Risk Management



PRK. “Off-label”

SAVE THIS FORM TO YOUR COMPUTER BY USING THE DOWNLOAD BUTTON. A PREVIEW IS DISPLAYED BELOW.

PLACE LETTERHEAD HERE AND REMOVE NOTE.
CHANGE FONT SIZE FOR LARGE PRINT

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.
Version 12/01/02

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

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.  OMIC has drafted the following consent clauses to assist you in addressing these off-label issues.  If you elect to develop your own consent clauses to address these issues and would like assistance or guidance, please contact OMIC’s risk management department.  Also, please remember that the FDA does not permit the promotion of off-label uses through marketing or advertising.

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.

Please refer to OMIC's Copyright and Disclaimer regarding the contents on this website

Leave a comment



Six reasons OMIC is the best choice for ophthalmologists in America.

#5. Expertise unmatched.

OMIC's sole mission is to serve ophthalmology. The premier source of ophthalmic claims data and loss prevention materials, OMIC's member hotline is the most used ophthalmic consultative service of its kind and OMIC.com is the most visited web site in America for ophthalmic risk management advice and patient consent documents.

61864684