Risk Management



AK Consent Form

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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 06/01/03

INFORMED CONSENT FOR ASTIGMATIC KERATOTOMY (“AK”)

Introduction

This information, including the benefits, alternatives, and possible complications of surgery, is being provided to you so that you can make an informed decision about having astigmatic keratotomy (“AK”) to treat your astigmatism.  You are encouraged to ask questions about any procedure and have them answered to your satisfaction before agreeing to have the operation.  Take as much time as you need to make your decision.

Astigmatic keratotomy is a surgical procedure which consists of making fine microscopic arcuate (curved) incisions, either singly or as a pair at optical zones of either 6 or 7 mm, or relaxing incisions at the limbus, which is the junction of the clear part of the eye (cornea) with the white (sclera) of the eye.  These cuts are made for the purpose of flattening the steepest part of the cornea in an attempt to obtain a more spherical cornea.  AK permanently changes the shape of the cornea.  Although the goal of AK is to improve vision to the point of not wearing glasses, this result is not guaranteed.

AK is an elective procedure:  There is no emergency condition or other reason that requires or demands that you have it performed.  You could continue wearing contact lenses or glasses and have adequate visual acuity.  This procedure, like all surgery, presents some risks, many of which are listed below.  You should also understand that there might be other risks not known to your doctor that may become known later.  Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.

Alternatives to AK

If you decide not to have AK, there are other methods of correcting your astigmatism.  These alternatives include, among others, eyeglasses, contact lenses, and other refractive surgical procedures such as PRK or LASIK.

PATIENT CONSENT

I give my consent to my ophthalmologist to perform AK, and I declare that I understand the following: I have received no guarantee as to the success of my particular case.  I understand that the following risks are associated with the procedure:

Potential Risks and Complications

I understand that there is a possibility that my vision may not improve with this surgery or that the desired results of surgery may not be obtained.  It is possible that I may require additional surgery at a later date or that I could still need glasses after surgery.  It is possible that I may not be able to wear contact lenses after having this surgery.

As a result of the surgery, it is possible that I could lose vision or lose best-corrected vision.  This could happen as a result of infection that could not be controlled with antibiotics or other means, which could even cause loss of my eye.

Irregular healing of incisions may cause the corneal surface to be distorted.  In that case, it may be necessary for me to wear a contact lens to affect useful vision, and there is a possibility that this may not restore useful vision.

I understand that I may experience incapacitating light sensitivity from sunlight or other bright light sources for a varying length of time, or possibly permanently.

I understand that I may experience incapacitating glare or halos from oncoming headlights or other bright light sources, particularly in the evening or nighttime, for a varying length of time or possibly permanently.  I am aware that this may interfere with driving for an indefinite period both day and night, and I understand that I am not to drive until I am certain that my vision is adequate both day and night.

I understand that fluctuations or variation in vision may occur during the day during the initial stabilization period (up to three months or longer).

As occurs in all surgical procedures, scarring is the result of making incisions in living tissue.  This particular surgery is no exception.

My eye will be more susceptible to a blow to the eye during the healing phase and possibly somewhat after healing as the microscopic scar tissue may not be as strong as the normal tissue.  Protective eyewear is recommended for all contact and racquet sports where a direct blow to the eye could cause permanent injury to the eye.

Additional reported complications include corneal perforation, which could possibly require sutures; incisional inclusions, corneal vascularization, corneal ulcer formation, endothelial cell loss, epithelial healing defects, and very rarely, endophthalmitis (internal infection of the eye, which could lead to permanent loss of vision).

I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions or other factors that may involve other parts of my body.  I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.

PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING

The details of the procedure known as AK have been presented to me in detail in this document and explained to me by my ophthalmologist.  My ophthalmologist has answered all my questions to my satisfaction.  I have read this informed consent form (or it has been read to me), and I fully understand it and the possible risks, complications, and benefits that can result from surgery.  I therefore consent to AK surgery.

I wish to have AK performed on my          right             left eye.

Patient (or person authorized to sign for patient)                        Date

Witness                                                    Date

I have been offered a copy of this consent form (patient initials) ________

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