Risk Management

PRK. “Off-label”

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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.  IT DOES NOT CONTAIN INFORMATION ABOUT LIMBAL RELAXING INCISION (LRI).  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.

All off-label uses of the excimer laser must be properly documented in your consent form, which can be accomplished by modification of your consent form or by addendum.

Check the label for the laser periodically so you know the current labeled indications. This information is current as of 12/01/02.

SUGGESTED INFORMED CONSENT CLAUSES FOR
DOCUMENTING “OFF-LABEL” PRK

PRK in eyes with more than 4 D of astigmatism:

I understand that the FDA approval of the excimer laser for PRK was based on attempting to correct eyes with no more than 4 D of astigmatism and that the amount of my astigmatism is greater than the amount approved for correction.  Nevertheless, I wish to have PRK performed on my eye, and I am willing to accept a residual amount of astigmatism, which my doctor has demonstrated to me.  I also understand that patients with more than 4 D of astigmatism have an increased likelihood of experiencing glare and halos.

I understand that my astigmatism may also be reduced if I undergo astigmatic keratotomy (microscopic incisions performed by my doctor with a special diamond scalpel) either before, during, or after my PRK procedure.  I also understand that these incisions may not completely correct my astigmatism and additional incisions may be required at a later date.  It is also possible that these incisions could over-correct my astigmatism, leaving me with astigmatism in a different direction.  This could require suturing of the incisions or possibly additional incisions.  Incisions in the cornea can also result in irregular healing, causing a distortion in vision that cannot be completely corrected with spectacle glasses.

Myopia greater than the amount approved for correction by the FDA:

I understand that the amount of my myopia is greater than the amount approved for correction by the FDA.  Nevertheless, I wish to have PRK performed on my eye, and I am willing to accept a residual amount of myopia, which my doctor has demonstrated to me.  I also understand that I may not obtain the full amount of correction attempted, and this has been demonstrated to me.  Following PRK, I may elect to wear glasses or contact lenses to correct my remaining myopia so that I may have better distance vision.  If I am not happy with my final result after PRK, I understand that I may have radial keratotomy surgery or repeat PRK surgery once my eye is stable, in an attempt to further correct my eye for distance vision.