Statement of epikeratoplasty. The Board of Directors of the International Society of Refractive Keratoplasty.

Epikeratoplasty procedures, which are a form of lamellar keratoplasty, involve the placement of preshaped corneal tissue lens on the surface of the patient's cornea. Epikeratoplasty changes the major function of the eye, and therefore it is functional surgery and not cosmetic surgery. Because all epikeratoplasty procedures are lamellar corneal transplants and are performed to improve the visual function of the eye, they should be reimbursed by third party payers. Commercially available lenses, freeze-dried or unfrozen, are ordered with specifications to meet the refractive needs of the patient. Alternatively, physicians can prepare their own epikeratoplasty lenticules. Plus lenses can be used to correct aphakia in adults and children. Plano lenses, used as an onlay lamellar graft, can reinforce and flatten a keratoconic cornea. Minus lenses can be used to correct myopia of even a high degree, but myopic epikeratoplasty is less accurate and less stable compared with the other epikeratoplasty procedures. After extensive review of the currently available literature and with the testimony of several experts in the field, on January 21, 1988 the Ophthalmic Device Advisory Panel of the Food and Drug Administration conferred about the epikeratoplasty procedure. The panel then offered the following recommendations for approval to the FDA. The Board of Directors of the ISRK agrees with these recommendations. Epikeratoplasty can be used for infants greater than 1 year of age who are not able to tolerate either spectacles or contact lenses. Additionally, in those children in the amblyopic age category there must be adequate amblyopia therapy available postoperatively.(ABSTRACT TRUNCATED AT 250 WORDS)