Keratoprosthesis (KP) is an artificial cornea that is intended to replace the opacified corneal tissue and restore vision when severe bilateral corneal disease exists (e.g., prior failed cadaveric corneal transplant, chemical injury or certain immunological condition). Many people with corneal disease can benefit from corneal transplantation involving tissue from human (cadaveric) donors. This is the most common treatment for severe corneal opacity. However, in some cases, this treatment fails. KP has been developed for use when corneal transplant is not an option. A permanent keratoprosthesis device (i.e., Boston KPro) is implanted in the eye to allow the transmission of light through an artificial cornea.Other keratoprosthesis devices (e.g., AlphaCor™, KereKlear™) and devices with a unique procedural approach such as the osteo-odonto-keratoprosthesis (OOKP) are available for individuals who have corneal blindness and have failed or are not candidates for human corneal transplantation. However, the clinical evidence for the other keratoprosthesis devices and the OOKP procedure is lacking and change in disease status, quality of life, and treatment-related morbidity are uncertain.
Keratoprosthesis using the Boston KPro for the treatment of severe corneal opacity or corneal blindness may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Keratoprosthesis using all other types of devices are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Keratoprosthesis is considered medically appropriate if ALL of the following criteria are met:
Boston Keratoprosthesis (Boston KPro) device is used
Corneal blindness as evidenced by best-corrected vision of 20/400 or less in the affected eye
Cornea is severely opaque and vascularized
No end-stage glaucoma is present
No retinal detachment is present
Individual is able to comply with post-operative care
The individual has ANY ONE of the following:
One or more failed corneal transplant allografts
Ocular cicatricial pemphigoid
Autoimmune conditions with rare ocular involvement
Ocular chemical burns
An ocular condition unlikely to respond favorably to primary corneal transplant surgery (e.g., limbal stem cell compromise or post-herpetic anesthesia)
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Two permanent keratoprostheses have received 510(k) marketing clearance by the FDA: the Dohlman Doane Keratoprosthesis, also referred to as the Boston Keratoprosthesis (KPro), and the AlphaCor™, previously known as the Chirila keratoprosthesis (Chirila KPro).
Ahmad, S., Akpek, E.K., Gehlbach, P.L., Dunlap, K., & Ramulu, P.Y. (2015). Predictors of visual outcomes following Boston type 1 keratoprosthesis implantation. American Journal of Ophthalmology, 159 (4), 739-747. Abstract retrieved July 9, 2015 from PubMed database.
Ahmad, S., Mathews, P., Lindsley, K., Alkharashi, M., Hwang, F., Ng, S., et al. (2016). Boston type 1 keratoprosthesis versus repeat donor keratoplasty for corneal graft failure. A systematic review and meta-analysis. Ophthalmology, 2016; 123:165-177. (Level 1 evidence)
Aldave, A.J., Kamal, K.M., Vo, R.C., & Yu, F. (2009). The Boston type 1 keratoprosthesis: improving outcomes and expanding indications. Ophthalmology, 116 (4), 640-651. Abstract retrieved July 10, 20215 from PubMed database.
American Academy of Ophthalmology (2013, September) Preferred Practice Pattern: Corneal Edema and Opacification. Retrieved April 11, 2017 from: www.aao.org/ppp.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2017). Keratoprosthesis (9.03.01). Retrieved April 10, 2017 from BlueWeb. (21 articles and/or guidelines reviewed)
Bradley, J., Hernandez, E., Schwab, I., & Mannis, M. (2009). Boston type 1 keratoprosthesis: the University of California Davis experience. Cornea, 28 (3) 321-327. (Level 4 evidence - Independent study)
Davies, E. & Chodosh, J. (2016). Infections after keratoprosthesis. Current Opinion in Ophthalmology, 27 (4), 373-377. Abstract retrieved June 24, 2016 from PubMed database.
Goins, K. M., Kitzmann, A.S., Greiner, M. A., Kwon, Y. H., Alward, W. L., Ledolter, J., et al. (2016). Boston type 1 keratoprosthesis: visual outcomes, device retention, and complications. Cornea, Epub ahead of print. Abstract retrieved June 24, 2016 from PubMed database.
Hicks, C., Crawford, G., Lou, X., Tan, D., Snibson, G., Sutton, G,, et. al., (2003) Corneal replacement using a synthetic hydrogel cornea, AlphaCor: device, preliminary outcomes and complications. Eye (London). 2003 Apr;17(3):385-92. Abstract retrieved April 11, 2017 from PubMed database.
Hoffart, L., Chalres, G, and Matonti, F. (2015, January-February) Lamellar corneal lenticule graft to treat keratolysis after AlphaCor keratoprosthesis implantation. European Journal of Ophthalmology. 2015 Jan-Feb;25(1):1-7. Abstract retrieved April 11, 2017 from PubMed database.
Jiraskova´ , N., Rozsival, P., Burova, M., and Kalfertova, M. (2011) AlphaCor™ artificial cornea: clinical outcome. Eye (2011) 25, 1138–1146. (Level 4 evidence)
Lee, W., Shtein, R., Kaufman, S., Deng, S., and Rosenblatt, M. (2015). Boston keratoprosthesis: outcomes and complications: a report by the American Academy of Ophthalmology. Ophthalmology, 122 (7), 1504-1511. Abstract retrieved July 9, 2015 from PubMed database.
Liu, C., Paul, B., Tandon, R., Lee, E., Fong, K., Mavrikakis, I., et. al. (2005) The Osteo-Odonto-Keratoprosthesis (OOKP) Seminars in Ophthalmology, 20:113–128. (Level 4 evidence)
Srikumaran, D., Munoz, B., Aldave, A.J., Aquavella, J.V., Hannush, S.B., Schultze, R., et al. (2014). Long-term outcomes of Boston type 1 keratoprosthesis implantation: a retrospective multicenter cohort. Ophthalmology, 121 (11), 2159-2164. Abstract retrieved July 10, 2015 from PubMed database.
U. S. Food and Drug Administration. (2002, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K013756 (AlphaCor™). Retrieved March 31, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2013, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K121203 (Boston KPro). Retrieved April 11, 2017 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 8/1988
MOST RECENT REVIEW DATE: 9/1/2017
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.
This document has been classified as public information.