BlueCross and BlueShield of Montana Medical Policy/Codes
Anterior Eye Segment Imaging
Chapter: Medicine: Tests
Current Effective Date: June 01, 2013
Original Effective Date: December 14, 2010
Publish Date: June 01, 2013
Revised Dates: June 1, 2011; April 17, 2013
Description

The classification of glaucoma (primary open-angle or angle-closure) relies heavily upon knowledge of the anterior segment anatomy, particularly that of the anterior chamber angle. Angle-closure glaucoma is characterized by obstruction of aqueous fluid drainage through the trabecular meshwork (the primary fluid egress site) from the eye's anterior chamber.  The width of the angle is one factor affecting the drainage of aqueous humor.  A wide unobstructed iridocorneal angle allows sufficient drainage of aqueous humor, whereas a narrow angle may impede the drainage system and leave the patient susceptible to angle-closure glaucoma.  The treatment for this condition is a peripheral iridotomy (laser) or peripheral iridectomy (surgery).

Slit lamp biomicroscopy is used to evaluate the anterior chamber; however, the chamber angle can only be examined with specialized lenses, the most common of these being the gonioscopic mirror.  In this procedure a gonio lens is applied to the surface of the cornea under topical anesthesia and the image magnified with the slit lamp.  Gonioscopy is the standard method for clinically assessing the anterior chamber angle.  Other techniques for imaging the anterior eye segment include ultrasonography and optical coherence tomography (OCT).

Ultrasonography uses high frequency mechanical pulses (10 to 20 MHz) to build up a picture of the front of the eye.  An ultrasound (US) scan along the optical axis assesses corneal thickness, anterior chamber depth, lens thickness and axial length.  Ultrasound scanning across the eye creates a two-dimensional image of the ocular structures.  It has a resolution of 100 microns, but only moderately high intra-observer and low inter-observer reproducibility.  Ultrasound biomicroscopy (about 50 MHz) has a resolution of 30 to 50 microns.  As with gonioscopy, this technique requires placement of a probe under topical anesthesia.

OCT is a non-invasive method that creates an image of light reflected from the ocular structures.  In this technique a reflected light beam interacts with a reference light beam.  The coherent (positive) interference between the two beams (reflected and reference) is measured by an interferometer, allowing construction of an image of the ocular structures.  This method allows cross-sectional imaging at a resolution of 6-25 microns.  The Stratus OCT™ (Carl Zeiss Meditec), which utilizes a 0.8 micron wavelength light source, was designed for evaluating the optic nerve head, retinal nerve fiber layer and retinal thickness.  The Zeiss Visante OCT™ uses a 1.3 micron wavelength light source and is designed specifically for imaging the anterior eye segment.  Light of this wavelength penetrates the sclera, allowing high-resolution cross-sectional imaging of the anterior chamber angle and ciliary body.  The light is, however, typically blocked by pigment, preventing exploration behind the iris.  Ultrahigh resolution OCT can achieve a spatial resolution of 1.3 microns, allowing imaging and measurement of corneal layers.

An early application of OCT technology was the evaluation of the cornea before and after refractive surgery; OCT is also commonly used to image the retina.  Since this is a non-invasive procedure that can be conducted by a technician, it has been proposed that this device may provide a rapid diagnostic and screening tool for the detection of angle closure in glaucoma.  Also being investigated is the possibility that the 0.8-micron wavelength Stratus OCT, which is already available in a number of eye departments, may provide sufficient detail for routine clinical assessment of the anterior chamber angle in glaucoma patients.  Add-on lens are also available for imaging the anterior segment with OCT devices designed for posterior segment imaging.

Regulatory Status

The Visante OCT™ received marketing clearance through the U.S Food and Drug Administration (FDA) 510(k) process in 2005, listing the Stratus OCT™ and Orbscan™ II as predicate devices.  The 510(k) summary describes the Visante OCT as “a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal and LASIK flap thickness.”

The AC Cornea OCT from Canada has not been cleared for marketing in the United States.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Blue Cross and Blue Shield of Montana (BCBSMT) considers scanning computerized ophthalmic imaging (e.g., optical coherence tomography) of the anterior eye segment  experimental, investigational and unproven.

Rationale

Optical Coherence Tomography versus Gonioscopy

Several studies have compared optical coherence tomography (OCT) with gonioscopy for the detection of primary angle closure.  For example, Nolan and colleagues assessed the ability of a prototype of the Visante OCT to detect primary angle closure in 203 Asian patients.  The patients, recruited from glaucoma clinics, had been diagnosed with primary angle closure, primary open-angle glaucoma, ocular hypertension, and cataracts; some had previously been treated with iridotomy.  Images were assessed by two glaucoma experts, and the results compared to an independently obtained reference standard (gonioscopy).  Data were reported from 342 eyes of 200 individuals.  A closed angle was identified in 152 eyes with gonioscopy and 228 eyes with OCT; agreement was obtained between the two methods in 143 eyes.  Although these results suggest low specificity for OCT, it is noted that gonioscopy is not considered to be a gold standard.  The authors suggest three possible reasons for the increase in identification of closed angles with OCT: lighting is known to affect angle closure, and the lighting conditions were different for the two methods (gonioscopy requires some light); placement of the gonioscopy lens on the globe may have caused distortion of the anterior segment; and landmarks are not the same with the two methods.  The authors noted that longitudinal studies will be required to determine whether eyes classified as closed by OCT but not by gonioscopy are at risk of developing primary angle closure glaucoma.

A 2009 publication examined the sensitivity and specificity of the Visante OCT when using different cut-off values for the angle-opening distances (AOD) measured at 250, 500, and 750 microns from the scleral spur.  OCT and gonioscopy records were available for 303 eyes of 155 patients seen at a glaucoma clinic.  The patients were asked to look at pre-positioned targets to prevent image distortion with low- and high-resolution OCT.  The parameters analyzed could not be measured by commercially available software at the time of the study, so the images were converted to a format that could be analyzed by ultrasound biomicroscopy software.  Blinded analysis showed sensitivity and specificity between 70% and 80% (in comparison with gonioscopy), depending on the AOD and the cut-off value.  Correlation coefficients between the qualitative gonioscopy grade and quantitative OCT measurement ranged from 0.75 (AOD 250) to 0.88 (AOD 750).  As noted by these investigators, “a truer measure of occludable angles is whether an eye develops angle-closure glaucoma in the future.”  Long-term follow-up of patients examined with these two methods would be informative.

A prospective observational study (n=26) evaluated imaging of the anterior angle chamber with the Stratus OCT, which had been developed for retinal imaging.  Ten eyes with normal open angles and 16 eyes with narrow or closed angles or plateau iris configuration as determined by gonioscopy were assessed.  The OCT image was rated for quality, for ability to demonstrate the anterior chamber angle, and for ability to visualize the iris configuration; patients were classified as having open angles, narrow angles, closed angles, or plateau iris configuration.  Ultrasound biomicroscopy was performed for comparison if plateau iris configuration was diagnosed.  The investigators reported that the Stratus OCT provided high-resolution images of iris configuration and narrow or closed angles, and imaging of the angle was found to be adequate in cases of acute angle-closure glaucoma where the cornea was too cloudy to enable a clear gonioscopic view. Open angles and plateau iris configurations could not be visualized with the 0.8-micron wavelength Stratus OCT.

OCT versus Ultrasound

Garcia and Rosen evaluated the clinical utility of AC Cornea OCT by comparing image results with ultrasound biomicroscopy in patients with conditions of the anterior segment.  The patients were recruited from various specialty clinics, and imaging with OCT and ultrasound was performed sequentially after obtaining informed consent.  Eighty eyes with pathologic conditions involving the anterior ocular segment were included in the study; six cases were reported in detail to demonstrate the imaging capabilities of OCT and ultrasound biomicroscopy. Comparison of OCT and ultrasound images shows that while the AC Cornea OCT has high resolution for the cornea, conjunctiva, iris, and anterior angle, ultrasound biomicroscopic images are also clear for these areas.  In addition, ultrasound biomicroscopy was found to be superior at detecting cataracts, anterior tumors, ciliary bodies, haptics, and posterior chamber intraocular lenses.  OCT was found to be superior at detecting a glaucoma tube and a metallic foreign body in the cornea when imaging was performed in the coronal plane.

2010 Update

Ideally, a diagnostic test would be evaluated based on its technical performance, diagnostic performance (sensitivity and specificity), and clinical validity.  Current literature consists primarily of assessments of qualitative and quantitative imaging and detection capabilities. Technically, the Visante OCT has the ability to create high resolution images of the anterior eye segment.  Studies indicate that the Visante OCT detects more eyes with narrow or closed angles than gonioscopy, showing high sensitivity and low specificity in comparison with the reference standard.  However, if the reference standard is flawed (e.g., does not detect all cases), the information provided by sensitivity and specificity is limited.

Evaluation of the diagnostic performance of anterior segment OCT depends, therefore, on demonstration of an improvement in clinical outcomes.  Although the resolution of the images and the ease of use might be considered advantageous, evidence is insufficient to determine whether use of OCT can improve detection and management of patients at risk of developing primary angle-closure glaucoma.  In addition, OCT imaging appears to be limited in comparison with ultrasound biomicroscopy for other pathologic conditions of the anterior segment.  Given the number of questions regarding the impact of this new technology on health outcomes, this procedure is considered investigational.

A search of the MEDLINE database to December 2010 focused on the use of anterior imaging techniques to diagnose or manage closed angle glaucoma.   Although the search identified a number of technical reviews, clinical research appears to be at an early stage of development.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
Investigational for all codes.
ICD-10 Codes
H40.20-H40.249
Procedural Codes: 92132
References
  1. Wolffsohn, J.S., and R.C. Peterson.  Anterior ophthalmic imaging.  Clinical Experimental Optomology (2006) 89(4):205-14.
  2. Nolan, W.P., See, J.L., et al.  Detection of primary angle closure using anterior segment optical coherence tomography in Asian eyes.  Ophthalmology (2007) 114(1):33-9.
  3. Kalev-Landoy, M., Day, A.C., et al.  Optical coherence tomography in anterior segment imaging. Acta Ophthalmologica Scandinavica (2007) 85(4):427-30.
  4. Garcia, J.P., Jr.and R.B. Rosen.  Anterior segment imaging: optical coherence tomography versus ultrasound biomicroscopy. Ophthalmic Surgical Lasers Imaging (2008) 39(6):476-84.
  5. Pekmezci M, Porco TC, Lin SC.  Anterior segment optical coherence tomography as a screening tool for the assessment of the anterior segment angle.  Ophthalmic Surg Lasers Imaging (2009) 40(4):389-98.
  6. Anterior Eye Segment Optical Imaging.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Manual (2009 December) Other 9.03.18.
History
June 2006 Medical Policy Development Meeting
June 2010 Medical Policy Physician's Committee Meeting/approved
June 2011 Policy reviewed; updated description, rationale, CPT Code (removed 0187T: deleted code 1/1/2011), and references
April 2012 Policy updated with literature search through November 2011; references 3, 8, and 10 added and references reordered; title changed to “Optical Coherence Tomography (OCT) of the Anterior Eye Segment” for clarity and consistency with other OCT policies; policy statement unchanged
April 2013 Title changed from "Optical Coherence Tomography (OCT) of the Anterior Eye Segment" to "Anterior Eye Segment Imaging".  Policy language and formatting revised.  No change to policy statement.
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Anterior Eye Segment Imaging