“SMILE” SURGICAL CONSENT FOR
THECORRECTION OF MYOPIA

INDICATIONS AND PROCEDURE
Bladeless LASIK surgery involves two steps. First, a Femtosecond laser is used to create a flap in the cornea to expose the underlying tissue. After the flap is created, an excimer laser is used to reshape the eye and the flap is then returned to its original position.
The SMILE (Small Incision Lenticule Extraction) procedure uses the same Femtosecond laser that is used to create a LASIK flap for the entire procedure. Instead of creating a flap of tissue that has to be lifted back before the underlying tissue can be removed, the Femtosecond laser cuts out a thin lenticule(small lens) of tissue underneath the corneal surface that is then removed through a smaller incision than LASIK.

The SMILE procedure has been FDA approved to treat nearsightedness and can be used in patients over 22 years of agefor a treatment of -1.00 to -10.00Diopters (D) of correction. SMILE is not currently approved to treat astigmatism. If you have astigmatism of -0.50D or less you may still be a candidate for SMILE because low amounts of astigmatism do not typically have a large impact on a patient’s vision. If you currently wear soft contact lenses that only treat nearsightedness and are happy with your vision, then you may be considered a good candidate for SMILE. In general, if you are a good candidate for refractive surgery such as LASIK, you would also be a good candidate for SMILE.
RISKS AND COMPLICATIONS
Like all surgery, this procedure presents some risks. Most of the potential complications and side effects listed in the consent for Bladeless LASIKalso apply to the SMILE procedure (except for flap complications). In addition to these risks, there are considerations specific to the SMILE procedure.

To successfully create the lenticule with the Femtosecond laser, suction needs to be maintained on each eye for about 40 seconds. Most patients do not feel this part of the procedure and there is a fixation light to look at during this time. If a patient were to excessively squeeze their eyelids during this time there is a chance that suction could be broken. If this were to happen within a specific portion of the treatment lasting about 15 seconds the procedure would need to be terminated without completion. Other times during the procedure, the suction can be reapplied and the procedure successfully completed.If the procedure is not completed the vision should return to its pre-surgical state. An alternative procedure such as LASIK or PRK can be performed either the same day or at another time.If you wish to have this potential option, a separate consent will need to be reviewed and signed giving your permission for this alternative procedure.

At the time of surgery, if the surgeon feels that a patient is not going to be able to maintain suction during the entire procedure then he may choose to recommend Bladeless LASIK instead of SMILE. This will be your option whether to proceed with this alternative treatment.

There is also a small chance of other complications including that the lenticule could be torn during removal, the cornea could be perforated or a small part of the lenticule could be left behind. In most cases, these do not present a problem as to the outcome, but a second surgery may need to be performed to remove the remaining parts of the lenticule or for other reasons thatsubsequent surgical treatment might be required. There is also a limitation on the types of retreatments that can be performed after SMILE to further improve vision as compared to LASIK. You should discuss these and any other questions you might have with your doctor.

Although SMILE has been performed internationally for several years with close to one million cases performed, it is relatively new in the United States, and the experience with this procedure is much more limited than with LASIK. You should weigh the risks versus benefits and alternatives in making your decision to have this elective procedure.

PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING

I have read the Consent for Bladeless LASIK Using the Femtosecond Laser and understand that all of the risks associated with this surgery also apply to the SMILE procedure.

[ ]I am electing to have SMILE performed, but in the event that my surgeon feels that it is unsafe to proceed with SMILE I consent to have Femtosecond LASIK performed.

[ ]If the surgeon performs SMILE surgery and my procedure cannot be completed, I request to have the Femtosecond LASIK surgery substituted at the same surgery session.

[ ] I understand that I may have to return for an alternative procedure at another date.
The details of the procedure known as SMILE, as well as alternative surgeries such as Bladeless LASIKhave been presented to me. My ophthalmologist and staff have answered all of my questions to my satisfaction. I have been offered a copy of this consent form and therefore I consent to SMILE on:
Right Eye ______Left Eye ______Both Eyes ______(Check One)
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Patient SignatureDate
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Surgeon SignatureDate

Updated 030717