Risk Management



PRK: Bilateral Simultaneous

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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 11/01/06

Addendum: Consent for Bilateral Simultaneous PRK

While many patients choose to have both eyes treated at the same surgical setting, there may be risks associated with simultaneous treatment that are not present when the eyes are treated on different days.  If you elect to have PRK surgery performed on both eyes at the same time, you should understand both the possible advantages and disadvantages of your decision.

Safety:  The risk of infection and other healing complications is applicable to both eyes simultaneously.  Therefore, if an infection occurs in one eye, it may also occur in the other eye.  Although rare, a serious infection in both eyes can cause significant loss of vision and even legal blindness.  By choosing to have PRK performed on separate days, you will avoid the risk of having one or more of these complications in both eyes at the same time.

Accuracy:  If there is an over-correction or under-correction in one eye, chances are it may happen in both eyes.  If a retreatment is required in one eye, it is quite possible that your fellow eye may also require a retreatment.  By having surgery on separate days, the doctor can monitor the healing process and visual recovery in the first eye and may be able to make appropriate modifications to the treatment plan for the second eye if necessary.  In some patients, this may improve the accuracy of the result in the second eye. By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of the first eye before treating the second eye.

Visual Recovery: Some patients may experience symptoms such as blurred vision, night glare or ghost images that may delay recovery of normal vision. Blurred vision may continue for several weeks, which could make driving difficult or dangerous and could interfere with your ability to work if it occurs in both eyes.  There is no way of predicting how long your eyes will take to heal.  If the eyes are operated separately, you can generally function with your fellow eye while the first eye is healing. However, there may be a period of imbalance in vision between your two eyes, producing a form of double vision.  If you are able to wear a contact lens in your unoperated eye, the corrective lens could minimize this imbalance. The balance in vision between your two eyes may be restored more rapidly if they are operated on the same day.

Satisfaction:  Both eyes tend to experience similar side effects.  If you experience undesirable side effects such as glare, ghost images, increased light sensitivity, or corneal haze in one eye, you will likely experience them in both eyes.  These side effects may cause a decrease in vision or other negative effects, and some patients have elected to not have their second eye treated.
By having each eye treated on separate dates, you will have the opportunity to determine whether the PRK procedure has produced satisfactory visual results without loss of vision or other undesirable side effects.  If you are over age 40, you will also have an opportunity to experience the change in your close vision that results from the correction of your nearsightedness or farsightedness.  This could influence your decision on whether or not to fully correct your other eye to maintain some degree of close vision without the need for glasses (monovision).

Convenience:  It may be inconvenient for you to have each eye treated at separate visits because it would necessitate two periods of recovery from the laser surgery and might require additional time away from work.

Cost:  Professional and facility fees may be greater if the eyes are operated on different days, and the additional time off work can be costly.
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Initial

Consent Statement:

“I have read and understand the above risks and benefits of bilateral simultaneous PRK, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous PRK.  My doctor has answered all of my questions about the PRK procedure.  I wish to have both of my eyes treated during the same treatment session if my doctor determines that the treatment in the first eye appeared to be technically satisfactory.

The reason(s) I wish to have both eyes treated at the same time are:

Greater convenience
Possible faster recovery
Less time away from work
Contact lens intolerance and/or difficulty wearing contacts
Elimination of possible vision imbalance between treated and untreated eyes
Other:

Patient signature                                Date

Witness                                        Date

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