there is a steepening, thinning, and irregularity of your cornea which may be progressive and may reduce your visual acuity. The treatment recommended by your doctor is corneal collagen cross-linking and it is designed to help slow the progression of, or improve, your corneal condition. Corneal cross-linking is currently experimental in this country, meaning that it is not an FDA approved therapy. The only approved treatments available in this country for progressive keratoconus or corneal ectasia are contact lenses and surgical treatments such as INTACS® implantation or corneal transplant surgery. Cross-linking may also be used to treat corneal ulcers or “shifting vision” from prior RK surgery. The corneal collagen cross-linking treatment may or may not involve removing the epithelium (skin) of your cornea, application of eye drops that contain riboflavin (vitamin B2), and exposure to an ultraviolet (UV) light source. The eye drop containing the riboflavin will be placed in your affected eye at two-minute intervals for approximately 30 minutes. Then, the cornea in your affected eye will be exposed to UV light for approximately another 10 to 30 minute period. During this period, more drops are added at two-minute intervals. A contact lens will then be placed on your eye for 3-7 days for comfort while the epithelium heals. Your vision will be blurry until the epithelium heals back smoothly and this may take between 1 to 2 weeks. You will then be followed over the next 6 to 12 months to evaluate the effectiveness of the treatment. Having this treatment is not likely to change your ability to wear contact lenses in the future, nor should it affect your ability to have the surgical options mentioned above if you need them in the future. Corneal collagen cross-linking was first used to treat patients in 1998 in Germany. Data to date, obtained mostly by physicians outside the United States, has strongly suggested this treatment as an acceptable alternative, and many subjects have had a lasting effect 3-5 years after their initial treatment. FDA trials are now ongoing in the United States with narrow selection criteria for candidates. This treatment may or may not be approved in a process that is likely to last at least a year or two. Your options are to continue with current approved treatment options including contact lenses and surgical treatments such as INTACS® implantation or fullthickness corneal transplant surgery; wait for an eventual FDA approval on cornea cross-linking; or seek treatment in another country. PROCEDURE Your procedure will be performed at Beyer Laser Center and will last about 1 ½ hours in duration, after which it is expected you will be able to return home. Prior to your procedure you
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will be asked questions about how you are feeling and any medications that you are taking, as well as questions to be sure your eye and medical history have not changed. Once in the room where treatment will take place, you will be positioned lying on your back to make you comfortable for the treatment, then some numbing eye drops will be put into your eye. The front layer of your cornea, called the epithelium, may or may not be gently removed by your doctor and then the riboflavin eye drops will be placed every 2 minutes for 30 minutes and your eye will then be checked by your doctor. If the doctor can see evidence that enough riboflavin has been absorbed by your eye, then your treatment can begin. If not, more drops may have to be applied. The treatment lasts approximately 15 to 30 minutes. Your eye must be open for this treatment to work. Your eyelids will be held open with a small instrument and numbing eye drops used to help you be comfortable during the treatment. During the treatment, the UV light is turned on and additional riboflavin drops are instilled every 2 minutes until a second 30 minute period is finished. The UV light is then turned off and an antibiotic eye drop placed on your eye. Then a bandage soft contact lens will be placed on your eye. This soft contact lens stays on your eye (for about a week) to make it feel better until the defect in the front layer of your cornea heals. You will be given written instructions about what you can do and how often to use the eye drops. You can then go home, but someone will need to drive you because your vision in the treated eye will be blurry. You can expect your treated eye to be painful for a few days after treatment. The bandage contact lens and some of the drops you will be taking will help make your eye feel better, but they will not make it feel completely normal. You will be given a prescription for pain medication that you can take if you need it. If you take the pain medication, it may make you drowsy and you should not drive, operate heavy or dangerous equipment, or drink alcoholic beverages while taking the pain medication. Please refer to the instruction sheet that your pharmacist gives you for other warnings and possible side effects of the pain medication. On the day after treatment, your vision will be checked and your eye examined by your doctor. You will be given instructions on how to use any drops prescribed by your doctor, you will continue wearing the bandage contact lens and an appointment will be scheduled to come back in about a week. At that appointment, if your eye has healed, the bandage contact lens will be removed. If not, you may be asked to return for its removal in a few days. The remainder of your follow-up care will then be scheduled. RISKS AND DISCOMFORTS Any time you have a procedure, there may be risks, discomfort, and side effects that are not yet known. There are some risks we do know about and they include infection, possible cataract formation or the worsening of an existing cataract, scarring or other damage to the cornea resulting in loss of vision, inflammatory response (pain, redness), increased intraocular pressure, or a decrease in visual acuity. Your condition may not get better, may get worse, or may re-occur after this treatment. In addition, there may be side effects that are not known at this time. If you currently suffer from a dry eye condition or herpes keratitis, corneal crosslinking may increase your symptoms or trigger a reoccurrence. Your doctor may decide to take preventative steps to treat these conditions prior to undergoing corneal cross-linking. Please contact your doctor right away if you have any discomfort, changes in your vision or other side effects. Also, please tell your doctor if you have any other problems with your health or any changes in the way you feel, whether or not you think they are related to your treatment. BENEFITS Your treatment may slow the progression of your keratoconus or ectasia; or may improve the condition of your cornea; however, this cannot be promised.
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COST Health insurance companies do not pay for treatments that are considered experimental. Fees range from $1995 to $2500 per eye. Your fee fee includes 6 months of follow-up visits. ALTERNATIVE TREATMENT There are non-experimental procedures available to you, which include contact lenses, INTACS速 implantation, and corneal transplantation. Your doctor will discuss these with you. You do not have to have corneal collagen cross-linking to be treated for progressive keratoconus or ectasia. Consent Instructions: Patients 18 years and older and able to provide consent must sign on the patient signature line below. Consent is provided by the Legally Authorized Representative for adult subjects unable to consent. For subjects under 18, consent is provided by the Legally Authorized Representative. Do not sign this consent form unless you have had a chance to ask questions and have gotten satisfactory answers. CONSENT I have read this consent form (or it has been read to me). I have had the opportunity to ask questions. Although it is impossible for the doctor to inform me of every possible complication that may occur, the doctor has answered all my questions to my satisfaction. I have been fully informed of my right to receive a copy of this signed and dated consent form. I understand my responsibilities and instructions as they relate to administration of medications and follow-up care and I will follow all instructions carefully and strictly adhere to the plan for my post-op care. I certify that I have read and understand all of the above.
Print Patient Name:
DOB:
Patient Signature:
Date:
Witness Signature:
Date:
Physician Signature:
Date:
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