Risk Management

Intacs. Bilateral Simultaneous Intacs for Treatment of Myopia

 Addendum: Consent for Bilateral Simultaneous Intacs for Treatment of Myopia

If you elect to have 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, delayed clouding of the cornea, corneal scarring and internal bleeding or retinal damage are very rare but potentially devastating.  If these serious but rare complications occur in one eye, they may also occur in the other eye. Should any of these complications happen, you could experience significant loss of vision and even legal blindness.  By choosing to have surgery on separate days, you 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 re-operation is required in one eye, it is quite possible that your fellow eye may also require a re-operation.  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 might 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: Although most Intacs patients experience a rapid recovery in their vision, some may experience symptoms such as blurred vision, night glare or ghost images that can result in prolonged 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 will usually 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 Intacs 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.   This could influence your decision on whether 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 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.

                                                                                                                                    Initial

 Consent Statement:

 “I have read and understand the above risks and benefits of bilateral simultaneous Intacs for treatment of myopia, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous Intacs.  My doctor has answered all of my questions about the Intacs 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 eye

 Other ____________________________________________

Patient signature                                                                         Date

Witness                                                                                            Date