Intrastromal corneal ring segments (e.g., Intacs®) have been investigated as a means of improving vision in diseases such as keratoconus, pellucid marginal degeneration, and for refractive surgery to correct myopia. Intrastromal corneal ring segments are prescribed, removable, micro-thin, soft plastic inserts that are designed to reshape the anterior surface of the cornea. The rings consist of 2 arc-shaped segments that are surgically inserted in the corneal stroma. The procedure is performed in an ambulatory setting under local anesthesia. These rings are designed to correct myopia by raising the peripheral cornea and indirectly flattening the central cornea.

Keratoconus, a progressive bilateral dystrophy, is a non-inflammatory eye condition in which the normally round dome-shaped cornea progressively thins in some places causing a cone-like bulge to develop. This results in significant visual impairment.

Pellucid marginal degeneration is a noninflammatory progressive degenerative disease, typically characterized by bilateral peripheral thinning (ectasia) of the inferior cornea. Deterioration of visual function results from the irregular astigmatism induced by asymmetric distortion of the cornea. Intracorneal ring segment implantation has been investigated as a treatment for pellucid marginal degeneration. Rigid gas permeable contact lenses may also be used to treat pellucid marginal degeneration.

POLICY

Intrastromal corneal ring segments are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Intrastromal corneal ring segments for the treatment of myopia are considered not medically necessary.
Intrastromal corneal ring segments for the treatment of all other conditions/diseases, including, but not limited to all other vision correction are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.

MEDICAL APPROPRIATENESS

Intrastromal corneal ring segments are considered medically appropriate if ALL of the following criteria are met:
- Diagnosis of keratoconus
- Age 21 years or older
- Progressive deterioration in vision
- Best correction using contact lenses or spectacles unable to achieve 20/40 or better
- Central cornea is clear
- Corneal thickness of 450 microns or greater at proposed incision site
- Inability to perform activities of daily living (ADLs) in current visual state
- Procedure intended to achieve ALL of the following:
- - Reduce or eliminate myopia and/or astigmatism associated with keratoconus
  - Restore functional vision
  - Defer the need for a corneal transplant procedure as the only remaining treatment option

IMPORTANT REMINDERS

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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

ADDITIONAL INFORMATION

No controlled studies were found in the published literature that validates the application of intrastromal corneal ring segments for the treatment of other conditions / diseases of the eye.

SOURCES

Alio, J., Vega-Estrada, A., Esperanza, S., Barraquer, R., Teus, M., and Murta, J. (2014). Intrastromal corneal ring segments: how successful is the surgical treatment of keratoconus? MEA Journal of Ophthalmology, 21 (1), 3-9. (Level 3 evidence)

American Academy of Ophthalmology. (2022). Refractive Errors & Refractive Surgery Preferred Practice Patterns. Retrieved May 5, 2023 from http://one.aao.org.

d’Azy, C.B., Pereira, B., Chiambaretta, F., & Dutheil, F. (2019). Efficacy of different procedures of intra-corneal ring segment implantation in keratoconus: a systematic review and meta-analysis. Translational Vision Science & Technology, 8 (3), 38. (Level 1 evidence)

Fernández-Vega-Cueto, L., Romano, V., Zaldivar, R., Gordillo, C.H., Aiello, F., Madrid-Costa, D., & Alfonso, J.F. (2017). Surgical options for the refractive correction of keratoconus: myth or reality. Journal of Ophthalmology, doi: 10.1155/2017/7589816 Published online 2017 Dec 18. (Level 2 evidence)

Izquierdo Jr, L., Mannis, M.J., Smith, J.A.M., & Henriquez, M.A. (2019). Effectiveness of intrastromal corneal ring implantation in the treatment of adult patients with keratoconus: A systematic review. Journal of Refractive Surgery, 35 (3), 191-200. Abstract retrieved July 27, 2020 from PubMed database.

National Institute for Health and Care Excellence. (2007). Corneal implants for keratoconus. Retrieved November 14, 2016 from www.nice.org.uk.

U. S. Food and Drug Administration. (1999, April). Center for Devices and Radiological Health. Premarket Approval Decision for P980031. Retrieved November 18, 2014 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2004, March). Center for Devices and Radiological Health. Summary of Safety and probable benefits H040002 (INTACS®). Retrieved September 26, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040002c.pdf.

Vega-Estrada. A., Alio’, J. L., & Plaza-Puche, A. B. (2015). Keratoconus progression after intrastromal corneal ring segment implantation in young patients: Five-year follow-up. Journal of Cataract Refractive Surgery, 41 (6), 1145-1152. Abstract retrieved February 8, 2016 from PubMed database.

Winifred S. Hayes, Inc. Medical Technology Directory. (2018, March; last update search February 2022). Intacs for the treatment of keratoconus. Retrieved July 11, 2024 from www.Hayesinc.com/subscribers. (44 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE: 3/1/2003

MOST RECENT REVIEW DATE: 9/12/2024

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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