DRI OCT Triton
Device Facts
| Record ID | K173119 |
|---|---|
| Device Name | DRI OCT Triton |
| Applicant | Topcon Corporation |
| Product Code | OBO · Ophthalmic |
| Decision Date | Jan 19, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
Intended Use
The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera 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. The DRI OCT Triton 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. It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
Device Story
Non-contact, high-resolution tomographic and biomicroscopic imaging system; merges swept-source OCT (SS-OCT) and fundus camera. Inputs: infrared/visible light reflected from ocular structures. Operation: sequential capture of OCT and fundus images (color, red-free, IR; Triton plus adds FA/FAF). Data transferred to off-the-shelf PC via LAN; dedicated software performs automatic retinal layer segmentation, thickness calculation, optic disc analysis, and reference database comparison. Output: processed images and quantitative measurements displayed on PC monitor. Used in clinics by eye care professionals. Output aids diagnosis, documentation, and management of ocular health/diseases; benefits patient through objective structural assessment.
Clinical Evidence
Two prospective clinical studies conducted. Study 1 (N=76): Agreement and precision study comparing Triton to Maestro; endpoints included repeatability/reproducibility of retinal thickness and optic disc measurements, and image quality grading. Results showed Triton measurements were mathematically similar and statistically consistent with Maestro. Study 2 (N=not specified): Comparison of Triton (plus) and TRC-50DX for FA/FAF imaging; image quality was comparable. A third study (N=410) established a reference database for normal eyes.
Technological Characteristics
Swept-source OCT (SS-OCT) with 1050 nm center wavelength. Fundus camera uses IR LED observation light, Xenon flash, and CMOS sensor. Connectivity via LAN to external PC. Software performs automated segmentation and analysis. Complies with ISO 15004-1, ISO 10940, ISO 15004-2, AAMI/ANSI ES 60601-1, and IEC 60601-1-2.
Indications for Use
Indicated for in vivo viewing, axial cross-sectional, and 3D imaging/measurement of posterior ocular structures (retinal nerve fiber layer, macula, optic disc) and anterior ocular structures in adults. Includes reference database for quantitative comparison of retinal nerve fiber layer, optic nerve head, and macula to normal subjects. Used to aid diagnosis, documentation, and management of ocular health and diseases.
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
Related Devices
- K161509 — 3D OCT-1 Maestro · Topcon Corporation · Jul 28, 2016
- K112184 — CIRRUS PHOTO · Carl Zeiss Meditec, Inc. · Jun 18, 2012
- K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) · Topcon Corporation · Oct 30, 2023
- K092470 — OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 · Topcon Corp. · Sep 2, 2009
- K170164 — 3D OCT-1 Maestro · Topcon Corporation · Mar 3, 2017
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 19, 2018
Topcon Corporation % Zvi Ladin, Ph.D. Principal Boston MedTech Advisors Inc. 990 Washington Street, Suite #204 Dedham, MA 02026
Re: K173119
Trade/Device Name: DRI OCT Triton Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI Dated: December 18, 2017 Received: December 20, 2017
Dear Zvi Ladin, Ph.D .:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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## Indications for Use
510(k) Number (if known) K173119
Device Name DRI OCT Triton
#### Indications for Use (Describe)
The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the retina and surrounding parts of the eye to be examined under Mydriatic and non-Mydriatic conditions.
The DRI OCT Triton 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.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) SUMMARY
## Topcon Corporation DRI OCT Triton and Triton (plus)
### Submitter Information:
| Applicant: | Topcon Corporation<br>75-1 Hasunuma-cho, Itabashi-ku<br>Tokyo, Japan 174-8580 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | (201) 599-5533 |
| Fax: | (201) 599-5248 |
| Contact Person: | Charles Reisman<br>Vice President of Research and Development<br>Topcon Healthcare Solutions, Inc.<br>111 Bauer Drive<br>Oakland, NJ 07436<br>1 (201) 599-5283 |
| Date Prepared: | January 17, 2018 |
| Subject Device: | |
| Device Name: | DRI OCT Triton and Triton (plus) |
| Common Name: | Optical Coherence Tomography |
| Classification Name: | Ophthalmoscope |
| Regulation: | Class II, 21 C.F.R. § 886.1570 |
| Product Code(s): | OBO, HKI |
| Predicate Device(s): | |
#### Primary Predicate: Topcon 3D OCT-1 Maestro (#K161509, #K170164)
Secondary Predicate: Topcon TRC-50DX Retinal Camera (#K123101)
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#### Indications for Use:
The Topcon DRI OCT Triton is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera 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.
The DRI OCT Triton 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.
It also includes a Reference Database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects. The DRI OCT Triton is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
#### Device Description:
The DRI OCT Triton ("Triton") and the DRI OCT Triton (plus)") are non-contact, highresolution, tomographic and bio-microscopic imaging systems that merge optical coherence tomography (OCT) and fundus camera into a single device. Triton and Triton (plus) employ the swept source OCT (SS-OCT) technology. Both can take anterior OCT images in addition to fundus OCT images. The fundus camera, in both Triton and Triton (plus), includes color imaging, red-free imaging, and infrared light imaging (hereinafter, IR imaging) capabilities for fundus observation. The Triton (plus) has fluorescein angiography (FA), and fundus autofluorescence angiography (FAF) imaging function in addition to all fundus functions for Triton.
The fundus photographs and OCT images are captured by different system components of this device, which enables Triton to capture an OCT image and a fundus image sequentially. It allows 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. It also has a reference database for posterior ocular measurements of normal subjects, which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head and the macula.
Captured images are transferred from the device to an off-the-shelf personal computer (PC) via LAN cable, where the dedicated software for this device is installed. The transferred data is then automatically processed with analysis functions such as the automatic retinal layers segmentation, the automatic thickness calculation with several grids, the optic disc analysis and comparison with a reference database of eyes free of ocular pathology, and is finally automatically saved to the PC. It allows the user to manually adjust the automated retinal layer segmentation results and optic disc analysis results.
Accessories include the power cord, chin-rest paper sheet, monitor cleaner, LAN cable; chin-rest paper pins, external fixation target, dust cover accessory case, user manual, unpacking and analysis software DVD.
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#### Substantial Equivalence
Triton is substantially equivalent to Topcon's 3D OCT-1 Maestro (#K161509, #K170164, "Maestro") cleared on 7/28/2016 and 3/3/2017 correspondingly. The secondary predicate device is Topcon's TRC-50DX Retinal Camera (#K123101) cleared on 6/5/2013. Triton's indications for use are identical to those of the Maestro device.
Both Triton and Maestro have the same technological characteristics of an optical coherence tomography (OCT) device and a fundus imaging device in a single system. Triton and Maestro are non-contact, high resolution tomographic and biomicroscopic imaging systems that include cameras for both OCT and fundus imaging. These devices can capture fundus OCT and color fundus images sequentially and can capture anterior segment OCT images. Both devices include a reference database tool, used as an aid in the detection and management of the same series of ocular diseases claimed in the indications for use.
Triton incorporates a swept-source (SS) light source to divide wavelengths temporally, while the Maestro incorporates a superluminescent diode (SLD) light source and a splitter to divide wavelengths spatially. Though the methods used to divide wavelengths are different, both are based on optical interference principles, and both spectral domain and swept-source OCT are generally thought to fall under the umbrella classification of Fourier Domain OCT.
Both systems are non-contact, ophthalmic diagnostic devices using infrared to visible light. Triton has a higher scan speed, a higher resolution of 3D scans and additional scan patterns compared to Maestro. There are slight differences in the axial resolutions, center wavelength and bandwidths of the light sources of both devices.
Triton and Maestro have the same technological characteristics regarding the fundus camera function, except for FA/FAF. Both devices employ an Infrared (IR) Light Emitting Diode (LED) for observation light source, a Xenon flash for photographing light source and a complementary metaloxide semiconductor (CMOS) for camera. Both Triton (plus) and TRC-50DX Retina Camera provide FA/FAF functionality. While Triton (plus) employs an IR LED for observation light source, TRC-50DX employs a Halogen lamp. Both devices employ a Xenon flash for photographing light source. For camera, Triton (plus) employs a CMOS while TRC-50DX employs a charge-coupled device (CCD). The minor differences between the candidate and predicate devices in technological implementation or performance do not raise new or different questions of safety or effectiveness.
#### Performance Data
Performance bench testing has been conducted on Triton to demonstrate substantial equivalence to the predicate devices. A list of testing conducted is as follows:
- . Axial and Transversal Resolutions
- . Trueness and Precision for Axial and Transversal Directions
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- Testing to Consensus Standards for Ophthalmic Devices .
- ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods - O Part1: General requirements applicable to all ophthalmic instruments, 2006
- ISO 10940, Ophthalmic instruments Fundus cameras, 2009 O
- ISO 15004-2, Ophthalmic instruments Fundamental requirements and test methods - O Part 2: Light hazard protection, 2007
- . Electrical Safety
- AAMI/ANSI ES 60601-1, Medical Electrical Equipment Part1: General requirements for O Safety and essential performance, 2005/(R)2012 and A1:2012, C1:2009 /(R) 2012 and A2:2010/(R)2012
- Electromagnetic Compatibility
- IEC 60601-1-2, Medical electrical equipment Part1-2: General requirements for Safety o and essential performance - Collateral standard : Electromagnetic compatibility -Requirements and tests, 2007
- Software Verification and Validation Testing .
- Software verification and validation testing were conducted and documentation was O provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- The software for this device was considered as 'Moderate Level of Concern' since a O failure or latent flaw in the software could result in an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Biocompatibility of materials used in the patient contacting components were already evaluated and established in company's predicate device submissions.
#### Clinical Data
Topcon conducted two clinical studies to demonstrate substantial equivalence of the investigational Triton device to the predicate devices, 3D OCT-1 Maestro (#K161509, #K170164) and TRC-50DX Retinal Camera (#K123101). An agreement and precision study was conducted at a single clinical site to determine precision (repeatability and reproducibility) and agreement with the predicate Maestro device. A second single-site study was performed to compare the performance of the Triton (plus) and TRC-50DX for FA/FAF imaging. These two studies were performed independently and in parallel. A third multi-center clinical study was performed to collect OCT data in order to establish a reference database for measurement comparisons.
#### Agreement and Precision Study
Topcon conducted a prospective comparative clinical study, at a U.S. clinical site, to compare the agreement and precision between Triton and Maestro. Participants, with and without eye disease, had OCT images and fundus photographs obtained using both Triton and Maestro devices. The studies included five main analyses: 1) precision analysis, 2) agreement analysis, 3) fundus photograph evaluation, 4) anterior segment image evaluation, and 5) posterior B scan image quality evaluation. The agreement and precision study compared the full retinal thickness, retinal nerve fiber
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layer thickness, Ganglion cell layer plus the IPL layer thickness, Ganglion cell complex thickness, and the optic disc measurements. In addition, the study estimated the precision of the small and large super pixel grid and the TSNIT circle profile measurements of the Triton.
Participants were randomized for the selection of study eye, operator order and device order. There were 13 planned scans during a single session, for all subject groups, per subject, per device (3 scans per 3D Wide, 3D Macula and 3D Disc scans; 1 scan per Radial cornea and angle scans; 1 per macula fundus and optic disc fundus photographs). The total number of planned scans for a subject was 78 (39 for each device). While the precision analysis utilized all acceptable scans for all measurement types, all other analysis utilized the first acceptable photograph of each scan type of each device from all study eyes. The image quality of the fundus photographs, and the image quality of anterior and posterior OCT B scans were graded by two masked independent experts on a scale based on the quality and clarity of the images. Quality assurance procedures were instituted to produce a consistent system for assessing, saving and processing study images.
Major eligibility criteria included participants age≥18 with: 1) normal eyes (excluding glaucomatous optic nerve damage), 2) Glaucomatous optic nerve damage, based on pattern deviation and Glaucoma hemi-field test or damage based on optic disc or retinal nerve fiber layer structural abnormalities (excluding other ocular pathology), and 3) Retinal pathology diagnosis (excluding glaucoma or any other ocular pathology).
Agreement between Triton and Maestro was evaluated by the 95% LOA, Bland-Altman plots, and the Deming regression for each subject population. The analysis of precision used a two-way random-effect ANOVA model to estimate the repeatability and reproducibility limits, and coefficient of variation of each scan parameter by subject population and study device. Image clarity analysis, for both fundus photographs and anterior and posterior OCT B scans, calculated the percentage of subjects whose Triton grades were equal to or better than their Maestro grades by photograph type and subject population, and the percentage of total inter-grader agreement by photograph type, subject population and study device with exact 95% confidence interval.
The rate of rejected scans for image quality reasons was in the range of 1% - 20%, and was similar for both the Triton and Maestro images. For each of the measurement types, image or scan type and size, and subject eye category, the measurements obtained with the Triton device as compared to the Maestro device were mathematically similar, statistically consistent with, and clinically useful in the assessment of normal and diseased eyes. In sum, the agreement results were expected based on minor differences in axial resolution, validated software and algorithm updates, and a minor difference in the pixel calibration factor between devices. Software and algorithm updates included improved fovea detection, ILM and RPE segmentation, artifact removal and cup map refinement. In addition, the Triton device uses a factory determined pixel calibration factor that is used for thickness calculations. The Maestro device uses a standard, average value for pixel measurements, while each Triton device relies on a device specific pixel size value. These results demonstrate that the Topcon DRI OCT Triton is substantially equivalent to the predicate device Topcon 3D OCT-1 Maestro (#K161509, # K170164).
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| | Normal<br>(N=25) | Retinal<br>(N=26) | Glaucoma<br>(N=25) | Total<br>(N=76) |
|-------------------------------------|------------------|-------------------|--------------------|-----------------|
| Age (years) | | | | |
| n | 25 | 26 | 25 | 76 |
| Mean (SD) | 42.7 (14.7) | 67.2 (11.3) | 67.6 (10.4) | 59.3 (16.8) |
| Median | 40.0 | 67.0 | 68.0 | 62.0 |
| Age group, n (%) | | | | |
| <65 years | 24 (96) | 11 (42) | 10 (40) | 45 (59) |
| ≥65 years | 1 (4) | 15 (58) | 15 (60) | 31 (41) |
| Gender, n (%) | | | | |
| Male | 14 (56) | 9 (35) | 12 (48) | 35 (46) |
| Female | 11 (44) | 17 (65) | 13 (52) | 41 (54) |
| Ethnicity, n (%) | | | | |
| Hispanic or Latino | 1 (4) | 0 (0) | 1 (4) | 2 (3) |
| Not Hispanic and not Latino | 24 (96) | 26 (100) | 24 (96) | 74 (97) |
| Race, n (%) | | | | |
| American Indian/Alaska<br>Native | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Asian | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Black/African American | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Native Hawaiian/Pacific<br>Islander | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| White | 25 (100) | 26 (100) | 25 (100) | 76 (100) |
| Other | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
## Table 1: Demographics and Baseline Characteristics
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#### Agreement Assessment
| Table 2. Limits of Agreement between Triton 7x7 Macula and Maestro 6x6 Macula: |
|--------------------------------------------------------------------------------|
| Full Retinal Thickness (mm) Agreement Analysis Population |
| Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference |
|-------------------------------|---------------------|-------------------------------------|-------------------------|----------------------------------|-----------------------------------|
| <b>Normal Eyes (N = 25)</b> | | | | | |
| Central Fovea | 252.783 (25.344) | 252.039 (27.524) | 0.744 (6.219) | -1.824, 3.311 | -11.695, 13.182 |
| Inner Superior | 318.430 (15.531) | 321.084 (16.041) | -2.653 (4.541) | -4.527, -0.779 | -11.734, 6.428 |
| Inner Nasal | 319.948 (16.716) | 321.864 (16.700) | -1.916 (4.247) | -3.669, -0.163 | -10.410, 6.578 |
| Inner Inferior | 313.842 (17.074) | 315.470 (17.704) | -1.628 (4.207) | -3.365, 0.108 | -10.043, 6.786 |
| Inner Temporal | 303.981 (17.133) | 305.390 (17.280) | -1.409 (4.432) | -3.238, 0.420 | -10.272, 7.454 |
| Outer Superior | 273.314 (15.440) | 276.887 (16.315) | -3.573 (3.436) | -4.992, -2.155 | -10.446, 3.300 |
| Outer Nasal | 289.616 (18.592) | 291.432 (18.750) | -1.815 (3.269) | -3.165, -0.466 | -8.354, 4.723 |
| Outer Inferior | 263.023 (17.675) | 265.177 (18.321) | -2.154 (3.584) | -3.633, -0.675 | -9.322, 5.014 |
| Outer Temporal | 257.459 (14.410) | 258.748 (15.657) | -1.288 (3.567) | -2.761, 0.184 | -8.423, 5.847 |
| <b>Retinal Eyes (N = 26)</b> | | | | | |
| Central Fovea | 287.357 (69.085) | 289.860 (71.068) | -2.503 (5.865) | -4.872, -0.134 | -14.233, 9.227 |
| Inner Superior | 319.017 (37.733) | 323.572 (40.551) | -4.555 (4.739) | -6.469, -2.640 | -14.034, 4.924 |
| Inner Nasal | 321.600 (34.510) | 325.010 (36.073) | -3.409 (4.412) | -5.191, -1.627 | -12.233, 5.414 |
| Inner Inferior | 315.722 (36.594) | 319.435 (37.898) | -3.712 (5.135) | -5.786, -1.638 | -13.982, 6.557 |
| Inner Temporal | 310.943 (40.324) | 315.846 (43.195) | -4.903 (6.001) | -7.327, -2.479 | -16.905, 7.100 |
| Outer Superior | 273.324 (25.716) | 277.460 (26.634) | -4.136 (3.377) | -5.500, -2.772 | -10.890, 2.618 |
| Outer Nasal | 285.318 (22.409) | 288.067 (22.352) | -2.748 (4.608) | -4.609, -0.887 | -11.964, 6.468 |
| Outer Inferior | 260.377 (25.022) | 265.861 (26.674) | -5.485 (7.538) | -8.529, -2.440 | -20.561, 9.592 |
| Outer Temporal | 256.704 (25.894) | 259.992 (26.967) | -3.287 (4.373) | -5.054, -1.521 | -12.033, 5.458 |
| <b>Glaucoma Eyes (N = 25)</b> | | | | | |
| Central Fovea | 243.749 (16.276) | 245.544 (18.331) | -1.795 (4.937) | -3.833, 0.243 | -11.670, 8.079 |
| Inner Superior | 286.105 (25.967) | 289.968 (28.053) | -3.864 (3.917) | -5.480, -2.247 | -11.698, 3.971 |
| Inner Nasal | 292.276 (17.609) | 296.114 (19.647) | -3.838 (4.251) | -5.592, -2.083 | -12.339, 4.664 |
| Inner Inferior | 284.798 (19.193) | 287.965 (20.269) | -3.167 (3.223) | -4.498, -1.837 | -9.613, 3.279 |
| Inner Temporal | 278.046 (15.855) | 281.840 (17.968) | -3.794 (4.544) | -5.670, -1.919 | -12.881, 5.293 |
| Outer Superior | 245.268 (17.305) | 248.721 (17.825) | -3.453 (3.861) | -5.047, -1.860 | -11.174, 4.268 |
| Outer Nasal | 259.902 (18.908) | 261.922 (19.747) | -2.021 (3.102) | -3.301, -0.740 | -8.225, 4.184 |
| Outer Inferior | 234.349 (15.412) | 237.959 (16.762) | -3.610 (2.900) | -4.807, -2.412 | -9.410, 2.191 |
| Outer Temporal | 235.496 (13.765) | 238.046 (14.187) | -2.550 (2.886) | -3.741, -1.359 | -8.323, 3.223 |
| | | | | 95% CI for | 95% LOA |
| Eye Population | Triton | Maestro | Difference | Mean | for Mean |
| Measurement | Mean (SD) | Mean (SD) | Mean (SD) | Difference | Difference |
| Normal Eyes (N = 25) | | | | | |
| Central Fovea | | 253.285 (25.739) 254.889 (27.233) | -1.604 (5.824) | -4.008, 0.801 | -13.253, 10.045 |
| Inner Superior | | 318.049 (15.025) 319.785 (15.322) | -1.736 (4.501) | -3.594, 0.122 | -10.738, 7.266 |
| Inner Nasal | | 320.078 (15.970) 321.635 (15.551) | -1.557 (4.414) | -3.379, 0.265 | -10.385, 7.271 |
| Inner Inferior | | 313.766 (16.641) 315.520 (16.579) | -1.754 (3.272) | -3.105, -0.403 | -8.298, 4.790 |
| Inner Temporal | | 304.453 (16.725) 306.027 (16.434) | -1.574 (4.205) | -3.310, 0.162 | -9.984, 6.837 |
| Outer Superior | 273.720 (14.840) | 276.277 (16.733) | -2.557 (3.362) | -3.945, -1.169 | -9.281, 4.168 |
| Outer Nasal | 290.864 (18.051) | 292.204 (18.195) | -1.340 (2.915) | -2.544, -0.137 | -7.170, 4.489 |
| Outer Inferior | 263.360 (17.043) | 264.814 (17.018) | -1.453 (2.954) | -2.673, -0.234 | -7.361, 4.455 |
| Outer Temporal | | 259.225 (14.143) 261.355 (14.541) | -2.130 (2.523) | -3.171, -1.088 | -7.176, 2.917 |
| | | | | | |
| Retinal Eyes (N = 26) | | | | | |
| Central Fovea | | 280.446 (64.997) 284.317 (65.981) | -3.871 (7.183) | -6.904, -0.838 | -18.236, 10.494 |
| Inner Superior | | 318.230 (39.994) 321.523 (39.990) | -3.293 (4.144) | -5.043, -1.543 | -11.581, 4.995 |
| Inner Nasal | | 320.276 (33.435) 323.884 (34.829) | -3.608 (4.875) | -5.666, -1.549 | -13.358, 6.142 |
| Inner Inferior | | 311.013 (35.923) 313.798 (36.435) | -2.786 (8.796) | -6.500, 0.928 | -20.378, 14.806 |
| Inner Temporal | | 304.876 (36.082) 307.938 (34.603) | -3.063 (6.983) | -6.011, -0.114 | -17.029, 10.904 |
| Outer Superior | | 272.455 (24.283) 275.740 (25.617) | -3.285 (3.760) | -4.873, -1.698 | -10.806, 4.235 |
| Outer Nasal | | 287.367 (21.331) 290.301 (23.553) | -2.935 (5.042) | -5.064, -0.806 | -13.018, 7.149 |
| Outer Inferior | 258.478 (23.809) | 261.797 (23.770) | -3.319 (8.331) | -6.836, 0.199 | -19.980, 13.343 |
| Outer Temporal | | 254.986 (25.005) 258.137 (24.698) | -3.151 (4.885) | -5.214, -1.088 | -12.922, 6.620 |
| | | | | | |
| Glaucoma Eyes (N = 25) | | | | | |
| Central Fovea | | 244.176 (17.544) 246.496 (17.721) | -2.320 (4.084) | -4.045, -0.595 | -10.489, 5.849 |
| Inner Superior | | 289.698 (16.230) 292.570 (16.785) | -2.871 (2.271) | -3.830, -1.912 | -7.413, 1.670 |
| Inner Nasal | 293.856 (17.489) | 296.396 (17.516) | -2.540 (3.067) | -3.835, -1.245 | -8.674, 3.594 |
| Inner Inferior | 284.328 (19.942) | 287.300 (19.458) | -2.972 (2.628) | -4.081, -1.862 | -8.228, 2.285 |
| Inner Temporal | 279.409 (17.073) | 282.387 (17.201) | -2.977 (2.872) | -4.190, -1.765 | -8.721, 2.766 |
| Outer Superior | 247.638 (14.386) | 250.155 (14.277) | -2.517 (2.431) | -3.544, -1.491 | -7.379, 2.345 |
| Outer Nasal | 261.083 (19.262) | 262.721 (19.460) | -1.638 (1.956) | -2.464, -0.812 | -5.551, 2.275 |
| Outer Inferior | | 234.086 (15.662) 236.015 (16.030) | -1.930 (1.765) | -2.675, -1.184 | -5.460, 1.600 |
| Outer Temporal | | 237.022 (14.366) 239.752 (14.588) | -2.730 (2.454) | -3.766, -1.694 | -7.638, 2.178 |
| | | | | | |
| | | | | 95% CI for | 95% LOA |
| Eye Population | Triton | Maestro | Difference | Mean | for Mean |
| Measurement | Mean (SD) | Mean (SD) | Mean (SD) | Difference | Difference |
| Normal Eyes (N = 25) | | | | | |
| Superior | 69.757 (5.703) | 72.561 (6.120) | -2.804 (1.492) | -3.419, -2.188 | -5.787, 0.179 |
| Superior Nasal | 74.469 (6.416) | 76.502 (6.824) | -2.032 (1.110) | -2.491, -1.574 | -4.252, 0.188 |
| Superior Temporal | 71.439 (4.766) | 72.628 (5.265) | -1.188 (1.238) | -1.699, -0.677 | -3.664, 1.287 |
| Inferior | 67.243 (6.226) | 69.742 (6.391) | -2.499 (1.242) | -3.011, -1.986 | -4.982, -0.016 |
| Inferior Nasal | 72.865 (6.786) | 74.972 (6.456) | -2.107 (0.833) | -2.451, -1.763 | -3.773, -0.441 |
| Inferior Temporal | 72.590 (6.395) | 73.938 (6.854) | -1.348 (1.238) | -1.859, -0.837 | -3.825, 1.129 |
| Average | 71.400 (5.756) | 73.396 (6.009) | -1.996 (0.782) | -2.319, -1.673 | -3.561, -0.431 |
| Retinal Eyes (N = 26) | | | | | |
| Superior | 66.450 (6.763) | 68.726 (7.568) | -2.276 (1.761) | -2.987, -1.565 | -5.797, 1.245 |
| Superior Nasal | 69.626 (6.088) | 71.558 (6.736) | -1.932 (1.806) | -2.661, -1.202 | -5.543, 1.680 |
| Superior Temporal | 72.453 (9.902) | 72.956 (10.478) | -0.503 (3.274) | -1.826, 0.819 | -7.052, 6.046 |
| Inferior | 64.326 (8.379) | 67.005 (8.407) | -2.680 (2.866) | -3.837, -1.522 | -8.411, 3.052 |
| Inferior Nasal | 69.661 (7.339) | 71.394 (8.164) | -1.733 (2.014) | -2.547, -0.920 | -5.762, 2.295 |
| Inferior Temporal | 73.395 (12.134) | 74.294 (12.198) | -0.899 (2.057) | -1.730, -0.068 | -5.014, 3.216 |
| Average | 69.331 (7.602) | 71.008 (8.053) | -1.677 (1.185) | -2.156, -1.198 | -4.047, 0.693 |
| Glaucoma Eyes (N = 25) | | | | | |
| Superior | 55.622 (8.631) | 56.998 (9.443) | -1.376 (1.457) | -1.978, -0.775 | -4.290, 1.538 |
| Superior Nasal | 59.672 (9.750) | 60.888 (10.400) | -1.216 (1.360) | -1.777, -0.654 | -3.935, 1.504 |
| Superior Temporal | 61.115 (6.586) | 61.802 (7.074) | -0.687 (1.624) | -1.357, -0.016 | -3.935, 2.561 |
| Inferior | 53.388 (6.721) | 55.223 (7.183) | -1.835 (2.017) | -2.668, -1.003 | -5.869, 2.198 |
| Inferior Nasal | 58.004 (9.676) | 59.361 (9.861) | -1.356 (1.564) | -2.002, -0.711 | -4.485, 1.772 |
| Inferior Temporal | 60.408 (7.330) | 60.734 (7.618) | -0.326 (1.820) | -1.077, 0.426 | -3.966, 3.314 |
| Average | 58.036 (7.172) | 59.192 (7.566) | -1.156 (1.045) | -1.587, -0.725 | -3.246, 0.934 |
N is the number of eyes with measurements from both devices.
Difference = Triton - Maestro
95% confidence interval (CI) for mean difference is based on t-distribution.
{10}------------------------------------------------
#### Table 3. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Full Retinal Thickness (mm) Agreement Analysis Population
N is the number of eyes with measurements from both devices.
Difference = Triton - Maestro
95% confidence interval (CI) for mean difference is based on t-distribution.
{11}------------------------------------------------
#### Table 4. Limits of Agreement between Triton 7x7 Macula and Maestro 6x6 Macula: Ganglion Cell + IPL Thickness (mm) Agreement Analysis Population
N is the number of eyes with measurements from both devices.
Difference = Triton - Maestro
95% confidence interval (CI) for mean difference is based on t-distribution.
{12}------------------------------------------------
| | Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference |
|------------------------|-------------------------------|---------------------|----------------------|-------------------------|----------------------------------|-----------------------------------|
| Normal Eyes (N = 25) | | | | | | |
| | Superior | 70.391 (5.561) | 72.198 (5.957) | -1.807 (0.985) | -2.214, -1.401 | -3.777, 0.162 |
| | Superior Nasal | 74.646 (6.561) | 76.435 (6.870) | -1.789 (0.952) | -2.182, -1.396 | -3.692, 0.115 |
| | Superior Temporal | 70.918 (5.407) | 72.358 (5.815) | -1.440 (0.861) | -1.796, -1.084 | -3.163, 0.283 |
| | Inferior | 67.660 (6.299) | 69.411 (6.190) | -1.751 (1.165) | -2.232, -1.270 | -4.081, 0.580 |
| | Inferior Nasal | 73.210 (6.506) | 75.078 (6.668) | -1.868 (0.954) | -2.262, -1.475 | -3.777, 0.040 |
| | Inferior Temporal | 72.144 (6.457) | 74.028 (6.788) | -1.884 (1.004) | -2.298, -1.469 | -3.892, 0.125 |
| | Average | 71.500 (5.857) | 73.256 (6.103) | -1.756 (0.593) | -2.001, -1.511 | -2.942, -0.570 |
| Retinal Eyes (N = 26) | | | | | | |
| | Superior | 67.840 (6.751) | 69.305 (7.067) | -1.466 (2.789) | -2.643, -0.288 | -7.043, 4.112 |
| | Superior Nasal | 72.020 (7.167) | 74.356 (9.542) | -2.336 (4.571) | -4.266, -0.406 | -11.478, 6.806 |
| | Superior Temporal | 69.399 (10.325) | 70.473 (9.534) | -1.073 (2.257) | -2.026, -0.120 | -5.587, 3.440 |
| | Inferior | 64.227 (8.273) | 65.463 (8.917) | -1.235 (4.215) | -3.015, 0.545 | -9.666, 7.195 |
| | Inferior Nasal | 71.283 (7.734) | 72.863 (8.840) | -1.580 (2.246) | -2.529, -0.632 | -6.072, 2.911 |
| | Inferior Temporal | 70.758 (10.839) | 72.162 (11.077) | -1.404 (3.130) | -2.726, -0.083 | -7.664, 4.855 |
| | Average | 69.254 (7.667) | 70.779 (7.956) | -1.525 (0.999) | -1.947, -1.103 | -3.523, 0.473 |
| Glaucoma Eyes (N = 25) | | | | | | |
| | Superior | 56.588 (8.355) | 57.728 (8.866) | -1.140 (1.125) | -1.615, -0.665 | -3.390, 1.110 |
| | Superior Nasal | 60.501 (9.182) | 61.990 (9.248) | -1.488 (0.719) | -1.792, -1.185 | -2.926, -0.050 |
| | Superior Temporal | 58.203 (8.942) | 58.782 (9.913) | -0.579 (1.360) | -1.153, -0.005 | -3.299, 2.141 |
| | Inferior | 52.420 (8.545) | 53.430 (8.592) | -1.010 (0.815) | -1.355, -0.666 | -2.641, 0.620 |
| | Inferior Nasal | 57.940 (10.485) | 59.125 (10.909) | -1.185 (0.881) | -1.557, -0.813 | -2.947, 0.577 |
| | Inferior Temporal | 55.950 (10.765) | 56.580 (11.330) | -0.630 (1.422) | -1.231, -0.030 | -3.475, 2.214 |
| | Average | 56.938 (8.605) | 57.946 (9.013) | -1.008 (0.752) | -1.326, -0.691 | -2.513, 0.496 |
#### Table 5. Limits of Agreement between Triton 12x9 Wide and Maestro 12x9 Wide: Ganglion Cell + IPL Thickness (mm) Agreement Analysis Population
N is the number of eyes with measurements from both devices.
Difference = Triton - Maestro
95% confidence interval (CI) for mean difference is based on t-distribution.
{13}------------------------------------------------
| Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference |
|-------------------------------|---------------------|----------------------|-------------------------|----------------------------------|-----------------------------------|
| Normal Eyes (N = 25) | | | | | |
| Superior | 107.598 (7.933) | 108.494 (7.993) | -0.896 (1.449) | -1.494, -0.298 | -3.793, 2.001 |
| Superior Nasal | 118.699 (8.723) | 119.427 (9.142) | -0.728 (1.396) | -1.304, -0.152 | -3.520, 2.064 |
| Superior Temporal | 93.898 (6.339) | 94.378 (6.634) | -0.480 (1.420) | -1.066, 0.106 | -3.321, 2.361 |
| Inferior | 106.720 (9.040) | 107.329 (9.340) | -0.609 (1.426) | -1.198, -0.021 | -3.461, 2.243 |
| Inferior Nasal | 119.495 (10.193) | 120.126 (10.434) | -0.631 (1.290) | -1.163, -0.099 | -3.210, 1.948 |
| Inferior Temporal | 97.209 (7.588) | 97.493 (8.034) | -0.284 (1.738) | -1.001, 0.433 | -3.760, 3.192 |
| Average | 107.268 (7.828) | 107.884 (8.129) | -0.616 (1.116) | -1.077, -0.155 | -2.847, 1.615 |
| Retinal Eyes (N = 26) | | | | | |
| Superior | 113.072 (19.742) | 113.830 (20.513) | -0.758 (1.803) | -1.486, -0.030 | -4.363, 2.848 |
| Superior Nasal | 121.294 (17.619) | 121.730 (17.969) | -0.436 (2.076) | -1.275, 0.402 | -4.588, 3.715 |
| Superior Temporal | 99.000 (15.413) | 99.509 (15.809) | -0.509 (1.879) | -1.268, 0.250 | -4.268, 3.249 |
| Inferior | 108.175 (17.234) | 109.512 (18.970) | -1.337 (4.332) | -3.086, 0.413 | -10.001, 7.328 |
| Inferior Nasal | 122.721 (18.189) | 122.751 (20.334) | -0.030 (3.392) | -1.400, 1.340 | -6.814, 6.754 |
| Inferior Temporal | 99.976 (17.182) | 100.722 (17.411) | -0.745 (2.251) | -1.655, 0.164 | -5.248, 3.757 |
| Average | 110.715 (16.225) | 111.373 (17.188) | -0.658 (1.845) | -1.403, 0.087 | -4.347, 3.032 |
| Glaucoma Eyes (N = 25) | | | | | |
| Superior | 86.832 (15.742) | 86.720 (15.991) | 0.111 (1.280) | -0.417, 0.640 | -2.449, 2.671 |
| Superior Nasal | 97.626 (17.241) | 97.097 (17.399) | 0.529 (2.786) | -0.621, 1.679 | -5.043, 6.101 |
| Superior Temporal | 78.534 (11.797) | 78.363 (12.093) | 0.172 (1.240) | -0.340, 0.683 | -2.308, 2.651 |
| Inferior | 83.838 (14.596) | 83.881 (15.292) | -0.044 (1.303) | -0.581, 0.494 | -2.649, 2.562 |
| Inferior Nasal | 96.685 (18.388) | 96.327 (19.027) | 0.358 (1.736) | -0.358, 1.074 | -3.113, 3.829 |
| Inferior Temporal | 77.714 (13.157) | 77.519 (13.613) | 0.195 (0.920) | -0.185, 0.575 | -1.646, 2.036 |
| Average | 86.876 (13.385) | 86.680 (13.651) | 0.196 (1.078) | -0.249, 0.641 | -1.959, 2.351 |
#### Table 6. Limits of Agreement between Triton 7x7 Macula and Maestro 6x6 Macula: Ganglion Cell Complex Thickness (mm) Agreement Analysis Population
N is the number of eyes with measurements from both devices.
Difference = Triton - Maestro
95% confidence interval (CI) for mean difference is based on t-distribution.
{14}------------------------------------------------
| | | | | 95% CI for | | 95% LOA |
|-------------------------------|---------------------|----------------------|-------------------------|----------------------------------|-----------------------------------|-----------------------------------|
| Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | Mean<br>Difference | for Mean<br>Difference | |
| Normal Eyes (N = 25) | | | | | | |
| Superior | 107.536 (7.455) | 107.604 (8.219) | -0.068 (1.815) | -0.818, 0.681 | -3.698, 3.561 | |
| Superior Nasal | 119.298 (8.820) | 119.394 (9.268) | -0.095 (1.486) | -0.709, 0.518 | -3.067, 2.876 | |
| Superior Temporal | 94.647 (6.099) | 94.778 (6.761) | -0.132 (1.215) | -0.633, 0.370 | -2.562, 2.299 | |
| Inferior | 106.996 (8.794) | 106.672 (8.999) | 0.324 (1.295) | -0.211, 0.858 | -2.267, 2.915 | |
| Inferior Nasal | 119.679 (9.927) | 119.590 (10.396) | 0.089 (1.282) | -0.440, 0.618 | -2.474, 2.652 | |
| Inferior Temporal | 97.922 (7.219) | 98.334 (7.825) | -0.412 (1.309) | -0.952, 0.129 | -3.030, 2.206 | |
| Average | 107.688 (7.626) | 107.732 (8.138) | -0.044 (1.158) | -0.522, 0.434 | -2.361, 2.273 | |
| Retinal Eyes (N = 26) | | | | | | |
| Superior | 112.223 (16.563) | 111.426 (17.341) | 0.797 (2.185) | -0.126, 1.720 | -3.573, 5.167 | |
| Superior Nasal | 121.542 (16.285) | 121.510 (17.564) | 0.032 (2.408) | -0.984, 1.049 | -4.784, 4.849 | |
| Superior Temporal | 97.254 (13.954) | 96.840 (13.564) | 0.415 (2.660) | -0.709, 1.538 | -4.905, 5.735 | |
| Inferior | 108.042 (13.646) | 107.501 (15.138) | 0.540 (5.328) | -1.710, 2.790 | -10.117, 11.197 | |
| Inferior Nasal | 121.860 (15.448) | 121.037 (15.073) | 0.824 (2.150) | -0.084, 1.732 | -3.476, 5.123 | |
| Inferior Temporal | 99.482 (14.282) | 99.227 (15.210) | 0.255 (3.842) | -1.367, 1.877 | -7.430, 7.940 | |
| Average | 110.075 (13.985) | 109.600 (14.167) | 0.475 (1.732) | -0.256, 1.206 | -2.988, 3.938 | |
| Glaucoma Eyes (N = 25) | | | | | | |
| Superior | 88.431 (13.569) | 88.082 (13.039) | 0.349 (1.287) | -0.195, 0.892 | -2.226, 2.923 | |
| Superior Nasal | 99.618 (15.248) | 99.090 (15.198) | 0.527 (1.184) | 0.028, 1.027 | -1.841, 2.896 | |
| Superior Temporal | 79.828 (11.212) | 79.573 (11.597) | 0.255 (1.152) | -0.232, 0.741 | -2.050, 2.559 | |
| Inferior | 83.691 (15.095) | 82.823 (14.813) | 0.868 (1.080) | 0.412, 1.324 | -1.292, 3.028 | |
| Inferior Nasal | 96.578 (19.085) | 95.675 (18.998) | 0.903 (1.141) | 0.421, 1.385 | -1.380, 3.186 | |
| Inferior Temporal | 77.887 (13.907) | 77.543 (14.068) | 0.344 (1.296) | -0.204, 0.891 | -2.248, 2.936 | |
| Average | 87.675 (13.555) | 87.138 (13.399) | 0.537 (0.791) | 0.204, 0.871 | -1.044, 2.119 | |
| Eye Population | Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference |
| Normal Eyes (N = 25) | C/D Vertical | 0.458 (0.195) | 0.454 (0.231) | 0.004 (0.110) | -0.041, 0.049 | -0.216, 0.224 |
| | C/D Area | 0.249 (0.156) | 0.255 (0.189) | -0.006 (0.118) | -0.055, 0.043 | -0.243, 0.231 |
| | Disc Area (mm2) | 1.754 (0.407) | 2.038 (0.415) | -0.285 (0.145) | -0.345, -0.225 | -0.575, 0.006 |
| | Cup Area (mm2) | 0.466 (0.341) | 0.537 (0.416) | -0.072 (0.211) | -0.159, 0.015 | -0.494, 0.350 |
| | Rim Area (mm2) | 1.287 (0.302) | 1.502 (0.426) | -0.215 (0.277) | -0.329, -0.100 | -0.769, 0.340 |
| | Cup Volume<br>(mm³) | 0.083 (0.079) | 0.089 (0.084) | -0.006 (0.008) | -0.009, -0.003 | -0.022, 0.010 |
| | Rim Volume (mm³) | 0.235 (0.102) | 0.288 (0.145) | -0.053 (0.069) | -0.082, -0.025 | -0.191, 0.084 |
| | Linear C/D Ratio | 0.459 (0.202) | 0.453 (0.227) | 0.006 (0.090) | -0.031, 0.043 | -0.174, 0.186 |
| Retinal Eyes (N = 26) | C/D Vertical | 0.527 (0.230) | 0.498 (0.212) | 0.029 (0.036) | 0.014, 0.044 | -0.044, 0.102 |
| | C/D Area | 0.305 (0.169) | 0.280 (0.155) | 0.025 (0.024) | 0.016, 0.035 | -0.023, 0.073 |
| | Disc Area (mm2) | 1.763 (0.361) | 2.003 (0.434) | -0.240 (0.214) | -0.326, -0.154 | -0.668, 0.188 |
| | Cup Area (mm2) | 0.549 (0.359) | 0.562 (0.365) | -0.013 (0.042) | -0.030, 0.004 | -0.097, 0.072 |
| | Rim Area (mm2) | 1.214 (0.334) | 1.442 (0.434) | -0.228 (0.198) | -0.308, -0.148 | -0.625, 0.168 |
| | Cup Volume<br>(mm³) | 0.095 (0.084) | 0.100 (0.087) | -0.005 (0.008) | -0.008, -0.002 | -0.021, 0.011 |
| | Rim Volume (mm³) | 0.213 (0.131) | 0.258 (0.172) | -0.045 (0.055) | -0.067, -0.023 | -0.156, 0.066 |
| | Linear C/D Ratio | 0.508 (0.219) | 0.488 (0.210) | 0.021 (0.019) | 0.013, 0.029 | -0.018, 0.060 |
| Glaucoma Eyes (N = 25) | C/D Vertical | 0.861 (0.097) | 0.823 (0.094) | 0.038 (0.052) | 0.016, 0.060 | -0.066, 0.142 |
| | C/D Area | 0.688 (0.175) | 0.623 (0.168) | 0.064 (0.055) | 0.042, 0.087 | -0.046, 0.175 |
| | Disc Area (mm2) | 1.796 (0.378) | 2.044 (0.473) | -0.247 (0.165) | -0.315, -0.179 | -0.576, 0.082 |
| | Cup Area (mm2) | 1.247 (0.459) | 1.297 (0.524) | -0.050 (0.114) | -0.097, -0.003 | -0.277, 0.177 |
| | Rim Area (mm2) | 0.549 (0.306) | 0.748 (0.332) | -0.198 (0.146) | -0.259, -0.138 | -0.491, 0.094 |
| | Cup Volume<br>(mm³) | 0.351 (0.212) | 0.360 (0.218) | -0.010 (0.057) | -0.033, 0.014 | -0.124, 0.104 |
| | Rim Volume (mm³) | 0.053 (0.046) | 0.071 (0.054) | -0.018 (0.020) | -0.026, -0.010 | -0.059, 0.023 |
| | Linear C/D Ratio | 0.822 (0.116) | 0.781 (0.113) | 0.041 (0.035) | 0.026, 0.055 | -0.030, 0.111 |
| Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference | |
| Normal Eyes (N = 25) | | | | | | |
| C/D Vertical | 0.476 (0.208) | 0.453 (0.199) | 0.023 (0.047) | 0.003, 0.042 | -0.072, 0.118 | |
| C/D Area | 0.254 (0.166) | 0.232 (0.160) | 0.022 (0.020) | 0.014, 0.030 | -0.017, 0.061 | |
| Disc Area (mm²) | 1.923 (0.411) | 2.232 (0.370) | -0.308 (0.168) | -0.378, -0.239 | -0.644, 0.027 | |
| Cup Area (mm²) | 0.518 (0.393) | 0.540 (0.410) | -0.022 (0.047) | -0.042, -0.003 | -0.116, 0.071 | |
| Rim Area (mm²) | 1.406 (0.327) | 1.693 (0.375) | -0.287 (0.175) | -0.360, -0.215 | -0.638, 0.063 | |
| Cup Volume<br>(mm³) | 0.086 (0.086) | 0.092 (0.091) | -0.006 (0.013) | -0.012, -0.001 | -0.032, 0.019 | |
| Rim Volume (mm³) | 0.261 (0.123) | 0.324 (0.157) | -0.063 (0.058) | -0.087, -0.039 | -0.178, 0.053 | |
| Linear C/D Ratio | 0.463 (0.205) | 0.440 (0.205) | 0.024 (0.022) | 0.014, 0.033 | -0.021, 0.068 | |
| Retinal Eyes (N = 26) | | | | | | |
| C/D Vertical | 0.525 (0.232) | 0.510 (0.205) | 0.015 (0.058) | -0.008, 0.039 | -0.101, 0.131 | |
| C/D Area | 0.294 (0.169) | 0.272 (0.153) | 0.022 (0.027) | 0.011, 0.033 | -0.032, 0.077 | |
| Disc Area (mm²) | 1.923 (0.376) | 2.222 (0.442) | -0.298 (0.148) | -0.358, -0.239 | -0.595, -0.002 | |
| Cup Area (mm²) | 0.577 (0.382) | 0.612 (0.395) | -0.035 (0.040) | -0.051, -0.019 | -0.115, 0.045 | |
| Rim Area (mm²) | 1.347 (0.371) | 1.609 (0.438) | -0.262 (0.154) | -0.325, -0.200 | -0.570, 0.046 | |
| Cup Volume<br>(mm³) | 0.094 (0.088) | 0.103 (0.094) | -0.010 (0.012) | -0.015, -0.005 | -0.034, 0.015 | |
| Rim Volume (mm³) | 0.242 (0.149) | 0.290 (0.181) | -0.048 (0.044) | -0.066, -0.031 | -0.137, 0.040 | |
| Linear C/D Ratio | 0.498 (0.219) | 0.485 (0.193) | 0.013 (0.047) | -0.006, 0.032 | -0.080, 0.106 | |
| Glaucoma Eyes (N = 25) | | | | | | |
| C/D Vertical | 0.855 (0.119) | 0.816 (0.105) | 0.038 (0.057) | 0.015, 0.062 | -0.075, 0.152 | |
| C/D Area | 0.679 (0.191) | 0.624 (0.184) | 0.056 (0.052) | 0.034, 0.077 | -0.049, 0.160 | |
| Disc Area (mm²) | 1.958 (0.384) | 2.225 (0.562) | -0.267 (0.247) | -0.369, -0.165 | -0.760, 0.226 | |
| Cup Area (mm²) | 1.338 (0.498) | 1.390 (0.541) | -0.051 (0.086) | -0.087, -0.016 | -0.223, 0.121 | |
| Rim Area (mm²) | 0.620 (0.382) | 0.836 (0.444) | -0.216 (0.212) | -0.303, -0.128 | -0.640, 0.209 | |
| Cup Volume<br>(mm³) | 0.359 (0.223) | 0.375 (0.236) | -0.016 (0.025) | -0.026, -0.005 | -0.065, 0.034 | |
| Rim Volume (mm³) | 0.063 (0.061) | 0.087 (0.078) | -0.024 (0.035) | -0.038, -0.010 | -0.094, 0.046 | |
| Linear C/D Ratio | 0.814 (0.132) | 0.780 (0.126) | 0.034 (0.034) | 0.020, 0.048 | -0.034, 0.102 | |
| Eye Population<br>Measurement | Triton<br>Mean (SD) | Maestro<br>Mean (SD) | Difference<br>Mean (SD) | 95% CI for<br>Mean<br>Difference | 95% LOA<br>for Mean<br>Difference | |
| Normal Eyes (N = 25) | | | | | | |
| Average | 105.171 (10.641) | 105.988 (11.016) | -0.817 (1.341) | -1.370, -0.263 | -3.499, 1.865 | |
| Superior Quadrant | 128.772 (16.413) | 130.712 (17.175) | -1.940 (3.498) | -3.384, -0.496 | -8.936, 5.056 | |
| Nasal Quadrant | 86.666 (15.590) | 84.632 (15.599) | 2.034 (3.442) | 0.613, 3.455 | -4.851, 8.918 | |
| Inferior Quadrant | 137.382 (18.034) | 140.049 (18.778) | -2.667 (3.141) | -3.963, -1.370 | -8.949, 3.615 | |
| Temporal<br>Quadrant | 67.763 (11.057) | 68.887 (12.430) | -1.124 (3.112) | -2.409, 0.160 | -7.348, 5.099 | |
| 12-Sector - T | 56.555 (9.167) | 57.592 (10.271) | -1.037 (2.600) | -2.110, 0.036 | -6.236, 4.163 | |
| 12-Sector - TS | 80.670 (13.210) | 82.116 (14.824) | -1.446 (3.994) | -3.094, 0.203 | -9.433, 6.542 | |
| 12-Sector - ST | 135.753 (23.322) | 137.138 (22.846) | -1.385 (5.559) | -3.680, 0.909 | -12.503, 9.733 | |
| 12-Sector - S | 130.320 (29.968) | 133.122 (31.334) | -2.802 (6.408) | -5.447, -0.157 | -15.617, 10.014 | |
| 12-Sector - SN | 120.430 (24.561) | 121.726 (24.006) | -1.295 (6.023) | -3.781, 1.191 | -13.341, 10.750 | |
| 12-Sector - NS | 106.190 (21.212) | 104.049 (21.605) | 2.142 (6.032) | -0.348, 4.631 | -9.922, 14.206 | |
| 12-Sector - N | 68.901 (13.540) | 66.560 (12.047) | 2.341 (3.369) | 0.950, 3.731 | -4.396, 9.078 | |
| 12-Sector - NI | 84.982 (16.951) | 83.355 (17.139) | 1.627 (4.641) | -0.288, 3.543 | -7.655, 10.909 | |
| 12-Sector - IN | 123.131 (28.022) | 125.184 (27.116) | -2.054 (5.219) | -4.208, 0.101 | -12.491, 8.384 | |
| 12-Sector - I | 151.904 (24.673) | 155.778 (25.809) | -3.874 (5.944) | -6.327, -1.421 | -15.761, 8.013 | |
| 12-Sector - IT | 137.190 (25.698) | 139.116 (26.460) | -1.926 (6.892) | -4.771, 0.918 | -15.710, 11.857 | |
| 12-Sector - TI | 66.050 (14.161) | 66.879 (15.433) | -0.829 (3.908) | -2.442, 0.784 | -8.644, 6.986 | |
| | | | | | | |
| Retinal Eyes (N = 26) | | | | | | |
| Average | 100.435 (17.661) | 100.430 (15.504) | 0.005 (4.542) | -1.829, 1.840 | -9.079, 9.089 | |
| Superior Quadrant | 115.893 (26.424) | 117.700 (22.481) | -1.807 (12.122) | -6.703, 3.089 | -26.050, 22.437 | |
| Nasal Quadrant | 79.862 (18.809) | 77.393 (16.593) | 2.469 (3.966) | 0.867, 4.071 | -5.464, 10.402 | |
| Inferior Quadrant | 126.865 (27.458) | 128.233 (23.241) | -1.368 (8.174) | -4.670, 1.933 | -17.716, 14.979 | |
| Temporal<br>Quadrant | 79.017 (13.687) | 78.399 (14.980) | 0.618 (5.460) | -1.587, 2.824 | -10.302, 11.539 | |
| 12-Sector - T | 68.023 (13.965) | 66.158 (14.830) | 1.865 (7.680) | -1.237, 4.967 | -13.494, 17.224 | |
| 12-Sector - TS | 96.645 (19.772) | 96.904 (20.124) | -0.260 (4.793) | -2.196, 1.676 | -9.846, 9.326 | |
| 12-Sector - ST | 130.406 (24.977) | 133.053 (23.804) | -2.648 (8.696) | -6.160, 0.865 | -20.040, 14.744 | |
| 12-Sector - S | 110.586 (39.114) | 112.312 (33.024) | -1.726 (17.118) | -8.640, 5.189 | -35.963, 32.511 | |
| 12-Sector - SN | 106.680 (27.637) | 107.807 (22.876) | -1.128 (14.292) | -6.900, 4.645 | -29.711, 27.456 | |
| 12-Sector - NS | 96.660 (22.892) | 93.253 (20.543) | 3.407 (5.571) | 1.156, 5.657 | -7.735, 14.548 | |
| 12-Sector - N | 67.715 (16.876) | 65.670 (16.091) | 2.044 (2.831) | 0.901, 3.188 | -3.617, 7.705 | |
| 12-Sector - NI | 75.138 (20.824) | 73.229 (17.150) | 1.908 (8.323) | -1.453, 5.270 | -14.738, 18.555 | |
| 12-Sector - IN | 103.739 (30.167) | 102.947 (23.195) | 0.792 (13.453) | -4.641, 6.226 | -26.114, 27.698 | |
| 12-Sector - I | 138.697 (36.060) | 140.203 (33.132) | -1.507 (9.879) | -5.497, 2.483 | -21.264, 18.251 | |
| 12-Sector - IT | 138.181 (28.232) | 141.444 (25.715) | -3.263 (8.790) | -6.813, 0.287 | -20.842, 14.316 | |
| 12-Sector - TI | 72.435 (11.994) | 72.117 (14.157) | 0.318 (7.489) | -2.707, 3.343 | -14.660, 15.296 | |
| | | | | 95% Cl for…
