Coverage Policy Manual
Policy #: 2020002
Category: Medicine
Initiated: January 2020
Last Review: April 2024
  Ophthalmologic Techniques That Evaluate the Posterior Segment for Glaucoma

Description:
Several techniques have been developed to measure the thickness of the optic nerve/retinal nerve fiber layer (RNFL) as a method to diagnose and monitor glaucoma. Measurement of ocular blood flow is also being evaluated as a diagnostic and management tool for glaucoma.
 
Glaucoma is a disease characterized by degeneration of the optic nerve (optic disc). Elevated intraocular pressure has long been thought to be the primary etiology, but the relationship between intraocular pressure and optic nerve damage varies among patients, suggesting a multifactorial origin. For example, some patients with clearly elevated intraocular pressure will show no optic nerve damage, while other patients with marginal or no pressure elevation will, nonetheless, show optic nerve damage. The association between glaucoma and other vascular disorders such as diabetes or
hypertension suggests vascular factors may play a role in glaucoma. Specifically, it has been hypothesized that reductions in blood flow to the optic nerve may contribute to the visual field defects associated with glaucoma.
 
A comprehensive ophthalmologic exam is required for the diagnosis of glaucoma, but no single test is adequate for establishing the diagnosis. A comprehensive ophthalmologic examination includes an examination of the optic nerve by fundoscopy, evaluation of visual fields, and measurement of ocular pressure. The presence of characteristic changes in the optic nerve or abnormalities in visual field,together with increased intraocular pressure, is sufficient for a definitive diagnosis. However, some patients will show ophthalmologic evidence of glaucoma with normal intraocular pressures, therefore an elevated intraocular pressure is not essential for diagnosis.
 
Conventional management of the patient with glaucoma principally involves drug therapy, to control elevated intraocular pressures, and serial evaluation of the optic nerve to follow disease progression. Standard methods of evaluation include careful direct examination of the optic nerve using ophthalmoscopy or stereophotography, or evaluation of visual fields. There has been interest in developing more objective, reproducible techniques both to document optic nerve damage and to detect early changes in the optic nerve and retinal nerve fiber layer (RNFL) before the development of permanent visual field deficits. Specifically, evaluating changes in the thickness of the RNFL has been investigated as a technique to diagnose and monitor glaucoma. In addition, there has been interest in measuring ocular blood flow as a diagnostic and management tool for glaucoma. A variety of new techniques have been developed, as described below.
 
Techniques to Evaluate the Optic Nerve/Retinal Nerve Fiber Layer (Note: This policy only addresses uses of these techniques related to glaucoma.)  
 
Confocal Scanning Laser Ophthalmoscopy
Confocal scanning laser ophthalmoscopy (CSLO) is a laser-based image acquisition technique, which is intended to improve the quality of the examination compared to standard ophthalmologic examination. A laser is scanned across the retina along with a detector system. Only a single spot on the retina is illuminated at any time, resulting in a high-contrast image of great reproducibility that canbe used to estimate the thickness of the RNFL. In addition, this technique does not require maximal mydriasis, which may be a problem in patients with glaucoma. The Heidelberg Retinal Tomography is probably the most common example of this technology.
 
Scanning Laser Polarimetry
The RNFL is birefringent, causing a change in the state of polarization of a laser beam as it passes. A 780-nm diode laser is used to illuminate the optic nerve. The polarization state of the light emerging from the eye is then evaluated and correlated with RNFL thickness. Unlike CSLO, scanning laser polarimetry (SLP) can directly measure the thickness of the RNFL. GDx® is a common example of a scanning laser polarimeter. GDx® contains a normative database and statistical software package to allow comparison to age-matched normal subjects of the same ethnic origin. The advantages of this system are that images can be obtained without pupil dilation, and evaluation can be done in
approximately 10 minutes. Current instruments have added enhanced and variable corneal compensation technology to account for corneal polarization.
 
Optical Coherence Tomography
Optical coherence tomography (OCT) uses near-infrared light to provide direct cross-sectional measurement of the RNFL. The principles employed are similar to those used in B-mode ultrasound except light, not sound, is used to produce the 2-dimensional images. The light source can be directed into the eye through a conventional slit-lamp biomicroscope and focused onto the retina through a typical 78-diopter lens. This system requires dilation of the patient’s pupil. OCT® is an example of this technology.
 
Pulsatile Ocular Blood Flow
The pulsatile variation in ocular pressure results from the flow of blood into the eye during cardiac systole. Pulsatile ocular blood flow can thus be detected by the continuous monitoring of intraocular pressure. The detected pressure pulse can then be converted into a volume measurement using the known relationship between ocular pressure and ocular volume. Pulsatile blood flow is primarily determined by the choroidal vessels, particularly relevant to patients with glaucoma, since the optic nerve is supplied in large part by choroidal circulation.
 
Doppler Ultrasonography
Color Doppler imaging has also been investigated as a technique to measure the blood velocity in the retinal and choroidal arteries.
 
Techniques to Measure Ocular Blood Flow
A number of techniques have been developed to assess ocular blood flow. They include laser speckle flowgraphy, color Doppler imaging, Doppler Fourier domain OCT, laser Doppler velocimetry, confocal scanning laser Doppler flowmetry, and retinal functional imaging (Mohindroo, 2016).
 
Laser Speckle Flowgraphy
Laser speckle is detected when a coherent light source such as laser light is dispersed from a diffusing surface such as retinal and choroidal vessels and the circulation of the optic nerve head. The varying patterns of light can be used to determine red blood cell velocity and retinal blood flow. However, due to differences in the tissue structure in different eyes, flux values cannot be used for comparisons between eyes. This limitation may be overcome by subtracting background choroidal blood flow results from the overall blood flow results in the region of interest.
 
Color Doppler Imaging
Color Doppler imaging has also been investigated as a technique to measure the blood flow velocity in the retinal and choroidal arteries. This technique delivers ultrasound in pulsed Doppler mode with a transducer set on closed eyelids. The examination takes 30 to 40 minutes, and is most effective for the mean velocity of large ophthalmic vessels such as the ophthalmic artery, the central retinal artery, and the short posterior ciliary arteries. However, total blood flow cannot be determined with this technique, and imaging is highly dependent on probe placement.  
 
Doppler Fourier Domain OCT
Doppler Fourier domain OCT is a noncontact imaging technique that detects the intensity of the light scattered back from erythrocytes as they move in the vessels of the ocular tissue. This induces a frequency shift that represents the velocity of the blood in the ocular tissue.
 
Laser Doppler Velocimetry
Laser Doppler velocimetry compares the frequency of reflected laser light from a moving particle with stationary tissue.
 
Confocal Scanning Laser Doppler Flowmetry
Confocal scanning laser Doppler flowmetry combines laser Doppler flowmetry with confocal scanning laser omography. Infrared laser light is used to scan the retina, and the frequency and amplitude of Doppler shifts are determined from the reflected light. Determinations of blood velocity and blood volume are used to compute the total blood flow and create a physical map of retinal flow values.
 
Regulatory Status
A number of confocal scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography (OCT) devices have been cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process for imaging the posterior eye segment. For example, the RTVue XR OCT Avanti™ (Optovue) is an OCT system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc as a tool and aid in the clinical diagnosis and management of retinal diseases. The RTVue XR OCT Avanti™ with Normative Database is a quantitative tool for comparing retina, retinal nerve fiber layer, and optic disk measurements in the human eye to a database of known normal subjects. It is intended as a diagnostic device to aid in the detection and management of ocular diseases. In 2016, the RTVue XR OCT with Avanti™ with AngioVue™ Software was cleared by FDA through the 510(k) process (K153080) as an aid in the visualization of vascular structures of the retina and choroid. FDA product code: HLI, OBO.
In 2012, the iExaminer™ (Welch Allyn) was cleared for marketing by FDA through the 510(k) process. The iExaminer™ consists of a hardware adapter and associated software (iPhone® App) to capture, store, send, and retrieve images from the PanOptic™ Ophthalmoscope (Welch Allyn) using an iPhone®. FDA product code: HKI.
 
Coding
There is a CPT code for scanning computerized imaging of the optic nerve in the posterior segment:
 
92133 Scanning computerized ophthalmic diagnostic imaging, posterior segment; with interpretation and report, unilateral or bilateral; optic nerve.
 
There is also a category III CPT code for measurement of ocular blood flow by repetitive ocular blood flow measurement:
 
0198T Measurement of ocular blood flow by repetitive pressure sampling, with interpretation and report.

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Analysis of the optic nerve (retinal nerve fiber layer) in the diagnosis and evaluation of patients with glaucoma or glaucoma suspects when using scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Analysis of the optic nerve (retinal nerve fiber layer) when using scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography for all other indications not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, analysis of the optic nerve (retinal nerve fiber layer) when using scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography for all other indications not described above is considered investigational.  
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
The measurement of ocular blood flow, pulsatile ocular blood flow, or blood flow velocity in the diagnosis and follow-up of patients with glaucoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, the measurement of ocular blood flow, pulsatile ocular blood flow, or blood flow velocity in the diagnosis and follow-up of patients with glaucoma  is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
The use of various techniques of retinal nerve fiber layer (RNFL) analysis (confocal scanning laser ophthalmoscopy [CSLO], scanning laser polarimetry [SLP], optical coheretomography [OCT]) for the diagnosis and management of glaucoma was addressed by 2 TEC Assessments (2001, 2003).
 
Imaging of the Optic Nerve and RNFL
In 2012, the Agency for Healthcare Research and Quality published a comparative effectiveness review of screening for glaucoma (Ervin, 2012). Included were randomized controlled trials (RCTs), quasi-RCTs, observational cohort and case-control studies, and case series with more than 100 participants. The interventions evaluated included ophthalmoscopy, fundus photography or computerized imaging (OCT, retinal tomography, SLP), pachymetry (corneal thickness measurement), perimetry, and tonometry. No evidence was identified that addressed whether an open-angle glaucoma screening program led to a reduction in IOP, less visual impairment, reduction in visual field loss or optic nerve damage, or improvement in patient-reported outcomes. No evidence was identified on harms of a screening program. Over 100 studies were identified on the diagnostic accuracy of screening tests. However, due to the lack of a definitive diagnostic reference standard and heterogeneity in study designs, synthesis of results could not be completed.
 
A Cochrane review  assessed the diagnostic accuracy of optic nerve head and RNFL imaging for glaucoma (Michelessi, 2015). Included were 103 case-control studies and 3 cohort studies (total N=16,260 eyes) that evaluated the accuracy of recent commercial versions of OCT (spectral domain), Heidelberg Retinal Tomograph (HRT) III, or SLP (GDx VCC or ECC) for diagnosing glaucoma. The population was patients referred for suspected glaucoma, typically due to an elevated IOP, abnormal optic disc appearance, and/or an abnormal visual field identified in primary eye care. Population-based screening studies were excluded. Most comparisons examined different parameters within the 3 tests, and the parameters with the highest diagnostic odds ratio were compared. The 3 tests (OCT, HRT, SLP) had similar diagnostic accuracy. Specificity was close to 95%, while sensitivity was 70%. Because a case-control design with healthy participants and glaucoma patients was used in nearly all studies, concerns were raised about the potential for bias, overestimation of accuracy, and applicability of the findings to clinical practice.
 
A technology assessment, conducted by Lin et al for the American Academy of Ophthalmology, reviewed 159 studies, published between 2003 and 2006, evaluating optic nerve head and RNFL devices used to diagnose or detect glaucoma progression (Lin, 2007). The assessment concluded: “The information obtained from imaging devices is useful in clinical practice when analyzed in conjunction with other relevant parameters that define glaucoma diagnosis and progression.” Management changes for patients diagnosed with glaucoma may include the use of IOP-lowering medications, monitoring for glaucoma progression, and potentially surgery to slow the progression of glaucoma.
 
Numerous studies and systematic reviews have described findings from patients with glaucoma using CSLO, SLP, and OCT. Although the specificity in these studies was high, it is likely that accuracy was overestimated due to the case-control designs used in the studies. The literature and specialty society guidelines have indicated that optic nerve analysis using CSLO, SLP, and OCT are established add-on tests that can be used with other established tests to improve the diagnosis and direct management of patients with glaucoma and those who are glaucoma suspects. Management changes for patients diagnosed with glaucoma may include the use of IOP-lowering medications, monitoring for glaucoma progression, and potentially surgery.
 
Evaluation of Ocular Blood Flow
Abegao Pinto et al reported on the results from the prospective, cross-sectional, case-control, Leuven Eye Study, which included 614 individuals who had primary open-angle glaucoma (n=214), NTG (n=192), ocular hypertension (n=27), suspected glaucoma (n=41), or healthy controls (n=140) (Abegao, 2016). The study objective was to identify the blood flow parameters most highly associated with glaucoma using technology commonly available in an ophthalmologist’s office or hospital radiology department. Assessment of ocular blood flow included CDI, retinal oximetry, dynamic contour tonometry, and OCT enhanced-depth imaging of the choroid. The glaucoma groups had higher perfusion pressure thancontrols (p<0.001), with lower velocities in both central retinal vessels (p<0.05), and choroidal thickness asymmetries. The NTG group, but not the primary open-angle glaucoma group, had higher retinal venous saturation thanhealthy controls (p=0.005). There were no significant differences in macular scans. The diagnostic accuracy and clinical utility were not addressed.
 
Kurysheva et al compared ocular blood flow with choroidal thickness to determine which had a higher diagnostic value for detecting early glaucoma (Kurysheva, 2017). Thirty-two patients with pre-perimetric glaucoma were matched with 30 control patients. Using OCT, RNFL thickness between groups was found to be comparable; the ganglion cell complex was thicker in the control patients, and there was no significant difference between groups for choroid foveal loss volume. Mean blood flow velocity in the vortex veins had the highest area under the receiver operating characteristic curve ROC (1.0) and z-value (5.35). Diastolic blood flow velocity in the central retinal artery had a diagnostic value of 2.74 and area under the receiver operating characteristic curve of 0.73. The authors concluded that this study suggested a diagnostic benefit in measuring blood flow velocities.
 
Witkowska et al investigated blood flow regulation using laser speckle flowgraphy in 27 individuals (Witkowska, 2017). In this prospective study, the authors specifically looked at mean blur rate blood flow in the optic nerve head and a peripapillary region. First, participants’ blood flow was measured when they were in a sitting position; then, participants were asked to perform an isometric “squatting” exercise for 6 minutes. Compared with baseline (sitting), exercise significantly increased ocular perfusion blood pressure (78.5%), mean blur rate in the tissue of the optic nerve head (18.1%), and mean blur rate in the peripapillary region (21.18.3%) (p<0.001). Few studies have used laser speckle flowgraphy to study autoregulation of ocular blood flow during a change in blood pressure, and this study is limited to Japanese populations. Despite the lack of literature and limited population, the authors noted laser speckle flowgraphy could be a valuable tool to study the regulation of blood flow in the optic nerve head, particularly in patients suspected of having glaucoma or patients who have glaucoma.
 
Rusia et al reported on use of CDI in normal and glaucomatous eyes (Rusia, 2011). Using data from other studies, a weighted mean was derived for the peak systolic velocity, end-diastolic velocity, and Pourcelot Resistive Index in the ophthalmic, central retinal, and posterior ciliary arteries. Data from 3061 glaucoma patients and 1072 controls were included. Mean values for glaucomatous eyes were within 1 standard deviation of the values for controls for most CDI parameters. Methodologic differences created interstudy variance in CDI values, complicating the construction of a normative database and limiting its utility. The authors noted that because the mean values for glaucomatous and normal eyes had overlapping ranges, caution should be used when classifying glaucoma status based on a single CDI measurement.
 
Techniques to measure ocular blood flow or ocular blood velocity are being evaluated for the diagnosis of glaucoma. Data for these techniques remain limited. Current literature focuses on which technologies are most reliably associated with glaucoma. Literature reviews have not identified studies that suggest whether these technologies improve the diagnosis of glaucoma or whether measuring ocular blood flow in patients with glaucoma or suspected glaucoma improves health outcomes.
 
For individuals who have glaucoma or suspected glaucoma who receive imaging of the optic nerve and RNFL, the evidence includes studies on diagnostic accuracy. Relevant outcomes are test accuracy, symptoms, morbid events, functional outcomes, and medication use. CSLO, SLP, and OCT can be used to evaluate the optic nerve and RNFL in patients with glaucoma and suspected glaucoma. Numerous articles have described findings from patients with known and suspected glaucoma using CSLO, SLP, and OCT. These studies have reported that abnormalities may be detected on these examinations before functional changes are noted. The literature and specialty society guidelines have indicated that optic nerve analysis using CSLO, SLP, and OCT are established add-on tests that may be used to diagnose and manage patients with glaucoma and suspected glaucoma. These results are often considered along with other findings to make diagnostic and therapeutic decisions about glaucoma care, including use of topical medication, monitoring, and surgery to lower IOP. Thus, accurate diagnosis of glaucoma would be expected to reduce the progression of glaucoma. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
 
For individuals who have glaucoma or suspected glaucoma who receive evaluation of ocular blood flow, the evidence includes association studies. Relevant outcomes are test accuracy, symptoms, morbid events, functional outcomes, and medication use. Techniques to measure ocular blood flow or ocular blood velocity are used to determine appropriate glaucoma treatment options. The data for these techniques remain limited. Literature reviews have not identified studies addressing whether these technologies improve diagnostic accuracy or whether they improve health outcomes in patients with glaucoma. Some have suggested that these parameters may inform understanding of the variability in visual field changes in patients with glaucoma, ie, they may help explain why patients with similar levels of IOP develop markedly different visual impairments. However, data on use of ocular blood flow, pulsatile ocular blood flow, and/or blood flow velocity are currently lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
SUPPLEMENTAL INFORMATION
 
Clinical Input From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
 
In response to requests, input was received from 1 physician specialty society and 3 academic medical centers while this policy was under review in 2009. Most reviewers supported use of confocal scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography in the care of patients with glaucoma and those with suspected glaucoma suspect. Reviewers provided data to demonstrate that this testing is equivalent to expert assessment of optic disc photography for both detecting glaucoma and showing disease progression. Reviewers also commented on favorable aspects of this testing. For example, unlike other glaucoma testing, these tests can be done more easily (eg, testing does not always need to be done with dilated pupils) and ambient light level may be (is) less critical. In addition, while serial stereophotographs of the optic nerves are considered by many as the criterion standard, they are not always practical, especially for general ophthalmologists. This testing also requires less cooperation from the patient, which can help when evaluating some older patients.
 
Practice Guidelines and Position Statements
American Academy of Ophthalmology
The American Academy of Ophthalmology issued 2 preferred practice patterns on primary open-angle glaucoma suspect and primary open-angle glaucoma, both recommending evaluation of the optic nerve and retinal nerve fiber layer (RNFL) (AAO, 2015; AAO, 2018). The documents stated that “Although they are distinctly different methodologies, stereoscopic disc photographs and computerized images of the nerve are complementary with regard to the information they provide the clinician who must manage the patient.” The guidelines described 3 types of computer-based imaging devices (confocal scanning laser ophthalmoscopy, scanning laser polarimetry, optical coherence tomography) currently available for glaucoma, which are similar in their ability to distinguish glaucoma from controls and noted that “computer-based digital imaging of the ONH [optic nerve head] and RNFL is routinely used to provide quantitative information to supplement the clinical examination of the optic nerve…. One rationale for using computerized imaging is to distinguish glaucomatous damage from eyes without glaucoma when thinning of the RNFL is measured, thereby facilitating earlier diagnosis and detection of optic nerve damage”. In addition, the Academy concluded that, as device technology evolves, the performance of diagnostic imaging devices is expected to improve.
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below.
 
Ongoing Clinical Trials:
NCT01957267 Longitudinal Observational Study Using Functional and Structural Optical Coherence Tomography to Diagnose and Guide Treatment of Glaucoma
Planned Enrollment: 160
Estimated Completion Date: December 2022
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A technology assessment, conducted by WuDunn et al for the AAO, reviewed 75 articles published through June 2020, evaluating the utility of optical coherence tomography angiography of the peripapillary or macular regions to help detect glaucomatous damage associated with the diagnosis of primary open-angle glaucoma (WuDunn, 2021). Per the AAO, the majority of data demonstrates that peripapillary microcirculation measured by vessel density on optical coherence tomography angiography is decreased in glaucomatous versus healthy eyes. Therefore, this technology can be helpful in detecting vessel density loss associated with glaucoma. Furthermore, peripapillary, macular, and choroidal vessel density parameters may complement visual field and structural optical coherence tomography measurements in the diagnosis of glaucoma.
 
Gu et al published a systematic review with meta-analysis evaluating the diagnostic value of laser speckle flowgraphy in glaucoma by investigating the mean blur rate in the optic nerve head (Gu, 2021). A total of 15 studies, including 692 glaucomatous and 386 healthy eyes, were included; only 1 study was based in the US. Briefly, the mean blur rate was significantly reduced in glaucomatous versus healthy eyes in the entire area, indicating that blood flow velocity in all areas of the optic nerve head was lower in glaucomatous eyes. Furthermore, the mean blur rate was significantly reduced in glaucomatous versus healthy eyes in the tissue area, indicating that there is insufficient blood supply in the deep fundus tissues and optic nerve head ischemia in glaucomatous eyes. Lastly, the mean blur rate was significantly reduced in glaucomatous versus healthy eyes in the vascular area, indicating that patients with glaucoma have an insufficient retinal blood supply. The authors concluded that while laser speckle flowgraphy is a feasible diagnostic tool for glaucoma, more prospective studies are needed to fully evaluate this technology.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A systematic review, conducted by Chou et al, was commissioned by the US Preventive Services Task Force (USPSTF) to update its recommendations on screening for glaucoma in adults (Chou, 2022). A total of 83 studies were included, of which 53 evaluated the diagnostic accuracy of screening tests (optical coherence tomography, optic disc photography, ophthalmoscopy and biomicroscopy, pachymetry, tonometry, and visual fields). Most studies evaluated spectral-domain optical coherence tomography (29 studies; n=11,434). Retinal nerve fiber layer thickness on spectral-domain optical coherence tomography was associated with a pooled sensitivity of 0.79 (95% confidence interval [CI], 0.75 to 0.83) and specificity of 0.92 (95% CI, 0.87 to 0.96) for distinguishing between glaucomatous eyes and controls, based on 15 studies; the pooled area under the receiver operating characteristic curve was 0.90 (95% CI, 0.86 to 0.93), based on 16 studies. Evidence on diagnostic accuracy was also robust for tonometry and the Humphrey Visual Field Analyzer but limited for other screening tests.
 
The U.S. Preventative Task Force (USPSTF) published recommendations on screening for primary open-angle glaucoma in adults (40 years or older) in 2022 (Mangione, 2022). Based on findings from the systematic review by Chou et al, the USPSTF concluded that the evidence is insufficient to assess the balance of benefits and harms of screening in these patients. This recommendation is consistent with the previous 2013 statement. With regard to screening tests, the USPSTF states: "Diagnosis of open-angle glaucoma is based on a combination of tests showing degenerative changes in the optic disc, increased IOP [intraocular pressure], and defects in visual fields... Imaging tests such as optical coherence tomography (OCT) or spectral-domain OCT (which analyzes the spectrum of reflected light on the retina) and optic disc photography (to view the optic nerve head, retina, or both) can supplement the clinical examination."
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
0198TMeasurement of ocular blood flow by repetitive intraocular pressure sampling, with interpretation and report
92133Scanning computerized ophthalmic diagnostic imaging, posterior segment, with interpretation and report, unilateral or bilateral; optic nerve

References: Abegao Pinto L, Willekens K, Van Keer K, et al.(2016) Ocular blood flow in glaucoma - the Leuven Eye Study. Acta Ophthalmol. Sep 2016;94(6):592-598. PMID 26895610

American Academy of Ophthalmology.(2015) Preferred Practice Pattern: Primary open-angle suspect. 2015; http://www.aaojournal.org/article/S0161-6420(15)01278-6/pdf. Accessed February 26, 2018.

Bafa M, Lambrinakis I, Dayan M, et al.(2001) Clinical comparison of the measurement of the IOP with the ocular blood flow tonometer, the Tonopen XL and the Goldmann applanation tonometer. Acta Ophthalmol Scand. Feb 2001;79(1):15-18. PMID 11167279.

Blue Cross and Blue Shield Technology Evaluation Center (TEC).(2001) Retinal nerve fiber analysis for the diagnosis and management of glaucoma. TEC Assessments. 2001;Volume 16:Tab 13.

Blue Cross and Blue Shield Technology Evaluation Center (TEC).(2003) Retinal nerve fiber layer analysis for the diagnosis and management of glaucoma. TEC Assessments. 2003;Volume 18:Tab 7.

Chou R, Selph S, Blazina I, et al.(2022) Screening for Glaucoma in Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. May 24 2022; 327(20): 1998-2012. PMID 35608575

Ervin AM, Boland MV, Myrowitz EH, et al.(2012) Screening for Glaucoma: Comparative Effectiveness (Comparative Effectiveness Review No. 59). Rockville, MD: Agency for Healthcare Research and Quality; 2012.

Gu C, Li A, Yu L.(2021) Diagnostic performance of laser speckle flowgraphy in glaucoma: a systematic review and meta-analysis. IntOphthalmol. Nov 2021; 41(11): 3877-3888. PMID 34327617

Harris A, Kagemann L, Ehrlich R, et al.(2008) Measuring and interpreting ocular blood flow and metabolism in glaucoma. Can J Ophthalmol. Jun 2008;43(3):328-336. PMID 18443609.

Kurysheva NI, Parshunina OA, Shatalova EO, et al.(2017) Value of structural and hemodynamic parameters for the early detection of primary open-angle glaucoma. Curr Eye Res. Mar 2017;42(3):411-417. PMID 27341295.

Lin SC, Singh K, Jampel HD, et al.(2007) Optic nerve head and retinal nerve fiber layer analysis: a report by the American Academy of Ophthalmology. Ophthalmology. Oct 2007;114(10):1937-1949. PMID 17908595.

Mangione CM, Barry MJ, Nicholson WK, et al.(2022) Screening for Primary Open-Angle Glaucoma: US Preventive Services Task Force Recommendation Statement. JAMA. May 24 2022; 327(20): 1992-1997. PMID 35608574

Michelessi M, Lucenteforte E, Oddone F, et al.(2015) Optic nerve head and fibre layer imaging for diagnosing glaucoma. Cochrane Database Syst Rev. Nov 30 2015(11):CD008803. PMID 26618332.

Mohindroo C, Ichhpujani P, Kumar S.(2016) Current imaging modalities for assessing ocular blood flow in glaucoma. J Curr Glaucoma Pract. Sep-Dec 2016;10(3):104-112. PMID 27857490.

Rusia D, Harris A, Pernic A, et al.(2011) Feasibility of creating a normative database of colour Doppler imaging parameters in glaucomatous eyes and controls. Br J Ophthalmol. Sep 2011;95(9):1193-1198. PMID 21106991.

Schmidl D, Garhofer G, Schmetterer L.(2011) The complex interaction between ocular perfusion pressure and ocular blood flow - relevance for glaucoma. Exp Eye Res. Aug 2011;93(2):141-155. PMID 20868686.

Shiga Y, Omodaka K, Kunikata H, et al.(2013) Waveform analysis of ocular blood flow and the early detection of normal tension glaucoma. Invest Ophthalmol Vis Sci. Nov 2013;54(12):7699-7706. PMID 24130177.

Witkowska KJ, Bata AM, Calzetti G, et al.(2017) Optic nerve head and retinal blood flow regulation during isometric exercise as assessed with laser speckle flowgraphy. PLoS One. Sep 12 2017;12(9):e0184772. PMID 28898284.

WuDunn D, Takusagawa HL, Sit AJ, et al.(2021) OCT Angiography for the Diagnosis of Glaucoma: A Report by the American Academy of Ophthalmology. Ophthalmology. Aug 2021; 128(8): 1222-1235. PMID 33632585


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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