CONSENT FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK)

Transcription

1 CONSENT FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK) Dr. Penick has described to me a procedure called Phototherapeutic Keratectomy (PTK). PTK is done by using the Excimer Laser, which is used to remove scars, smooth the surface of the cornea, treat cornea erosions, or change the shape of a cornea that has been distorted by injury or surgery. PTK removes the diseased portion of the cornea. This hopefully will improve the vision and comfort of the eye. PTK lasts anywhere from 10 seconds to 5 minutes. I will be given a topical anesthetic to help ensure that there will be little or no discomfort during the procedure. Dr. Penick will put medication in the treated eye and cover it with a contact lens. Following the procedure, there may be some degree of eye pain for a day or two, requiring medication prescribed by Dr. Penick. I understand that I must be examined closely to assure proper healing of the treated eye. Benefits: Benefits can include: relief of pain or restoration of visual function. The benefits of PTK cannot be guaranteed. It is possible the procedure will be of no benefit and may be harmful. Alternatives: Alternatives include: living with my current condition, contact lenses, stromal punctures, or selection of another surgical procedure, such as a corneal transplant. Complications and Risks: I understand that my vision may be made worse by this procedure. Complications could include: loss of sharp vision, increased corneal scarring, increased night glare, or corneal infection. Any pre-existing viral infections may reappear with the use of post-operative drops. If the eye changes such as infections or cataracts, there may be the need for additional surgery. I understand that I must be examined closely to assure proper healing of the treated eye. I understand that I may choose to live with the limitations and symptoms caused by my condition and that other surgical alternatives may be available to me. I further understand that the nature of corneal scars and irregularities are so diverse that it is not possible to go into detail on this form. I have, however, discussed with Dr. Penick the alternatives that may be available. Patient s Initials

2 Patient Consent In giving my permission for excimer laser surgery, I have been advised by Dr. Penick and understand the items listed below: 1. The surgical removal of the superficial layers of my cornea using the excimer laser has been elected by me as an alternative to other forms of corneal surgery. 2. As with all surgery, I understand the results cannot be guaranteed. 3. I understand with Phototherapeutic Keratectomy (PTK) with the excimer laser may increase my need for glasses and may require the use of corrective lenses to achieve my best vision. 4. I understand that although sharper vision and less glare are anticipated, it is possible that glare and clarity may be made worse following this procedure. 5. I understand that for those with severe corneal problems, where the surgical option for me as a corneal transplant, excimer laser PTK may not eliminate the need for a corneal transplant. 6. I understand it is impossible to state every possible complication that may occur as a result of this surgical procedure. 7. I understand that not all the beneficial effects of PTK are currently known. 8. I also understand that all the risks and complications are not known. 9. I acknowledge this disclosure of information has been made to me and that all my questions have been answered to my satisfaction by Dr. Penick. 10. I have read this form (or it has been read to me), and I fully understand the complications, risks, and benefits that can result from PTK surgery. I realize that there are no guarantees with PTK surgery. I still, however, elect to have PTK laser treatment. Patient Signature Date Witness Signature Date Physician Signature Date

3 4942 West Markham Little Rock, AR (501) BRING THIS FORM WITH YOU ON THE DAY OF YOUR SURGERY TO SIGN INFORMED CONSENT FOR PHOTOREFRACTIVE KERATECTOMY (PTK) This information and the excimer laser patient information booklet must be reviewed so that you can make an informed decision regarding PRK surgery to reduce or eliminate your nearsightedness, hyperopia, and/or astigmatism. Only you and your doctor can determine if you should have laser vison correction based on your own visual needs and medical considerations. Any situation and needs should be directed to your doctor. IN GIVING MY PERMISSION FOR PRK SURGERY, I DECLARE THAT I UNDERSTAND THE FOLLOWING INFORMATION: The long-term risks and effects of PRK (Photorefractive Keratectomy) beyond 18 years are unknown. The goals of PRK are to reduce or eliminate the dependence on or need for contact lenses and/or eyeglasses; however, you should understand that with all forms of treatment, the results in each case cannot be guaranteed. For example: 1. There is no guarantee that you will completely eliminate reliance on eyeglasses and/or contact lenses, and it is possible that treatment could result in undercorrection, where some degree of near sightedness, farsightedness, or astigmatism may remain, later requiring the use of glasses or contact lenses. 2. The treatment may also result in overcorrection causing hyperopia (farsightedness), undercorrection (myopia), or astigmatism that may, or may not, later require the use of glasses or contact lenses. 3. If you currently need reading glasses, then you will probably still need reading glasses after this treatment. Discuss the monovision treatment option with your doctor. 4. Further Treatment may be necessary including a variety of eye drops, the wearing of eyeglasses or contact lenses (hard or soft), or additional refractive surgery. 5. Your best vision, even with glasses or contacts, may become worse following surgery. 6. There may be a difference in spectacle (glasses) correction between eyes, making the wearing of spectacles difficult or impossible. 7. Wearing contact lenses may be more difficult following any refractive procedures.

4 Alternatives to PRK Surgery: The alternatives include eyeglasses, contact lenses, and other refractive surgery procedures such as LASIK or Intrastromal Corneal Rings. I have been informed and understand that certain complications and side effects have been reported in the post-treatment period by patients who have had PRK and include the following: Possible short term effects of PRK surgery: the following have been reported in the short-term post-treatment period and are associated with the normal post-treatment healing process: mild discomfort or pain (first 24 to 48 hours), corneal swelling, double vision, feeling like something is in the eye, ghost images, light sensitivity, and tearing. Possible long-term complications of PRK surgery: Haze: loss of perfect clarity of the cornea, usually not affecting vison, which usually resolves over time, but may take months or years to do so. Glare: sensation produced by bright light that is greater than normal and can cause discomfort and annoyance. Halos: hazy rings surrounding bright lights may be seen, particularly at night. Loss of best-corrected vision: an increase in the inner eye pressure due to posttreatment medications, which is usually resolved by drug therapy or discontinuation of post-treatment medications. The following complications have been reported infrequently by those who have had PRK surgery: itching, dryness of the eye, or foreign body sensation of the eye; double or ghost images; eye discomfort, inflammation of the cornea or iris; persistent corneal surface defect, persistent corneal scarring or haze severe enough to effect vision; ulceration/infection; irregular astigmatism (warped corneal surface which causes distorted images); cataract; and drooping of the eyelid. I understand there is a remote change of partial or complete loss of vision in the eye that has PRK surgery. I understand that it is not possible to state every complication that may occur as a result of any of these surgical procedures. I also understand that complications or a poor outcome may manifest weeks, months, or even a year after PRK surgery. I understand that this is an elective procedure and that refractive surgery is not reversible. I understand that I may still require the use of eyeglasses or contact lenses following refractive surgery, either as a result of undercorrection, overcorrection, presboyopia (the need for bifocal or reading lenses after the age of 40), or because of monovision. Monovison correction occurs when the dominate eye is corrected for distance vision, and the non-dominant eye remains slightly undercorrected (nearsighted) in the distance. Monovision can better allow reading (near vision) unaided by using the non-dominant eye, the results being less dependent of the need for reading glasses around the age of 40.

5 The above description of monovision has been adequately explained and demonstrated to me in the advance of surgery, and I give my consent to: HAVE monovision outcome with my refractive surgery. I understand that I might still require the use of corrective eyewear following my surgery, to balance my vision between the two eyes; however, my dependence on reading glasses beyond the age of 40 should be less with this method. (Initial ). Not to have monovision outcome with my refractive surgery, choosing to have both eyes closely matched for distance correction instead. I understand that I will require the use of reading corrections following my surgery from the approximate age of 40 onward. (Initial ). FOR WOMEN ONLY: I am not pregnant or nursing. I understand that pregnancy could adversely affect my treatment results. (Initial ). My personal reasons to have PRK are as follows (i.e., I wish to have less dependence on glasses and contact lenses) I have read and understand the information in the VISX patient information booklet that has been provided to me. I have spoken with my physician who has explained PRK procedures to my satisfaction, their risks and alternatives, and has adequately answered any questions. I therefore give my consent to have PRK surgery on my (circle one) RIGHT/LEFT EYE/BOTH EYES Patient Signature Date Witness Signature Date Physician Signature Date BANDAGE SOFT CONTACT LENS: I understand that occasionally therapeutic use of a soft disposable contact lens is required following laser vision correction. My surgeon has informed me that in the unlikely even my bandage contact lens should for some reason come out of my operative eye, I am NOT to replace it with either the same lens, or any other contact lens back in my eye, as this would cause serious risk for infection. I have been instructed to reach my surgeon immediately in the even my contact comes out of my operative eye. I consent to a therapeutic bandage lens, if appropriate, as recommended, by my surgeon. PRK ON SECOND EYE BEFORE 3-MONTH WAIT RECOMMENDED BY THE FDA: I understand that the time interval between eyes undergoing PRK recommended by the FDA is three (3) months based on studies performed in the United States. I have decided that I would like to have the option of my second eye treated after my first eye has visually healed to a satisfactory level. I understand that the result in my first eye may change before 3 months, and I am willing to accept those risks. My surgeon has recommended my second eye undergo PRK sooner than 3 months after my first eye, depending on healing.

6 To help assure that you understand the information presented, please copy the following statement in your own handwriting: I understand the information presented and am willing to accept the fact that I may need glasses, contact lenses, or further surgery following my refractive eye surgery to achieve my best possible vision level. The cost of post-treatment eyeglasses or contact lenses is my responsibility. POST-OPERATIVE INSTRUCTIONS: Following surgery you will be given medications and instructions to help prevent infection and promote healing. It is imperative that you follow ALL instructions exactly as they are given to you. It is also imperative that all follow-up appointments with your eye doctor be kept as directed. Rest for the first 24 hours after surgery and do not plan any activities for the first evening. No rubbing, poking, or pushing on the eye. No swimming for 2 weeks. No eye cosmetics for 2 weeks after surgery. In signing this form you are stating that you have read this document entirely and although it contains medical terms, which you may or may not completely understand, you have had the opportunity to ask questions and have them adequately answered by your surgeon. You have also read all related materials presented to you by your surgeon. You also give your permission for medical data concerning your operation and related treatment and any video recordings of your surgery to be released to physicians and other demonstrating a need-to-know for clinical study. You are giving your permission to allow the attendance of observers while under the care of your physician, and for the photography or videotaping of your surgery for teaching purposes. I am making an informed decision in giving my permission to have PRK surgery performed on my: (circle one) RIGHT/LEFT/BOTH EYES. Patient Signature Date Witness Signature Date Physician Signature Date