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PRK Surgery - Consent Form

Informed Consent for Performance of the PRK Procedure.

Below you will find information and consent regarding the refractive surgery technique used during Photorefractive keratectomy (PRK), including the risks of treatment and alternatives to them. Please read this document thoroughly and discuss the content with your doctor so that all of your questions are answered to your satisfaction.

All surgical procedures including PRK involve risks of unsuccessful results, complications, infection, injury or even death, from unforeseen or known causes. Neither your surgeon, your optometrist, the Center or its staff can promise or guarantee that the procedures will be effective or make your vision better than it was prior to surgery.

There is a possibility that the procedure or a complication arising from the procedure could make your vision worse. Your cornea or retina could be damaged which could result in partial or total blindness or could require a corneal transplant. Certain inflammatory conditions can cause severe postoperative complications such as corneal inflammation. This could result in a permanent loss of vision. Likely outcomes may be conveyed to you during your pre-operative exams. These will be based on a number of factors including your level of refractive error and surgeon's opinion.

You may need glasses or other corrective lenses AFTER the procedure either on a temporary or permanent basis. PRK will not prevent and may even unmask the need for reading glasses. This is especially true for patients near or over the age of forty years.

Although it is not possible to list every potential risk or complication that may result from your choosing to have the procedure, a number of them are described below.

Patient Statement

I have a refractive error (myopia, astigmatism, or hyperopia), which requires me to wear corrective lenses in order to see clearly for my daily activities. I have been clearly informed of the alternatives including eyeglasses, contact lenses or having no surgery at this time. I have decided to undergo the PRK procedure with VISX excimer laser.

In giving my permission for this treatment, I declare that I have had ample time to read and completely understand the following information:

• The goal of the PRK treatment is to reduce or eliminate my refractive error, thereby reducing my dependence or need for contact lenses and/or eyeglasses for my distance correction.
• I understand that as with all forms of treatment, the results in my case cannot be guaranteed. There is no guarantee that I will completely eliminate my reliance on eyeglasses and/or contact lenses. It is possible that the treatment could result in under-correction, over-correction, and/or a change in my astigmatism where some degree of refractive error may remain requiring the use of glasses or contact lenses. I understand further treatment may be necessary including a variety of eye drops, the wearing of eyeglasses or contact lenses (hard or soft), or additional treatments.
• I understand that if I currently need reading glasses, I will likely still need reading glasses after this treatment. I also understand that if I do not currently need reading glasses, I may need them following surgery depending on my current age.
• (FEMALE ONLY) I am not pregnant or nursing. If it is possible that I am pregnant, I have informed my surgeon and we have discussed how that may affect my treatment. If I become pregnant in the 6 months following treatment, I will notify my eye doctor immediately.
• I understand the treatment should not be performed on persons: with uncontrolled collagen vascular disease such as Rheumatoid arthritis, SLE, autoimmune disease or keloid formation, who are immunocompromised or on drugs or therapy which suppress the immune system, so I have told the doctor if I have any of these or other medical conditions.

(Please initial you understand______________)

I have been informed, and I understand, that certain complications have been reported in the long term, post-treatment period by patients who have had PRK including:

• Under or Over Correction: The treatment of your refractive error (glasses prescription) is designed to completely neutralize your need for glasses (unless otherwise discussed with your surgeon). This treatment is aimed at the "average" eye. If your individual healing response varies from the average, you may be over or under corrected. Usually this can be corrected with glasses, contact lenses or additional surgery. In some instances, this may be permanent and not amenable to surgery because of structural stability issues or the presence of an irregular corneal surface.
• Increased Intra-ocular Pressure: A small percentage of patients who have PRK may develop sensitivity to the steroid eye drops used during the healing phase. This small percentage may experience a rise in the pressure inside the eye. This is not usually noticed by the patient, does not cause any discomfort and will be monitored by your eye doctor at your regular postoperative visits. This condition is temporary and can be treated with additional eye drops.
• Glare/Halos/Starbursts: Sensations producing hazy rings or starbursts surrounding bright lights may be seen particularly at night. This is for the most part temporary but in some cases may be permanent. These conditions are more likely to occur in patients with higher levels of nearsightedness (myopia) or farsightedness (hyperopia), astigmatism or in patients with larger than average pupils. These patients may need to wear glasses at night or use eye drops to help reduce these symptoms although it may not be possible to treat this successfully.
• Loss of Best Spectacle Corrected Visual Acuity: A decrease in best-corrected visual acuity with glasses.
• Equipment malfunction: The laser is maintained according to the manufacturer's specifications. Despite proper maintenance, it is possible the laser could malfunction requiring the procedure to be stopped prior to completion. In some instances this could lead to rescheduling the procedure or even loss of vision.

(Please initial you understand_______________)

The following complications have been reported in less than 1% of eyes treated by PRK:

• Corneal Ectasia: A stretching or weakness of the cornea causing decrease of vision. This may require the use of contact lenses or a corneal transplant to correct the problem.
• Corneal Infection: A rare event, estimated to occur in 1 in 10,000 cases.
• Corneal scarring/hazing: Although uncommon, it may occur and could decrease vision significantly. It can often be treated by topical medications.
• Shadow images/Corneal Irregularity: Microscopic irregularities in the cornea's surface can cause a decrease in vision. Rarely patients can lose up to 1 to 2 lines of vision. These surface changes may be temporary.
• Dryness of the eye/foreign body sensation: While it is normal for the eye/eyes to be dry in the first 4-6 weeks following surgery, rarely dryness has been reported for longer periods. Frequent use of lubricating drops in the early post-operative period can help with this sensation.
• Irregular astigmatism, Lens Opacity/Cataract formation, Double Vision, Continued patient discomfort, drooping lid

(Please initial you understand_______________)

I understand that in addition to the above listed complications, the following have been reported in the short-term post-treatment period by patients who have had PRK and are associated with the normal post-treatment healing process. These include: pain (first 24-48 hours), corneal swelling, double vision, foreign body sensation, shadow images, light sensitivity, tearing and pupil enlargement.

It is impossible to state every complication that may occur as a result of PRK.

• I understand that the above list of complications is not complete or exhaustive.
• I understand that the doctor will prescribe certain medications as part of the treatment. I have informed my surgeon of any known drug allergies that pertain to me.
• I understand that this is an elective treatment and that I do not have to have this treatment. I understand that the treatment (PRK) is not reversible.
• I understand that PRK will require follow-up care at frequent intervals for one year after treatment and I agree to return for required examinations.

Statement of Voluntary Participation

In signing this Consent Form for performing the PRK procedure, I am stating that I have had ample time to read the foregoing information (or it has been read to me) and I fully understand it including the possible risks, complications and benefits that can result from the treatment. Although it is impossible for the doctor to inform me of every conceivable complication that may occur, the doctor has answered all my questions to my satisfaction.

I understand that if I have any questions with respect to the treatment I can discuss them with _________________prior to proceeding with the proposed surgery.

By signing below, I agree that:

• PRK treatment has been explained to me in terms that I understand.
• I have had the opportunity to have my questions answered.
• I understand that I can walk away at any time and am not obligated to go through with the procedure.
• I fully understand the possible risks, complications and benefits that can result from treatment.

My decision to undergo the PRK treatment has been my own and has been made without duress of any kind. I hereby request and consent to PRK by __________________ on my ____ Right Eye    ____ Left Eye

 

____________________           __________________           ________
PATIENT NAME (Type or Print)           SIGNATURE                        DATE

 

I confirm that I have reviewed this consent form with ______________________ and have provided further explanations of the foregoing potential risks, complications and benefits to him/her when requested to do so. I confirm that ______________

has acknowledged to me that he/she understands the information herein and has voluntarily signed this consent form in my presence.

 

____________________           __________________           ________
WITNESS NAME (Type or Print)           SIGNATURE                       DATE

 

I confirm that I have explained the nature and effect of this procedure and the risks and alternatives thereto, to the person who signed the above consent.                         

 

________________________             _______________
PHYSICIAN'S SIGNATURE                              DATE