Risk Management

Intacs™ by Keravision® for Myopia

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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 12/01/02

INFORMED CONSENT FOR KERAVISION® INTACS™

The following information is being provided so that I can make an informed decision about having KeraVision Intacs to correct my nearsightedness (myopia).  I may take as much time as I need to read, fully understand, and ask any questions I may have before signing this consent form.

Introduction
This information is to help you make an informed decision about having KeraVision Intacs to correct your nearsightedness (myopia).  Every surgery has risks as well as benefits and each person must evaluate this risk/benefit ratio for himself/herself based on the patient information given to you as well as the conversation with your physician and staff.  You are encouraged to ask any questions and have them answered to your satisfaction before you give your permission for surgery.

Expected Benefits:
KeraVision Intacs may correct nearsightedness between -1.00 and -3.00 diopters with 1.00 diopter or less of astigmatism.
KeraVision Intacs may reduce overall nearsightedness while also reducing or eliminating dependency upon eyeglasses.
KeraVision Intacs corrects nearsightedness without permanently altering the central part of the cornea which is critical for clear vision.
KeraVision Intacs can be removed and replaced, if desired.

Possible Risks:
As with any refractive surgery procedure, there are certain risks and complications you need to be aware of when considering KeraVision Intacs.

If the results of KeraVision Intacs are not satisfactory or sufficiently effective, you may need to have an additional procedure to replace your KeraVision Intacs or to have them removed.
You may have discomfort and/or pain for up to 48 hours following the procedure.  Your doctor may recommend a medication to help ease your discomfort.
You may have blurred vision, fluctuating vision and tearing following the procedure.
You may be sensitive to bright light or glare following the procedure.
You may experience astigmatism (a temporary blurring or distortion of your vision) for several days after the procedure. This type of visual distortion is normal during the healing process and, in most cases, it decreases overtime.  However, in rare instances, it may be permanent.
Infection is a risk with any surgical procedure.
Certain patients have reported continued visual distortion related to KeraVision Intacs.
The US Studies showed that the following potential vision-threatening events happened less than 1% of the time after KeraVision Intacs.  All patients returned to the vision they had prior to the procedure.
-Infection (0.2%)
-Stromal thinning due to shallow placement (0.2%)

There are risks associated with any surgery.  Since it is impossible to state every risk or complication that may occur as a result of any surgery, the possible risks and complications listed in this informed consent may be incomplete.  There may be risks or complications associated with this surgery that are unknown because this is a relatively new procedure.

By signing this form I acknowledge that I understand the following:
The procedure to be performed on my eye consists of inserting two small transparent half rings into the peripheral cornea through a tiny incision.  KeraVision Intacs are designed to remain permanently in the eye, yet they can also be removed and replaced, if desired.
KeraVision Intacs is purely an elective procedure.
The alternatives to KeraVision Intacs for correcting nearsightedness include eyeglasses, contact lenses, and other kinds of refractive surgery procedures such as Radial Keratotomy (RK), Photorefractive Keratectomy (PRK) and Laser in situ keratomileusis (LASIK).
KeraVision Intacs will not prevent the development of naturally occurring eye problems such as glaucoma, cataracts, retinal degeneration or detachment.  KeraVision Intacs do not correct the condition known as presbyopia (or aging of the eye) which may require reading glasses for close-up work.
I understand that having KeraVision Intacs does not necessarily mean total freedom from eyeglasses because excellent vision without eyeglasses cannot be guaranteed.
It has been brought to my attention that KeraVision Intacs are not risk-free.  The complications that may occur include improper correction, decrease in best-corrected visual acuity, fluctuating vision, glare, halo, corneal edema, corneal perforation and infection.  There is a possibility of other complications due to anesthetic drops, eye drop reaction or other factors.
I understand that there are risks associated with any surgery including this procedure.  There may be risks and complications associated with this surgery that are unknown because this is a relatively new procedure.
I understand that there is a possibility that my surgeon may not be able to insert INTACS into my cornea and that the surgery may have to be cancelled.
Please initial after reading this page
In signing this form, I am stating that I have read this consent (or it has been read to me) and understand the complications.  I have had the opportunity to ask questions and have had them answered to my satisfaction.  It is understood that further procedures may be required to reach the desired result.  However, there is no guarantee with an additional procedure the desired change in refractive error can be obtained, though there could be significant improvement in uncorrected vision.
I authorize the sharing of my relevant medical information among doctors regarding my pre- and post- operative care.
I have arranged for transportation after the procedure and to my next appointment.  I understand that my doctor will advise me when I can safely resume driving.
I accept full personal financial responsibility for payment of all fees related to my KeraVision Intacs.  These include the procedure itself, possibly necessary medications, eyeglasses required after the procedure, and expenses connected with my travel to and from the surgery site or office.
I understand and am acknowledging my willingness to follow the doctors instructions and attend regular postoperative visits to reduce the risk of long-term complications.
Although it is impossible to be informed regarding every possible complication that may occur, all my questions have been answered to my satisfaction.  The decision to undergo KeraVision Intacs has been my own and been made without duress of any kind.  I understand that I will receive a copy of this  form, if requested.
I have been given a copy of the Patient Booklet, entitled “Facts You Need to Know About KERAVISION ® INTACS™ for Nearsightedness” and have discussed it with my doctor.

I give permission for my doctor to:
Record on video or photographic equipment my procedure for purposes of education, research or the training of other health care professionals.
Use the data about my procedure in subsequent procedures without reference to my name, to further the understanding of refractive surgery.
Allow observers during this procedure for educational, medical and scientific purposes.

I understand that my permission is voluntary that I may refuse to participate or may withdraw consent or discontinue participation at any time, without prejudice to my present or future care.

I am making an informed decision in giving my permission to have KeraVision Intacs performed on my
right eye          left eye

All of my questions have been answered to my satisfaction.

Patient Signature    Date                 Patient’s Printed Name