CIRRUS PHOTO

K112184 · Carl Zeiss Meditec, Inc. · OBO · Jun 18, 2012 · Ophthalmic

Device Facts

• Record ID: K112184
• Device Name: CIRRUS PHOTO
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Jun 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2

Intended Use

The CIRRUS photo (Models 600 and 800) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions. These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea. It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Device Story

Non-contact, high-resolution digital tomographic and biomicroscopic imaging device; merges fundus camera and spectral domain optical coherence tomography (SD-OCT) into single system. Uses shared beam delivery for imaging and scanning. Captures retinal/ocular images and cross-sectional data; processes data to provide quantitative measurements of RNFL, ONH, and macular thickness. Includes normative database for comparison against known normal subjects. Operated by clinicians in eye care settings. Output displayed for visual monitoring and photographic documentation of ocular diseases; aids diagnosis and management decisions. Benefits include integrated workflow for comprehensive posterior and anterior segment assessment.

Clinical Evidence

Two prospective studies (normal eyes, n=63; diseased eyes, n=73) evaluated comparability, repeatability, and reproducibility of 31 measurement parameters (RNFL, ONH, macular thickness) against Cirrus HD-OCT Model 4000. Results showed mean values were very similar between devices. Repeatability and reproducibility were established using ANOVA with random effect models; device demonstrated good performance for both normal and diseased eyes. Regression analysis supported the use of existing normative databases.

Technological Characteristics

Non-contact, high-resolution digital tomographic and biomicroscopic imaging system. Combines fundus camera and spectral domain optical coherence tomography (SD-OCT). Features include fluorescein angiography (FA), indocyanine green angiography (ICGA), and fundus autofluorescence filters. System utilizes shared beam delivery for imaging and scanning. Electrical and optical safety verified to applicable standards.

Indications for Use

Indicated for in vivo viewing, axial cross-sectional, and 3D imaging/measurement of posterior ocular structures (retina, RNFL, macula, optic disc) and anterior ocular structures (cornea) in patients requiring eye disease monitoring. Used for detection and management of conditions including macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma. Suitable for mydriatic and non-mydriatic conditions.

Regulatory Classification

Identification

An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

Special Controls

*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268)
• Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer (K083291; K111157)
• Carl Zeiss Meditec FF450 plus Fundus Camera (K011877)
• Topcon TRC-NW8F (K100207)
• Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470)

Submission Summary (Full Text)

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# 510(K) SUMMARY

#### 510(K) SUMMARY

JUN 1 8 2012

This 510(k) Summary information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

## SUBMITTER NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED

Applicant:

Carl Zeiss Meditec AG Goeschwitzer Strasse 51-52 07745 Jena 'Germany

Contact Person:

Judith A. Brimacombe, MA Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 USA [e-mail] Tel: [phone] Fax: [phone]

Summary Prepared:

June 14, 2012

Fundus Camera

## NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME

Trade/Proprietary Name:

CIRRUS photo Models 600 and 800

Optical Coherence Tomography

Tomography, Optical coherence Camera, Ophthalmic, AC-powered

Common/Usual Name:

Classification Name:

Product Code and Class:

OBO - Class II HKI - Class II

Classification Number:

886.1570 886.1120

1

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## PREDICATE DEVICES

The CIRRUS photo (Models 600 and 800) is substantially equivalent to the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT Optical Coherence Tomographer with Retinal Nerve Fiber Layer (RNFL), Macular and Optic Nerve Head Normative Databases, Model 4000 (K083291; K111157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D Optical Coherence Tomography 3D OCT-2000 (K092470).

The CIRRUS photo is substantially equivalent to these cleared devices with regard to indications for use and technological characteristics.

#### DEVICE DESCRIPTION

The CIRRUS photo is a non-contact, high resolution digital, tomographic and biomicroscopic imaging device that merges fundus imaging and optical coherence tomography into a single device. To optimize the workflow, the system applies the same beam delivery system for imaging and scanning.

#### INDICATIONS FOR USE

The CIRRUS photo is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera which is suitable for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic and non-mydriatic conditions.

These photographs support the diagnosis and subsequent observation of eye diseases which can be visually monitored and photographically documented. The CIRRUS photo is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula, and optic disc as well as imaging of anterior ocular structures, including the cornea.

It also includes a Retinal Nerve Fiber Layer (RNFL), Optic Nerve Head (ONH), and Macular Normative Database which is a quantitative tool for the comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

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#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The CIRRUS photo has very similar indications for use and operating characteristics as the predicate devices. The CIRRUS photo combines into a single system the functionalities and indications for use from each of the predicate devices.

The fundus camera unit of the CIRRUS photo utilizes the same imaging properties and technology as the cleared VISUCAM PRO NM Digital Camera to record morphologic images of the human retina under mydriatic and non-mydriatic conditions, respectively. The spectral domain optical coherence tomographer SD-OCT Module is the same optical coherence tomography system as in the cleared Cirrus HD-OCT Optical Coherence Tomographer, Model 4000 (K083291; K111157). The CIRRUS photo includes the fluorescein angiography (FA), and indocyanine green angiography (ICGA) functionalities of the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877) and also contains filters for Fundus Autofluorescence. Filters for Fluorescein Angiography, ICG Angiography, and Fundus Autofluorescence are available in the Topcon TRC-NW8F (K100207). The Topcon 3D Optical Coherence Tornography 3D OCT-2000 (K092470), like the CIRRUS photo, incorporates a high resolution fundus camera with a Spectral Domain Optical Coherence Tomographer.

The CIRRUS photo is therefore substantially equivalent to the predicate devices. i.e., the Carl Zeiss Meditec VISUCAM PRO NM Digital Camera (K052268), the Carl Zeiss Meditec Cirrus HD-OCT, Model 4000 (K083291; K11157), the Carl Zeiss Meditec FF450 plus Fundus Camera (K011877), the Topcon TRC-NW8F (K100207), and the Topcon 3D OCT-2000 (K092470).

#### BRIEF SUMMARY OF NONCLINICAL AND CLINICAL TESTS AND RESULTS

The CIRRUS photo has been designed and tested to the applicable standards for electrical and optical safety and verified to established specifications. In addition, the following clinical testing, which includes repeatability and reproducibility, was performed.

## CLINICAL TESTING

Two prospective studies were conducted to determine comparability, repeatability and reproducibility of the measurement data between the CIRRUS photo and Cirrus HD-OCT Model 4000 instruments.

#### NORMAL EYES STUDY

Sixty-three normal subjects were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two phases. Thirty subjects were enrolled in Phase 1 that evaluated inter-operator variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three Macular Cube 512x128 scans were taken on the fellow eye by each of the four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument. Thirty-three subjects were enrolled in Phase 2 that evaluated interdevice variability. Three Optic Disc Cube 200x200 scans were taken on one eye and three

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Macular Cube 512x128 scans were taken on the fellow eye from each of the four Cirrus HD-OCT Model 4000 instruments and each of the four CIRRUS photo instruments by one operator. Subjects could not participate in both phases.

## DISEASED EYES STUDY

Seventy-three subjects with either macular disease or glaucoma were enrolled in a study to evaluate the equivalence of the means of 31 measurement parameters: retinal nerve fiber layer (RNFL) thickness (17 parameters), optic nerve head (ONH) (5 parameters), and macular thickness (9 parameters) between the CIRRUS photo and Cirrus HD-OCT Model 4000. The study was divided into two study arms; study arm 1 enrolled subjects with retina disease and study arm 2 enrolled subjects with glaucoma. Each study arm had two phases; phase 1evaluated inter-device variability and phase 2 evaluated inter-operator variability. Subjects could not participate in both phases of the study.

Nineteen subjects with retinal disease were enrolled in the inter-device phase of the study. Three Macular Cube 512x128 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Nineteen different subjects with retinal disease were enrolled in the inter-operator phase of the study. Three Macular Cube 512x128 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.

Seventeen subjects with glaucoma were enrolled in the inter-device phase of the study. Three Optic Disc Cube 200x200 scans were taken by one operator using four Cirrus HD-OCT Model 4000 and four CIRRUS photo instruments. Eighteen subjects with glaucoma were enrolled in the inter-operator phase of the study. Three Optic Disc Cube 200x200 scans were taken by four operators using one Cirrus HD-OCT Model 4000 and one CIRRUS photo instrument.

## DATA ANALYSIS

For each of the two study devices and each measurement parameter, the mean of the available measurements was calculated for each study eye. The difference in each of the 31 measurement parameters between the CIRRUS photo and Cirrus HD-OCT Model 4000 were calculated for each study eye. The mean difference, the corresponding 95% confidence intervals, and 95% limits of agreement were calculated for each measurement parameter. As the inter-operator phase utilized only one device, only the results for the inter-device phase are presented in Tables 1 and 2 for the normal and diseased eye studies, respectively.

The mean values of the 31 thickness parameters were very similar for the two devices. The results of these two studies support the incorporation of the normative databases established with the Cirrus HD-OCT Model 4000 instrument into the CIRRUS photo instrument with an adjustment based on regression analysis.

Additionally, analysis of variance (ANOVA) with random effect models was used to evaluate the repeatability, inter-device variability and inter-operator variability of each measurement parameter for the CIRRUS photo. The repeatability standard deviation (SD) and limits for the CIRRUS photo are shown in Tables 3 and 4 for the normal and diseased eyes studies, respectively. Cirrus photo showed good repeatability and reproducibility for both normal and diseased eyes.

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# TABLE 1

## MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODEL 4000 (NORMAL EYES)

| | Cirrus 4000<br>Cirrus photo | | Difference | | 95% | 95% |
|------------------------------|-----------------------------|-----------------|------------------|--|-------------------------------------------------|------------------------|
| | Mean (SD) | Mean (SD) | Mean (SD) | | Confidence<br>Interval of<br>Mean<br>Difference | Limits of<br>Agreement |
| RNFL Parameter | N = 33 | N = 33 | N = 33 | | | |
| Average RNFL Thickness (µm) | 94.3 (9.7) | 93.7 (9.8) | 0.6 (1.2) | | (0.2, 1.0) | (-1.7, 2.9) |
| Temporal (µm) | 68.8 (13.1) | 68.4 (12.3) | 0.4 (1.9) | | (-0.3, 1.0) | (-3.3, 4.1) |
| Superior (µm) | 119.3 (12.2) | 121.0 (12.7) | -1.7 (2.4) | | (-2.5, -0.8) | (-6.3, 2.9) |
| Nasal (µm) | 69.8 (15.9) | 68.2 (16.8) | 1.6 (3.0) | | (0.6, 2.7) | (-4.3, 7.6) |
| Inferior (µm) | 119.4 (17.4) | 117.5 (16.8) | 1.9 (2.9) | | (0.9, 2.9) | (-3.7, 7.5) |
| Clock hour 9 (µm) | 53.3 (9.8) | 53.8 (8.9) | -0.5 (2.1) | | (-1.2, 0.3) | (-4.6, 3.6) |
| Clock hour 10 (µm) | 82.0 (18.7) | 83.8 (17.6) | -1.7 (3.1) | | (-2.8, -0.6) | (-7.9, 4.4) |
| Clock hour 11 (µm) | 134.8 (24.2) | 137.4 (23.5) | -2.6 (4.1) | | (-4.0, -1.2) | (-10.6, 5.4) |
| Clock hour 12 (µm) | 116.5 (20.8) | 117.1 (21.4) | -0.6 (4.5) | | (-2.2, 1.0) | (-9.3, 8.2) |
| Clock hour 1 (µm) | 106.5 (15.0) | 108.3 (15.8) | -1.8 (4.7) | | (-3.5, -0.1) | (-11.1, 7.5) |
| Clock hour 2 (µm) | 86.9 (21.3) | 83.5 (21.7) | 3.4 (3.9) | | (2.0, 4.8) | (-4.2, 10.9) |
| Clock hour 3 (µm) | 58.2 (12.3) | 56.1 (13.0) | 2.1 (3.5) | | (0.9, 3.4) | (-4.8, 9.0) |
| Clock hour 4 (µm) | 64.3 (18.1) | 64.8 (19.2) | -0.5 (3.8) | | (-1.8, 0.9) | (-8.0, 7.0) |
| Clock hour 5 (µm) | 93.0 (18.8) | 93.1 (18.9) | -0.2 (4.3) | | (-1.7, 1.4) | (-8.6, 8.2) |
| Clock hour 6 (µm) | 130.5 (31.2) | 130.3 (29.2) | 0.2 (5.6) | | (-1.7, 2.2) | (-10.7, 11.1) |
| Clock hour 7 (µm) | 134.8 (18.5) | 129.1 (17.7) | 5.7 (4.3) | | (4.2, 7.2) | (-2.7, 14.1) |
| Clock hour 8 (µm) | 71.0 (14.5) | 67.6 (14.1) | 3.4 (3.5) | | (2.2, 4.7) | (-3.4, 10.2) |
| ONH Parameters | N = 33 | N = 33 | N = 33 | | | |
| Average Cup-to-Disc Ratio | 0.455 (0.158) | 0.466 (0.154) | -0.012 (0.012) | | (-0.016, -0.007) | (-0.035, 0.011) |
| Vertical Cup-to-Disc Ratio | 0.430 (0.153) | 0.440 (0.152) | -0.010 (0.013) | | (-0.015, -0.005) | (-0.036, 0.016) |
| Disc Area (mm2) | 1.753 (0.294) | 1.822 (0.310) | -0.068 (0.034) | | (-0.081, -0.056) | (-0.135, -0.001) |
| Rim Area (mm2) | 1.317 (0.177) | 1.352 (0.186) | -0.034 (0.027) | | (-0.044, -0.025) | (-0.088, 0.019) |
| Cup Volume (mm3) | 0.1293 (0.1246) | 0.1382 (0.1309) | -0.0089 (0.0104) | | (-0.0126, -0.0052) | (-0.0292, 0.0114) |
| Macular Thickness Parameters | N = 33 | N = 33 | N = 33 | | | |
| Central Subfield (µm) | 265.0 (23.7) | 262.8 (23.4) | 2.2 (2.1) | | (1.5, 3.0) | (-1.8, 6.3) |
| Inner Temporal (µm) | 310.2 (13.7) | 308.6 (13.2) | 1.6 (2.5) | | (0.7, 2.5) | (-3.3, 6.6) |
| Inner Superior (µm) | 324.6 (14.8) | 323.6 (14.1) | 1.1 (3.1) | | (-0.0, 2.2) | (-5.1, 7.2) |
| Inner Nasal (µm) | 328.8 (15.4) | 326.6 (14.6) | 2.2 (3.0) | | (1.2, 3.3) | (-3.6, 8.1) |
| Inner Inferior (µm) | 320.7 (15.7) | 319.1 (14.9) | 1.6 (2.8) | | (0.6, 2.5) | (-3.9, 7.0) |
| Outer Temporal (µm) | 260.5 (13.6) | 261.0 (13.3) | -0.6 (1.9) | | (-1.2, 0.1) | (-4.3, 3.2) |
| Outer Superior (µm) | 279.7 (13.1) | 279.7 (12.7) | -0.0 (2.1) | | (-0.8, 0.7) | (-4.1, 4.0) |
| Outer Nasal (µm) | 299.4 (16.1) | 298.9 (15.2) | 0.5 (2.2) | | (-0.3, 1.3) | (-3.7, 4.7) |
| Outer Inferior (µm) | 266.2 (14.0) | 266.1 (13.4) | 0.2 (2.2) | | (-0.6, 0.9) | (-4.1, 4.4) |

For the inter-device phase of the study, 33 subjects were enrolled.

For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.

Difference = Cirrus-4000 - Cirrus-photo.

95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.

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## TABLE 2

# MEAN DIFFERENCE IN RNFL, ONH AND MACULAR THICKNESS MEASUREMENTS BETWEEN CIRRUS PHOTO AND CIRRUS HD-OCT OPTICAL COHERENCE TOMOGRAPHER, MODE + 4000 (DISEASED EYES)

| | Cirrus 4000<br>Mean (SD) | Cirrus photo<br>Mean (SD) | Difference<br>Mean (SD) | 95%<br>Confidence<br>Interval of<br>Mean<br>Difference | 95%<br>Limits of<br>Agreement |
|------------------------------|--------------------------|---------------------------|-------------------------|--------------------------------------------------------|-------------------------------|
| RNFL Parameter | N = 17 | N = 17 | N = 17 | | |
| Average RNFL Thickness (µm) | 63.8 (10.0) | 63.1 (9.6) | 0.8 (1.3) | (0.1, 1.4) | (-1.7, 3.2) |
| Temporal (µm) | 47.1 (8.3) | 48.1 (8.0) | -0.9 (1.7) | (-1.8, -0.1) | (-4.2, 2.4) |
| Superior (µm) | 78.5 (16.7) | 78.9 (17.7) | -0.3 (1.8) | (-1.3, 0.6) | (-3.9, 3.3) |
| Nasal (µm) | 58.7 (7.3) | 55.8 (5.8) | 2.9 (2.9) | (1.3, 4.4) | (-2.9, 8.6) |
| Inferior (µm) | 70.8 (18.1) | 69.4 (16.9) | 1.4 (2.3) | (0.2, 2.6) | (-3.1, 5.9) |
| Clock hour 9 (µm) | 41.6 (8.7) | 43.2 (8.8) | -1.6 (2.0) | (-2.6, -0.5) | (-5.6, 2.4) |
| Clock hour 10 (µm) | 52.4 (12.8) | 53.8 (14.2) | -1.3 (2.5) | (-2.6, -0.0) | (-6.3, 3.6) |
| Clock hour 11 (µm) | 78.9 (20.9) | 80.3 (21.5) | -1.4 (2.8) | (-2.9, 0.0) | (-7.0, 4.1) |
| Clock hour 12 (µm) | 81.4 (23.1) | 81.0 (24.6) | 0.4 (4.0) | (-1.7, 2.5) | (-7.5, 8.3) |
| Clock hour 1 (µm) | 75.3 (17.5) | 75.4 (17.8) | -0.1 (1.9) | (-1.1, 0.8) | (-3.8, 3.6) |
| Clock hour 2 (µm) | 66.5 (9.2) | 63.8 (9.3) | 2.7 (3.0) | (1.2, 4.2) | (-3.1, 8.5) |
| Clock hour 3 (µm) | 55.2 (10.0) | 51.1 (7.7) | 4.1 (3.9) | (2.1, 6.1) | (-3.5, 11.7) |
| Clock hour 4 (µm) | 54.4 (7.8) | 52.8 (6.7) | 1.6 (4.3) | (-0.5, 3.8) | (-6.7, 10.0) |
| Clock hour 5 (µm) | 64.7 (16.7) | 64.7 (17.4) | -0.1 (3.9) | (-2.0, 1.9) | (-7.6, 7.5) |
| Clock hour 6 (µm) | 75.3 (20.5) | 74.5 (18.6) | 0.8 (5.5) | (-2.0, 3.6) | (-9.9, 11.5) |
| Clock hour 7 (µm) | 72.6 (21.3) | 69.0 (18.8) | 3.5 (4.3) | (1.3, 5.8) | (-4.9, 12.0) |
| Clock hour 8 (µm) | 47.5 (10.2) | 47.4 (8.8) | 0.1 (2.8) | (-1.3, 1.6) | (-5.4, 5.7) |
| ONH Parameters | N = 17 | N = 17 | N = 17 | | |
| Average Cup-to-Disc Ratio | 0.732 (0.097) | 0.738 (0.093) | -0.006 (0.007) | (-.010, -.002) | (-.021, 0.008) |
| Vertical Cup-to-Disc Ratio | 0.736 (0.094) | 0.742 (0.088) | -0.006 (0.012) | (-.013, -.000) | (-.031, 0.018) |
| Disc Area (mm²) | 1.758 (0.489) | 1.853 (0.523) | -0.095 (0.045) | (-.118, -.072) | (-.184, -.006) |
| Rim Area (mm²) | 0.770 (0.216) | 0.795 (0.222) | -0.024 (0.016) | (-.032, -.016) | (-.055, 0.006) |
| Cup Volume (mm³) | 0.4105 (0.2230) | 0.4419 (0.2376) | -0.0315 (0.0181) | (-.0408, -.0222) | (-.0669, 0.0039) |
| Macular Thickness Parameters | N = 19 | N = 19 | N = 19 | | |
| Central Subfield (µm) | 343.8 (107.9) | 341.4 (108.8) | 2.4 (5.2) | (-0.1, 4.9) | (-7.9, 12.6) |
| Inner Temporal (µm) | 366.4 (92.7) | 365.0 (94.4) | 1.4 (9.3) | (-3.1, 5.9) | (-16.8, 19.6) |
| Inner Superior (µm) | 364.6 (86.3) | 364.7 (87.9) | -0.1 (5.4) | (-2.7, 2.5) | (-10.7, 10.5) |
| Inner Nasal (µm) | 366.1 (83.7) | 366.5 (85.3) | -0.4 (6.8) | (-3.6, 2.9) | (-13.6, 12.9) |
| Inner Inferior (µm) | 365.1 (85.7) | 365.1 (86.5) | -0.0 (5.1) | (-2.5, 2.4) | (-10.0, 10.0) |
| Outer Temporal (µm) | 283.7 (44.7) | 285.3 (45.6) | -1.6 (2.3) | (-2.7, -0.5) | (-6.0, 2.8) |
| Outer Superior (µm) | 299.6 (49.5) | 301.7 (50.0) | -2.1 (2.8) | (-3.5, -0.7) | (-7.7, 3.5) |
| Outer Nasal (µm) | 308.2 (45.7) | 310.0 (46.6) | -1.8 (2.6) | (-3.0, -0.5) | (-6.8, 3.3) |
| Outer Inferior (µm) | 285.7 (46.6) | 288.1 (48.5) | -2.4 (3.8) | (-4.2, -0.5) | (-9.9, 5.1) |

For the inter-device phase of the study, 17 glaucomatous eyes with retinal disease were enrolled. For each of the two study devices, the average of measurements from different units were calculated for each eye and this average was treated as the measurement for the corresponding eye.

Difference = Cirrus-4000 - Cirrus-photo.

95% Confidence Interval of Mean Difference = mean ± 1.96 ×SE. 95% Limits of Agreement = mean ± 1.96 ×SD.

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## TABLE 3.

# CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (NORMAL EYES)

| | Repeatability | | Reproducibility | | COV % | |
|------------------------------|---------------|---------|-----------------|---------|------------------------|--------------------------|
| | SD | Limit | SD | Limit | Based on Repeatability | Based on Reproducibility |
| RNFL Parameter | | | | | | |
| Average RNFL Thickness (µm) | 1.4634 | 4.0974 | 2.1899 | 6.1319 | 1.5660 | 2.3436 |
| Temporal (µm) | 3.1109 | 8.7106 | 3.4480 | 9.6544 | 4.6498 | 5.1536 |
| Superior (µm) | 4.0906 | 11.4538 | 5.2156 | 14.6038 | 3.4418 | 4.3884 |
| Nasal (µm) | 2.9302 | 8.2045 | 3.7041 | 10.3714 | 4.2513 | 5.3742 |
| Inferior (µm) | 3.4906 | 9.7737 | 4.8547 | 13.5930 | 2.9296 | 4.0744 |
| Clock hour 9 (µm) | 2.9861 | 8.3610 | 3.5083 | 9.8232 | 5.5946 | 6.5730 |
| Clock hour 10 (µm) | 4.2639 | 11.9388 | 4.6703 | 13.0768 | 5.2313 | 5.7299 |
| Clock hour 11 (µm) | 4.6518 | 13.0249 | 6.5183 | 18.2512 | 3.5278 | 4.9434 |
| Clock hour 12 (µm) | 6.6529 | 18.6281 | 7.7500 | 21.7000 | 5.6827 | 6.6198 |
| Clock hour 1 (µm) | 5.9988 | 16.7968 | 7.5104 | 21.0291 | 5.5767 | 6.9818 |
| Clock hour 2 (µm) | 5.1422 | 14.3981 | 6.4081 | 17.9426 | 6.0570 | 7.5481 |
| Clock hour 3 (µm) | 2.8467 | 7.9707 | 3.6839 | 10.3149 | 5.0520 | 6.5378 |
| Clock hour 4 (µm) | 3.4901 | 9.7722 | 4.2787 | 11.9803 | 5.3322 | 6.5371 |
| Clock hour 5 (µm) | 5.3422 | 14.9581 | 7.2244 | 20.2284 | 5.5214 | 7.4668 |
| Clock hour 6 (µm) | 5.9229 | 16.5841 | 8.1056 | 22.6956 | 4.4538 | 6.0951 |
| Clock hour 7 (µm) | 5.4060 | 15.1368 | 7.5886 | 21.2480 | 4.2341 | 5.9435 |
| Clock hour 8 (µm) | 3.8676 | 10.8293 | 4.9749 | 13.9296 | 5.8758 | 7.5580 |
| ONH Parameters | | | | | | |
| Cup Disc Ratio | 0.0236 | 0.0660 | 0.0245 | 0.0685 | 5.1582 | 5.3539 |
| Vertical CD Ratio | 0.0277 | 0.0774 | 0.0289 | 0.0809 | 6.3477 | 6.6278 |
| Disc Area (mm²) | 0.0888 | 0.2486 | 0.1009 | 0.2825 | 4.8833 | 5.5498 |
| Rim Area (mm²) | 0.0483 | 0.1352 | 0.0626 | 0.1752 | 3.5837 | 4.6455 |
| Cup Volume (mm³) | 0.0105 | 0.0294 | 0.0124 | 0.0349 | 7.5869 | 9.0060 |
| Macular Thickness Parameters | | | | | | |
| Central Subfield (µm) | 1.6398 | 4.5914 | 2.7756 | 7.7718 | 0.6308 | 1.0677 |
| Inner Temporal (µm) | 2.0716 | 5.8006 | 3.4834 | 9.7536 | 0.6683 | 1.1238 |
| Inner Superior (µm) | 2.1805 | 6.1054 | 3.4096 | 9.5470 | 0.6732 | 1.0527 |
| Inner Nasal (µm) | 2.1538 | 6.0307 | 3.1998 | 8.9594 | 0.6591 | 0.9792 |
| Inner Inferior (µm) | 2.0770 | 5.8156 | 3.2125 | 8.9951 | 0.6484 | 1.0029 |
| Outer Temporal (µm) | 1.7440 | 4.8833 | 2.8387 | 7.9483 | 0.6648 | 1.0820 |
| Outer Superior (µm) | 1.9601 | 5.4884 | 2.7409 | 7.6744 | 0.6997 | 0.9784 |
| Outer Nasal (µm) | 1.9932 | 5.5811 | 2.9532 | 8.2689 | 0.6662 | 0.9871 |
| Outer Inferior (µm) | 2.2541 | 6.3115 | 3.2616 | 9.1325 | 0.8427 | 1.2194 |

Repeatability SD is the standard deviations. Repeatability conditions. Repeatability Limit is the upper 95 % limit for the difference between repeated results under repeatability conditions. Per ISO 5725-6, Repeatability Limit = 2.8 x Repeatability SD. Reproducibility SD is the standard deviation under reproducibility conditions. It was estimated by the sum of repeatability variance and the variance components of operator "subjects, device and device *subjects. Reproducibility Limit is the upper 95 % limit for the difference between repeated results under reproducibility conditions. Reproducibility Limit = 2.8 × Reproducibility SD.

COV = Coefficient of variation = SD +Mean. ×100. SD is either Repeatability SD or Reproducibility SD.

{7}------------------------------------------------

#### TABLE 4

## CIRRUS PHOTO REPEATABILITY AND REPRODUCIBILITY IN MEASURING RNFL, ONH AND MACULAR THICKNESS (DISEASED EYES)

| | Repeatability | | Reproducibility | | COV % | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------------------|---------------|---------|-----------------|---------|---------------------------|-----------------------------|---------------------|--------|---------|--------|---------|--------|--------|--------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|-------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|-------------------|--------|---------|--------|---------|--------|--------|-------------------|--------|---------|--------|---------|--------|--------|-------------------|--------|--------|--------|--------|--------|--------|----------------|--------|--------|--------|--------|--------|--------|------------------|--------|--------|--------|--------|--------|--------|------------------------------|--------|--------|--------|--------|--------|--------|-----------------|-----------------------|--------|---------|--------|---------|--------|----------------|---------------------|--------|---------|--------|---------|--------|------------------|---------------------|--------|---------|--------|---------|--------|------------------------------|------------------|--------|---------|--------|---------|--------|--------|-----------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|---------------------|--------|--------|--------|--------|--------|--------|---------------------|--------|--------|--------|--------|--------|--------|------------------|--------|--------|--------|--------|--------|--------|---------------------|--------|---------|--------|---------|--------|--------|
| | SD | Limit | SD | Limit | Based on<br>Repeatability | Based on<br>Reproducibility | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| RNFL Parameter | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Average RNFL Thickness (µm) | 1.4634 | 4.0976 | 1.8796 | 5.2629 | 2.2840 | 2.9336 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Temporal (µm) | 2.2956 | 6.4276 | 2.5546 | 7.1529 | 4.7043 | 5.2351 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Superior (µm) | 2.8264 | 7.9140 | 3.5281 | 9.8787 | 3.5930 | 4.4850 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Nasal (µm) | 2.8991 | 8.1176 | 3.9553 | 11.0748 | 4.9599 | 6.7668 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Inferior (µm) | 2.5395 | 7.1106 | 2.9880 | 8.3664 | 3.6115 | 4.2493 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 9 (µm) | 2.4813 | 6.9476 | 2.8941 | 8.1034 | 5.5483 | 6.4713 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 10 (µm) | 3.4895 | 9.7705 | 3.9555 | 11.0755 | 6.4194 | 7.2768 | Clock hour 11 (µm) | 3.8494 | 10.7784 | 4.0928 | 11.4599 | 4.9950 | 5.3108 | Clock hour 12 (µm) | 4.4919 | 12.5774 | 5.7878 | 16.2060 | 5.4955 | 7.0809 | Clock hour 1 (µm) | 3.9406 | 11.0336 | 4.6576 | 13.0414 | 5.1041 | 6.0328 | Clock hour 2 (µm) | 3.4231 | 9.5848 | 3.9783 | 11.1394 | 5.1747 | 6.0140 | Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | ONH Parameters | | | | | | | Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | Vertical CD Ratio | 0.0307 | 0.0860 | 0.0313 | 0.0877 | 4.0501 | 4.1308 | Disc Area (mm²) | 0.0584 | 0.1635 | 0.0624 | 0.1746 | 3.0618 | 3.2703 | Rim Area (mm²) | 0.0367 | 0.1027 | 0.0395 | 0.1106 | 4.5529 | 4.9033 | Cup Volume (mm³) | 0.0220 | 0.0615 | 0.0247 | 0.0692 | 4.8135 | 5.4138 | Macular Thickness Parameters | | | | | | | | Central Subfield (µm) | 5.6224 | 15.7427 | 7.6068 | 21.2992 | 1.5989 | 2.1632 | Inner Temporal (µm) | 4.3574 | 12.2007 | 5.1083 | 14.3032 | 1.1857 | 1.3900 | Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 |
| Clock hour 11 (µm) | 3.8494 | 10.7784 | 4.0928 | 11.4599 | 4.9950 | 5.3108 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 12 (µm) | 4.4919 | 12.5774 | 5.7878 | 16.2060 | 5.4955 | 7.0809 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 1 (µm) | 3.9406 | 11.0336 | 4.6576 | 13.0414 | 5.1041 | 6.0328 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 2 (µm) | 3.4231 | 9.5848 | 3.9783 | 11.1394 | 5.1747 | 6.0140 | Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | ONH Parameters | | | | | | | Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | Vertical CD Ratio | 0.0307 | 0.0860 | 0.0313 | 0.0877 | 4.0501 | 4.1308 | Disc Area (mm²) | 0.0584 | 0.1635 | 0.0624 | 0.1746 | 3.0618 | 3.2703 | Rim Area (mm²) | 0.0367 | 0.1027 | 0.0395 | 0.1106 | 4.5529 | 4.9033 | Cup Volume (mm³) | 0.0220 | 0.0615 | 0.0247 | 0.0692 | 4.8135 | 5.4138 | Macular Thickness Parameters | | | | | | | | Central Subfield (µm) | 5.6224 | 15.7427 | 7.6068 | 21.2992 | 1.5989 | 2.1632 | Inner Temporal (µm) | 4.3574 | 12.2007 | 5.1083 | 14.3032 | 1.1857 | 1.3900 | Inner Superior (µm) | 4.5687 | 12.7923 | 5.3448 | 14.9653 | 1.2562 | 1.4696 | Inner Nasal (µm) | 4.1606 | 11.6498 | 6.3917 | 17.8968 | 1.1298 | 1.7356 | Inner Inferior (µm) | 5.4349 | 15.2178 | 5.7159 | 16.0046 | 1.5167 | 1.5951 | Outer Temporal (µm) | 2.9954 | 8.3870 | 3.3484 | 9.3755 | 1.0367 | 1.1588 | Outer Superior (µm) | 2.8585 | 8.0038 | 3.3155 | 9.2835 | 0.9475 | 1.0989 | Outer Nasal (µm) | 2.7562 | 7.7173 | 3.4669 | 9.7073 | 0.8862 | 1.1147 | Outer Inferior (µm) | 4.2730 | 11.9645 | 4.6956 | 13.1476 | 1.5132 | 1.6628 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 3 (µm) | 3.4882 | 9.7670 | 5.0632 | 14.1771 | 6.5627 | 9.5259 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 4 (µm) | 3.8452 | 10.7666 | 4.7855 | 13.3993 | 6.8533 | 8.5291 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 5 (µm) | 3.8818 | 10.8691 | 4.5783 | 12.8192 | 5.6594 | 6.6747 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 6 (µm) | 3.9587 | 11.0845 | 4.3994 | 12.3182 | 5.3266 | 5.9195 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 7 (µm) | 3.6302 | 10.1644 | 4.6261 | 12.9530 | 5.3360 | 6.7998 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Clock hour 8 (µm) | 2.5716 | 7.2005 | 3.0180 | 8.4503 | 5.4299 | 6.3724 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ONH Parameters | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cup Disc Ratio | 0.0276 | 0.0774 | 0.0278 | 0.0777 | 3.7279 | 3.7449 | | | | | | | | | | | | | | | | | | | | |…