Pending Policies - Surgery
Transciliary Fistulization for the Treatment of Glaucoma
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Transciliary fistulization to reduce intraocular pressure in patients with glaucoma is considered experimental, investigational and/or unproven.
Glaucoma is the second-leading cause of blindness in the United States (U.S.) and is the most prominent in individuals over age 40. Specific individuals have an increased risk of developing develop glaucoma which may include: family history of glaucoma, individuals over the age of 40, individuals with thinner corneas, chronic eye inflammation and taking medications that increases ocular pressure. (1)
Glaucoma is a disease characterized by the degeneration of the optic nerve (optic disc) which may or may not be accompanied by elevated intraocular pressure (IOP). (2) There are 2 classifications:
• Primary condition (without an underlying known medical condition); or
• Secondary condition (the result of a known underlying medical condition such as trauma to the eye).
Glaucoma is also broadly defined as two types: open angle and closed angle (angle closure). In primary open-angle glaucoma, the most common disease type, ocular hypertension is caused by a partial blockage of the trabecular meshwork, causing fluid to back up inside the eye and eventually resulting in damage to the optic nerve and a progressive reduction in peripheral vision.If left untreated, irreversible blindness may occur. (2, 3)
Closed-angle glaucoma is a more serious condition and is treated as a medical emergency. Urgent intervention to reduce IOP often includes both medications and surgery. Elevated intraocular lens (IOL) pressure has long been thought to be the primary etiology of glaucoma, but the relationship between IOL pressure and optic nerve damage varies among each individual therefore, suggesting a multifactorial origin. Some individuals with clearly elevated IOL pressure will show no damage to the optic nerve, while other individuals with marginal or no pressure elevation will show optic nerve damage. (2, 3)
Treatment of glaucoma aims to reduce the patient’s elevated IOP, either by administering ocular medications to slow aqueous-fluid production or by using surgical procedures to directly drain aqueous humor from the eye or increase the rate of fluid circulation. Medication is usually the first therapeutic option. Topical medications (eye drops) containing prostaglandins, for instance, are a typical first option for treating open-angle glaucoma and may aid in increasing the outflow of fluid inside the eye. Other medications such as beta blockers can limit aqueous humor production besides improving fluid outflow. When the maximum tolerated medical therapy fails to control optic neuropathy, surgical care is considered the next treatment option. Surgical procedures include laser trabeculoplasty, incisional or filtering surgery, such as trabeculectomy or drainage implants, and as a last resort, ablation of the ciliary body. (2)
Transciliary fistulization is a glaucoma filtering procedure in which a Fugo Blade (a specialized laser device) is used to create a small opening in the sclera under the conjunctival flap. Through this opening, excess fluid can drain into the eye’s posterior chamber (behind the iris), where it is slowly absorbed by the body. This procedure results in a rapid reduction in IOP and takes less than 15 minutes to perform (as compared to 30 to 45 minutes for traditional glaucoma filtering procedures). Additionally, because the Fugo Blade ablates tissue rather than cauterizing or cutting it, bleeding may be reduced. (2) The proposed advantages of this procedure are the posterior route of aqueous filtration, lack of use of antifibrotic agents, low relative cost and shorter surgery time relative to trabeculectomy. (4)
In October 2004, the Fugo Blade (MediSURG Ltd., Norristown, PAreceived 510(k) clearance for marketing from the U.S. Food and Drug Administration (FDA) for sclerostomy for the treatment of primary open-angle glaucoma where maximum tolerated medical therapy and trabeculoplasty have failed. (2, 5) Product code NCR.
This policy was originally developed in August 2012 and has been updated with searches of the Medline database through August 31, 2018. Following is a summary of the key literature to date.
There is little evidence regarding the safety and efficacy for transciliary fistulization. In 2002, Singh and Singh (6) conducted a case series of 147 patients treated with transciliary filtration (or fistulization) for the treatment of glaucoma followed for up to six months. The authors reported at six months that intraocular pressures (IOPs) were reduced to 21 mm Hg or below without medication in 132 eyes. The decrease in IOP was statistically significant (p<0.02), and no cases of anterior chamber flattening occurred. Adverse events included the need for surgical revision in seven patients three months after surgery, and choroidal effusion in two patients, which resolved within one month after surgery. No data on changes in vision or optic neuropathy were reported.
In 2008, Dow and deVenecia (7) reported use of transciliary (Singh) filtration with the Fugo plasma blade in 60 eyes of 36 patients at a Philippine mission for indigent patients. The authors propose that this procedure may be a possible answer for patients who do not have access to more complicated glaucoma procedures and/or medications. Filtration was performed on consecutive patients requiring surgical filtration surgery; 15 of the patients had pain due to high IOP and 24 had IOP greater than 50 mmHg. The average time required to perform the procedure was about three minutes. Postoperative IOP was compared with results from a published study on trabeculectomy versus thermosclerotomy with follow-up at one day, 1–3 months, and 6–12 months postoperatively. The results appeared similar to trabeculectomy, although the patients treated with transciliary filtration and lost to follow-up at 6–12 months was greater than 50%. It was noted in the discussion that 14 eyes (23%) failed the procedure by six months, including all five eyes with neovascular glaucoma. This study is limited by the absence of a concurrent control, lack of detail in the reporting, and the loss to follow-up.
Additional surgical procedures have been proposed for the treatment of glaucoma. In an effort to forego the complications of trabeculectomy, the established surgical treatment for glaucoma, new surgical techniques are being investigated. These proposed procedures include transciliary fistulization; however, there is insufficient published medical literature to support the safety and efficacy of these evolving surgical interventions for the treatment of glaucoma. The limited number of studies are primarily in the form of case series and retrospective reviews with small patient populations (n=16–147) and 6 to 12 months follow-up. Studies lacked specific inclusion and exclusion criteria and paucity of data. (7)
In 2017 Lavia et al. (8) published a systematic review on nine randomized controlled trails (RCTs) and 21 case series evaluating minimally invasive glaucoma surgeries (MIGSs) including
but not limited to the use of the Fugo Blade for open-angle glaucoma. No RCTs evaluated the Fugo Blade and because the systematic review did not include studies with follow-up <12 months or those that lost greater than or equal to 15% at follow-up, none of the case studies on the Fugo Blade met inclusion criteria. The authors concluded that although MIGS seem efficient in the reduction of the IOP and show good safety profile, the available evidence is mainly derived from non-comparative studies and additional good quality RCTs are warranted.
In 2015, Up-to-date published an evidence-based recommendation for Open-Angle Glaucoma (3) The authors stated that lowering the IOP is the primary goal of therapy, as it has shown to reduce the progression of visual field loss. The authors recommended pharmacologic or laser therapy as a first-line treatment rather than surgery (Grade 1B)
Practice Guidelines and Position Statements
American Academy of Ophthalmology (AAO)
In 2011, the AAO published an ophthalmic technology assessment on novel glaucoma procedures. (4) The assessment included Fugo blade transciliary filtration, iStent, Ex-PRESS glaucoma shunt, SOLX Gold Shunt, canaloplasty, and trabectome. The AAO concluded that clinical trials were limited to “nonrandomized, retrospective or prospective, interventional, clinical case series, generally classified as providing only level III evidence in support of the procedures”. Randomized clinical trials (RCT’s) are needed to compare these procedures to trabeculectomy and phacoemulsification. The AAO concluded “it is possible to state that these novel procedures show potential for the treatment of glaucoma and that they warrant continued support and future studies. It is not possible to conclude if they are superior, equal to, or inferior to surgery such as trabeculectomy or to one another”.
In 2015, AAO published preferred practice patterns for primary open-angle glaucoma which state: “medical therapy is presently the most common initial intervention to lower IOP. Laser trabeculoplasty can be considered as initial therapy in select patients or an alternative for patients at high risk for non-adherence to medical therapy who cannot or will not use medications reliably.” (9)
In 2017, the AAO updated their summary benchmarks for glaucoma but do not mention tranciliary fistulization as a treatment modality. (10)
Summary of Evidence
Published literature for transciliary fistulization is limited to small case series and review articles; no published randomized controlled trials (RCTs) were identified. It is unknown whether transciliary fistulization offers any benefit in the treatment of glaucoma compared to standard medical and surgical treatments. The limited literature suggests poor acceptance of this procedure by the ophthalmologic community; the reasons for this are not clear. While this procedure is similar to other filtration procedures commonly performed for the surgical treatment of glaucoma, further well-designed, RCTs comparing transciliary fistulization to trabeculectomy (the current standard of care) is needed to establish the safety and effectiveness of this procedure. Overall, data is insufficient to determine the long-term health outcomes of transciliary fistulization for the treatment of glaucoma. In addition, there are no evidence-based clinical practice guidelines from U.S. professional associations that recommend the use of transciliary fistulization for the treatment of glaucoma.
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ICD-9 Diagnosis Codes
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ICD-9 Procedure Codes
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ICD-10 Diagnosis Codes
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ICD-10 Procedure Codes
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The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.
A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.
1. American Optometric Association. Glaucoma. Available at <https://www.aoa.org> (accessed September 7, 2018).
2. ECRI Institute. Transciliary Fistulization for Treating Glaucoma. Plymouth Meeting (PA): ECRI Institute; 2013 Dec. (Hotline Response).
3. Jacobs, Deborah. Open-Angle Glaucoma: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated: December 22, 2015. Available at <http://www.uptodate.com> (accessed September 15, 2016).
4. Francis BA, Singh K, Lin S, et al. Novel glaucoma procedures: A report by the American Academy of Ophthalmology. Ophthalmology. 2011 July; 118(7):1466-80. Available at <https://www.aaojournal.org> (accessed September 7, 2018).
5. FDA-510(k) premarket notification. Fugo Blade. (October 2004). Available at <http:// www.accessdata.fda.gov> (accessed September 7, 2018).
6. Singh, D, and Singh K. Transciliary filtration using the Fugo Blade. Ann Ophthalmology. (2002) 34(3):183-7.
7. Dow, C.T., and G. deVenecia. Transciliary filtration (Singh filtration) with the Fugo plasma blade. Ann Ophthalmol. (2008) 40(1):8-14. PMID 18556974
8. Lavia C, Dallorto L, Maule M, et al. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis. PLoS One. 2017 Aug 29; 12(8):e0183142. Available at <https://journals.plos.org> (accessed September 7, 2018).
9. American Academy of Ophthalmology. Primary Open-Angle Glaucoma Preferred Practice Guidelines (2015 September). Available at <https://www.aao.org> (accessed September 7, 2018).
10. American Academy of Opthomology. Glaucoma summary benchmarks for preferred practice guidelines. (2017 November). Available at <https://www.aao.org> (accessed September 7, 2018).
11. Transciliary Fistulization for the Treatment of Glaucoma – Archived. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 February) Other 9.03.17.
|11/1/2018||Document updated with literature review. Coverage unchanged. Added references 8, 10.|
|10/15/2017||Reviewed. No changes.|
|12/15/2016||Document updated with literature review. Coverage unchanged.|
|10/15/2015||Reviewed. No changes.|
|9/15/2014||Document updated with literature review. Coverage unchanged.|
|8/15/2012||New medical document originating from SUR713.030, Surgical Treatments for Glaucoma that has been deleted.|
|Title:||Effective Date:||End Date:|
|Transciliary Fistulization for the Treatment of Glaucoma||10-15-2017||10-31-2018|
|Transciliary Fistulization for the Treatment of Glaucoma||12-15-2016||10-14-2017|
|Transciliary Fistulization for the Treatment of Glaucoma||10-15-2015||12-14-2016|
|Transciliary Fistulization for the Treatment of Glaucoma||09-15-2014||10-14-2015|
|Transciliary Fistulization for the Treatment of Glaucoma||08-15-2012||09-14-2014|