Archived Policies - Other
*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*
Corneal hysteresis (CH) determination by air impulse stimulation for the diagnosis and management of glaucoma and corneal disorders is considered experimental, investigational and/or unproven.
Glaucoma is a group of diseases that damage the eye’s optic nerve and is a leading cause of blindness. Intraocular pressure measurements are used in the management of glaucoma; however it is not the only criteria by which glaucoma is diagnosed. Intraocular pressure is a risk factor that can be modified. (1)
Accurate intraocular pressure measurements began in 1950 with the Goldman applanation tonometer and it is still the most used tonometer in the world. The principle on which applanation tonometers are founded is in a thin-walled sphere; the internal pressure can be closely approximated by the force in grams necessary to flatten (applanate) a specific area. Other physical properties of the thin-walled sphere can affect the force needed to flatten the wall such as elasticity (or its opposite, rigidity), thickness, and compressibility. (1)
A version of tonometry is a non-contact tonometry such as the Ocular Response Analyzer®. The Ocular Response Analyzer measures corneal hysteresis (CH), which is an indication of the biomechanical properties of the cornea. This device is essentially an air puff tonometer, in which a column of air keeps increasing in force until the cornea is indented. The force of the air column is decreased until applanation is again achieved. The difference in the pressures at the two applanation points is a measure of corneal elasticity (hysteresis). (1) Measurement of the biomechanical properties of the cornea allows the device to provide a corneal compensated intraocular pressure. One of the clinical applications proposed for the Ocular Response Analyzer is that the CH measurement provides clinicians a new method to assist in identifying those patients at risk of glaucoma progression. (2)
Through the U.S. Food and Drug Administration (FDA) 510(k) process Ocular Response Analyzer (ORA) (Reichert, Inc.) received clearance in January 2004 for the following indicated use: To measure intra-ocular pressure of the eye and the biomechanical response of the corneal for the purpose of aiding in the diagnosis and monitoring of glaucoma. (3)
This medical policy was originally created in 2015 and has been updated with searches of the MEDLINE database. The most recent literature search was performed through June 2017. The following is a summary of the key literature to date.
In a systematic review by Cook et al. the objective noted was to assess the agreement of the Goldmann applanation tonometer (GAT), the most commonly accepted reference device with tonometers available for clinical practice. (4) Eight tonometers were represented: dynamic contour tonometer, noncontact tonometer (NCT), ocular response analyzer, Ocuton S, handheld applanation tonometer (HAT), rebound tonometer, transpalpebral tonometer, and Tono-Pen. The following results of 102 studies, including 130 paired comparisons were noted by the authors: The agreement (95% limits) seemed to vary across tonometers: 0.2 mmHg (-3.8 to 4.3 mmHg) for the NCT to 2.7 mmHg (-4.1 to 9.6 mmHg) for the Ocuton S. The estimated proportion within 2 mmHg of the GAT ranged from 33% (Ocuton S) to 66% and 59% (NCT and HAT, respectively). Substantial inter- and intraobserver variability were observed for all tonometers. Conclusions noted by the authors were NCT and HAT seem to achieve a measurement closest to the GAT. However, there was substantial variability in measurements both within and between studies.
In a prospective cross-sectional study, Kaushik et al. evaluated corneal biomechanical properties across the glaucoma spectrum. (5) The relationship between these measurements and intraocular pressure measured by Goldmann applanation tonometry (GAT-IOP) and central corneal thickness (CCT) were studied. Participants (71 normal, 101 glaucoma suspect [GS], 38 ocular hypertension [OHT], 59 primary angle-closure disease [PACD], 36 primary open-angle glaucoma [POAG], and 18 normal-tension glaucoma [NTG]) who had received no ophthalmic treatment were included in the study. The authors noted the following results: Corneal hysteresis (CH) measurements were significantly less in POAG and NTG compared to normal subjects (P=.034 and P=.030 respectively), regardless of the intraocular pressure. The corneal resistance factor (CRF) was significantly less in NTG and maximum in POAG and OHT. Regression analysis with CH as dependent variable showed significant association with GAT-IOP and CRF (P < .001) but not CCT, persisting on multivariate analysis (adjusted R(2) = 0.483). GAT-IOP correlated strongly with Goldmann-correlated IOP on the ORA (IOPg) (r = 0.82; P < .001), but limits of agreement between the measurements were poor. Conclusions noted by the authors included: CH and CRF may constitute a pressure-independent risk factor for glaucoma. CRF appears to influence GAT-IOP measurements more than simple geometric thickness measured by CCT. However, IOP measurements from the Ocular Response Analyzer (ORA) are not interchangeable with, and are unlikely to replace, Goldmann applanation tonometry at the present time.
Nessim et al. using multiple tonometry devices investigated the relationship between measured intraocular pressure (IOP) and central corneal thickness (CCT), CH and CRF in OHT primary open-angle and normal tension glaucoma eyes. (6) The following four devices were used in measuring the IOP: Goldmann applanation tonometry (GAT); Pascal dynamic contour tonometer (DCT); Reichert ocular response analyzer (ORA); and Tono-Pen XL. The following results were reported by the authors: Compared to the GAT, the Tonopen and ORA Goldmann equivalent (IOPg) and corneal compensated (IOPcc) measured higher IOP readings (F=19.351, p<0.001), particularly in NTG (F=12.604, p<0.001). DCT was closest to Goldmann IOP and had the lowest variance. CCT was significantly different (F=8.305, p<0.001) between the 3 conditions as was CH (F=6.854, p=0.002) and CRF (F=19.653, p<0.001). IOPcc measures were not affected by CCT. The DCT was generally not affected by corneal biomechanical factors. The authors concluded that the study suggested that measurements from any tonometer should be interpreted with care, particularly when alterations in the corneal tissue are suspected, the true pressure of the eye cannot be determined non-invasively.
Mubig et al. investigated how modern screening methods support the diagnosis of keratoconus. (7) A prospective study that included 93 eyes of 93 keratoconus patients and 107 eyes of 107 healthy subjects (control group) was conducted. Exclusion criteria for both groups included previous eye surgery, cross-linking therapy, glaucoma, uveitis or other inflammatory diseases of the eye. As well as all patients with a thyroid disorder were excluded from the control group. Devices used to examine participants’ eyes included; TMS-5 topographer, Pentacam and Ocular Response Analyzer (ORA). The authors note in their results that all parameters showed statistically highly significant differences between the keratoconus and control group (p ≤ 0.0001). The ORA indices CH, CRF and Keratoconus Match Index (KMI) showed slightly poorer performance with CH (8.22/11.48/0.909), CRF (7.25/11.20/0.951), and KMI (0.31/1.05/0.909). In this study, the authors concluded tomography and topography was more reliable in diagnosing keratoconus than evaluating the biomechanical properties of the cornea. Surface Asymmetry Index (SAI) and Keratoconus Severity Index (TMS) as well as Topographic keratoconus Classification (TKC) and Index of Surface Variance (Pentacam) showed improved recognition rates compared to the Keratoconus Match Index (ORA). However, individual parameters alone are not sufficient for the diagnosis of keratoconus.
In another study concerning keratoconic eyes, the relationship of corneal biomechanical properties to refraction and corneal aberrometry were evaluated by Pinero et al. (9) Three groups, noted as mild, moderate and severe, were differentiated according to the severity of keratoconus. Evaluations made included visual acuity, refraction, corneal topography, and corneal aberrations. Additionally, corneal biomechanics were analyzed in relation to two parameters: corneal resistance factor and corneal hysteresis. Results noted by the authors included: CH and CRF in the severe keratoconus group were significantly lower than those in the other two groups (P < or = 0.01). A significant difference in CRF was found between mild and moderate cases (P = 0.04). A moderate correlation was found between the CRF and mean keratometry in the overall sample (r = -0.564). In addition, multiple regression analysis revealed that CRF correlated significantly with keratometry and the corneal spherical-like RMS (R(2) = 0.40, P < 0.01). The authors concluded the following CRF correlates with the magnitude of corneal spherical-like aberrations, especially in severe keratoconus and should be considered an additional factor in keratoconus grading.
In 2012, Mansouri et al. conducted an observational cross-sectional study to investigate the association between corneal biomechanical parameters and the severity of glaucoma. (10) The study included a total of 299 eyes of 191 patients with confirmed (148) or suspected (151) glaucoma. CH and CRF were obtained from all participants.Both were positively associated with mean defect (MD) (R(2) = 0.03; P<.01 and R(2) = 0.10; P< .01, respectively). In multivariable analysis, the association between CRF and MD remained significant while CH to MD did not (P < .01 and P = .77). In the GDx enhanced corneal compensation (ECC) subgroup (204 eyes), there was a weak association between CH and CRF and average retinal nerve fiber layer (RNFL) thickness (R(2) = 0.07; P < .01 and R(2) = 0.05; P < .01, respectively), which was not observed in the spectral domain optical coherence tomography (SD-OCT) subgroup (146 eyes) (R(2) = 0.01; P = .30 and R(2) = 0.01; P = .21). After adjusting for central corneal thickness, age, and axial length, the relationship of CH and CRF to RNFL thickness no longer reached statistical significance. The authors concluded that there was only a week relationship between corneal biomechanical parameters and measures of structural and functional damage in glaucoma.
Nongpiur et al. (2015) investigated the association between CH and CRF with glaucoma severity in primary angle closure glaucoma (PACG). Investigators recruited 204 subjects with PACG. (11) Each subject underwent CH and CRF measurements using the ORA, optic nerve head topography measurement using scanning laser ophthalmoscopy, and visual field assessment. Glaucoma severity was based on the visual field MD and classified as mild (71), moderate (55), and severe (78). Corneal hysteresis and CRF were lowest in the severe PACG group (9.32 ± 1.86 and 9.50 ± 1.67 mm Hg) followed by moderate PACG (9.38 ± 1.88 and 9.73 ± 1.88 mm Hg) and mild PACG (9.47 ± 1.90 and 9.85 ± 1.75 mm Hg) respectively, but the differences were not significant (P = 0.89 and P = 0.46, respectively). There was a significant positive correlation between CH and central corneal thickness (CCT) (correlation coefficient [r] = 0.26, P < 0.001), CRF and CCT (r = 0.43, P < 0.001), and negative correlation between CRF and vertical cup-disc ratio (VCDR) (r = -0.20, P = 0.004), and CRF with cup-disc area (r = -0.14, P = 0.04). Corneal hysteresis and CRF were not correlated with MD (r = 0.01 for CH, r = 0.1 for CRF). After multivariate analyses, adjusting for age, sex, CCT, axial length, intraocular pressure, and number of glaucoma medication, no significant associations were noted between CH and CRF with MD, VCDR, disc area, rim area, or cup area. Authors concluded that corneal biomechanical parameters measured by the ORA are not associated with severity of glaucoma in PACG. (11)
Practice Guidelines and Position Statements
The American Academy of Ophthalmology (AAO) Preferred Practice Patterns for both Primary Open-Angle Glaucoma and for Primary Open-Angle Glaucoma Suspect (2015) state that low corneal hysteresis is associated with glaucoma progression. (12, 13)
Intraocular pressure monitoring is used in the management of glaucoma patients. Accurate IOP measurements are necessary in that intraocular pressure is a risk factor that may be modified to help manage the progression of glaucoma. The measurement of corneal hysteresis has also been investigated in other corneal disorders. At this time there is insufficient evidence available from the peer reviewed literature to demonstrate that clinical management or that health outcomes are improved by the measurement of corneal hysteresis.
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.
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.
The following codes may be applicable to this Medical policy and may not be all inclusive.
ICD-9 Diagnosis Codes
Refer to the ICD-9-CM manual
ICD-9 Procedure Codes
Refer to the ICD-9-CM manual
ICD-10 Diagnosis Codes
Refer to the ICD-10-CM manual
ICD-10 Procedure Codes
Refer to the ICD-10-CM manual
The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.
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. Stamper, Robert L. MD. A History of Intraocular Pressure and Its Measurement. Optometry and Vision Science: January 2011 Volume 88, Issue 1. pp E16-28. PMID 21150677
2. Clinical Applications of the Ocular Response Analyzer: Glaucoma (Product information). Available at: <http://www.reichert.com> (accessed on 2014 October 14).
3. FDA – Summary Ocular Response Analyzer. Food and Drug Administration. Available at: <http://www.fda.gov> (accessed 2014 October 14).
4. Cook, J., Botello, A., et al. Systematic review of the agreement of tonometers with Goldmann applanation tonometry. Ophthalmology. 2012 Aug; 119(8): 1552-7. Epub 2012 May 10. PMID 22578443
5. Kaushik S., Pandav, S., et al. Relationship between corneal biomechanical properties, central corneal thickness and intraocular pressure across the spectrum of glaucoma. Am J Ophthalmol. 2012 May: 153(5):840-849.e2. PMID 22310080
6. Nessim M., Mollan S., et al. The relationship between measurement method and corneal structure on apparent intraocular pressure in glaucoma and ocular hypertension. Cont Lens Anterior Eye. 2013 Apr; 36(2):57-61. PMID 23253796
7. Mubig, L., Zemova, E., et al. A comparison of Device-Based Diagnostic Methods for keratoconus. Klin Monbl Augenheilkd. 2014 Jul 15. [Epub ahead of print]. PMID 25025647
8. Facts about Glaucoma. NIH. National Eye Institute. Available at: <http://www.nei.nih.gov> (accessed 2014 October 15).
9. Pinero, D., Alio J., et al. Corneal biomechanics, refraction and corneal aberrometry in keratoconus: an integrated study. Invest Ophthalmol Vis Sci. 2010 Apr: 51(4): 1948-55. PMID 19907021
10. Mansouri K, Leite MT, Weinreb RN, et al. Association between corneal biomechanical properties and glaucoma severity. Am J Ophthalmol. 2012 Mar; 153(3):419-427. PMID 22018707
11. Nongpiur ME, Png O, Chiew JW, et al. Lack of association between corneal hysteresis and corneal resistance factor with glaucoma severity in primary angle closure glaucoma. Invest Ophthalmol Vis Sci. 2015; 56(11):6879-6885. PMID 26517405
12. American Academy of Ophthalmology (AAO). Primary open-angle glaucoma. Preferred Practice Pattern. October 2010. Updated 2015. Available at: <https://www.aao.org> (accessed 2017 June 16).
13. American Academy of Ophthalmology (AAO). Primary open-angle glaucoma suspect. Preferred Practice Pattern. October 2010. Updated 2015. Available at: <https://www.aao.org> (accessed 2017 June 16).
|7/15/2017||Document updated with literature review. Coverage unchanged.|
|9/1/2016||Reviewed. No changes.|
|1/1/2015||New medical document. Corneal hysteresis (CH) determination by air impulse stimulation for the diagnosis and management of glaucoma and corneal disorders is considered experimental, investigational and/or unproven.|