DESCRIPTION
Keratoprosthesis (KP) is an artificial cornea. It is intended to replace the opacified corneal tissue and provide vision when severe bilateral corneal disease exists. There are two main types of keratoprosthesis devices, temporary and permanent. A temporary keratoprosthesis (TKP) device is used intraoperatively to aid in the visualization of the ocular structures. This device is intended to be removed following surgery. A permanent keratoprosthesis device is implanted in the eye to allow the transmission of light through an opacified cornea. Permanent devices vary in design but in general consist of a central rigid polymethacrylate optic that perforates the cornea and is covered or surrounded by various tissues or surfaces to anchor the prosthesis. Cadaveric corneal transplantation is the standard procedure to restore sight in corneal disease.
POLICY
Temporary keratoprosthesis for the treatment of unilateral or bilateral corneal injury is considered medically necessary.
Temporary keratoprosthesis for the treatment of unilateral or bilateral corneal disease is considered investigational.
Permanent keratoprosthesis for the treatment of unilateral or bilateral corneal disease or injury is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
ADDITIONAL INFORMATION
Penetrating Keratoplasty (PKP) is a partial or total replacement of all layers of a central portion of the cornea. A temporary or permanent keratoprosthesis can be utilized in the performance of this procedure.
Published literature reveals ongoing modifications in the design in the optics and the techniques used for anchoring the optic in place, the surgical techniques and the postoperative management. Currently there is insufficient evidence to permit conclusions about the health outcome effects.
SOURCES
Akpek, E. K., Harissi-Dagher, M., Petrarca, R., Butrus, S. I., Pineda, II, R., & Aquavella, J. V., et al. (2007). Outcomes of Boston keratoprosthesis in Aniridia: A retrospective multicenter study. American Journal of Ophthalmology, 144 (2), 227-231. (Level 4 Evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2007). Keratoprosthesis (9.03.01). Retrieved May 7, 2008 from BlueWeb. (13 articles and/or guidelines reviewed)
Dong, X., Wang, W., Xie, L., & Chiu, AM-C. (2006). Long-term outcome of combined penetrating keratoplasty and vitreoretinal surgery using temporary keratoprosthesis. Eye, 20 (1), 59-63. (Level 4 Evidence - Independent study)
Kapusta, M. A., & Lopez, P. F. (2004). Choroidal Hemorrhage. In N. Andjelkovic, & K. Flak (Eds.), Ophthalmology, (2nd ed., pp. 997-1001). Saint Louis Missouri: Mosby, Inc.
Levy, j., Kratz, A., Klemperer, L., & Lifshitz, T. (2005). Outcome of combined penetrating keratoplasty with vitreoretinal surgery using temporary Eckardt keratoprosthesis. Harefuah, 144 (11), 781-784, 822. Abstract retrieved May 7, 2008 from PubMed database.
Roters, S., Szurman, P., Hermes, S., Thumann, G., Bartz-Schmidt, L. U., & Kirchhof, B. (2003). Outcome of combined penetrating keratoplasty with vitreoretinal surgery for management of severe ocular injuries. Retina, 23 (1), 48-56. (Level 4 Evidence - Independent study)
U. S. Food and Drug Administration. (1989, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K895013. Retrieved May 15, 2008 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=PMN&ID=K895013.
U. S. Food and Drug Administration. (1999, March). Center for Devices and Radiological Health. Guidance on 510(K) submissions for keratoprosthesis. Retrieved January 28, 2002 from http://www.fda.gov/cdrh/ode/1351.pdf.
Yan, H., Cui, J., Zhang, J., Chen, S., & Xu, Y. (2006). Penetrating keratoplasty combined with vitreoretinal surgery for severe ocular injury with blood-stained cornea and no light perception. Ophthalmologica, 220 (3), 186-189. (Level 4 Evidence - Independent study)
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EFFECTIVE DATE |
1/10/2009 |
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ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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