BlueCross BlueShield of Tennessee Medical Policy Manual

Corneal Collagen Cross-Linking

DESCRIPTION

Corneal collagen cross-linking (CXL) is a photochemical procedure being evaluated as a method to stabilize the cornea in individuals with progressive keratectasia such as keratoconus and pellucid marginal degeneration.  CXL may also have anti-edematous and antimicrobial properties.

Keratoconus is a bilateral dystrophy characterized by progressive ectasia (paracentral steepening and stromal thinning) that impairs visual acuity.  Keratoconus can be idiopathic or iatrogenic and may be seen as a result of laser in situ keratomileusis (LASIK).  Pellucid marginal degeneration is a noninflammatory progressive degenerative disease, typically characterized by bilateral peripheral thinning (ectasia) of the inferior cornea. 

CXL is performed with the photosensitizer riboflavin (vitamin B2) and ultraviolet-A (UVA) irradiation. A common CXL protocol removes about 8 mm of the central corneal epithelium under topical anesthesia to allow better diffusion of the photosensitizer riboflavin into the stroma. Following de-epithelialization, a solution with riboflavin is applied to the cornea (every 1-3 minutes for 30 minutes) until the stroma is completely penetrated. The cornea is then irradiated with UVA at a maximal wavelength to allow for absorption by riboflavin. The interaction of riboflavin and UVA causes the formation of reactive oxygen species, leading to additional covalent bonds (cross-linking) between collagen molecules that results in stiffening of the cornea.

POLICY

See also:  Intrastromal Corneal Ring Segments (ICRS) for Vision Correction

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

No CXL devices have received FDA approval for the treatment of keratoconus in the U.S. Phase III clinical trials evaluating safety and efficacy are on-going.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2016). Corneal collagen cross-linking (9.03.28). Retrieved July 21, 2016 from BlueWeb. (21 articles and/or guidelines reviewed)

Kanellopoulos, A. (2012). Long term results of a prospective randomized bilateral eye comparison trial of higher fluence, shorter duration ultraviolet A radiation, and riboflavin collagen cross linking for progressive keratoconus. Clinical Ophthalmology, 2012 (96), 97-101. (Level 3 evidence)

National Institute for Health and Clinical Excellence. (2013, September). Photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A for keratoconus and keratectasia. Retrieved July 21, 2016 from www.nice.org.uk/guidance/ipg466.

National Institute of Health. (2016).Facts about the cornea and corneal disease. Retrieved July 22, 2016 from https://nei.nih.gov/health/cornealdisease/.

Padmanabhan, P., & Abhishek, D. (2013). Collagen cross-linking in thin corneas. Indian Journal of Ophthalmology, 61 (8), 422-424. Abstract retrieved September 10, 2015 from PubMed database.

Sorkine, N., & Varssanoe, D. (2014). Corneal collagen crosslinking: A systematic review. Ophthalmologica, 232 (1), 1-60. (Level 1 evidence)

ORIGINAL EFFECTIVE DATE:  11/10/2012

MOST RECENT REVIEW DATE:  8/11/2016

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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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