Risk Management

Conductive Keratoplasty (CK) for Hyperopia

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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 11/01/2006

INFORMED CONSENT FOR CONDUCTIVE KERATOPLASTY (CK) FOR THE CORRECTION OF HYPEROPIA (FARSIGHTEDNESS)

INTRODUCTION

This information and the Patient Information booklet are being provided to you so that you can make an informed decision about the use of a device known as the Viewpoint CK System, to perform CK.  CK is one of a number of alternatives for correcting farsightedness.  The CK treatment utilizes a controlled release of radiofrequency (RF) energy to increase the temperature of corneal tissue.  The treatment is applied with a probe that is introduced 8 to 32 times into the cornea in a circular pattern, which results in an increased curvature of the cornea to correct your vision.  The correction you achieve from CK may be temporary.

CK 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 may be other risks not known to your doctor, which 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 CK

If you decide not to have CK, there are other methods of correcting your farsightedness.  These alternatives include, among others, eyeglasses, contact lenses, and other refractive surgical procedures.

PATIENT CONSENT

In giving my permission for CK, I understand the following: The long-term risks and effects of CK are unknown.  I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:

VISION THREATENING COMPLICATIONS

I understand that it is possible that damage to my cornea could also be caused by scarring, ulceration, or an eye infection that could not be controlled with antibiotics or other means.

NON-VISION THREATENING SIDE EFFECTS

I understand that visual acuity I initially gain from CK could regress, and that my vision may go partially or completely back to the level it was immediately prior to having the procedure.
I understand that I may not get a full correction from my CK procedure and this may require future enhancement procedures or the use of glasses or contact lenses.  This procedure may also cause an increase in my astigmatism, which may cause blurred vision.
I understand that an over-correction could occur, causing me to become nearsighted, and that this nearsightedness could be either permanent or treatable.
I understand that the correction that I can expect to gain from CK may not be perfect and it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life.  I understand I may need glasses to refine my vision for some purposes requiring fine detailed vision after some point in my life, and that this might occur soon after surgery or years later.
Patient Initials

I understand that there may be pain, scratchiness, a foreign body sensation, or slight dryness in my eye, particularly during the first 48 hours after surgery.
I understand that there may be increased sensitivity to light.  I understand this condition usually resolves within the first few weeks following treatment, but it may also be permanent.
I understand that there may be a “balance” problem between my two eyes after CK has been performed on one eye, but not the other.  This phenomenon is called anisometropia.  I understand this would cause eyestrain and make judging distance or depth perception more difficult.  I understand that my first eye may take longer to heal than is usual, prolonging the time I could experience anisometropia.
I understand I may temporarily experience corneal haze, small round hazy areas where the cornea was heated during the CK treatment.  This haze will usually fade over time and may only be visible with a microscope within 3 months following surgery.
I understand that if I currently need reading glasses, I will still likely need reading glasses after this treatment.
Even 90% clarity of vision is still slightly blurry.  Enhancement surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. An assessment and consultation will be held with the surgeon at which time the benefits and risks of an enhancement surgery will be discussed.
I understand that there is a natural tendency of the eyelids to droop with age and that eye surgery may hasten this process.
I understand that the follow-up effects of CK are unknown and that CK has not been in use long enough to measure long-term effects (those occurring after 10 years or more) following the procedures, and that unforeseen complications or side effects could occur.
I understand that I may be given medication in conjunction with the procedure.  I understand that I must not drive for at least one day following the procedure and not until I am certain that my vision is adequate for driving.
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

I have read and understand the information in the Patient Information booklet that has been provided to me.  The details of the procedure known as CK 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 therefore consent to CK surgery.

I give permission for my ophthalmologist to record on video or photographic equipment my procedure, for purposes of education, research, or training of other health care professionals.  I also give my permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand CK.  I understand that my name will remain confidential, unless I give subsequent written permission for it to be disclosed outside my ophthalmologist’s office or the center where my CK procedure will be performed.

Patient Signature                            Date

Witness    Signature                        Date

I have been offered a copy of this consent form (please initial)