LogoFDA 510(k) Search
K Number
K180660
Device Name
Avanti
Manufacturer
Optovue, Inc.
Date Cleared
2018-06-08

(86 days)

Product Code
OBO,HLI
Regulation Number
886.1570
Type
Traditional
Panel
Ophthalmic
Reference & Predicate Devices
K163475,K153080,K111505
Predicate For
K213265,K221320,K222166
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

Device Description

The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.

AI/ML Overview

The provided text describes acceptance criteria and study details for the Optovue Avanti device. Here's a structured summary based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly present a discrete "table of acceptance criteria and reported device performance" as typically found in clinical trial reports with pass/fail metrics against a predefined threshold. Instead, it details various performance metrics (repeatability, reproducibility, agreement) in descriptive tables (Tables 6-16 for AngioRetina scans, Tables 12-13 for AngioDisc scans, Tables 27-31 for Corneal Epithelial Thickness R&R, and Tables 39-43 for Corneal Epithelial Thickness Agreement with Manual measurements) that implicitly demonstrate the device's performance is acceptable for its intended use, especially when compared to predicate devices or manual methods.

The overall conclusion states: "The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices." This implies that the performance demonstrated in the various tables met the internal acceptance criteria for substantial equivalence.

As a representative example, here's how some of the reported performance metrics could be conceptualized in a table:

Metric CategoryParameter Example (from given tables)Reported Performance (Mean or LOA)Implicit Acceptance Criteria (Inferred from context of Substantial Equivalence and ranges presented)
Non-clinical Performance (Accuracy)Superficial Vessel Density (%)Average Difference: 2.3%Differences between software-reported and expected "vascular" density values must be small.
Deep Vessel Density (%)Average Difference: 0.0%
Clinical Performance (R&R - Normal)3-mm AngioRetina Scan: Superficial WIReproducibility CV: 4.8%Reproducibility CV should be low, indicating consistent measurements.
4.5-mm HD AngioDisc: RNFL Thickness PPReproducibility CV: 1.5%
Clinical Performance (Agreement)FAZ Area (OCTA vs. FA)Mean Difference: 0.070 mm²Differences between device and reference standard should be clinically acceptable.
FAZ Perimeter (OCTA vs. FA)Mean Difference: 0.205 mm
ET Epithelium C_2 (Software vs. Manual)Mean Difference: -0.4Differences between device and manual measurements should be clinically acceptable.

Detailed Study Information:

  1. A table of acceptance criteria and the reported device performance:
    As noted above, explicit pass/fail acceptance criteria are not presented in a direct table. The document demonstrates performance across various metrics and clinical populations. The overall "acceptance" is implied by the FDA's clearance of the device based on the provided data and the statement of substantial equivalence to predicate devices. The tables throughout the document (e.g., Tables 6-16, 27-31, 39-43) present the reported device performance.

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

    • Clinical Performance Testing (Section 1 - AngioVue R&R):
      • Sample Size: 67 participants (15 Normal, 16 Glaucoma, 36 Retinal conditions).
      • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
    • FAZ Parameter Validation (Section 2 - non-vascular FAZ Parameters):
      • Sample Size: 30 eyes of 26 subjects.
      • Provenance: Case series from 3 clinical sites (country not specified, but likely U.S. given the FDA submission). Data origin (retrospective/prospective) is not explicitly stated, but the "case series" implies existing data.
    • FAZ Parameters Agreement between 3-mm AngioRetina and 6-mm HD AngioRetina Scans (Section 3):
      • Sample Size: 62 subjects/eyes (from the R&R study data set, after exclusions).
      • Provenance: Derived from the prospective R&R study data.
    • Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement Evaluation (Section 4):
      • Sample Size: 67 subjects for Full and Inner Retina thickness; 31 subjects for RNFL thickness and optic disc measurement.
      • Provenance: Subset of the prospective R&R study data.
    • Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping with SD-OCT (Section 5):
      • Sample Size: 60 participants (12 Normal, 12 Contact Lens, 11 Dry Eye, 12 Post-LRS, 13 Keratoconus).
      • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
    • Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT (Section 6):
      • Sample Size: 85 subjects (17 Normal, 15 Contact Lens, 18 Dry Eye, 19 Post-LRS, 16 Keratoconus).
      • Provenance: Prospective, observational study conducted at three study sites (country not specified, but likely U.S.).

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

    • FAZ Parameter Validation (Section 2): "Three readers experienced in FA image grading performed FAZ measurements." Specific qualifications (e.g., years of experience, board certification) are not provided.
    • Corneal Epithelial Thickness Agreement (Section 6): "Manual measurements performed by three qualified graders." Specific qualifications are not provided.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • FAZ Parameter Validation (Section 2): Graders were "masked to each other's results through the entire grading process". No explicit mention of an adjudication process (e.g., tie-breaking by a senior reader) if reader consensus was needed. It seems individual reader measurements were compared against the device.
    • Corneal Epithelial Thickness Agreement (Section 6): Similar to FAZ, graders were masked. No explicit mention of an adjudication process.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No MRMC comparative effectiveness study involving human readers with/without AI assistance is described in this document. The studies primarily focus on the device's technical performance (repeatability, reproducibility, and agreement with human or phantom measurements) rather than its impact on human reader performance.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Yes, a standalone performance evaluation was done for the Non-clinical Performance Testing (phantoms) to validate the accuracy of the software's vessel density measurements (Section 7, page 7-8). The tables (e.g., for 3-mm AngioRetina Scan) present the difference between software-reported values and "expected 'vascular' density values computed directly from the model." This represents an algorithm-only performance assessment against a known ground truth.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • Non-clinical Performance Testing (Phantoms): "Known ground truth" from 3D phantom models with predefined vessel densities.
    • Clinical Performance Testing (R&R of AngioVue, Retinal/RNFL/Disc Measurements): Implicitly, the Avanti software's measurements were compared against its own repeated measurements (for R&R) and against the predicate device's measurements (for agreement), establishing consistency and comparability rather than an external "ground truth" like pathology.
    • FAZ Parameter Validation: Manually graded FAZ measurements from fluorescein angiography images by "three readers experienced in FA image grading." This is a form of expert consensus/manual measurement ground truth.
    • Corneal Epithelial Thickness Mapping Agreement: Manual measurements performed by "three qualified graders" using a caliper tool on a previously cleared device. This is a form of expert consensus/manual measurement ground truth.

  8. The sample size for the training set:

    • The document does not specify the sample size of any training set used for the device's algorithms. This information is typically proprietary to the manufacturer and not included in 510(k) summaries unless directly relevant to a specific re-training or modification evaluation.

  9. How the ground truth for the training set was established:

    • Since the training set size is not provided, the method for establishing its ground truth is also not detailed in this document.

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June 8, 2018

Optovue, Inc. Indu Lakshman Senior Director, Regulatory Affairs and Quality Assurance 2800 Bayview Drive Fremont, CA 94538

Re: K180660

Trade/Device Name: Avanti Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI Dated: March 12, 2018 Received: March 14, 2018

Dear Indu Lakshman:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 comprehensive regulatory information about medical devices and radiation-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

Enclosure

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Indications for Use

510(k) Number (if known) K180660

Device Name Avanti

Indications for Use (Describe)

The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information

CompanyOptovue, Inc2800 Bayview DriveFremont, CA 94538(510) 897-1734
Contact PersonIndu LakshmanSenior Director, Regulatory Affairs and Quality AssuranceTel: (510) 897-1575Email: indu_lakshman@optovue.com
Date Prepared04 June 2018

Device Information

Device Trade NameAvanti
Device Common NameOptical Coherence Tomography
Classification Regulation21 CFR 886.1570
Classification NameOphthalmoscope
Device ClassClass II
Device Regulation PanelOphthalmic
Product CodeOBO, HLI
Predicate Devices
CompanyOptovue, Inc.
Devices1) Optovue RTVue XR OCT Avanti with AngioVue Software (K153080)2) Optovue RTVue CAM with Corneal Power Upgrade (K111505)
Reference Device

Optovue, Inc. Company Device Optovue iVue (K163475)

Indications for Use

The Avanti is an optical coherence tomography system intended for the in vivo imaging, crosssectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc,

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cornea, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avanti is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eve to a database of known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects, and in subjects with glaucoma and retinal diseases.

Device Description

The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.

Description of Key Functional Components

The Avanti device consists of the following components.

Avanti Scanner Head

The Avanti scanner head is the main component of the Avanti device. It is used to view and scan the patient's eye, collect the OCT signal, and send it to the computer for processing and storage. Communication between the camera and computer is achieved via a USB connection. The Avanti device uses a medical-grade power supply.

Computer with Application Software

The Avanti computer supports scanner operation, and processes, stores, and displays exam data through the Avanti application software. The searchable database stores and organizes patient and exam data. The computer is used to control the camera's image acquisition and image processing during the patient examination. The application software also is a data processing, presentation, and storage center. The computer is powered by a medical-grade power supply.

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Chinrest/Forehead Rest Assembly

The chinrest/forehead rest assembly is for ensuring patient alignment and stability for imaging. This is the only point of direct patient contact with the device. The chinrest/forehead rest assembly is part of the Avanti scanner head assembly.

Joystick

The joystick assembly allows the Avanti scanner head to be moved in the X, Y, and Z directions using the joystick. The joystick includes a button that captures an image when depressed. The joystick assembly is part of the Avanti scanner head assembly.

System Table

The system table holds all system components and powers them through a medical-grade isolation transformer, which prevents current leakage from main AC power. It rests on lockable wheels, making the system portable, and its height is adjustable through a medical-grade motorized telescopic lift.

Corneal Adapter Module (CAM) Lens

The Avanti device may be used with the Avanti CAM lens, which is used for imaging the cornea and anterior chamber of the eye. The Avanti CAM lens is supplied with the Avanti device.

Comparison of Technological Characteristics with the Predicate Device

The Avanti device with software modification is substantially equivalent to its RTVue XR Avanti and RTVue CAM predicate devices, cleared in K153080 on February 11, 2016 and K111505 on September 8, 2011, respectively. The intended use, system performance, subassemblies, and key components remain the same. The design and performance characteristics of the subject and predicate devices remain the same. The indications for use for the Avanti device are similar to the indications for use of its RTVue XR Avanti and RTVue CAM predicate devices with the addition of measurement of vascular density and the foveal avascular zone which can be assessed qualitatively with the predicate device and the addition of measurement of the corneal epithelia thickness and the corneal stroma thickness which can be measured with a manual caliper in the predicate device. The differences are not critical to the intended diagnostic use of the device, and do not affect the safety and effectiveness of the device when used as labeled.

The following are the proposed software modifications to the Avanti device:

New Quantitative analysis of vascular structures based on OCTA scan en face images:

  • Measurement of the vessel density of the Superficial (ILM to IPL-10 O um) and the Deep (IPL-10 um to OPL+10 um) en face slabs of the retinal microvasculature in the macula
  • Measurement of the vessel density of the RPC en face slab (ILM to O NFL) surrounding the optic disc

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  • Measurement of the foveal avascular zone (FAZ) area. FAZ perimeter, O and vessel density of the region 300 µm beyond the FAZ perimeter.
    New

  • Measurement of corneal layers based on PachymetryWide cornea scan:

    • o Added PachymetryWide cornea scan pattern with scan area of 9 mm in diameter
    • Measurement of the full corneal thickness (pachymetry) of the 9 mm O diameter area
    • o Measurement of the corneal epithelial thickness of the 9 mm diameter area
    • Measurement of the corneal stromal thickness of the 9 mm diameter O area

Updated 3D segmentation and quantitative analysis of posterior ocular structures based on OCTA scans:

  • o AngioRetina scan segmentation (8 layers)
  • o Automatic fovea center detection for the 3-mm AngioRetina and 6-mm HD AngioRetina scan patterns
  • o Measurement of the thickness of the retina and layers of retina in the macula
  • AngioDisc scan segmentation (7 layers) O
  • Automatic optic disc margin detection o
  • Measurement of the thickness of the retinal nerve fiber layer (RNFL) O and layers of retina in the peripapillary region
  • o Measurement of the optic disc parameters at the plane of Bruch's membrane opening (BMO)
  • Manual editing of segmentation error and propagation O
  • Updated OCTA Scan Projection Artifacts Removal (PAR): Expansion of PAR implementation to the Outer Retina, Deep Plexus, and Choroid en face slabs.
  • Updated Scan Quality (SQ) index for OCTA scans: An image quality indicator for OCTA scans based on signal-to-noise ratio, image sharpness (i.e., focus), and motion artifacts.

Risk Analysis

The risk management process at Optovue complies with BS EN ISO 14971:2012, Medical devices - Application of risk analysis to medical devices. All software modifications were assessed to make sure all risks were sufficiently mitigated and that no new hazards were introduced in to the Avanti device as a result of the new software features according to the intended use.

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Performance Data

The following performance data are provided to support substantial equivalence determination.

Software Verification and Validation Testing

Device software was verified and validated to support the indications for use according to BS EN 62304:2006 Medical device software - Software life cycle processes and FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff. In accordance with the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005," documentation was provided that demonstrates the software changes performed as intended, met acceptance criteria, and did not have a negative impact on product performance, overall product safety, or patient safety.

The software for this device was determined to be a "moderate" level of concern, since a malfunction of, or a latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. There was no change in the level of concern from the proposed Avanti and its RTVue XR Avanti and RTVue CAM predicate devices.

Non-clinical Performance Testing

A series of 3D phantom models with known ground truth for vessel density measurements was designed to validate the accuracy of the proposed device software for measurement of vessel density from 3-mm AngioRetina, 6-mm HD AngioRetina, and 4.5-mm HD AngioDisc scans. The vessel diameters covered in these phantoms range from 7um to 25um for small vessels and 50um to 180um for large vessels. The phantoms were designed to assess the impact of projection artifacts removal (PAR) on vessel density measurements (especially Deep vessel density) and large vessel masking for RPC vessel density.

The 3D phantoms were constructed with the same raw data format as that of an OCTA scan of the eye, containing an OCT volume and an OCTA volume with spatial colocalization. A series of phantoms containing different wireframe densities and/or patterns to cover a range of physiologically relevant vascular densities and pathologies, such as branch occlusions, were designed. Projection artifacts were simulated in the OCTA volume for each phantom throughout the depth. Larger vessels with varying diameters (50um ~ 180μm) were included in the AngioDisc scan 3D phantom design. Vessel density measurements by the software are based on the RPC en face images for all vessels and for small vessels (applying large vessel mask to mask the regions occupied by large vessels).

Phantoms were processed directly with the device software with all the steps that lead to the generation of vessel density map and associated measurement parameters, including en face slab generation, projection artifacts removal, image processing to generate vessel density map/measurements, and detection of large vessel mask for RPC vessel density analysis.

The agreement between software reported measurements and the expected "vascular" density values computed directly from the model were used to validate the accuracy of the software.

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3-mm AngioRetina Scan

To evaluate accuracy of measurements of 3-mm AngioRetina scan, 4 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern.

The measurement parameters tested included all software density measurement parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density (FD-300) based on the Retina slab.

The difference between the software reported vessel density value and the expected vessel density value of the phantom were evaluated for each parameter and for each of the 4 phantoms.

The range and accuracy for the 3-mm AngioRetina scan parameters are summarized below, for Superficial and Deep plexuses.

SuperficialVessel Density (%)ExpectedSWReportedDifferenceDeepVessel Density (%)ExpectedSWReportedDifference
Average46.548.72.3Average39.839.80.0
Std Dev13.013.01.0Std Dev14.313.91.2
Min17.220.2-1.0Min0.20.2-3.0
Max73.575.74.3Max50.550.92.4

Accuracy for 3-mm AngioRetina scan (pooled results of 4 individual phantoms and all zonal parameters)

FD-300Vessel Density(%)ExpectedSWReportedDifference
Average57.555.3-2.2
Std Dev2.21.5-0.7
Min54.753.5-1.2
Max60.057.0-3.0

Pooling results of the 4 phantoms and both plexuses, the measured vessel density values cover a broad range (from ~ 20% to ~ 75% as measured by the software).

6-mm HD AngioRetina Scan

To evaluate accuracy of measurements of 6-mm HD AngioRetina scan, 3 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern.

The measurement parameters tested included all software density measurement parameters for Superficial plexus and Deep plexus, as well as the foveal vessel density (FD-300) based on the Retina slab.

The difference between the software reported vessel density value and the expected vessel density value (i.e., the "known" vessel density value of the phantom) were evaluated for each parameter respectively and for each of the 3 phantoms.

The tables below summarize the measurement range for the 6mm HD Angio Retina scan parameters, for Superficial and Deep plexuses.

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SuperficialVessel Density(%)ExpectedSWReportedDifferenceDeepVessel Density(%)ExpectedSWReportedDifference
Average49.048.7-0.2Average63.063.30.3
Std Dev9.810.01.3Std Dev12.512.02.5
Min28.630.7-3.7Min0.81.4-4.7
Max62.562.82.3Max68.269.25.8
FD-300Vessel Density(%)ExpectedSWReportedDifference
Average63.062.1-0.9
Std Dev3.96.12.2
Min60.758.5-1.6
Max67.569.31.8

Accuracy for 6mm HD AngioRetina scan (pooled results of 3 individual phantoms and all zonal parameters)

Pooling results of the 3 phantoms and both plexuses, the measured vessel density values cover a broad range (from ~ 31 % to ~ 69% as measured by the software).

4.5-mm HD AngioDisc Scan, with and without Large Vessel Masking

To evaluate accuracy of measurements of 4.5mm HD AngioDisc scan, 3 phantoms with various vessel density were used, including one phantom with occlusion (vessel dropout) pattern.

The measurement parameters tested included all software density measurement parameters for RPC slab, small vessels only vessel density (with applying large vessel mask) and all vessels density (without large vessel mask), respectively.

The small vessels only vessel density is measured with the application of large vessel mask which has threshold of 3 pixels (approximately 33um for the 4.5-mm HD AngioDisc scans), therefore representing small vessels in the RPC slab.

The difference between the software reported vessel density value and the expected vessel density value of the phantom were evaluated for each parameter and for each of the 3 phantoms.

The tables below summarize the measurements range for the 4.5-mm AngioDisc scan parameters, RPC plexus; small vessels only vessel density (with applying large vessel mask) and RPC all vessels density, respectively.

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Image /page/10/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular design that is colored with a gradient from orange to yellow. The circle is not fully closed, with a small gap at the top left.

Small VesselDensity (%)ExpectedSWReportedDifferenceAll VesselsDensity (%)ExpectedSWReportedDifference
Average46.947.91.0Average56.155.6-0.5
Std Dev10.210.31.1Std Dev9.48.61.7
Min7.06.3-1.1Min22.423.6-2.9
Max56.957.13.4Max68.365.52.9

Accuracy for 4.5-mm HD AngioDisc scan (pooled results of 3 individual phantoms and all zonal parameters)

Pooling results of the 3 phantoms, the measured vessel density values cover a broad range (from ~ 6.0% to ~ 57% for small vessels only and from ~ 24% to ~ 66% for all vessels as measured by the software).

Overall, phantom model testing produced acceptable accuracy results, while covering a sufficiently wide range of vessel density and vessel pattern distribution.

Clinical Performance Testing

A clinical study was conducted according to BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice, to demonstrate substantial equivalence of the subject Avanti device to the predicate Avanti device software. The repeatability and reproducibility were evaluated for the measurements of vessel density, retinal thickness, retinal sub-layer thicknesses, and optic disc measurements based on the AngioRetina scans and AngioDisc scans. Measurement for structural parameters measured by both devices was also evaluated.

In addition, two anterior segment clinical studies were conducted to demonstrate substantial equivalence of the subject device to the predicate RTVue XR with CAM for pachymetry, corneal epithelial thickness, and corneal stromal thickness measurements with PachymetryWide scan. One study evaluated the repeatability and reproducibility of the cornea measurements, and the second study evaluated agreement with manual measurements based on the PachymetryWide scan software results.

1. Evaluation of the Repeatability and Reproducibility ("R&R") of AngioVue in Normal Subjects, Retinal Patients, and Glaucoma Patients

This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants age 18 or older were enrolled and assigned to one of three study groups: 1) individuals with no ocular disease; 2) individuals with glaucoma of varying severity (with confirmed glaucomatous visual field defect and/or glaucomatous optic nerve changes), and 3) individuals with exudative age-related macular degeneration (AMD), proliferative and nonproliferative diabetic retinopathy (DR), and other retinal vascular conditions. Individuals with media opacity or significant refractive error precluding adequate image quality were excluded. For repeatability/reproducibility and agreement, the study eve is imaged three times using relevant OCTA scan patterns with each of three Avanti instrument-operator pairs. For agreement assessment of retinal thickness and optic nerve head (ONH) parameters, study eyes were also scanned once with each of four predicate ("legacy") posterior segment scan patterns. All eligible study eyes with at least two acceptable scans were included into

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Image /page/11/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the text is a circular graphic that is colored with a gradient from yellow to orange. The graphic is not a complete circle, but rather an arc that wraps around the left side of the text.

final statistical analyses. All scans underwent post-acquisition image quality review. OCTA scans with a SQ score of less than 6 were excluded from analysis; "legacy" scan SSIs of <39 (Retina Map), <32 (GCC), or <28 (ONH scan pattern) were also excluded. Repeatability and reproducibility of the measured parameters (new OCTA parameters and non-OCTA thickness parameters) were calculated using a random-effects analysis of variance (ANOVA) model. Agreement was evaluated with calculation of 95% limits of agreement (LOAs) and Deming regression analyses.

A total of 70 participants were consented and enrolled, 15 "normals," 16 with glaucoma ("Glaucoma" sub-group), and 39 with retinal conditions ("Retina" sub-group). Three participants from the Retina sub-group could not complete the required imaging. Therefore, a total of 67 eligible participants completed the study. Of the 36 "Retina" sub-group participants, 12 were assigned to the exudative AMD, DR, and "other" groups each. The age distribution and clinical characteristics of the study cohort are shown in Tables 1 through 5.

MeanSDMedianMinMax
Normal (n=15)4721.8411984
Glaucoma (n=16)727.4736287
Retina (n=36)6816.1712195
Wet AMD (n=12)779.6746695
DR (n=12)5612.7573177
Retina other (n=12)7018.0752190
Table 1. Age Distribution for All Subjects by Enrollment Category
Table 2. Visual Field and Optic Nerve Head Characteristics Distribution in Glaucoma Group
--------------------------------------------------------------------------------------------
Glaucoma Stage(Total N=16)VF PSD mean(range) dBVF MD mean(range) dBVF GHT outsidenormal limits(N of eyes)ONH rimthinning(N of eyes)RNFLdefect(N of eyes)ONHcupping(N of eyes)
EarlyN=72.69(1.76 to 3.52)-1.71(-2.71 to -0.32)5507
ModerateN=44.74(3.33 to 6.08)-3.62(-4.42 to -3.04)4413
AdvancedN=511.66(10.72 to 12.23)-14.06(-25.79 to -7.84)5525

Table 3. Imaging Findings and Treatment in Retina Wet AMD Sub-group

SubjectEyeSub-GroupType 1CNVType 2CNVIRFSRFPEDCNV seenon OCTATreatment
SD7529OSwetAMD111
SD7533ODwetAMD1111
SD7549OSwetAMD1111
SD7551ODwetAMD111
SD7553OSwetAMD11
SD7555OSwetAMD11
SD7557ODwetAMD111
SD7558ODwetAMD111
SD7561ODwetAMD111
SD7563OSwetAMD11
SD7564ODwetAMD1111
SD7568OSwetAMD111
Sum7544178

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Image /page/12/Picture/1 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a simple, sans-serif font, with the letters in a light gray color. To the left of the word is a circular graphic that is open on the right side. The graphic transitions in color from a bright orange at the bottom to a lighter yellow at the top, creating a gradient effect.

SubjectEyeSub-GroupDR Severityw/ DMEw/o DMEIRFReduced RetinalVascular DensityOther VascularChangeTreatment
SD7537ODDRModerate NPDR111
SD7538ODDRPDR111
SD7539OSDRModerate NPDR111IRMA
SD7540OSDRPDR11dilation, tortuosity
SD7543OSDRModerate NPDR111dilation,tortuosity, MA
SD7547OSDRPDR111FAZ Outpouching1
SD7554ODDRModerate NPDR111dilation, tortuosity
SD 7556ODDRModerate NPDR111
SD7560OSDRPDR111FAZ outpouching1
SD7565OSDRPDR11FAZ outpouching1
SD7566OSDRPDR1FAZ outpouching1
SD7567ODDRMild NPDR11
Sum838104

Table 4. Clinical and Imaging Findings, and Treatment in Retina DR Sub-group

Table 5. Clinical and Imaging Findings, and Treatment in Retina Other Sub-group

SubjectEyeSub-GroupDetailsIRFSRFCNV onOCTAReduced RetinalVascular DensityOther VascularChangeTreatment
SD7528OSOtherERM
SD7534ODOtherBRVO w/CME11
SD7535ODOtherdryAMD
SD7541ODOtherdryAMD
SD7542ODOtherdryAMD
SD7544OSOtherTraumaticCNV1
SD7545ODOtherPCV111
SD7546OSOtherBRVO111
SD7548OSOther
SD7550ODOtherERM w/lamellar hole
SD7559ODOtherBRVO111
SD7569ODOtherBRVO11dilation,tortuosity1
Sum31245

Results

The frequency of scan exclusion due to insufficient image quality are shown as follows:

  • 3-mm AngioRetina scan 12.9% (77 out of 595 scans) ●
  • 6-mm HD AngioRetina scan - 14.4% (86 out of 598 scans)
  • . 4.5-mm HD AngioDisc – 3.7% (10 out of 268 scans) (only Normal and Glaucoma groups)

For the 3-mm AngioRetina scan, the edit rates were: IPL 13.3%, BRM 11.6%, OPL 6%, RPE 3.5%, and ILM 0% for segmentation, FAZ boundary 10.8%, and ETDRS grid re-centering 1.5%. For the 6-mm HD AngioRetina scan, the edit rates were: IPL 13.9%, BRM 10.4%,

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Image /page/13/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a sans-serif font, with the letters in gray. To the left of the word is a circular design that is colored in shades of orange and yellow, creating a gradient effect. The circular design appears to be incomplete, with an opening at the top.

OPL 5.5%, RPE 2.3%, and ILM 0.6% for segmentation, FAZ boundary17.7%, and ETDRS grid re-centering 1.8%.

The results are provided below, organized by scan patterns and measurements.

Vascular Parameters of the 3-mm Angio Retina and 6-mm HD AngioRetina Scans Tables 6 through 11 summarize the results of the R&R analysis of vascular parameters of 3-mm Angio Retina and 6-mm HD AngioRetina scans.

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Image /page/14/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized orange circle on the left, with the word "OPTOVUE" in gray, sans-serif font to the right of the circle. The circle is not a complete circle, but rather an arc that fades from a darker orange at the bottom to a lighter orange at the top.

Table 6 Vascular Parameters of AngioRetina Scans, Normal Group

Normal
6-mm HD AngioRetina Scan3-mm AngioRetina Scan
ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibilityScan #MeanSDminmaxabilitySDrepeat reproducibilitySDReproducibilityCV95% limitsof reproducibility
WI12850.53.241.056.02.32.44.8%6.712948.03.538.353.21.71.93.9%5.2
WI_S_Hemi12850.83.340.856.52.32.54.9%6.912948.73.838.054.41.82.14.2%5.7
WI_I_Hemi12850.33.341.155.92.42.44.9%6.812947.33.538.554.32.02.14.4%5.8
All (0-6)C (1)12812850.627.43.37.140.68.656.144.32.31.92.42.24.8%8.2%6.76.112912947.624.03.46.537.97.953.139.61.61.41.81.53.7%6.4%4.94.2
All (1-3)12853.03.542.759.22.72.85.4%7.912950.73.341.655.71.81.93.7%5.2
S_Hemi (1-3)12853.33.445.060.02.42.64.9%7.312950.83.541.356.61.71.93.7%5.2
I_Hemi (1-3)12852.74.036.258.53.23.36.4%9.212950.53.441.155.92.12.14.3%6.0
T (1-3)12853.83.435.860.22.72.85.3%7.912950.22.942.356.01.71.93.8%5.3
ર (1-3)12812853.552.23.84.043.640.561.258.72.73.32.93.35.5%6.4%8.19.312912951.549.93.83.640.638.958.256.72.01.92.22.14.2%4.2%6.05.8
SuperficialN (1-3)I (1-3)12852.54.730.659.03.94.07.6%11.012851.14.040.457.42.52.54.9%7.0
(ILM toAll (3-6)12850.73.440.756.72.32.44.8%6.8------
IPL-10μm)S_Hemi (3-6)12850.93.540.256.32.42.65.1%7.1----
VesselI_Hemi (3-6)12850.53.541.257.22.42.54.9%6.8------
DensityT (3-6)12847.63.436.753.32.52.75.7%7.5-----
(%)ર (3-6)N (3-6)12812851.054.13.83.740.444.557.860.32.62.42.72.55.4%4.6%7.66.9------------
ા (3-6)12850.23.838.357.02.62.65.2%7.3------
G1112852.16.336.861.92.52.54.8%6.912950.74.237.658.92.42.54.9%6.9
G1212851.63.741.758.62.62.85.4%7.712952.23.639.758.12.02.14.1%5.9
C1312848.96.433.961.42.93.36.7%9.112949.74.935.359.32.42.95.8%7.9
G2112851.64.340.159.32.62.65.1%7.312949.73.438.955.82.02.24.4%6.0
G22G2312812848.350.83.54.337.638.054.959.92.42.42.62.75.4%5.3%7.27.412912929.549.35.73.114.241.242.155.31.81.61.91.86.5%3.6%5.34.9
G3112851.06.036.161.32.72.75.3%7.412950.54.830.657.43.23.26.4%8.9
G3212850.74.035.758.22.92.95.7%8.012950.34.138.657.22.62.75.3%7.4
૯૩૩12849.65.635.661.32.82.95.9%8.212950.34.239.157.62.32.54.9%6.9
WI12850.74.840.464.53.93.97.8%10.912949.53.542.059.22.32.55.0%6.8
WI_S_Hemi12850.95.040.864.94.14.28.3%7.6%11.712950.03.742.260.42.42.75.3%4.9%7.4
WI_I_HemiAll (0-6)12812850.452.04.94.738.042.364.564.73.83.73.83.87.3%10.610.512912949.149.43.53.441.643.058.659.92.42.02.42.14.3%6.75.9
C (1)12838.27.816.850.91.92.05.2%5.412933.07.413.946.21.31.34.1%3.7
All (1-3)12854.03.646.163.52.82.85.2%7.812951.53.543.162.22.22.44.6%6.6
S_Hemi (1-3)12854.23.645.662.72.92.95.3%8.012951.63.543.363.22.32.44.7%6.7
l_Hemi (1-3)12853.83.942.664.73.03.25.9%8.812951.53.643.061.32.32.54.8%6.8
T (1-3)12812854.953.33.84.138.943.164.263.42.93.43.03.55.4%6.5%8.29.612912952.151.23.33.945.439.962.264.02.12.62.22.84.3%5.5%6.27.8
ટ (1-3)N (1-3)12855.03.846.364.93.13.15.6%8.612951.93.542.862.52.12.34.5%6.4
DeepI (1-3)12852.84.630.065.43.73.97.5%10.912850.84.041.260.22.82.95.6%7.9
(IPL-10μ toAll (3-6)12851.95.239.965.94.24.28.2%11.7----
OPL+10μ)S_Hemi (3-6)12852.25.341.466.04.34.48.5%12.2-----
VesselDensityI_Hemi (3-6)12851.65.436.066.54.24.38.3%11.8----יי
(%)1 (3-6)ર (3-6)12812854.851.74.45.843.640.865.067.73.64.73.74.86.7%9.3%10.113.3---------
n (3-6)12850.46.036.566.64.95.09.9%13.8--------
ા (3-6)12850.75.932.966.44.74.79.3%13.0---
G1112849.06.437.766.65.65.711.6%15.812950.24.339.860.73.63.77.4%10.2
G1212851.25.740.467.24.74.89.3%13.212951.13.940.562.12.72.85.5%7.8
G13G2112812849.552.86.74.933.542.365.066.44.94.15.14.110.4%7.8%14.211.412912950.852.24.33.339.244.562.560.83.02.13.42.16.7%4.1%ਰੇ.55.9
G2212851.83.245.260.42.32.34.4%6.312937.55.820.248.91.82.05.4%5.6
G2312853.74.841.564.03.83.97.2%10.712952.03.345.062.22.02.14.0%5.8
G3112848.16.331.665.84.94.910.2%13.612950.34.439.560.33.53.67.1%ਰੇ. 9. 9
G3212850.95.534.965.84.54.69.0%12.712951.34.241.061.63.03.16.0%8:5
G3312849.17.330.164.34.64.69.5%12.912950.34.538.760.83.43.67.2%10.0
FAZFAZ (mm")PERIM (mm)1281280.2701.9750.1200.4560.0690.9640.5853.0800.0120.0850.0120.0864.2%4.3%0.0320.2381291290.2842.0920.1270.4940.0801.1270.5823.1890.0080.0630.0090.0663.0%3.1%0.0240.182
FD-300 (%)12854.04.139.661.62.52.64.9%7.312950.73.741.257.72.02.03.8%5.4
Glaucoma
6-mm HD AngioRetina Scan3-mm AngioRetina Scan
repeatreproduReprodu95% limitsrepeatreproduReprodu95% limits
ParameterScan #MeanSDminmaxabilitySDcibilitySDcibilityCVof reproducibilityScan #MeanSDminmaxabilitySDcibilitySDcibilityCVof reproducibility
WI13342.64.830.851.22.22.45.7%6.713442.85.327.853.22.12.45.7%6.7
WI_S_Hemi13343.54.831.153.02.32.65.9%7.113443.35.127.652.82.32.76.3%7.5
WI_l_Hemi13341.75.230.051.12.32.45.7%6.613442.46.028.154.72.22.45.7%6.7
All (0-6)C (1)13313343.021.24.96.730.87.551.435.42.32.02.42.25.7%10.2%6.76.013413443.120.35.36.427.36.653.335.92.01.42.31.75.4%8.7%6.54.8
All (1-3)13347.55.333.556.72.72.96.1%8.013446.05.629.557.12.22.55.4%6.9
S_Hemi (1-3)13347.75.233.657.62.93.16.5%8.613446.25.528.757.32.32.65.6%7.1
I_Hemi (1-3)13347.36.031.756.62.82.96.2%8.113445.86.130.256.92.32.65.6%7.1
T (1-3)13347.05.233.057.32.62.96.1%7.913444.75.131.757.92.32.65.8%7.2
S (1-3)N (1-3)13313348.147.85.66.334.329.258.159.93.43.33.63.57.4%7.3%9.89.613413446.846.55.86.529.624.458.856.82.52.62.82.85.9%6.1%7.77.9
SuperficialI (1-3)13347.06.631.257.03.33.47.4%9.613346.06.828.756.32.62.86.1%7.8
(ILM toAll (3-6)13342.55.030.751.22.32.55.8%6.9-------
IPL-10μm)S_Hemi (3-6)13343.55.130.553.42.42.66.1%7.3-------
VesselI_Hemi (3-6)13341.55.629.351.52.52.56.0%6.9---
Density(%)T (3-6)13339.84.729.650.22.42.66.4%7.1-------
ર (3-6)и (3-е)13313342.747.35.45.830.132.453.257.22.72.52.92.76.8%5.7%8.07.5-----
। (3-6)13340.25.927.352.62.72.76.8%7.6---
G1113343.36.329.356.62.62.66.1%7.313444.76.327.557.43.03.27.2%8.9
G1213343.55.429.454.53.03.27.3%8.813447.25.928.959.62.72.86.0%7.8
ਦਾਤ13341.57.327.757.22.73.07.2%8.213443.76.330.558.73.23.78.4%10.2
G21G2213313345.643.66.44.931.029.157.851.32.42.42.62.65.7%5.9%7.17.113413445.225.86.56.225.211.957.639.32.62.22.92.56.5%9.7%8.16.8
G2313344.05.731.258.22.62.96.6%8.013446.05.033.956.42.62.86.2%7.9
G3113341.66.827.752.72.32.35.6%6.413443.97.429.255.82.72.86.5%7.9
G3213341.75.628.752.52.82.97.0%8.013445.37.124.556.32.93.06.7%8.4
૯૩૩13338.56.624.651.72.93.07.9%8.413443.67.025.255.63.03.58.1%9.7
WI13313347.948.15.15.136.135.861.361.13.33.43.84.17.9%8.5%10.511.313413448.648.93.33.540.540.855.756.72.42.42.62.65.3%5.4%7.17.3
WI_S_HemiWI_l_Hemi13347.75.335.361.53.43.77.7%10.213448.23.340.255.62.52.75.5%7.4
All (0-6)13349.34.937.362.63.23.67.4%10.013448.53.041.556.12.22.34.8%6.4
C (1)13333.09.211.353.02.32.37.0%6.313429.98.112.949.41.71.75.7%4.6
All (1-3)13352.83.544.163.42.62.95.5%8.113450.93.343.058.82.32.54.9%6.9
S_Hemi (1-3)13352.93.63.744.642.463.62.73.05.6%6.0%8.213451.13.343.658.72.32.44.8%5.4%6.8
I_Hemi (1-3)T (1-3)13313352.653.73.644.663.262.52.92.63.12.95.4%8.78.013413450.851.33.33.642.041.358.963.22.62.82.73.05.9%7.68.4
ડ (1-3)13352.74.143.464.73.33.56.7%ਰੇ 813451.23.741.259.02.52.75.3%7.5
N (1-3)13352.83.735.062.43.23.46.4%9.413450.43.043.958.82.32.44.8%6.7
Deep। (1-3)13351.94.339.864.03.53.77.2%10.313350.83.839.857.82.83.05.8%8.2
(IPL-10μ toAll (3-6)13348.95.636.063.43.64.08.2%11.1------
OPL+10μ)VesselS_Hemi (3-6)I_Hemi (3-6)13313349.348.45.45.936.433.163.463.43.53.94.24.18.5%8.5%11.611.4--------
DensityT (3-6)13351.05.037.562.73.23.67.2%10.1l-י-
(%)ર (3-6)13348.56.232.163.34.14.810.0%13.4----
N (3-6)13348.75.829.965.04.04.49.1%12.3-------
। (3-6)13347.27.030.462.64.44.59.6%12.5--
G11G1213313346.848.76.25.932.231.159.563.54.44.05.04.710.7%9.7%13.913.113413449.651.24.13.938.841.458.158.93.12.73.32.86.6%5.5%9.17.8
G1313345.26.528.759.34.65.411.9%14.813449.54.639.457.93.53.87.7%10.6
G2113350.65.427.864.23.63.97.7%10.813451.03.640.161.52.52.75.3%7.5
G2213350.13.239.758.52.22.34.7%6.513434.96.320.950.61.92.05.7%5.4
G2313350.74.940.262.53.03.56.9%9.713451.13.644.267.02.62.95.6%7.9
G31G3213313346.448.26.06.331.433.162.063.14.24.14.44.29.5%8.8%12.211.713413449.650.94.23.838.838.659.460.23.23.03.43.16.9%6.2%9.48.7
G3313344.67.326.961.34.44.710.7%13.113449.24.537.058.33.43.67.3%ਰੇ.9
FAZ (mm2)1240.3350.1270.1510.6440.0100.0103.1%0.0291250.3340.1200.1480.6110.0110.0113.3%0.032
FAZPERIM (mm)1242.2170.4191.4713.1840.0660.0663.0%0.1821252.2930.4111.5003.1220.0620.0622.7%0.171
FD-300 (%)12450.64.939.763.03.13.16.2%8.712548.94.535.359.92.02.14.3%5.9
Retina
6-mm HD AngioRetina Scan3-mm AngioRetina Scanrepeat reprodu Reprodu
ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibilityScan #MeanSDminmaxabilitySDcibilitySDcibilityCV95% limitsof reproducibility
WI25145.63.934.253.81.92.04.5%5.625542.14.133.252.81.92.04.9%5.6
WI_S_Hemi25145.73.833.954.32.02.24.9%6.125542.44.233.554.52.02.25.3%6.1
WI_I_Hemi25145.44.330.554.02.02.14.5%5.725541.74.531.252.92.12.25.3%6.1
All (0-6)25145.54.034.654.02.02.14.7%5.925541.84.431.752.91.92.15.0%5.7
C (1)All (1-3)25125126.046.98.24.45.735.443.857.92.92.53.02.711.3%5.8%8.27.425525522.644.27.64.66.234.440.955.31.72.01.92.28.5%5.0%5.36.1
S_Hemi (1-3)25147.04.535.258.72.62.86.1%7.825544.34.734.355.52.12.25.1%6.2
I_Hemi (1-3)25146.94.933.557.22.93.06.5%8.325544.14.932.156.42.22.45.5%6.6
T (1-3)25146.36.226.756.73.13.16.8%8.725542.66.124.354.12.32.55.9%6.9
S (I-3)25147.74.732.359.02.83.16.6%8.625545.25.229.657.12.32.45.4%6.7
N (1-3)25146.45.026.257.93.33.57.7%9.825544.24.531.954.42.42.65.9%7.1
SuperficialI (1-3)25125147.45.332.833.559.554.63.43.57.3%4.7%die5.9249-45.05.331.057.32.5-2.65.9%7.3
(ILM toIPL-10μm)All (3-6)S_Hemi (3-6)25145.845.94.24.034.655.52.02.12.12.24.9%6.2-------
VesselI_Hemi (3-6)25145.84.828.154.22.12.24.9%6.2----
DensityT (3-6)25141.74.925.651.72.42.66.2%7.1----
(%)ર (3-6)25145.84.433.255.52.32.55.5%6.9------
n (3-6)25150.53.740.858.12.12.24.3%6.0------
ા (3-૯)24945.25.624.854.62.32.45.2%6.5-------
G1125146.76.431.959.12.22.35.0%6.425544.45.328.557.12.72.76.3%7.6
G12ਦਾਤ25125146.145.24.57.334.626.956.159.62.52.42.72.56.0%5.5%7.66.925525545.25.65.425.326.357.556.72.52.52.72.76.0%6.2%7.4
G2125146.06.025.056.32.52.65.7%7.225543.842.76.016.855.02.62.86.6%7.47.7
G2225143.44.429.555.22.42.66.0%7.125527.26.112.741.72.02.17.9%5.9
G2325146.05.828.460.12.42.65.7%7.325543.35.030.954.02.52.86.5%7.7
G3125145.67.820.158.12.32.35.1%6.325543.27.314.656.73.03.07.0%8.3
G3225145.65.326.656.42.52.55.6%7.125544.75.328.057.52.93.06.7%8.2
૯૩૩25145.46.428.559.22.52.55.5%7.025543.95.032.055.92.62.76.3%7.6
WI25146.94.530.158.13.13.26.8%8.825543.04.730.555.63.43.47.8%ਰ 3
WI_S_Hemi25125147.046.84.64.933.458.559.13.43.23.53.27.5%6.7%9.78.725525543.44.75.230.330.156.256.33.43.53.43.57.9%8.1%9.6
WI_l_HemiAll (0-6)25148.04.626.830.759.33.23.26.7%8.925542.742.84.830.855.53.33.37.6%9.79.1
C (1)25135.98.014.952.53.53.59.7%die25530.97.413.453.92.72.78.7%7.5
All (1-3)25149.94.634.562.33.53.56.9%die25544.35.030.956.93.53.57.9%9.8
S_Hemi (1-3)25150.24.737.663.73.73.77.4%10.225544.74.931.457.63.53.57.8%9.7
I_Hemi (1-3)25149.65.231.562.13.73.77.4%10.225544.05.629.757.23.83.88.4%10.4
T (1-3)25149.95.929.363.04.04.07.9%11.025544.45.626.458.23.33.37.3%9.1
ડ (1-3)25149.55.529.563.14.24.28.5%8.3%11.725544.35.727.859.43.83.88.5%10.6
DeepN (1-3)I (1-3)25125150.949.15.15.233.234.266.963.24.24.44.24.48.9%11.712.125524944.744.05.25.529.125.959.258.03.84.13.84.18.5%9.3%10.611.5
(IPL-10μ toAll (3-6)25147.95.029.459.33.33.47.1%9.4------
OPL+10μ)S_Hemi (3-6)25147.95.033.060.73.63.77.7%10.2-------
VesselI_Hemi (3-6)25147.85.525.761.83.43.47.2%ਰੇ 5--י-
DensityT (3-6)25149.55.526.460.22.93.06.2%8.5--------
(%)ર (3-6)25147.45.430.961.83.83.98.3%10.9--
N (3-6)25147.56.034.362.44.44.49.4%12.3
ા (3-૯)GIT24925147.046.56.35.822.823.262.859.63.84.43.84.58.2%9.6%10.612.4-25544.15.527.0-59.04.34.39.7%12.0
G1225147.45.334.361.23.94.18.6%11.325544.26.524.058.93.94.08.8%11.0
G1325144.46.424.361.14.34.610.3%12.625544.05.626.357.34.14.19.3%11.4
G2125149.25.628.363.83.83.87.7%10.525544.06.516.862.43.63.78.2%10.1
G2225147.84.435.259.03.13.16.6%8.725534.35.920.353.63.03.08.8%8.4
G2325148.85.532.461.53.43.57.1%die25545.54.532.456.63.43.47.5%વે રે
G3125145.56.618.261.04.04.18.9%11.225542.97.612.158.44.54.510.3%12.5
G3225147.06.025.762.03.93.98.4%10.925544.35.926.560.04.34.39.5%11.8
૯૩૩FAZ (mm-)25123445.45.629.30.08859.10.5764.04.08.9%6.6%11.20.04825523743.95.40.1229.20.10260.74.54.50.01010.1%3.8%12.4
FAZPERIM (mm)2340.2591.9690.1170.4461.1303.1300.0170.0920.0170.0934.7%0.2572370.2672.0750.481.2760.6034.1820.0100.0970.0974.6%0.0290.270
FD-300 (%)23447.15.418.757.93.73.88.1%10.523743.94.831.154.02.12.35.2%6.3
Retina: Wet AMD Sub-group
6-mm HD AngioRetina Scan3-mm AngioRetina Scan
ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibilityScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibility
WI8746.43.238.553.82.22.35.0%6.48943.12.733.248.21.61.74.0%4.8
WI_S_Hemi8746.43.537.454.32.32.45.2%6.78943.52.934.348.61.81.94.5%5.3
WI_I_Hemi8746.33.139.554.02.22.35.0%6.48942.73.032.148.41.81.94.4%5.2
All (0-6)8746.43.338.454.02.32.45.2%6.68943.02.933.048.51.71.84.2%5.0
C (1)All (1-3)878724.449.08.63.95.737.343.855.72.62.62.72.710.5%5.5%7.57.4898921.445.78.53.16.334.640.950.11.81.82.11.99.1%4.2%5.75.3
S_Hemi (1-3)8748.74.136.555.42.82.96.0%8.08945.83.334.650.31.92.04.4%5.6
I_Hemi (1-3)8749.34.138.156.32.92.95.9%8.08945.63.234.250.62.02.04.5%5.7
T (1-3)8749.54.239.856.72.72.75.5%7.58945.53.333.750.32.22.45.3%6.6
ર (1-3)8748.94.636.556.33.23.36.8%9.28946.53.932.153.72.32.45.1%6.5
N (1-3)8748.04.434.856.33.03.16.6%8.78945.03.236.451.31.92.04.5%5.5
Superficial(ILM to। (1-3)All (3-6)878749.646.44.93.436.538.459.554.63.42.33.42.46.9%5.3%ਰੇ 36.88846.0-3.9-32.7-52.1-2.3-2.3-5.1%-6.4-
IPL-10μm)S_Hemi (3-6)8746.33.838.255.52.42.65.6%7.1--------
VesselI_Hemi (3-6)8746.53.338.554.02.42.55.4%6.9------
DensityT (3-6)8743.43.535.351.42.62.76.2%7.4----
(%)ર (3-6)8745.84.136.655.52.72.96.3%8.0--------
n (3-6)8750.43.442.257.92.32.44.7%6.6-------
ા (3-6)G11878745.947.93.85.537.934.354.657.82.62.22.72.36.0%5.0%7.66.58944.9-4.329.051.4-2.32.45.4%-6.6
G128746.44.337.955.63.03.16.7%8.68947.34.135.053.52.32.45.2%6.7
ਵਾਤ8744.87.529.258.02.72.96.4%8.08944.03.936.354.02.32.55.7%7.0
G218747.63.837.455.62.52.65.4%7.18945.23.035.552.42.22.24.9%6.1
G228745.03.633.352.62.42.45.4%6.88926.66.114.141.72.22.38.4%6.4
G238746.94.636.657.42.52.75.7%7.48945.13.234.749.92.22.45.3%6.5
C318747.05.233.856.42.42.45.2%6.78945.04.033.052.12.42.45.4%6.7
G32૯૩૩878746.745.04.07.138.631.556.459.22.82.72.92.86.2%6.2%7.97.8898945.544.34.83.928.034.853.352.72.82.72.92.76.4%6.0%7.97.3
WI8747.84.138.058.13.13.16.6%8.78944.24.534.355.63.43.47.7%વે 5
WI_S_Hemi8747.54.635.258.53.33.36.9%9.08944.54.436.755.93.43.47.7%9.6
WI_I_Hemi8748.13.940.659.13.23.26.7%8.98943.84.830.356.33.63.68.2%10.1
All (0-6)8749.24.040.159.33.13.16.4%8.78943.74.633.055.53.43.47.7%9.4
C (1)8735.38.816.152.52.72.77.4%7.68930.79.413.453.92.42.47.4%6.7
All (1-3)S_Hemi (1-3)878751.351.43.83.841.441.361.861.63.53.63.53.66.8%7.0%9.610.0898945.445.64.54.435.137.656.857.63.73.63.73.68.0%7.8%10.210.0
I_Hemi (1-3)8751.14.241.362.13.63.77.2%10.28945.24.931.157.24.04.08.8%11.2
T (1-3)8751.93.843.462.73.33.36.4%9.28946.14.332.956.83.53.57.5%9.7
ટ (1-3)8750.94.437.262.74.34.38.5%11.98945.84.936.559.43.83.88.1%10.4
N (1-3)8751.94.641.966.94.04.07.7%11.18944.75.033.259.24.14.19.2%11.5
Deep। (1-3)8750.34.839.263.24.44.48.8%12.38844.95.034.058.04.34.39.5%11.8
(IPL-10μ toOPL+10μ)All (3-6)S_Hemi (3-6)878749.148.74.55.137.133.859.360.73.43.63.43.66.9%7.4%ਰੇ 310.0-------------י-
VesselI_Hemi (3-6)8749.54.240.559.83.33.36.8%9.2---------
DensityT (3-6)8752.03.542.560.12.82.85.4%7.8----l-י
(%)ર (3-6)8747.45.930.961.84.04.08.4%11.0
и (3-е)8748.35.835.762.44.14.18.6%11.5----
। (3-6)8748.74.834.259.43.93.98.1%10.9----
G11G12878746.347.96.15.423.234.357.761.24.33.64.33.69.4%7.6%12.010.0898944.846.45.54.831.835.859.058.64.33.84.33.89.5%8.0%12.010.4
G138744.16.527.958.34.04.29.6%11.68945.15.634.457.14.34.39.4%11.9
G218750.94.539.763.83.53.67.0%9.98945.44.934.658.43.73.77.9%10.1
G228748.73.741.659.03.03.16.3%8.58934.46.920.553.62.92.98.0%8.0
G238750.74.939.061.53.23.26.3%8.88946.14.035.656.53.73.77.9%10.2
G318746.95.234.361.04.44.49.4%12.28945.35.229.658.44.54.59.8%12.4
G328748.745.84.537.460.23.93.98.1%8.9%10.98944.95.330.960.04.14.64.29.3%11.8
G33FAZ (mm-)87790.3005.40.13835.10.11958.10.5764.10.0164.10.0165.5%11.30.044898045.30.3105.50.15329.20.15060.70.6030.0114.60.01110.1%3.6%12.80.030
FAZPERIM (mm)792.1160.5101.5033.1300.0830.0844.0%0.234802.2250.6051.4964.1820.1290.1295.9%0.358
FD-300 (%)7947.74.733.856.33.43.47.1%9.38043.74.231.151.62.02.25.1%6.1
Retina: DR Sub-group
6-mm HD AngioRetina Scan3-mm AngioRetina ScanreprodurepeatReprodu95% limitsrepeat reprodu
ParameterScan #MeanSDminmaxabilitySDcibilitySDcibilityCVof reproducibilityScan #MeanSDminmaxabilitySDcibilitySDReproducibilityCV95% limitsof reproducibility
WI7645.12.838.250.71.71.73.8%4.87339.33.433.247.11.71.94.83%5.2
WI_S_Hemi7645.02.939.251.31.81.94.2%5.37339.43.333.546.31.82.05.07%5.5
WI_l_HemiAll (0-6)767645.244.83.02.736.938.050.850.51.81.71.81.84.0%3.9%5.04.9737339.138.63.83.931.231.748.047.62.21.82.31.95.81%4.92%6.35.2
C (1)7626.38.06.640.43.43.413.0%9.47322.06.97.034.21.71.88.43%5.0
All (1-3)7644.33.035.450.52.32.55.6%6.87340.83.834.449.31.82.04.83%5.4
S_Hemi (1-3)l_Hemi (1-3)767644.444.23.43.335.233.551.253.22.42.82.82.86.2%6.3%7.67.7737340.840.93.64.434.332.648.351.61.92.02.02.14.83%5.26%5.46.0
T (1-3)7643.44.030.851.53.73.78.5%10.27338.64.431.048.12.32.46.26%6.7
ર (1-3)7645.43.636.153.32.32.86.2%7.97341.73.335.449.02.02.04.80%5.5
N (1-3)7643.74.926.254.53.74.09.2%11.07341.14.732.351.42.12.45.82%6.6
Superficialto(ILM। (1-3)All (3-6)767644.745.74.03.032.839.353.651.43.21.83.21.87.1%3.9%8.85.068-41.75.0-31.0-53.62.32.3-5.50%-6.4
IPL-10μm)S_Hemi (3-6)7645.53.238.751.31.71.73.8%4.8-------
VesselI_Hemi (3-6)7646.03.138.751.52.02.04.4%5.6------
DensityT (3-6)7640.33.232.446.42.02.15.3%6.0-------
(%)ર (3-૯)N (3-6)767646.150.33.73.338.042.354.256.62.02.22.02.24.4%4.4%5.66.2--i--------
ા (3-6)7646.23.338.652.92.12.14.6%5.8--
C117648.56.634.859.12.02.04.1%5.57342.2ર્ડ28.552.12.62.76.46%7.4
G127645.84.138.154.42.32.45.3%6.77341.93.833.449.72.52.55.94%6.9
C13G21767643.746.06.25.832.229.959.655.72.52.42.52.55.7%5.4%7.06.9737340.839.13.54.930.827.547.949.62.32.52.62.76.45%6.85%7.37.4
G227640.53.729.547.42.42.46.0%6.77325.75.912.738.91.91.97.64%5.4
G237643.24.034.353.92.32.55.8%7.07339.44.430.950.22.42.87.23%7.9
C317647.67.632.757.52.12.14.5%5.97342.65.631.056.52.62.66.21%7.2
G32૯૩૩767645.944.83.45.438.134.552.756.32.32.42.32.45.0%5.3%6.46.6737341.040.44.73.429.232.051.648.32.92.62.92.66.95%6.51%7.97.3
WI7646.83.938.757.53.23.47.3%9.47341.85.330.551.43.94.09.49%11.2
WI_S_Hemi7646.84.138.957.73.74.08.5%11.07341.9ર્ડ30.353.34.04.19.66%11.4
WI_l_Hemi7646.94.338.559.03.33.37.0%9.27341.75.230.750.94.04.19.64%11.3
All (0-6)C (1)767647.835.34.17.839.414.958.550.33.44.33.54.37.3%12.2%9.711.9737341.629.95.15.630.819.150.945.23.82.93.92.99.22%9.75%10.88.1
All (1-3)7649.74.441.162.34.04.08.0%11.07343.15.730.954.34.14.29.51%11.6
S_Hemi (1-3)7649.44.940.363.74.34.48.9%12.37343.35.831.454.64.14.29.53%11.7
l_Hemi (1-3)7649.94.641.461.04.44.48.7%10.9%12.17343.05.830.254.04.34.39.87%12.0
T (1-3)ડ (1-3)767649.149.35.6ર્ રે29.638.263.063.15.44.65.44.89.8%14.813.4737342.943.15.06.233.631.255.256.43.84.43.84.68.68%10.34%10.612.6
N (1-3)7651.06.033.263.35.15.19.9%14.17343.86.429.158.64.34.49.88%12.2
Deep। (1-3)7649.45.434.261.05.35.310.7%14.66843.36.225.954.55.05.011.48%13.9
(IPL-10μ toAll (3-6)S_Hemi (3-6)767647.747.64.24.339.239.958.758.83.43.83.64.07.5%8.5%10.0-----i------
OPL+10μ)VesselI_Hemi (3-6)7647.94.838.061.83.63.77.7%11.210.2---
DensityT (3-6)7648.73.838.957.83.23.57.1%9.6-----
(%)ર (3-૯)7647.24.438.957.24.04.29.0%11.7---------
n (3-6)ા (3-6)767647.547.56.35.434.634.761.162.85.04.05.14.110.6%8.6%14.011.4--l---
G117645.96.233.859.65.25.311.5%14.87342.46.327.056.74.95.111.81%14.0
G127647.15.036.258.74.54.910.5%13.67342.37.724.058.94.54.610.58%12.8
C137645.25.129.661.14.34.610.3%12.77343.65.830.557.34.54.710.60%12.9
G21G22767648.747.65.14.638.437.661.258.04.63.94.73.99.5%8.1%12.910.7737342.633.06.44.829.824.662.448.04.13.14.23.29.61%9.51%11.78.8
G237649.14.440.060.53.43.57.1%9.77343.84.932.454.93.73.88.57%10.7
G317645.15.733.558.04.14.39.5%11.97342.46.526.753.75.15.111.99%14.3
G327647.55.334.162.04.34.39.1%12.07342.57.026.556.75.15.211.95%14.4
G33FAZ (mm")7645.40.2725.10.09032.558.93.70.0203.80.0208.3%7.3%10.4737343.45.50.09229.354.44.70.0104.70.01010.73%13.0
FAZPERIM (mm)76762.0500.3610.1271.3740.4622.7850.0950.0954.6%0.0560.263730.2812.1680.3650.1451.4810.4412.7800.0750.0773.5%3.5%0.0280.212
FD-300 (%)7646.8ਟ. ਰੇ18.757.94.34.39.3%12.07343.65.131.554.02.22.35.2%6.3
Retina: Other Sub-group
6mm HD Angio Retina Scan3mm Angio Retina Scan
ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibilityScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95% limitsof reproducibility
WI8845.15.034.253.21.72.04.5%ર્ડિਰੇਤੇ43.34.734.852.82.12.45.6%6.6
WI_S_Hemi8845.54.633.953.01.82.24.9%6.1ਰੇਤੇ43.74.834.154.52.22.66.1%7.2
WI_l_Hemi8844.75.930.553.61.92.04.5%4.8%5.5ਰੇਤ42.95.331.752.92.32.45.7%6.7
All (0-6)C (1)888845.327.45.27.634.612.752.942.11.92.72.12.810.5%5.97.8ਰੇਤਰੇਤੇ43.024.24.76.934.56.252.937.22.11.62.41.85.7%7.8%6.75.1
All (1-3)8847.24.838.057.92.52.96.2%8.0ਰੇਤੇ45.54.936.055.32.32.65.8%7.2
S_Hemi (1-3)8847.64.738.258.72.42.86.0%7.8ਰੇਤ45.75.135.0રેકે રહ2.42.65.7%7.1
I_Hemi (1-3)8846.95.633.857.23.03.37.1%9.1ਰੇਤ45.25.632.156.42.42.86.3%7.9
T (1-3)8845.77.826.756.12.83.06.7%8.4ਰੇਤੇ42.97.424.354.12.42.66.1%7.2
ડ (1-3)N (1-3)888848.547.14.94.732.331.059.057.92.63.13.13.56.6%7.6%8.79.8ਰੇਤੇਰੇਤੇ46.645.96.24.329.631.957.154.42.63.02.83.16.0%6.9%7.78.6
SuperficialI (1-3)8847.55.633.359.33.53.88.0%10.5ਰੇਤ46.35.833.357.32.73.26.9%8.8
(ILM toAll (3-6)8845.35.633.553.91.92.14.6%5.7-------
IPL-10μm)S_Hemi (3-6)8845.94.934.653.61.92.35.0%6.2----
VesselI_Hemi (3-6)8844.86.828.154.22.02.14.7%5.8--------
DensityT (3-6)8841.36.725.651.72.52.86.7%7.6-------
(%)ર (3-6)8845.65.133.255.22.12.45.4%3.8%6.7----------
N (3-6)ા (3-6)888650.743.74.27.940.824.858.154.61.82.11.92.14.9%5.35.9-----
G118843.96.031.957.12.32:55.8%7.0ਰੇਤੇ45.65.733.657.13.03.16.8%8.5
G128846.25.034.656.12.22.65.7%7.2ਰੇਤੇ45.96.725.357.52.73.16.8%8.5
ਵਾਤ8846.97.626.956.11.81.94.2%5.4ਰੇਤ46.06.526.356.72.72.96.4%7.9
G218844.47.325.056.32.62.76.1%7.5ਰੇਤ43.27.416.855.03.03.37.7%9.2
G228844.24.434.555.22.42.86.5%7.8ਰੇਤ28.96.013.641.72.12.17.4%5.7
G23G31888847.642.47.19.028.420.160.158.12.22.22.72.35.7%5.4%7.46.3ਰੇਤਰੇਤ44.742.15.110.133.214.654.056.72.73.73.13.76.9%8.9%8.510.3
G328844.27.226.654.22.32.45.5%6.7ਰੇਤ46.74.937.357.52.73.37.1%9.0
૯૩૩8846.36.528.555.32.32.35.0%6.4ਰੇਤ46.25.533.255.92.62.96.5%8.1
WI8846.15.230.156.23.03.06.5%8.3ਰੇਤੋ42.94.333.5રેકે રહ2.72.76.4%7.6
WI_S_Hemi8846.65.033.455.83.23.37.0%9.0ਰੇਤ43.54.135.456.22.72.96.7%8.0
WI_I_Hemi8845.56.026.857.33.03.06.5%8.2ਰੇਤ42.35.330.154.72.92.96.8%8.0
All (0-6)888846.937.05.47.330.721.257.751.63.03.33.03.46.3%9.3%8.39.3ਰੇਤਰੇਤ42.831.94.56.433.414.7ર્ટ ર44.82:52.82.62.86.1%9.0%7.27.8
C (1)All (1-3)8848.65.234.558.92.92.96.0%8.0ਰੇਤ44.24.634.256.92.72.86.3%7.7
S_Hemi (1-3)8849.55.037.660.43.03.06.2%8.4ਰੇਤ44.84.433.856.82.72.86.2%7.8
I_Hemi (1-3)8847.76.031.559.93.13.16.4%8.5ਰੇਤ43.66.029.757.03.03.06.9%8.4
T (1-3)8848.67.329.362.23.03.06.3%8.4ਰੇਤ43.96.726.458.22.62.76.1%7.4
ડ (1-3)8848.36.329.559.93.63.67.4%ਰੇ ਰੇਰੇਤ43.85.827.825.83.23.37.5%9.2
N (1-3)8849.947.74.65.136.837.259.73.53.53.53.57.0%7.2%9.7ਰੇਤਰੇਤ45.54.25.336.634.057.33.03.23.06.7%8.4
Deep(IPL-10μ to। (1-3)All (3-6)888846.85.829.459.657.83.23.26.8%9.68.943.757.8--3.2-7.4%9.0י
OPL+10μ)S_Hemi (3-6)8847.55.533.057.93.33.47.1%9.3---
VesselI_Hemi (3-6)8846.06.725.758.03.33.37.1%9.1----
DensityT (3-6)8847.67.326.460.22.82.96.0%7.9----
(%)ર (3-6)8847.65.634.058.43.53.67.7%10.1--------
N (3-6)8846.85.834.359.94.14.29.0%7.7%11.7-----
ા (3-6)G11868844.847.17.75.022.830.658.559.33.53.63.53.77.9%9.710.3ਰੇਤੇ44.84.534.456.03.63.78.4%10.4
G128847.35.434.357.63.73.77.9%10.4ਰੇਤੇ43.86.526.158.03.63.68.2%10.0
૯૩૩8844.17.324.356.74.74.810.9%13.29343.15.526.355.13.43.47.9%9.5
G218847.96.528.358.13.23.26.6%8.8ਰੇਤੇ43.77.716.858.93.03.37.5%9.1
G228847.14.935.257.82.42.45.2%6.8ਰੇਤੇ35.35.420.346.23.13.18.8%8.5
G238846.744.46.232.460.43.73.53.73.57.9%7.8%10.2ਰੇਤੇਰੇਤੇ46.34.49.634.956.62.64.02.94.06.3%8.1
G31G32888844.88.17.118.225.758.158.33.63.67.9%9.79.99341.145.05.112.136.653.658.63.43.49.7%7.6%11.2વે છ
૯૩૩8845.16.229.359.14.24.29.4%11.89342.85.031.657.64.04.19.6%11.4
FAZ (mm")790.2050.0950.0880.5100.0150.0167.2%0.044840.2150.0890.1020.5040.0100.0104.3%0.028
FAZPERIM (mm)791.7450.3611.1302.7990.0980.0995.4%0.274841.8530.3391.2762.7620.0750.0753.9%0.209
FD-300 (%)7946.85.634.555.63.63.67.8%10.18444.55.032.354.02.22.35.1%6.3

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Table 7. Vascular Parameters of AngioRetina Scans, Glaucoma Group

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Table 8. Vascular Parameters of AngioRetina Scans, Retina Group

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Table 9. Vascular Parameters of AngioRetina Scans, Retina Wet AMD Sub-group

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Table 10. Vascular Parameters of AngioRetina Scans, Retina DR Sub-group

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Table 11. Vascular parameters of AngioRetina scans, Retina Other Sub-group

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Vessel Density and RNFL Thickness Results within (2-4) mm, and Disc Parameters for 4.5 mm HD AngioDisc Scan

Tables 12 and 13 summarize the results of the R&R analysis of vascular and RNFL thickness parameters of (2-4) mm peripapillary grid, and Disc Parameters of the 4.5-mm HD AngioDisc scan.

Table 12. Vascular and RNFL Thickness Parameters of (2-4) mm Peripapillary Grid, and Disc Parameters of the 4.5-mm HD AngioDisc Scan, Normal Group

ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibilityCV95%limits_ofreproducibility
PP (2-4)129108.39.994.6125.81.61.61.5%4.4
RNFLThickness (µm)S_Hemi (2-4)129108.311.089.1130.72.02.01.9%5.6
I_Hemi (2-4)129108.39.387.7124.62.22.32.1%6.3
NS (2-4)129101.613.572.4133.93.93.93.9%10.9
NI (2-4)12990.112.569.6113.73.03.03.4%8.4
IN (2-4)129138.518.092.7173.14.74.93.5%13.5
IT (2-4)129144.718.497.1173.03.53.52.5%9.8
TI (2-4)12967.311.950.195.22.02.03.0%5.6
TS (2-4)12976.111.955.5108.42.42.43.1%6.6
ST (2-4)129135.924.675.8174.82.82.92.1%7.9
SN (2-4)129128.619.187.3168.13.94.03.1%11.1
WI_All Vessels12956.82.346.560.41.51.52.7%4.2
WI_Small Vessels12949.72.040.953.01.51.52.9%4.0
Disc_All Vessels12960.03.544.968.02.72.74.5%7.5
Disc_Small Vessels12950.04.233.061.72.93.05.9%8.2
PP (2-4)_All Vessels12958.82.548.262.71.51.52.6%4.2
PP (2-4)_Small Vessels12951.82.243.155.41.51.52.9%4.1
S_Hemi (2-4)_All Vessels12959.12.549.063.71.61.62.7%4.5
I_Hemi (2-4)_All Vessels12958.42.647.462.51.61.62.8%4.6
S_Hemi (2-4)_Small Vessels12951.82.244.355.81.61.73.2%4.6
I_Hemi (2-4)_Small Vessels12951.72.641.655.81.61.63.2%4.5
NS (2-4)_Small Vessels12949.13.336.256.52.22.24.4%6.0
NI (2-4)_Small Vessels12948.34.432.856.42.02.04.1%5.5
IN (2-4)_Small Vessels12950.93.839.560.82.42.54.9%6.9
RPC VesselDensity (%)IT (2-4)_Small Vessels12955.43.739.663.02.72.75.0%7.6
TI (2-4)_Small Vessels12952.92.846.160.21.81.83.4%5.0
TS (2-4)_Small Vessels12955.72.948.861.61.71.73.1%4.7
ST (2-4)_Small Vessels12953.64.243.562.42.62.85.1%7.7
SN (2-4)_Small Vessels12949.14.036.856.92.12.34.7%6.4
G11_All Vessels12956.44.039.764.12.12.13.7%5.8
G12_All Vessels12958.93.245.566.22.02.13.5%5.7
G13_All Vessels12956.24.944.565.41.92.03.6%5.5
G21_All Vessels12955.14.534.862.12.22.34.3%6.5
G22_All Vessels12960.33.545.167.42.82.94.8%8.0
G23_All Vessels12954.53.643.962.21.81.93.4%5.2
G31_All Vessels12954.54.935.364.01.92.03.7%5.6
G32_All Vessels12961.53.948.468.62.42.43.9%6.6
G33_All Vessels12954.24.641.561.91.71.93.4%5.2
Disc_H_Size (mm)1291.5580.0941.3471.7590.0510.0513.3%0.142
Disc_V_Size (mm)1291.6390.1341.3461.8580.0540.0563.4%0.155
DiscArea (mm²)1292.0110.2481.4792.5670.0510.0552.7%0.153
CupArea (mm²)1290.2740.2010.0000.7660.0150.0186.6%0.049
RimArea (mm²)1291.7370.1691.2352.0140.0450.0462.7%0.129
Optic DiscCupVolume (mm³)1290.0400.0360.0000.1290.0040.00512.1%0.013
RimVolume (mm³)1290.5050.0930.3430.6760.0140.0142.7%0.038
C_D_Area_Ratio1290.1300.0860.0000.3050.0060.0065.1%0.018
C_D_H_Ratio1290.2890.1640.0000.5290.0060.0062.2%0.018
C_D_V_Ratio1290.3490.1890.0000.5810.0150.0164.5%0.043
DiscElevation (µm)129234.665.3102.1365.84.24.61.9%12.7
CupDepth (µm)129104.569.50.0217.77.77.87.7%21.7

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Table 13. Vascular and RNFL Thickness Parameters of (2-4) mm Peripapillary Grid, and Disc Parameters of the 4.5-mm HD AngioDisc Scan, Glaucoma Group

Glaucoma
ParameterScan #MeanSDminmaxrepeatabilitySDreproducibilitySDReproducibility CV95%limits_ofreproducibility
PP (2-4)13774.417.142.6111.20.90.91.2%2.5
S_Hemi (2-4)13777.217.845.4111.81.11.21.5%3.2
RNFL Thickness(μm)I_Hemi (2-4)13771.418.537.6111.01.11.11.6%3.1
NS (2-4)13779.420.339.4110.92.42.43.1%6.8
NI (2-4)13771.319.834.0103.72.52.53.5%6.9
IN (2-4)13787.428.139.0166.72.82.83.2%7.8
IT (2-4)13774.230.833.7131.92.32.33.1%6.4
TI (2-4)13753.913.534.788.41.11.12.1%3.1
TS (2-4)13759.716.134.996.41.31.32.2%3.7
ST (2-4)13780.729.230.8131.22.32.32.8%6.3
SN (2-4)13791.026.454.5147.62.72.83.0%7.7
WI_All Vessels13748.75.235.757.01.21.32.7%3.6
WI_Small Vessels13741.95.427.851.21.21.33.0%3.5
RPC VesselDensity (%)Disc_All Vessels13755.06.539.664.62.02.34.1%6.3
Disc_Small Vessels13747.17.531.359.92.02.34.8%6.3
PP (2-4)_All Vessels13749.86.133.459.11.31.42.8%3.8
PP (2-4)_Small Vessels13743.16.225.652.81.41.43.2%3.8
S_Hemi (2-4)_All Vessels13750.86.335.459.91.31.42.8%3.9
I_Hemi (2-4)_All Vessels13748.86.531.360.21.51.63.3%4.4
S_Hemi (2-4)_Small Vessels13744.06.426.854.11.51.53.3%4.1
I_Hemi (2-4)_Small Vessels13742.07.024.355.01.61.63.9%4.5
NS (2-4)_Small Vessels13742.77.715.752.21.91.94.4%5.2
NI (2-4)_Small Vessels13740.27.018.351.32.32.35.8%6.4
IN (2-4)_Small Vessels13739.58.218.960.92.12.15.2%5.7
IT (2-4)_Small Vessels13739.812.115.260.12.32.46.1%6.7
TI (2-4)_Small Vessels13747.66.928.960.12.32.34.7%6.2
TS (2-4)_Small Vessels13750.66.133.559.02.22.24.4%6.2
ST (2-4)_Small Vessels13741.89.620.757.82.12.14.9%5.7
SN (2-4)_Small Vessels13739.68.320.453.51.91.94.8%5.2
G11_All Vessels13747.76.136.859.01.61.63.3%4.4
G12_All Vessels13749.67.632.462.91.81.93.8%5.2
G13_All Vessels13745.36.530.057.41.91.94.3%5.4
G21_All Vessels13749.96.433.061.91.81.83.6%5.0
G22_All Vessels13755.06.837.566.62.02.44.4%6.7
G23_All Vessels13750.07.224.560.72.02.04.1%5.7
G31_All Vessels13744.66.630.060.02.12.55.5%6.8
G32_All Vessels13750.08.628.767.52.12.14.2%5.8
G33_All Vessels13746.66.830.357.12.02.14.4%5.7
Disc_H_Size (mm)1371.5340.1941.2721.9930.0430.0442.9%0.123
Disc_V_Size (mm)1371.6100.2031.3122.1640.0410.0412.6%0.114
DiscArea (mm²)1371.9670.5031.4133.2660.0340.0351.8%0.098CupArea (mm²)1370.7210.4430.0001.6740.0170.0172.4%0.048Optic DiscRimArea (mm²)1371.2460.3080.6361.8230.0290.0292.3%0.082CupVolume (mm³)1370.1480.1700.0000.6440.0130.0138.7%0.035RimVolume (mm³)1370.2490.0980.0980.4180.0080.0083.1%0.021C_D_Area_Ratio1370.3480.1710.0000.6020.0070.0072.0%0.019C_D_H_Ratio1370.4940.1970.0000.8160.0090.0091.8%0.024C_D_V_Ratio1370.6390.2110.0000.9160.0120.0121.9%0.034DiscElevation (μm)13764.5109.8-184.3253.85.85.88.8%15.9CupDepth (μm)137156.095.20.0402.16.06.03.9%16.7
DiscArea (mm²)1371.9670.5031.4133.2660.0340.0351.8%0.098
CupArea (mm²)1370.7210.4430.0001.6740.0170.0172.4%0.048
Optic DiscRimArea (mm²)1371.2460.3080.6361.8230.0290.0292.3%0.082
CupVolume (mm³)1370.1480.1700.0000.6440.0130.0138.7%0.035
RimVolume (mm³)1370.2490.0980.0980.4180.0080.0083.1%0.021
C_D_Area_Ratio1370.3480.1710.0000.6020.0070.0072.0%0.019
C_D_H_Ratio1370.4940.1970.0000.8160.0090.0091.8%0.024
C_D_V_Ratio1370.6390.2110.0000.9160.0120.0121.9%0.034
DiscElevation (μm)13764.5109.8-184.3253.85.85.88.8%15.9
CupDepth (μm)137156.095.20.0402.16.06.03.9%16.7

Retinal Thickness and Volume Parameters of 3-mm AngioRetina and 6-mm HD AngioRetina Scans

Tables 14 through 16 summarize the results of R&R analysis of retinal thickness and volume parameters of 3 mm AngioRetina and 6 mm HD AngioRetina scans for Normal, Glaucoma and Retina groups.

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Normal
6 mm HD Angio Retina3 mm Angio Retina
repeat reprodu Reprodu 95%_limitsrepeatreprodu Reprodu95%limits
ParameterScan # MeanSDminmaxabilitycibilitycibilityof_reprodu Scan # MeanSDminmaxabilitycibilitycibilityof_reprodu
SDSDCVcibilitySDSDCVcibility
C (1)12843.311.524.171.10.80.92.1%2.412943.311.324.771.51.11.22.7%3.3
T (1-3)128102.410.379.1123.10.70.70.7%2.1129102.410.778.5123.90.70.80.8%2.2
S (1-3)128113.711.989.3135.10.91.00.9%2.8129113.712.288.6136.21.01.00.9%2.8
N (1-3)128109.812.578.8132.10.70.80.8%2.3129109.612.879.2133.61.11.11.0%2.9
I (1-3)128114.412.382.9133.71.01.10.9%2.9128114.012.883.0135.41.21.21.1%3.4
S_Hemi (1-3)128109.611.584.4131.00.70.80.8%2.3129109.511.883.2132.00.80.90.8%2.4
I_Hemi (1-3)128110.611.881.1130.90.70.70.7%2.1129110.212.281.0132.61.01.00.9%2.8
All (1-3)128110.111.682.8130.50.60.70.6%1.8129109.812.083.3132.30.70.70.6%1.9
T (3-6)12885.78.069.499.10.90.91.1%2.6------
12899.810.81.01.11.1%3.0--
ILM ~ IPLટ (3-6)77.6117.3
ThicknessN (3-6)128116.512.987.8141.90.91.00.8%2.7--
(µm)I (3-6)12898.511.469.6124.11.01.01.1%2.9----
S_Hemi (3-6)12899.7ਰੇ ਰੇ78.4114.30.80.80.8%2.3--
I_Hemi (3-6)128100.511.174.0124.00.70.80.8%2.2-------
All (3-6)128100.110.276.4118.70.60.70.7%2.0---
S_Hemi (0-6)/(0-3)128100.410.078.3116.20.70.70.7%2.1129102.111.476.7123.10.80.80.8%2.3
I_Hemi (0-6)/(0-3)128101.210.974.4122.50.60.70.7%1.9129102.511.874.7123.51.01.00.9%2.7
All (0-6)/(0-3)128100.810.376.6118.40.50.60.6%1.7129102.311.576.8123.30.70.70.7%1.9
WI_S_Hemi12899.810.275.3117.71.61.61.6%4.4129103.811.178.9123.81.01.11.0%3.0
WI Hemi128101.710.576.6121.51.11.11.1%3.0129104.111.677.0124.91.11.11.1%3.2
WI128100.710.276.8119.51.21.21.2%3.2129104.111.378.9124.50.90.90.8%2.4
ILM ~ IPLC (1)1280.0340.0090.0190.0560.0010.0012.3%0.0021290.0340.0090.0190.0560.0010.0012.7%0.003
VolumeAll (0-6)/(0-3)1282.8310.2862.1143.3070.0170.0180.6%0.0491290.7090.0790.5320.8660.0110.0111.5%0.030
(mm3)WI1283.6340.3672.7704.3120.0420.0421.2%0.1171290.9390.1020.7121.1230.0080.0080.8%0.021
C (1)128253.621.6212.9291.01.51.80.7%5.0129253.322.0212.0292.41.71.90.8%5.4
T (1-3)128315.316.9288.9347.61.31.40.5%4.0129314.917.3288.6347.51.31.50.5%4.2
S (1-3)128329.018.1293.2360.01.31.70.5%4.7129328.818.5292.7360.51.41.50.5%4.3
N (1-3)128329.217.3299.0361.51.11.50.4%4.0129329.017.5298.5360.51.01.40.4%3.8
I (1-3)128325.216.9296.0356.11.51.60.5%4.4128325.217.4296.3356.81.61.60.5%4.5
S_Hemi (1-3)128325.717.5293.5357.01.11.50.5%4.2129325.417.9293.1356.41.11.40.4%3.9
I_Hemi (1-3)128323.716.7295.6354.21.21.40.4%3.8129323.417.2295.6354.41.31.40.4%3.9
All (1-3)128324.717.0294.6355.21.11.30.4%3.7129324.417.4294.6355.41.11.30.4%3.6
T (3-6)128271.613.8252.3303.91.61.80.7%5.1-
ILM ~ RPEર (3-6)128288.515.3260.6314.51.41.80.6%5.0----
ThicknessN (3-6)128303.516.3271.3333.51.21.50.5%4.1--
(μm)। (3-6)128275.414.1254.3311.51.51.80.6%4.9-----
S_Hemi (3-6)128288.314.6261.3312.71.21.60.6%4.5---
I_Hemi (3-6)128281.214.0258.6313.01.31.50.6%4.3-
All (3-6)128284.814.0261.6312.91.11.50.5%4.1----
S_Hemi (0-6)/(0-3)128295.714.9267.2321.41.11.50.5%4.1129317.317.7284.2347.51.11.40.4%3.8
I_Hemi (0-6)/(0-3)128290.014.4267.2321.31.21.40.5%3.9129315.417.2285.9345.31.31.40.4%3.9
All (0-6)/(0-3)128292.814.4267.7321.31.01.40.5%3.8129316.317.3285.3346.41.11.30.4%3.5
WI_S_Hemi128289.514.6263.9317.52.42.40.8%6.6129315.917.2282.2344.61.21.40.4%3.8
WI Hemi128284.813.8261.3314.61.61.90.7%5.2129314.016.7284.3343.21.41.50.5%4.1
WI128287.214.0263.8316.21.71.80.6%4.9129315.116.8283.6344.11.11.30.4%3.5
ILM ~ RPEC (1)1280.2000.0170.1680.2290.0010.0010.7%0.0041290.1990.0170.1670.2300.0010.0020.8%0.004
VolumeAll (0-6)/(0-3)1288.2270.4037.4428.9890.0420.0440.5%0.1221292.1940.1221.8932.4270.0290.0291.3%0.079
(mm3)WI12810.360.5059.51911.410.0610.0640.6%0.1771292.8440.1522.5603.1060.0100.0110.4%0.032
C (1)128210.212.4181.4229.91.21.40.6%3.7129209.913.0181.0230.21.51.50.7%4.2
T (1-3)128212.99.2198.6 230.41.31.30.6%3.7129212.49.3196.0230.51.31.40.6%3.7
S (1-3)128215.38.7198.1 231.50.91.10.5%3.1129215.19.0197.9 233.01.21.30.6%3.7
203.9 233.60.5%1.3
N (1-3)128219.58.80.81.02.8129219.48.9202.4 234.11.00.6%3.5
I (1-3)128210.88.2198.4 225.01.31.40.6%3.8128211.38.2197.9 226.61.31.40.7%3.9
S_Hemi (1-3)128216.18.7199.9 231.60.81.00.5%2.8129215.98.9199.4232.61.11.20.6%3.3
I_Hemi (1-3)128213.18.3200.5 227.71.11.20.6%3.4129213.28.3200.5228.81.21.30.6%3.6
All (1-3)128214.68.4200.5229.70.91.00.5%2.9129214.68.5200.0230.01.01.20.5%3.2
T (3-6)128185.98.1173.0 206.51.41.60.9%4.5------
IPL ~ RPEર (3-6)128188.88.6171.5 204.01.01.30.7%3.5--
ThicknessN (3-6)128187.18.3166.8 199.81.31.30.7%3.7--------
(um)। (3-6)128176.86.6164.4188.41.31.40.8%3.8-
S_Hemi (3-6)128188.68.3172.3 203.71.01.20.6%3.3------
I_Hemi (3-6)128180.76.6168.2 192.01.11.20.7%3.4--
All (3-6)128184.77.4170.7 196.60.91.10.6%3.1-----
215.21.2
S_Hemi (0-6)/(0-3)128195.38.2178.8 210.20.91.10.6%3.01299.0197.4231.41.10.5%3.3
I_Hemi (0-6)/(0-3)128188.86.8176.5 199.11.01.20.6%3.2129212.88.4198.3228.91.11.20.6%3.4
All (0-6)/(0-3)128192.17.4178.4204.10.91.10.6%2.9129214.08.6197.9230.01.01.10.5%3.2
WI_S_Hemi128189.78.0174.4203.61.21.30.7%3.5129212.18.9193.8229.21.21.30.6%3.5
WI I Hemi128183.16.7169.9194.21.21.40.7%3.7129209.98.0195.8225.51.31.50.7%4.1
WI128186.47.2173.4 198.21.21.10.6%3.0129211.08.3195.1226.01.11.20.6%3.3
IPL ~ RPEC(1)1280.1660.0100.143 0.1811.20.0010.7%0.0031290.1650.0100.1420.1810.0010.0010.8%0.004
VolumeAll (0-6)/(0-3)1285.3960.2095.0245.7511.20.0340.6%0.0961291.4840.0651.3101.6040.0190.0191.3%0.053
(mm3)WI1286.730 0.262 6.260 7.1531.20.0390.6%0.1091291.905 0.0751.7622.0410.0100.0110.6%0.030

Table 14. Retinal Thickness and Volume of Retinal Layer of AngioRetina Scans, Normal Group

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Volume

All (0-6)/(0-3)

133

133 6.424 0.212

6.048 6.822 0.026

0.031

0.033

0.026

0.6%

0.4%

0.091

0.073

134

134

1.842 0.127

0.056

0.621

1.552 0.020

1.977 0.101 0.021

0.101

6 mm HD Angio Retina 3 mm Angio Retina repeat | reprodu Reprodu 95% limits repeat reprodu Reprodu 95% limits Mear SD min ahility cihility cibility SD ahility cihility cibility Parameter of_reprodu Scan Mear min max of_reprodu SD SD CV cibility SD SD CV cibility C (1) 133 36.9 10.8 20.2 58.4 0.8 0.8 2.1% 2.2 134 38.0 10.4 21.0 59.2 1.3 1.3 3.6% 3.7 16.4 134 T (1-3) 133 81.5 50.1 113.6 0.8 0.8 1.0% 2.2 83.2 15.8 51.5 114.9 0.7 0.7 0.9% 2.0 0.9% 94.4 18.9 126.5 0.9% 134 95.7 19.6 52.6 127.7 0.9 S (1-3) 133 51.6 0.9 0.9 0.9 2.4 2.4 N (1-3) 133 95.9 17.1 46.3 126.6 1.4 1.4 1.4% 3.7 134 96.7 18.0 46.3 127.2 1.0 1.0 1.0% 2.7 124.2 0.9 0.9 2.5 133 90.2 21.0 54.1 1.1% 2.8 I (1-3) 133 89.0 21.1 51.6 1.0% 124.6 1.0 1.0 2.7 S_Hemi (1-3) 133 92.0 17.4 53.3 121.6 1.0 1.0 1.1% 134 93.3 17.7 53.4 122.9 0.8 0.8 0.8% 2.1 54.6 0.9% Hemi (1-3) 133 88.5 18.8 121.6 0.7 0.7 0.8% 2.0 134 89.5 18.8 54.3 122.3 0.8 0.8 2.3 All (1-3) 133 90 2 168 54.2 121 4 0 7 0 7 0.8% 20 134 91.5 16.9 54.3 122 4 0.6 0 6 0 6% 1.6 T (3-6) 133 65.3 8.8 48.6 86.6 0.6 0.6 0.9% 1.7 ILM ~ IPL S (3-6) 133 79.5 14.3 55.5 107.2 0.8 0.8 1.0% 2.2 ---. -Thickness N (3-6) 133 95.4 14.8 53.0 128.2 2.3 2.3 2.5% 6.5 ---------(um) 49.6 133 104.7 1.4 1.9% I (3-6) 72.6 14.0 1.4 3.8 ----S_Hemi (3-6) 133 80.9 13.0 57.4 107.6 0.8 0.8 0.9% 2.1 --. ---I_Hemi (3-6) 133 75.6 12.8 52.7 105.0 1.0 1.1 1.4% 2.9 133 78.3 12.0 56.4 106.3 0.7 0.7 0.9% 2.0 All (3-6) 133 134 50.2 115.1 2.0 S_Hemi (0-6)/(0-3) 82.2 13.6 55.4 109.2 0.6 0.6 0.8% 1.8 87. 16.5 0.7 0.7 0.8% 77.4 1.1% 2.4 134 50.6 114.4 0.8 0.8 1.0% 2.2 l_Hemi (0-6)/(0-3 133 13.7 53.3 107.3 0.9 0.9 83.7 17.3 All (0-6)/(0-3) 133 79.8 12.8 54.9 108.1 0.6 0.6 0.8% 1.7 134 85.4 15.8 50.6 114.6 0.6 0.6 0.7% 1.5 WI S Hemi 133 80.7 13.0 56.2 109.5 1.0 1.0 1.2% 2.7 134 87.9 16.3 53.2 116.3 0.8 0.8 0.9% 2.2 76.7 1.4% 134 2.9 133 12.9 53.4 107.5 1.1 1.1 3.0 83.7 16.9 52.5 115.4 1.0 1.0 1.3% WI I Hemi 133 55.4 1.0% 2.2 134 86.1 15.3 53.1 115.8 0.8 0.9% 2.2 WI 78.8 12.1 108.5 0.8 0.8 0.8 0.003 0.029 0.009 0.046 0.001 0.001 2.3% 0.002 134 0.030 0.008 0.017 0.047 0.001 0.001 3.5% ILM ~ IPL C (1) 133 0.016 Volume All (0-6)/(0-3) 133 2.238 0.358 1.528 3.041 0.020 0.020 0.9% 0.056 134 0.592 0.109 0.344 0.805 0.009 0.010 1.6% 0.027 (mm3) 133 WI 2.843 0.435 1.999 3.916 0.028 0.028 1.0% 0.079 134 0.774 0.146 0.170 1.045 0.028 0.028 3.7% 0.078 133 244.4 208.3 0.5% 134 246.0 208.0 292.9 0.6% 4.2 C (1) 22.2 291.3 1.1 1.2 3.2 21.6 1.4 1.5 T (1-3) 133 289.9 20.2 257.1 329.6 1.2 1.2 0.4% 3.2 134 290.9 20.4 257.8 331.4 0.8 0.9 0.3% 2.6 S (1-3) 133 303.0 22.1 262.7 341.9 1.0 1.2 0.4% 3.2 134 304.3 23.3 261.9 343.4 1.1 1.2 0.4% 3.4 0.4% 0.4% N (1-3) 133 310.1 21.8 253.7 351.9 1.2 1.2 3.3 134 311.2 22.9 253.9 354.6 1.0 1.1 3.1 133 0.4% 1.0 3.2 I (1-3) 296.5 23.3 250.7 333.3 1.1 1.1 3.1 133 298.1 23.3 251.4 333.5 1.2 0.4% 259.5 0.4% 134 340.2 0.3% S_Hemi (1-3) 133 301.9 21.2 339.0 1.0 1.1 2.9 303.2 22.2 259.9 0.9 1.0 2.9 l_Hemi (1-3) 133 297.8 21.9 252.9 334.1 1.0 1.0 0.3% 2.8 134 299.0 22.2 253.2 334.7 0.9 1.0 0.3% 2.8 All (1-3) 133 299.9 20.8 256.2 336.5 0.9 0.9 0.3% 2.6 134 301.1 21.5 256.6 337.2 0.8 0.9 0.3% 2.4 133 240.5 12.9 212.9 264.8 0.5% 3.0 T (3-6) 1.1 1.1 133 0.5% ILM ~ RPE S (3-6) 256.8 16.9 231.0 282.0 1.1 1.2 3.2 228.1 Thickness N (3-6) 133 273.0 19.0 302.7 1.0 1.1 0.4% 2.9 (um) 1 (3-6) 133 242.5 16.3 211.0 274.2 1.2 1.2 0.5% 3.3 -----S Hemi (3-6) 133 258.6 16.2 229.9 283.7 0.9 1.0 0.4% 2.8 -. -----0.4% I Hemi (3-6) 133 247.9 16.2 214.7 277.0 1.0 1.0 2.7 . --------0.7 0.7 0.3% 1.9 All (3-6) 133 253.3 15.5 224.6 280.4 133 0.3% 134 296.7 256.6 333.2 0.9 0.3% 2.9 S_Hemi (0-6)/(0-3) 267.9 16.9 236.5 295.5 0.8 0.9 2.5 21.3 1.0 l_Hemi (0-6)/(0-3) 133 259.0 16.8 226.3 289.3 0.9 0.9 0.3% 2.5 134 293.0 21.3 250.3 328.7 0.9 1.0 0.3% 2.8 All (0-6)/(0-3 133 263.5 16.2 231.8 292.4 0.7 0.7 0.3% 1.9 134 294.9 20.7 253.6 331.0 0.8 0.9 0.3% 2.5 133 260.7 230.6 288.7 1.2 1.4 0.5% 3.8 134 293.0 21.1 253.7 330.4 1.3 1.4 0.5% 3.9 WI S Hemi 16.2 WI_I_Hemi 133 252.6 16.0 221.8 284.5 1.1 1.1 0.4% 3.1 134 289.1 20.4 247.8 324.2 1.5 1.5 0.5% 4.1 133 256.7 15.4 226.5 286.2 0.9 0.9 0.3% 2.4 134 291.2 20.2 250.9 327.3 1.0 1.1 0.4% 3.0 WI ILM~RPE ((1) 133 0.193 0.018 0.164 0.230 0.001 0.001 0.5% 0.003 134 0.193 0.017 0.163 0.230 0.001 0.001 0.6% 0.003 Volume 8.250 0.6% 0.082 All (0-6)/(0-3) 133 7.390 0.459 6.447 0.039 0.041 0.113 134 2.045 0.144 1.725 2.324 0.028 0.029 1.4% (mm3) WI 133 9.267 0.554 8.175 10.329 0.031 0.031 0.3% 0.085 134 2.616 0.241 0.791 2.955 0.128 0.128 4.9% 0.355 133 207.4 182.9 0.5% 134 207.9 14.1 180.5 234.1 0.8% 4.6 C (1) 14.0 234.2 1.1 1.1 3.0 1.6 1.7 194.9 0.4% 192.7 2.8 133 208.4 223.0 0.9 0.9 134 207.7 8.3 223.8 0.5% T (1-3) 2.5 1.0 1.0 7.7 133 208.6 194.9 218.6 0.8 0.5% 2.7 134 208.6 194.4 220.4 0.5% S (1-3) 7.1 1.0 7.4 1.0 1.1 3.1 N (1-3) 133 214.3 7.8 202.1 232.8 0.9 0.9 0.4% 2.6 134 214.5 8.4 201.5 233.2 1.2 1.3 0.6% 3.6 I (1-3) 133 207.5 8.1 195.8 227.5 1.0 1.0 0.5% 2.7 133 207.9 8.6 193.8 229.3 1.1 1.2 0.6% 3.2 133 0.9 0.4% 134 209.9 7.3 196.7 222.2 0.5% 3.0 S Hemi (1-3) 210.0 6.8 197.1 221.1 0.8 2.4 1.0 1.1 I Hemi (1-3) 209.4 197.5 0.9 0.9 0.4% 209.5 195.5 230.6 0.5% 133 229.4 134 8.5 1.0 1.0 2.9 7.9 2.4 123 209 7 198.1 つつ」 2 0.7 0 7 0 2% 20 134 209.7 7.7 197.8 225.0 0.8 0.9 0.4% 2.4 All (1-3) 7.1 T (3-6) 133 175.2 7.7 159.6 189.0 0.8 0.9 0.5% 2.5 IPL ~ RPE 133 165.6 187.9 0.8 0.5% 2.3 S (3-6) 177.3 6.5 0.8 -Thickness 133 177.6 150.0 192.9 2.3 1.3% 6.6 N (3-6) 7.8 2.4 -(um) 1 (3-6) 133 169.8 6.4 152.3 182.6 1.4 1.4 0.8% 3.8 S Hemi (3-6) 133 177.7 6.7 165.4 187.7 0.9 1.0 0.6% 2.8 I Hemi (3-6) 133 172.3 6.7 158.6 184.6 1.1 1.1 0.6% 2.9 -------All (3-6) 133 175.0 6.5 162.5 185.8 0.8 0.9 0.5% 2.4 0.9 0.5% 134 209.7 7.7 196.8 223.5 1.0 0.5% S Hemi (0-6)/(0-3) 133 185.7 6.3 174.7 195.5 0.8 2.6 1.1 2.9 123 181.6 6.4 169.2 194.2 00 0.9 0 5% 25 13/1 200 2 8.7 196.2 279.0 1.0 1.0 0.5% 2.9 I Hemi (0-6)/(0-3) All (0-6)/(0-3) 133 183.7 6.2 172.7 194.7 0.7 0.8 0.4% 2.1 134 209.5 8.0 197.9 225.0 0.8 0.9 0.4% 2.5 180.1 0.6% 134 4.0 WI S Hemi 133 6.0 169.1 190.4 0.9 1.0 2.9 205.1 7.5 191.5 219.6 1.3 1.4 0.7% 0.6% 0.6% WI_I_Hemi 133 175.9 6.2 164.1 188.3 1.1 1.1 3.1 134 205.4 8.6 226.7 1.3 1.3 3.6 191.8 133 178.0 5.9 167.6 189.0 0.7 0.7 0.4% 2.0 134 205.1 7.6 193.6 218.9 0.9 1.0 0.5% 2.7 WI 0.001 0.001 0.5% 0.002 0.011 0.004 IPI ~ RPF C (1) 133 0.164 0.011 0.144 0.185 134 0.163 0.142 0.184 0.001 0.001 0.8% 5.474 5.152 0.176 4.755 1.453 1.324 1.4%

Table 15. Retinal Thickness and Volume of Retinal Layer of AngioRetina Scan, Glaucoma Group

5.5%

0.058

0.280

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Retina
3 mm Angio Retina
ParameterScan #MeanSDminmaxrepeatabilitySDcibilitySDreprodu ReproducibilityCV95%limitsof_reproducibilityScan #MeanSDminmaxrepeatabilitySDcibilitySDcibilityCVreprodu Reprodu 95%limitsof_reproducibility
C (1)25151.513.324.887.82.12.14.1%5.925551.813.226.386.81.41.42.7%3.9
T (1-3)251103.413.674.5141.41.21.21.2%3.3255104.214.274.9142.51.11.11.1%3.0
S (1-3)251116.317.351.5170.91.71.71.5%4.7255116.617.962.5168.31.51.51.3%4.1
N (1-3)251114.015.375.7156.61.91.91.7%5.2255113.815.575.6157.01.61.61.4%4.3
I (1-3)251251116.0112.517.614.882.567.7173.7159.51.71.31.71.31.5%1.1%4.83.5249255115.6112.916.915.582.873.8178.2157.71.41.11.41.11.2%1.0%3.93.1
S_Hemi (1-3)I_Hemi (1-3)251112.315.483.2161.81.41.41.2%3.8255112.314.983.2165.01.21.21.1%3.3
All (1-3)251112.414.486.7160.10.90.90.8%2.6255112.614.588.2161.40.80.80.7%2.3
T (3-6)25186.113.156.9130.51.41.41.7%4.0-------
ILM ~ IPLર (3-6)251100.614.766.2144.31.61.61.6%4.4--
ThicknessN (3-6)251120.117.092.5157.11.41.41.2%3.8-
(μm)I (3-6)S_Hemi (3-6)24925199.5101.215.713.865.873.3150.4135.52.11.22.11.32.1%1.2%5.83.5--------।
I_Hemi (3-6)251102.015.669.4152.41.41.41.4%3.8----
All (3-6)251101.613.971.5136.60.90.90.9%2.6---------
S_Hemi (0-6)/(0-3)251102.313.271.5137.71.01.01.0%2.8255106.014.670.3147.01.11.11.0%3.0
I_Hemi (0-6)/(0-3)251102.914.572.0150.31.11.11.1%3.1255105.314.079.2153.61.11.11.1%3.1
All (0-6)/(0-3)251102.613.174.9135.60.80.80.8%2.1255105.713.781.4150.30.80.80.8%2.2
WI_S_HemiWI Hemi251251101.4103.012.813.772.272.3137.0141.41.31.51.41.61.4%1.5%3.84.3255254107.0106.514.614.171.878.4147.9150.31.71.51.71.51.6%1.4%4.84.1
WI251102.212.673.8133.21.11.11.1%3.1255106.913.883.0149.31.11.11.1%3.1
ILM ~ IPLC (1)2510.0410.0100.0200.0690.0020.0024.1%0.0052550.0410.0100.0210.0680.0010.0012.8%0.003
VolumeAll (0-6)/(0-3)2512.8780.3672.1033.7680.0280.0281.0%0.0762550.7290.0940.5381.0480.0160.0162.2%0.044
(mm3)WI2513.6570.4702.1944.8040.1140.1163.2%0.3232540.9500.1400.2721.3470.0630.0636.7%0.176
C (1)251251285.9315.787.449.6112.6223.6609.05.13.15.11.8%1.0%14.29.0255255285.5314.588.3116.6222.3610.3495.39.51.99.53.3%0.6%26.3
T (1-3)S (1-3)251325.355.0231.6495.2562.11.83.21.90.6%5.1255324.950.554.9233.0566.42.92.02.90.9%5.58.0
N (1-3)251324.846.6216.6493.73.23.31.0%9.0255322.945.6218.0491.18.78.72.7%24.0
I (1-3)251320.948.8229.4535.34.84.81.5%13.4249318.848.5220.8530.74.84.81.5%13.4
S_Hemi (1-3)251323.250.6232.8530.61.81.80.6%5.0255322.350.6234.0531.04.44.41.4%12.1
I_Hemi (1-3)251320.246.1218.0503.73.43.41.1%9.3255318.345.6212.6506.43.63.61.1%ਰੇ ਰੇ
All (1-3)T (3-6)251251321.7273.047.527.9225.7225.8516.2374.32.11.82.11.80.7%0.7%5.85.0255320.347.1224.0518.6-3.13.11.0%8.7-
ILM ~ RPEર (3-6)251287.034.1219.9411.02.02.00.7%5.6----
ThicknessN (3-6)251300.331.3227.4394.71.61.60.5%4.4
(μm)। (3-6)249277.826.2230.7355.91.61.60.6%4.4---------
S_Hemi (3-6)251286.631.2222.9396.21.41.40.5%4.0-
I_Hemi (3-6)251282.426.2232.0349.11.41.40.5%3.9---------
All (3-6)S_Hemi (0-6)/(0-3)251251284.5294.827.435.2227.6222.3365.0432.41.01.41.01.40.4%0.5%2.83.8255-318.154.1220.9-540.14.24.21.3%11.6
l_Hemi (0-6)/(0-3)251291.029.6225.4380.61.41.50.5%4.0255314.549.5201.4518.24.04.01.3%11.1
All (0-6)/(0-3)251292.931.5224.0405.41.11.10.4%3.1255316.351.0211.8529.13.43.41.1%તે. રે
WI_S_Hemi251288.932.1223.2414.21.51.50.5%4.2255316.050.7223.7525.74.34.31.4%11.9
WI_I_Hemi251285.726.5226.0362.51.61.80.6%4.9254312.044.7204.0492.13.83.81.2%10.4
ILM ~ RPEWIC (1)251251287.30.22528.40.069224.50.089384.10.4801.10.0041.10.0040.4%1.8%3.10.011255255314.00.22446.50.069216.10.092506.90.4803.10.0073.10.0071.0%3.3%8.70.021
VolumeAll (0-6)/(0-3)2518.2140.8856.17311.3620.0590.0590.7%0.1652552.1830.3561.4263.6810.0450.0452.1%0.126
(mm3)WI251#####1.0896.40913.8650.3200.3223.1%0.8922542.7970.4730.7094.5780.1690.1696.0%0.469
C (1)251234.481.887.7551.35.35.42.3%14.9255233.783.689.4549.69.3ਰੇ:34.0%25.8
T (1-3)251212.341.9126.8353.83.13.11.5%8.7255210.342.8125.5354.12.02.01.0%5.6
S (1-3)N (1-3)251251208.9210.844.037.4134.3116.2395.4338.52.02.92.02.91.0%1.4%5.68.1255255208.3209.244.137.2134.0117.0400.8338.12.78.82.88.81.3%4.2%7.624.3
I (1-3)251205.037.6121.1362.74.84.82.4%13.4249203.238.0116.4356.34.74.72.3%13.2
S Hemi (1-3)251210.641.0136. /315.81.91.90.9%5.4255209.441.3136.33/5.14.34.32.0%11.9
I_Hemi (1-3)251207.936.7113.0348.13.53.51.7%9.6255206.036.9110.0343.63.63.61.7%10.0
All (1-3)251251209.3186.938.418.4124.9152.0361.9267.72.11.92.12.01.0%1.1%5.85.5255-207.7-38.4123.9-359.53.13.11.5%8.7
IPL ~ RPET (3-6)ર (3-6)251186.424.0133.7273.92.02.01.1%5.6---
ThicknessN (3-6)251180.222.4113.1244.11.81.81.0%5.1---------
(µm)I (3-6)249178.216.7139.4249.92.32.31.3%6.3-----
S_Hemi (3-6)251185.421.8134.8263.81.51.50.8%4.3---------
I_Hemi (3-6)All (3-6)251251180.4182.915.618.0139.9137.9230.7237.41.71.21.71.21.0%0.7%4.83.3-----
S_Hemi (0-6)/(0-3)251192.426.2134.2296.11.41.40.7%3.9255212.145.5131.0395.74.14.11.9%11.3
I Hemi (0-6)/(0-3)251188.119.9132.9251.91.61.60.9%4.5255209.241.4107.6367.03.93.91.9%10.9
All (0-6)/(0-3)251190.322.6133.9273.31.21.20.6%3.3255210.743.0119.9381.23.43.41.6%9.4
WI_S_HemiWI Hemi251251187.5182.723.317.4135.7133.9280.5233.81.51.91.71.90.9%1.1%4.65.3255254209.0205.442.036.5133.6107.7383.1344.24.03.74.03.71.9%1.8%11.010.3
WI251185.119.8135.6255.31.21.20.7%3.4255207.138.3122.9361.43.03.01.5%8.4
IPL ~ RPEC(1)2510.1850.0640.0690.4350.0040.0042.3%0.0122550.1840.0660.0700.4320.0070.0074.0%0.020
VolumeAll (0-6)/(0-3)2515.3370.6373.6947.6600.0460.0470.9%0.1302551.4540.3000.8082.6440.0340.0342.3%0.093
(mm3)WI2516.6260.7544.2159.2210.2140.2143.2%0.5942541.8460.3770.4373.2660.1080.1085.8%0.299

Table16. Retinal Thickness and Volume of Retinal Layers of AngioRetina Scan, Retina Group

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2. FAZ Parameter Validation (for non-vascular FAZ Parameters)

To validate OCTA-based FAZ measurements with the device software, the OCTA derived FAZ area and FAZ perimeter parameters were compared to manually graded FAZ measurements from fluorescein angiography images.

Study Data

The case series consisted of 30 eyes of 26 subjects (14 Males and 12 Females) from 3 clinical sites. One early phase FA image with sufficient quality to visualize the FAZ per case was included in the FA grading set, and one 3 mm AngioRetina scan per case with sufficient scan quality was included in the OCTA measurement set. The case series consisted of 4 normal eyes, 3 eyes of wet AMD with CNV, 7 eyes with NPDR, 5 eyes with PDR, 4 eyes with BRVQ, and remaining 7 eyes with other retinal pathologies (including dryAMD, CSC, MacTel, and ERM).

Methods

Three readers experienced in FA image grading performed FAZ measurements. Each grader followed a grader-specific randomized grading order, masked to each other's results through the entire grading process, and masked to the OCTA images and measurements. Measurement of Foveal Avascular Zone (FAZ) parameters was done using ImageJ software.

Results

Table 17a. Distribution of FAZ measurements based on FA and OCTA for the case series

FA (Manual Grading)OCTA (Device Software)
Area (mm²)Perimeter (mm)Area (mm²)Perimeter (mm)
Mean0.3992.7520.3282.547
SD0.3281.3680.3061.572
Median0.3332.4970.2812.201
Min0.1201.5840.0370.860
Max1.9579.0391.8019.896

Table 17b. Limits of Agreement Analysis for FAZ measurements between OCTA and FA

Difference(FA - OCTA)meanmean(%)SDminmaxLOAlowerbound*LOAupperbound**lower95%CIfor LOAlowerupper95%CIfor LOAlowerlower95%CIfor LOAupperupper95%CIfor LOAupper
Area (mm²)0.07017.7%0.132-0.1290.356-0.1890.330-0.349-0.0290.1700.489
Perimeter (mm)0.2057.5%0.761-1.4801.121-1.2871.697-1.697-0.8761.2872.108
  • LOA lower bound = mean-1.96xSD

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ninterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
Area (mm²)30-0.043-0.1230.0380.9290.7211.136
Perimeter (mm)30-0.655-1.017-0.2921.1631.0311.296

Table 17c. Deming Regression Analysis for FAZ measurements between OCTA and FA

3. FAZ Parameters Agreement between 3-mm AngioRetina and 6-mm HD AngioRetina Scans

The agreement between the 3-mm and 6-mm AngioRetina scan patterns for FAZ parameters (FAZ area, FAZ perimeter, and FD-300 vessel density) was evaluated on the R&R study data set. Of the 67 subjects enrolled in the R&R study, 5 subjects were excluded for following reasons: no FAZ, indeterminant FAZ, or missing one of the scan type for comparison. The evaluation was then performed for the combined group of 15 Normal, 15 Glaucoma and 32 Retina study eyes (62 subjects/eyes). Agreement (Bland-Altman analysis, Deming regression analysis) between 3 mm AngioRetina and 6 mm HD AngioRetina FAZ measurements are provided based on the first replicate per study eye per scan pattern.

Results

Table 18a. Limits of Agreement Analysis for FAZ measurements between 3-mm AngioRetina and 6-mm HD AngioRetina Scans

Difference(6-mm Scan -3-mm Scan)meanmean(%)SDminmaxLOAlowerbound*LOAupperbound**lower95%CIfor LOAlowerupper95%CIfor LOAlowerlower95%CIfor LOAupperupper95%CIfor LOAupper
Area (mm²)-0.007-0.3%0.024-0.0550.089-0.0550.04-0.0671-0.04570.03110.0524
Perimeter (mm)-0.107-5.0%0.107-0.3040.182-0.3170.103-0.3697-0.27580.06190.1558
FD-300 (%)3.1956.9%3.695-5.813.89-4.04710.436-5.8568-2.62239.011612.2462
  • LOA lower bound = mean-1.96xSD

** LOA upper bound = mean+1.96xSD

Table 18b. Deming Regression Analysis for FAZ measurements between 3-mm AngioRetina and 6-mm HD AngioRetina Scans

ninterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
Area (mm²)62-0.007-0.0220.0071.0020.9521.052
Perimeter (mm)620.004-0.1210.1290.9480.8911.006
FD-300 (%)62-0.464-13.14512.2181.0790.8181.340

4. Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement Evaluation

A subset of the R&R study data was used to perform the agreement assessment of structural measurements (Full Retina, Inner Retina or GCC, and RNFL thickness) with the predicate. The

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agreement was assessed based on the combined group of 67 study eyes of 67 subjects (15 Normal, 16 Glaucoma, and 36 Retina) for evaluation of Full Retina and Inner Retina thickness, and 31 subjects (15 Normal and 16 Glaucoma) for evaluation of RNFL thickness and optic disc measurement. 64 subjects had matched scan pairs for comparison between 3 mm AngioRetina scan and Retina Map scan, 63 subjects had matched scan pairs for comparison between the 6 mm HD AngioRetina scan and Retina Map scan, 62 subjects had matched scan pair for comparison between 6mm HD AngioRetina scan and GCC scan, and 30 subjects (normal subjects and glaucoma subjects only) with matched scan pair for the comparison between the 4.5mm HD AngioDisc scan and the ONH scan. Overall scan attrition was low for any given scan type (< 5.0%). A summary of key parameters is shown in the table below for Mean of Differences and standard deviation (STDEV) of differences.

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Table 19. Limits of Agreement Analysis for Full Retina (i.e. GCC), RNFL and Optic Disc Measurements (All Groups Combined)

Difference (6-mm HD AngioRetina Scan vs. Retina Map Scan)6-mm HD AngioRetina Scan vs. Retina Map Scan
ParametermeanSDLOA lower bound*LOA upper bound**lower 95%CI for LOA lowerupper 95%CI for LOA lowerlower 95%CI for LOA upperupper 95%CI for LOA upperParameterninterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
C (1)-1.76.9-15.311.9-18.2-12.48.914.8C (1)63-3.3-9.52.91.010.981.03
All (1-3)3.85.1-6.213.8-8.4-4.011.716.0All (1-3)632.0-17.621.61.010.941.07
S_Hemi (1-3)3.55.3-6.913.9-9.1-4.611.616.1S_Hemi (1-3)636.0-4.316.30.990.961.02
I_Hemi (1-3)4.16.0-7.615.8-10.1-5.113.218.3I_Hemi (1-3)63-1.3-30.327.61.020.921.11
T (1-3)4.26.8-9.217.6-12.1-6.314.720.5T (1-3)639.8-2.922.50.980.941.02
S (1-3)3.35.9-8.214.8-10.6-5.712.317.3S (1-3)633.5-8.915.91.000.961.04
RetinaThickness(μm)N (1-3)2.56.8-10.815.7-13.6-7.912.918.6RetinaThickness(μm)N (1-3)639.4-9.328.10.980.921.04
I (1-3)5.06.3-7.417.5-10.1-4.714.820.2I (1-3)63-2.1-51.547.31.020.861.18
All (3-6)-4.74.9-14.44.9-16.5-12.32.87.0All (3-6)634.5-16.425.40.970.891.04
S_Hemi (3-6)-5.05.3-15.45.5-17.6-13.13.27.7S_Hemi (3-6)6310.8-2.123.70.940.900.99
I_Hemi (3-6)-4.75.9-16.36.9-18.8-13.84.49.4I_Hemi (3-6)63-3.0-29.523.40.990.901.09
T (3-6)-7.46.4-20.05.1-22.7-17.22.47.8T (3-6)6314.02.125.90.920.880.97
S (3-6)-4.66.6-17.58.3-20.2-14.75.511.1S (3-6)6315.2-1.231.50.930.870.99
N (3-6)-2.96.3-15.29.4-17.8-12.56.812.1N (3-6)63-5.0-23.813.81.010.941.07
I (3-6)-4.57.7-19.510.5-22.7-16.27.313.8I (3-6)63-1.0-40.538.60.990.841.14
Difference (6-mm HD AngioRetina Scan vs. GCC Scan)6-mm HD AngioRetina Scan vs. GCC Scan
ParametermeanSDLOA lower bound*LOA upper bound**lower 95%CI for LOA lowerupper 95%CI for LOA lowerlower 95%CI for LOA upperupper 95%CI for LOA upperParameterninterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
GCCThickness(µm)All (0-6)4.43.9-3.212.1-4.9-1.510.413.7GCCThickness(μm)All (0-6)62-1.2-7.14.81.061.001.12
S_Hemi (0-6)4.64.3-3.913.0-5.7-2.011.114.8S_Hemi (0-6)620.2-7.07.41.050.971.12
I_Hemi (0-6)4.34.3-4.112.7-5.9-2.310.814.5I_Hemi (0-6)62-3.3-9.52.91.081.021.15
Difference (4.5-mm HD AngioDisc Scan vs. ONH Scan)4.5-mm HD AngioDisc Scan vs. ONH Scan
ParametermeanSDLOA lower bound*LOA upper bound**lower 95%CI for LOA lowerupper 95%CI for LOA lowerlower 95%CI for LOA upperupper 95%CI for LOA upperParameterninterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
TS (μm)-2.97.4-17.411.7-22.0-12.87.116.2TS (μm)30-4.1-13.04.71.020.881.16
ST (μm)-11.17.3-25.43.3-29.9-20.9-1.27.8ST (μm)30-29.1-38.4-19.81.151.071.24
SN (μm)-3.610.3-23.816.6-30.2-17.410.222.9SN (μm)30-24.7-35.3-14.21.211.101.32
NS (μm)-3.08.2-19.213.2-24.3-14.18.118.3NS (μm)30-3.6-15.68.31.010.841.17
NI (μm)-1.77.5-16.313.0-20.9-11.78.417.6NI (μm)30-14.1-25.3-2.91.181.031.33
IN (μm)-3.510.3-23.716.7-30.1-17.310.323.0IN (μm)30-19.8-32.0-7.71.161.031.29
RNFLThickness(φ3.45)IT (μm)-9.27.7-24.36.0-29.1-19.51.210.8RNFLThickness(ø3.45)IT (μm)30-22.3-31.1-13.41.121.041.20
TI (μm)-3.48.2-19.412.6-24.5-14.47.517.6TI (μm)307.5-9.324.30.820.541.09
T (μm)-3.27.1-17.010.7-21.4-12.66.315.1T (μm)301.5-10.513.50.930.741.11
S (μm)-7.47.1-21.36.5-25.7-16.92.210.9S (μm)30-26.1-34.2-18.01.171.091.26
N (μm)-2.37.0-16.111.5-20.5-11.87.115.9N (μm)30-8.4-18.71.81.080.951.22
I (μm)-6.37.6-21.38.6-26.0-16.63.913.4I (μm)30-20.2-29.6-10.71.131.041.23
S_Hemi (μm)-5.24.9-14.84.5-17.9-11.81.57.6S_Hemi (μm)30-12.2-20.0-4.31.080.981.17
I_Hemi (μm)-4.44.6-13.54.6-16.3-10.61.87.5I_Hemi (μm)30-9.9-16.7-3.11.060.981.15
All (μm)-4.84.2-13.03.5-15.7-10.40.96.1All (μm)30-10.3-16.4-4.11.060.991.14
DiscArea (mm²)-0.1300.147-0.4180.157-0.508-0.3270.0660.247DiscArea (mm²)30-0.148-0.4700.1731.010.861.15
CupArea (mm²)-0.4500.186-0.816-0.085-0.931-0.700-0.2000.031CupArea (mm²)30-0.219-0.325-0.1130.750.630.88
RimArea (mm²)0.3190.190-0.0520.691-0.1690.0650.5740.808RimArea (mm²)300.5110.2430.7800.840.631.05
OpticDiscCupVolume (mm³)-0.1620.168-0.4910.166-0.595-0.3870.0630.270DiscCupVolume (mm³)30-0.024-0.038-0.0090.460.400.53
RimVolume (mm³)0.2630.0950.0760.4500.0170.1350.3910.509RimVolume (mm³)300.1200.0630.1772.221.622.83
C_D_Area_Ratio-0.1940.075-0.340-0.047-0.386-0.294-0.094-0.001C_D_Area_Ratio30-0.122-0.185-0.0580.830.690.98
C_D_H_Ratio-0.2560.090-0.433-0.078-0.489-0.377-0.134-0.022
  • LOA lower bound = mean-1.96xSD

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Table 20. Deming Regression Analysis for Full Retina (i.e. GCC), RNFL and Optic Disc Measurements (All Groups Combined)

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5. Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping with SD-OCT

This was a prospective, observational study conducted at a single clinical U.S. site. Eligible participants age 18 or older were enrolled and assigned to one of two study groups: 1) individuals with no corneal pathology, eyelid margin disease, or conditions in qualifying for the other sub-group; 2) those with four specified corneal conditions (soft and hard contact lens wearers, post-refractive surgery, dry eye, keratoconus). Each study eye was imaged at least three times using the PachymetryWide scan pattern with each of three Avanti instrument/operator pairs. Post-acquisition image review of signal strength, pupil alignment, eyelid artifact, scan range, and motion artifact was conducted on all scans. Repeatability and reproducibility of the parameters (all zonal thicknesses [epithelial and stromal thickness], "summary statistics" parameters) were calculated using a crossed, random-effects ANOVA model.

Results

A total of 62 participants were consented and enrolled, 12 "normals," 12 contact lens wearers, 12 with dry eye, 12 post-laser refractive surgery (post-LRS), and 14 with keratoconus (KCN). Analysis was conducted on scans from 60 participants. The age distribution and clinical characteristics of the study cohort are shown in Tables 21 through 26.

64 of 581 total acquired scans (11%) were excluded from R&R analysis due to scan quality issues. Out of 517 scans qualified for final R&R analysis, 60 (12%) required manual edits of the segmentation lines.

Age by Category (n=60)MinMedianMeanMaxSD
Normal (n=12)2145.546.37215.68
Contact Lens (n=12)3140.546.76714.43
Dry Eye (n=11)3966.063.0759.79
Post Laser Refractive Surgery (n=12)1947.544.77316.34
Keratoconus (n=13)1838.039.47116.31

Table 21. Age Distribution for All Subjects by Enrollment Group

All subjects in the Contact Lens group wore soft contact lens regularly for eight or more hours per day, and for at least three months at the time of enrollment.

Table 22. Contact Lens Wear Data for the Contact Lens Study Group
Contact Lens WearMinMedianMeanMaxSD
Duration (yr.)215.522.54514.77
Hours/Day1014.513.7161.84

The severity of dry eye condition was documented using Ocular Surface Disease Index (OSDI) score with a scale from 0 to 100 (mild to severe) in the table below.

Table 23. OSDI Score Distribution of the Dry Eve Study Group
Dry Eye AssessmentMinMedianMeanMaxSD
ODSI Score14.5833.3342.87521.42

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ProcedureTotal% Total
LASIK975.0%
PRK325.0%
Correction
Myopic1083.3%
Hyperopic18.3%
Astigmatism18.3%
Duration since procedure
> 1yr1083.3%
> 3mo18.3%
> 1mo18.3%

Table 24. Post-LRS Group Clinical Data Summary

The subjects in the KCN group all had a clinical diagnosis of keratoconus. None of the KCN subjects had any prior surgical treatment.

Clinical SignsTotal% Total
Slit lamp exam857.1%
Topographic patterns214.3%
Slit lamp exam & Topographic patterns428.6%
Retinoscope reflex00.0%
Severity (clinically established by PI)Total% Total
Mild642.9%
Moderate535.7%
Severe321.4%

Table 25. KCN Group Distribution by Clinical Signs and Severity

Table 26. Distribution of Steep K and Delta K (difference between Steep K and Flat K) in KCN Group
----------------------------------------------------------------------------------------------------
Corneal CurvatureMinMedianMeanMaxSD
Steep K45.7352.3652.2762.725.098
Delta K1.023.234.7521.95*5.154

The repeatability and reproducibility (R&R) results are show in Tables 27 through 31.

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Image /page/32/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a simple, sans-serif font. To the left of the word is a circular graphic that appears to be a gradient of orange and yellow, resembling a sunrise or a stylized eye. The text is in a light gray color, providing a subtle contrast against the white background.

Normal Group (n = 105 scans)
PachymetryEpitheliumStroma
RepeatabilityReproducibilityRepeatabilityReproducibilityRepeatabilityReproducibility
MeanSDMinMaxSDSD COV95%LimitsMean SD Min MaxSDSD COV95%LimitMeanSDMinMaxSDSD COV95%Limits
C_2551.3 23.2518.4 608.11.41.5 0.3%4.354.55.945.369.10.70.8 1.4%2.1496.723.2467.2546.61.21.2 0.3%3.5
T_2_5564.723.9527.5 615.02.32.3 0.4%6.353.85.144.566.10.80.8 1.5%2.2510.9 23.4 476.9555.32.12.1 0.4%5.9
ST_2_5580.922.4547.8 625.73.43.5 0.6%9.653.94.546.063.90.90.9 1.7%2.6527.0 22.0 494.1 569.43.33.4 0.7%9.6
S 2 5593.9 20.7 561.7 639.14.04.0 0.7%11.054.24.3 46.163.91.21.2 2.2%3.3539.7 20.8 507.5581.83.94.0 0.7%11.0
SN 2 5590.5 19.8554.1 639.94.14.1 0.7%11.554.54.546.365.71.21.22.2%3.3536.0 20.1 500.9580.64.04.1 0.8%11.3
N_2_5579.2 20.3545.6 631.23.33.3 0.6%9.154.94.9 46.267.30.91.0 1.8%2.7524.3 20.5493.0 570.93.13.1 0.6%8.7
IN_2_5571.2 21.8 542.0 625.92.72.7 0.5%7.556.05.6 48.369.10.70.7 1.3%2.1515.2 21.5 488.6 564.12.52.5 0.5%6.9
I_2_5565.4 23.2530.1 623.92.12.2 0.4%6.156.26.6 46.971.70.80.8 1.5%2.3509.2 22.4 482.3 559.72.12.1 0.4%5.8
IT_2_5560.323.9523.2 617.71.81.8 0.3%4.954.86.0 45.770.10.90.9 1.7%2.6505.5 23.3474.2 555.51.91.9 0.4%5.1
T_5_7592.9 23.6 544.7 634.73.83.8 0.6%10.453.24.1 42.0 61.00.90.9 1.6%2.4539.7 22.8 500.3 578.83.83.8 0.7%10.7
ST_5_7621.0 20.9584.5661.54.85.0 0.8%13.852.03.5 45.261.11.11.1 2.2%3.1569.0 20.7 533.7 609.85.05.2 0.9%14.4
S_5_7641.9 19.2 609.0 683.75.15.2 0.8%14.452.33.4 45.8 65.01.41.5 2.9%4.1589.6 20.1 555.1 630.45.25.4 0.9%14.9
SN 5 7634.518.9600.1675.25.96.0 1.0%16.754.23.147.962.11.21.32.3%3.5580.3 19.2 544.8 618.55.75.9 1.0%16.4
N_5_7615.2 18.2584.0 654.94.94.9 0.8%13.655.24.1 48.565.00.91.0 1.8%2.7560.1 18.2 529.9 596.54.64.6 0.8%12.8
IN 5 7604.3 20.3 569.9 652.94.74.7 0.8%13.156.35.247.968.70.80.8 1.3%2.1548.0 19.9 521.9 598.34.54.5 0.8%12.5
I_5_7597.6 22.7553.3 646.64.14.2 0.7%11.656.76.7 45.171.10.80.8 1.4%2.1540.9 21.6 508.2 592.14.14.2 0.8%11.6
IT_5_7588.123.2540.4 636.73.93.9 0.7%10.755.15.6 45.166.81.01.0 1.8%2.7533.0 22.5493.2 575.14.04.0 0.7%11.1
T_7_9628.0 24.6 569.6 674.76.87.0 1.1%19.552.23.6 42.958.40.90.9 1.7%2.5575.8 23.9 525.6 623.06.87.1 1.2%19.7
ST_7_9666.2 22.1 616.6 703.47.98.3 1.2%22.949.33.3 41.557.11.11.2 2.3%3.2616.9 22.3571.6 655.88.18.5 1.4%23.7
S_7_9688.2 19.6 641.0 724.08.18.2 1.2%22.749.73.4 41.356.51.51.5 3.0%4.1638.4 21.1 588.6 676.48.18.3 1.3%23.0
SN_7_9681.9 19.7 635.0 724.98.28.2 1.2%22.753.43.0 48.061.01.51.52.9%4.3628.520.6 578.2 672.38.18.1 1.3%22.5
N_7_9658.0 20.3 619.7 697.46.86.8 1.0%18.856.44.1 49.766.81.41.4 2.5%4.0601.6 20.4 567.5 643.36.46.4 1.1%17.9
IN_7_9646.2 23.0 598.0 713.37.37.3 1.1%20.256.55.3 49.269.90.90.9 1.6%2.6589.7 23.4 548.0 658.27.17.1 1.2%19.8
I_7_9635.725.4 578.6 701.06.76.8 1.1%18.956.46.6 46.971.00.70.7 1.2%1.9579.3 25.2 531.4 646.36.86.9 1.2%19.2
IT_7_9623.8 24.0 563.5 663.16.56.5 1.0%18.155.25.8 44.268.00.80.9 1.5%2.4568.6 23.8 518.0 610.96.56.6 1.2%18.2

Table 27. Normal Group R&R Results (Zonal Parameters)

Table 28. Contact Lens Group R&R Results (Zonal Parameters)
-------------------------------------------------------------------------
Contact Lens Group (n = 101 scans)
PachymetryEpitheliumStroma
MeanSDMinMaxRepeatabilityReproducibilityMean SD Min MaxRepeatabilityReproducibilityMeanSDMin MaxRepeatabilityReproducibility
SDSDCOV95%LimitsSDSD COV95%LimitsSDSDCOV95%Limits
C_2555.446.1454.7 662.62.32.6 0.5%7.151.14.240.363.02.02.1 4.0%5.7504.3 46.5400.5 610.51.21.50.3%4.2
T_2_5569.2 47.2465.1679.23.33.40.6%9.450.43.841.160.32.02.0 3.9%5.5518.9 47.9412.3 630.42.62.60.5%7.3
ST_2_5587.6 45.8 474.0 699.04.64.70.8%12.951.03.942.7 61.01.91.9 3.8%5.3536.5 47.0 420.6 651.64.34.40.8%12.3
S_2_5602.6 45.8 482.3 712.24.64.90.8%13.551.43.741.8 60.71.71.73.4%4.8551.2 46.9 427.7 663.84.44.80.9%13.4
SN_2_5598.145.1482.6 704.94.24.50.8%12.451.83.9 40.361.21.71.8 3.4%4.9546.3 46.2426.5 655.34.04.40.8%12.1
N_2_5584.1 46.1477.3 690.43.33.60.6%9.951.53.742.458.91.71.7 3.3%4.7532.6 46.7420.2 637.93.33.50.7%9.6
IN_2_5574.348.2476.9 686.03.03.10.5%8.551.63.543.958.91.01.0 2.0%2.8522.7 47.9 418.9 631.12.92.90.6%8.1
I_2_5568.3 49.7 472.9 685.42.62.60.5%7.151.8 3.6 44.9 59.41.31.3 2.5%3.5516.5 49.0 416.7 629.12.22.20.4%6.0
IT_2_5564.0 49.4466.8 678.62.72.70.5%7.550.83.7 42.8 61.01.81.8 3.6%5.1513.2 49.0 412.3 624.61.81.80.3%4.9
T_5_7598.2 49.7487.5 712.94.84.80.8%13.450.32.8 43.1 57.2ાં ડ1.5 3.0%4.2547.9 49.8 434.7 665.24.54.50.8%12.4
ST_5_7630.5 47.7508.4 745.16.46.41.0%17.949.93.739.559.01.92.1 4.1%5.7580.7 48.2 453.6 698.96.56.61.1%18.3
S_5_7655.546.1526.8 756.65.96.10.9%16.850.13.343.859.21.92.0 4.0%5.6605.4 47.0 471.0 709.85.86.11.0%16.9
SN 5 7645.1 45.4 518.2 747.36.06.41.0%17.751.83.3 41.4 61.41.81.8 3.5%5.0593.3 46.2 463.7 698.15.96.31.1%17.4
N_5_7620.0 45.4504.8 721.45.05.20.8%14.452.03.4 42.359.61.41.4 2.7%3.9568.0 45.8 450.6 669.45.05.10.9%14.2
IN_5_7608.1 47.9 502.9 714.15.15.10.8%14.252.32.7 46.8 58.81.01.0 1.9%2.8555.9 47.8 447.8 661.54.94.90.9%13.5
I_5_7601.8 50.4500.9 716.84.34.30.7%11.852.63.0 47.0 60.61.31.3 2.5%3.7549.2 50.0 443.9 662.04.24.20.8%11.7
IT_5_7592.9 51.5 490.3 710.24.44.40.7%12.151.6 2.6 45.5 60.01.41.4 2.7%3.8541.3 51.1 435.6 657.03.93.90.7%10.9
T 7 9633.6 51.4 521.0 755.49.49.41.5%26.050.23.3 44.259.91.71.8 3.5%4.9583.4 51.0 469.8 709.28.88.81.5%24.5
ST_7_9677.748.4549.7 790.112.012.1 1.8%33.648.95.234.564.62.12.24.5%6.1628.8 48.9499.5 747.712.112.22.0%33.9
S 7 9706.0 45.6 571.7 797.49.69.61.4%26.647.75.138.2 64.92.62.6 5.5%7.3658.3 46.1523.7 759.210.210.2 1.6%28.3
SN_7_9695.244.5566.3 780.67.37.81.1%21.750.84.739.7 62.61.91.9 3.7%5.2644.4 45.3516.7 736.77.78.21.3%22.7
N_7_9662.3 43.9 550.3 759.26.06.20.9%17.153.83.741.8 62.61.41.4 2.6%3.8608.5 44.7 497.4 708.25.55.60.9%15.5
IN_7_9649.547.0 544.1 750.77.77.71.2%21.453.23.7 44.9 62.71.11.1 2.1%3.1596.3 47.5 489.4 702.17.37.31.2%20.2
I_7_9640.249.8 537.5 753.66.66.61.0%18.353.0 3.2 45.7 60.91.21.3 2.4%3.5587.3 50.7 480.6 703.06.76.81.2%18.8
IT_7_9628.0 52.5 524.0 747.37.77.71.2%21.252.7 2.7 45.2 62.11.31.3 2.5%3.7575.4 52.5 470.6 695.97.37.31.3%20.3

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Image /page/33/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized circle on the left, with the word "OPTOVUE" to the right of the circle. The circle is colored with a gradient that transitions from orange to yellow. The text "OPTOVUE" is in a simple, sans-serif font and is colored in gray.

Dry Eye Group (n = 89 scans)
PachymetryEpitheliumStroma
MeanSDMinMaxRepeatabilityReproducibilityMean SD Min MaxRepeatabilityReproducibilityMeanSDMinMaxRepeatabilityReproducibility
SDSDCOV95%LimitsSDSD COV95%LimitsSDSD COV95%Limits
C_2536.1 29.0 485.0 588.51.62.0 0.4%5.554.02.8 48.859.81.11.3 2.3%3.5482.1 28.9 428.6 529.21.41.5 0.3%4.2
T_2_5549.7 29.1 493.0 598.52.92.90.5%8.153.42.6 47.959.40.91.0 1.9%2.8496.3 29.3436.5 541.32.72.7 0.5%7.5
ST 2 5565.9 27.7507.4 609.74.04.00.7%11.152.12.6 45.6 59.51.31.3 2.5%3.6513.8 28.0 453.6 553.13.93.9 0.8%10.8
S_2_5578.7 26.8527.1619.44.34.40.8%12.252.02.745.359.21.41.4 2.8%4.0526.7 27.2473.7 566.34.54.5 0.9%12.6
SN 2 5574.8 26.4525.1621.44.14.30.7%11.952.82.846.659.91.51.5 2.9%4.2522.0 26.8470.8 561.84.24.4 0.8%12.1
N_2_5562.3 27.4510.1614.73.33.70.7%10.253.82.8 48.662.31.31.4 2.6%3.8508.6 27.5454.3555.43.33.6 0.7%10.0
IN_2_5554.7 28.5506.3 606.22.52.8 0.5%7.754.62.8 48.6 63.51.21.2 2.3%3.4500.1 28.8 449.5 546.62.42.5 0.5%7.0
I_2_5550.4 29.2502.6 598.12.32.6 0.5%7.255.12.8 49.760.91.11.2 2.1%3.2495.3 29.4 444.2 543.12.02.2 0.4%6.0
IT_2_5545.2 30.1 491.2 596.12.02.30.4%6.354.32.8 48.160.70.91.0 1.8%2.7490.9 30.0 433.6 537.01.71.9 0.4%5.2
T_5_7576.6 28.7513.3 621.64.64.60.8%12.952.32.6 46.159.21.01.1 2.0%2.9524.3 29.1458.4563.74.74.7 0.9%12.9
ST_5_7605.3 28.1542.2 657.25.65.60.9%15.649.23.141.457.21.31.3 2.7%3.7556.2 28.8492.3 608.65.85.8 1.0%16.1
S_5_7627.1 27.4581.3 682.85.96.01.0%16.748.54.0 35.257.11.71.7 3.6%4.8578.6 28.2 528.1 634.06.36.3 1.1%17.6
SN_5_7616.9 26.1566.3654.15.66.0 1.0%16.651.53.543.0 59.81.51.5 3.0%4.2565.4 27.2511.7603.05.96.2 1.1%17.3
N_5_7594.6 26.9538.5 641.35.15.4 0.9%14.953.32.6 49.4 63.81.31.4 2.6%3.8541.3 27.4 484.0 582.34.95.2 1.0%14.4
IN_5_7584.6 27.8536.6 630.43.94.00.7%11.254.13.1 49.0 63.71.31.4 2.6%4.0530.5 28.6 480.5578.53.83.9 0.7%10.7
I_5_7580.1 28.7533.6 634.53.84.10.7%11.354.43.348.760.81.21.4 2.5%3.8525.7 29.9476.1584.43.53.7 0.7%10.1
IT_5_7571.6 29.9516.6 622.14.04.10.7%11.454.32.749.960.71.21.22.3%3.4517.329.9459.6 568.13.73.8 0.7%10.6
T_7_9607.4 30.3538.3656.07.67.61.3%21.150.03.2 41.156.11.21.2 2.4%3.4557.4 31.4 485.3 607.67.97.9 1.4%21.8
ST 7 9645.1 31.7586.2 730.98.28.2 1.3%22.846.24.0 37.6 53.71.21.3 2.9%3.7598.9 32.9 534.8 679.98.28.3 1.4%23.0
S_7_9675.3 34.3614.5 790.913.514.2 2.1%39.446.44.927.355.92.02.0 4.3%5.5628.934.6566.9 742.314.014.7 2.3%40.7
SN_7_9658.8 33.0 604.2 733.18.69.1 1.4%25.149.54.4 37.8 56.61.61.7 3.4%4.6609.3 34.2 548.7 680.69.09.4 1.5%26.1
N_7_9626.4 30.8562.0 670.37.07.3 1.2%20.353.23.246.364.81.71.8 3.4%5.0573.2 31.4 506.0 619.96.57.0 1.2%19.5
IN_7_9615.4 29.2563.4 663.86.96.91.1%19.253.35.344.263.61.81.9 3.6%5.4562.1 31.6 506.7618.66.86.8 1.2%18.8
I_7_9611.1 31.7557.5 667.85.75.70.9%15.853.25.2 40.362.01.21.3 2.5%3.7557.9 34.1502.7 627.66.16.1 1.1%16.9
IT_7_9603.7 31.7 540.9 659.56.06.2 1.0%17.253.53.1 48.259.61.01.0 1.9%2.8550.2 32.6 483.6 608.66.16.2 1.1%17.2

Table 29. Dry Eye Group R&R Results (Zonal Parameters)

Table 30. Post-LRS Group R&R Results (Zonal Parameters)

Post-LRS Group (n = 112 scans)
PachymetryEpitheliumStroma
MeanSDMinMaxRepeatabilityReproducibilityMean SD Min MaxRepeatabilityReproducibilityMeanSDMinMaxRepeatabilityReproducibility
SDSDCOV95%LimitsSDSD COV95%LimitsSDSD COV95%Limits
C_2504.6 44.6 418.3 573.51.31.6 0.3%4.457.44.3 46.9 64.10.70.8 1.4%2.3447.2 46.4359.2 519.21.21.40.3%3.8
T_2_5531.2 35.5 459.4 594.24.24.2 0.8%11.758.23.4 50.7 66.51.01.1 1.8%3.0473.1 37.5396.3 539.34.34.30.9%12.0
ST_2_5548.2 39.1 461.7 611.95.96.0 1.1%16.557.44.348.5 65.41.01.1 1.8%2.9490.741.1399.5 555.96.06.01.2%16.6
S_2_5562.3 40.4 474.6 630.07.07.11.3%19.756.94.7 44.3 65.71.11.22.1%3.3505.442.7412.2 575.77.07.11.4%19.8
SN_2_5556.6 40.4 466.2 633.86.87.0 1.3%19.458.04.0 49.1 66.41.11.2 2.1%3.3498.6 42.4 403.1 577.17.07.21.4%20.0
N_2_5544.138.1460.5 617.85.15.4 1.0%14.958.53.152.1 64.60.91.0 1.8%2.9485.739.7398.4 560.95.35.71.2%15.7
IN_2_5539.1 35.3 465.5 599.84.54.5 0.8%12.658.03.2 50.9 63.30.80.9 1.6%2.6481.1 37.0 405.1 546.14.94.9 1.0%13.5
I_2_5535.7 34.7 463.2595.84.74.70.9%13.158.33.5 50.7 63.70.80.8 1.3%2.1477.336.9400.4 542.94.94.9 1.0%13.5
IT_2_5528.9 34.1 454.6 586.94.74.70.9%13.058.33.0 50.4 63.70.90.9 1.5%2.4470.6 36.0 390.8 530.44.94.91.0%13.6
T_5_7575.3 27.9 515.1634.25.15.2 0.9%14.454.73.5 47.6 65.11.21.22.3%3.4520.5 29.6 457.3 582.15.65.61.1%15.5
ST_5_7606.6 30.1 541.1669.77.77.71.3%21.453.64.2 40.3 61.71.61.73.2%4.7553.1 31.2 481.8 616.98.58.51.5%23.6
S_5_7631.8 30.0 562.8 700.78.18.1 1.3%22.552.04.0 39.5 58.61.81.9 3.6%5.2579.8 30.4 506.4 647.18.78.81.5%24.4
SN_5_7620.1 31.5 547.4 699.18.38.4 1.4%23.354.33.8 41.3 60.71.41.6 3.0%4.5565.8 31.7 492.0 645.78.89.01.6%25.0
N_5_7598.0 31.0 537.3 680.86.26.4 1.1%17.755.5 4.0 46.1 65.11.11.2 2.2%3.4542.6 31.6 484.5 625.46.66.8 1.3%18.9
IN 5 7591.5 28.9 534.6 662.45.45.4 0.9%14.954.83.3 47.7 61.40.80.8 1.4%2.2536.729.6 474.4 606.75.75.71.1%15.8
I_5_7588.3 27.2 538.0 658.36.16.2 1.0%17.155.42.6 49.459.90.90.9 1.7%2.6532.9 27.8 479.7 604.16.36.41.2%17.7
IT_5_7574.1 26.0 520.3 639.66.46.4 1.1%17.855.83.4 49.5 64.51.11.22.1%3.3518.3 27.1 463.4 585.66.86.81.3%18.9
T_7_9616.6 23.3 564.0 679.76.26.4 1.0%17.751.42.6 44.455.71.11.22.3%3.3565.223.7 510.5 627.86.56.71.2%18.7
ST_7_9653.7 23.8 608.0 712.38.58.5 1.3%23.650.33.8 41.0 59.61.51.5 3.1%4.2603.4 22.6 558.2 659.78.98.9 1.5%24.6
S_7_9682.2 26.6 622.0 739.112.613.6 2.0%37.848.74.2 36.5 57.52.52.5 5.2%7.0633.525.2 576.2 690.012.813.92.2%38.4
SN_7_9673.9 24.9 613.8 730.77.97.9 1.2%21.952.15.3 41.5 66.61.41.4 2.7%3.9621.7 22.5 566.5 676.77.87.81.2%21.5
N 7 9647.5 25.4 604.7 717.35.96.2 1.0%17.254.63.6 47.8 65.11.31.32.3%3.5592.924.7552.8 661.45.76.11.0%16.9
IN_7_9638.126.6 575.3 704.77.67.6 1.2%21.153.82.6 47.0 60.30.90.9 1.6%2.5584.325.8 524.6 648.77.67.61.3%21.2
I_7_9633.1 24.8 595.2 699.46.16.1 1.0%16.953.82.6 47.3 58.01.01.12.0%2.9579.4 25.1 541.7 646.16.36.31.1%17.5
IT_7_9618.1 23.7 575.7 683.97.57.5 1.2%20.953.72.5 47.459.21.21.32.3%3.5564.4 24.3 524.3 631.07.67.61.3%21.0

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Keratoconus Group (n = 110 scans)
PachymetryEpitheliumStroma
MeanSDMinMaxRepeatabilityReproducibilityMeanSDMinMaxRepeatabilityReproducibilityMeanSDMinMaxRepeatabilityReproducibility
SDSDCOV95%LimitsSDSDCOV95%LimitsanSDCOV95%Limits
C_2487.028.1403.4523.77.07.01.4%19.450.94.840.665.51.9193.7%5.2436.026.9358.3473.16.46.41.5%17.8
T_2_5503.529.4411.4553.58.08.01.6%22.247.35.336.659.02.12.14.4%5.7456.128.4366.3502.76.97.01.5%19.3
ST_2_5540.329.4458.6595.97.37.51.4%20.852.44.739.866.02.12.13.9%5.7488.029.7406.5537.46.26.51.3%18.0
S_2_5559.432.6473.2617.97.98.11.4%22.454.43.445.462.62.12.23.9%6.0505.032.5413.9561.06.97.21.4%19.9
SN_2_5555.832.1466.2615.77.57.51.4%20.954.84.641.963.91.8193.4%5.2501.032.2405.4556.76.97.01.4%19.5
N 2 5537.531.9454.7596.28.78.71.6%24.054.65.143.267.51.61.63.0%4.5482.931.0395.9536.17.97.91.6%22.0
IN_2_5509.934.0431.0557.99.59.51.9%26.253.94.744.571.62.12.13.9%5.8456.132.4380.2502.79.39.32.0%25.8
I_2_5480.036.3397.4533.17.27.31.5%20.250.94.840.963.92.32.34.6%6.4429.136.2341.1478.57.67.71.8%21.3
IT_2_5477.729.2392.0529.98.08.11.7%22.447.04.737.456.919194.0%5.3430.827.6346.1476.47.67.71.8%21.3
T_5_7539.042.4402.1600.59.29.21.7%25.550.55.437.060.41.61.63.2%4.5488.542.2347.7546.78.78.81.8%24.5
ST_5_7586.445.8460.1675.87.57.81.3%21.652.44.343.063.01.8193.6%5.2534.043.9413.9619.47.47.81.5%21.5
S_5_7610.149.3474.5689.36.97.11.2%19.551.73.745.060.61.81.83.5%5.0558.446.9426.7633.87.07.21.3%20.1
SN 5 7604.042.7486.2684.78.58.61.4%24.052.73.743.063.01.92.03.8%5.6551.341.3431.4628.28.79.01.6%25.0
N_5_7580.539.3479.2667.18.48.41.4%23.353.64.344.463.11.41.42.6%3.8527.037.3424.2605.98.58.51.6%23.6
IN_5_7553.834.9463.6608.29.19.11.6%25.354.15.544.468.51.61.63.0%4.4499.731.0414.6550.59.09.01.8%25.0
I_5_7520.540.3413.6571.28.08.31.6%23.052.08.336.869.52.02.03.8%5.5468.536.7374.1516.67.88.01.7%22.3
IT_5_7514.439.4380.4583.09.99.91.9%27.550.35.636.859.62.32.34.6%6.4464.138.5331.9526.09.09.01.9%24.8
T_7_9587.042.0463.1663.512.412.62.1%35.051.03.742.858.21.11.12.2%3.1536.040.8414.5615.512.112.42.3%34.5
ST 7 9613.251.0474.3730.715.415.42.5%42.849.63.043.158.31.61.73.4%4.6563.650.7427.2683.515.615.62.8%43.2
S_7_9638.653.8479.1745.718.318.32.9%50.647.54.135.856.12.22.24.5%6.0591.152.9437.3693.918.318.33.1%50.7
SN_7_9635.842.6505.4704.113.613.72.1%37.850.84.339.061.41.71.73.4%4.8585.040.3459.4655.713.613.62.3%37.8
N_7_9617.036.9522.4688.19.99.91.6%27.552.84.643.466.71.21.22.3%3.4564.233.5474.5629.69.79.71.7%26.8
IN_7_9602.941.3491.8698.013.613.62.2%37.753.25.541.363.01.31.32.5%3.6549.736.8447.8638.013.613.62.5%37.7
I_7_9579.750.9438.8692.416.317.02.9%47.252.67.931.167.02.12.14.0%5.9527.045.3400.0628.115.916.73.2%46.2
IT_7_9572.547.8413.0663.514.814.92.6%41.252.25.337.861.21.71.73.3%4.8520.344.3367.5604.614.414.52.8%40.1

Table 31. KCN Group R&R Results (Zonal Parameters)

6. Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT

This was a prospective, observational study conducted at three study sites to evaluate the agreement of the Avanti 9mm ETM software with manual measurements performed by three qualified graders. Eligible participants age 18 or older were enrolled and assigned to one of two groups as described under #5 above. The manual measurements were performed at 15 locations along each of the eight meridians in the PachymetryWide scan pattern in a randomized order with a 2-section caliper tool that was available in the previously cleared RTVue XR with CAM device. One eye per study subject was included in the study. One scan of sufficient image quality was required per study eye. Agreement was evaluated with calculation of 95% limits of agreement (LOAs) and Deming regression analyses.

A total of 89 subjects were enrolled. Scans from a total of 85 (17 "normal," 15 contact lens wearers, 18 with dry eye, 19 post-laser refractive surgery, and 16 with keratoconus) were included in analyses. The age distribution and clinical characteristics of the study cohort are shown in Tables 32 through 38.

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Age DistributionMinMedianMeanMaxSD
Entire Group233438.67312.6
Normal253233.56610.4
Contact Lens253035.25811.1
Dry Eye245146.57315.3
Post Laser Refractive Surgery233838.8568.9
Keratoconus253438.06211.7

Table 32. Age Distribution by Entire Study Group and by Sub-Groups

Of the 16 subjects enrolled in the Contact Lens group, 15 wore soft contact lens and one wore hard contact lens. Subjects wore contact lenses for eight or more hours each day for at least one year prior to testing.

Table 33. Contact Lens Wear Data for the Contact Lens Sub-Group

Contact Lens WearMinMedianMeanMaxSD
Duration (yr)11011206.07
Hours/Day81212.6162.06

For the subjects in the Dry Eye group, the severity of the dry eye condition for each study subject was documented using Ocular Surface Disease Index (OSDI) score with a scale from 0 to 100 (mild to severe) and Tear Break Up Time (TBUT).

Dry EyeMinMedianMeanMaxSD
OSDI score6.320.822.240.95.28
TBUT14.84.671.83

Table 34. OSDI Score and Tear Break Up Time (TBUT) Distribution of the Dry Eve Sub-Group

For the subjects in the Post-LRS group, the majority (75%) had had a LASIK procedure versus the PRK procedure (25%), mainly for myopic vision correction (83.3%) and most had the procedure done at least one year or more prior to testing (83.3%).

ProcedureTotal% Total (n=20)
LASIK1575.0%
PRK525.0%
Correction
Myopic1365.0%
Hyperopic420.0%
Astigmatism00.0%
Mixed*315.0%
Duration since procedure
> 1yr1680.0%
> 3mo420.0%
> 1mo00.0%

Table 35. Summary of the Post LRS Sub-Group

  • Mixed represented procedures either combining myopic correction with astigmatism correction or hyperopic correction with astigmatism correction.

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The 16 subjects in the KCN sub-group all had a clinical diagnosis of keratoconus. None of the subjects in the KCN sub-group underwent any surgical treatment for KCN. The clinical signs of KCN diagnosis for the study subjects, severity of keratoconus for the KCN subjects, and details on corneal curvature are summarized in the table below.

Subject IDSeverityslit lampthinningslit lampprotrusionslit lampmunsonslit lampvogtslit lampfleisherslit lamprizuttitopo bow-tietoposteeptopoclaw
DS-10moderate11
DS-12mild11
DS-21moderate111
DS-29moderate1111
DS-31severe111
DS-32moderate111
DS-34severe111
DS-36moderate111
DS-37mild11
MP-08severe1
MP-14moderate11
MP-19moderate11
MP-25mild1
MP-28severe1
MP-31moderate1
K1, SHmoderate1

Table 36. KCN Subiects Diagnosis by Clinical Signs

Table 37. KCN Group Distribution by Severity

SeverityTotal% Total (n=16)
Mild318.8%
Moderate956.3%
Severe425.0%
Table 38. Distribution of Steep K and Delta K (difference between Steep K and Flat K) of the KCN Sub-
Group
CornealCurvatureMinMedianMeanMaxSD
Steep K41.8047.7649.6570.806.47
Delta K0.362.673.308.332.17

12 of the 85 total study scans required manual segmentation editing (five from the keratoconus sub-group, three from the post-laser refractive surgery group, three from the contact lens groups, and one from the normal group).

Manual image grading was performed by three qualified grader was assigned one randomized grading order to follow. The graders were masked to each other's results.

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Results

Normal Group Agreement

Epithelial ThicknessStromal ThicknessCorneal Thickness
ParametermeanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**
C_2-0.41.3-3.12.2-2.51.6-5.60.6-2.90.8-4.4-1.4
T_2_5-0.22.0-4.13.71.01.9-2.84.80.80.9-1.02.6
ST_2_5-0.32.0-4.13.62.12.0-1.86.11.91.0-0.13.8
S_2_50.41.8-3.24.02.91.8-0.56.43.30.91.65.0
SN_2_50.31.7-3.03.62.61.6-0.65.82.91.10.75.0
N_2_50.51.4-2.33.31.61.7-1.74.82.10.90.33.9
IN_2_50.71.7-2.74.11.12.0-2.84.91.81.0-0.13.7
I_2_50.31.8-3.33.91.12.1-3.15.21.41.0-0.53.3
IT_2_5-0.11.8-3.63.41.02.0-2.95.01.01.0-1.13.0
T_5_70.52.3-4.15.0-1.12.2-5.43.2-0.70.9-2.51.2
ST_5_7-0.22.4-4.84.41.02.7-4.36.30.81.9-2.94.5
S_5_70.01.9-3.83.72.13.2-4.18.32.02.5-2.96.9
SN_5_71.21.9-2.65.0-0.22.1-4.33.91.01.2-1.33.3
N_5_71.62.0-2.35.6-1.72.2-6.02.70.01.2-2.42.4
IN_5_71.52.1-2.65.6-1.22.3-5.73.30.30.9-1.52.2
I_5_70.92.1-3.14.90.12.8-5.55.71.01.8-2.54.5
IT_5_70.62.3-3.95.10.34.3-8.18.70.93.9-6.78.5
T_7_9-0.52.9-6.35.30.64.7-8.59.80.13.1-5.96.1
ST_7_9-1.83.5-8.75.06.68.5-10.123.34.87.7-10.219.8
S_7_9-1.92.9-7.53.711.311.4-11.233.79.410.6-11.430.2
SN_7_9-0.82.9-6.54.97.18.3-9.223.46.36.9-7.219.9
N_7_91.33.0-4.67.1-0.45.4-11.010.20.94.4-7.89.5
IN_7_90.82.6-4.36.00.74.8-8.710.01.53.9-6.29.2
I_7_9-0.33.1-6.45.92.45.7-8.913.72.14.5-6.610.9
IT_7_90.13.1-5.96.22.57.4-12.016.92.67.0-11.116.3

Table 39a. Limits of Agreement Analysis between Software and Manual Measurements Difference (Software vs. Manual). Normal Group (n= 17)

  • LOA lower bound = mean-1.96xSD

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Table 39b. Deming Regression Analysis between Software and Manual Measurements

Normal Group (n= 17)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParameterinterceptinterceptCI lowerinterceptCl upperslopeslopeCI lowerslopeCI upperinterceptinterceptCl lowerinterceptCl upperslopeslopeCI lowerslopeCI upperinterceptinterceptCl lowerinterceptCl upperslopeslopeCl lowerslopeCl upper
C_2-10.1-22.42.31.180.951.413.0-5.511.60.990.971.01-1.8-5.11.41.000.991.00
T_2_5-20.6-42.10.91.380.971.783.1-11.718.01.000.971.03-1.2-8.35.91.000.991.02
ST_2_5-8.7-19.62.11.160.951.363.8-5.212.81.000.981.01-0.2-7.67.21.000.991.02
S_2_5-8.2-19.93.51.160.941.384.6-4.814.01.000.981.01-1.8-4.00.31.011.011.01
SN_2_5-11.0-22.70.81.211.001.423.6-6.513.61.000.981.02-3.1-11.85.51.011.001.03
N_2_5-7.4-19.75.01.150.921.381.6-3.87.11.000.991.011.7-3.16.51.000.991.01
IN_2_5-10.3-21.81.21.200.991.425.3-2.813.40.990.981.012.4-5.09.91.000.991.01
I_2_5-11.4-23.40.71.210.991.435.7-6.117.50.990.971.011.6-3.97.11.000.991.01
IT_2_5-18.8-32.9-4.71.341.081.600.9-10.512.21.000.981.02-2.6-8.13.01.011.001.02
T_5_7-14.9-45.615.81.290.711.874.9-8.718.60.990.961.010.9-11.313.11.000.981.02
ST_5_7-10.9-20.1-1.71.201.031.379.5-0.819.80.980.971.008.40.616.20.990.981.00
S_5_7-8.3-15.9-0.61.161.021.2918.09.526.50.970.960.9915.85.825.90.980.960.99
SN_5_7-8.4-21.54.61.180.931.424.9-6.316.10.990.971.01-0.6-7.46.11.000.991.01
N_5_7-2.3-17.813.31.070.791.367.0-11.525.50.980.951.023.4-11.318.10.990.971.02
IN_5_7-4.3-13.65.01.110.941.28-3.1-10.54.31.000.991.02-3.8-9.82.31.011.001.02
I_5_7-8.2-16.70.31.171.011.323.1-12.118.30.990.961.02-0.8-11.710.01.000.981.02
IT_5_7-12.0-29.45.51.230.901.56-5.4-26.816.11.010.971.05-13.1-35.29.01.020.981.07
T_7_9-8.0-54.738.71.140.262.0220.3-5.746.40.960.921.0113.7-13.941.40.980.931.02
ST_7_9-8.1-49.633.41.120.331.9216.8-28.362.00.980.911.0612.0-50.174.20.990.891.08
S_7_9-1.8-18.014.41.000.681.315.6-109.4120.61.010.831.1911.0-98.8120.91.000.841.16
SN_7_9-0.6-11.310.11.000.801.19-16.8-89.055.41.040.921.16-21.4-91.748.91.040.931.15
N_7_97.4-6.221.00.890.641.1310.9-33.355.10.980.901.063.5-41.047.91.000.931.07
IN_7_9-0.6-9.78.51.030.851.207.5-12.727.80.990.951.025.6-13.424.70.990.961.02
I_7_9-14.3-27.4-1.21.261.021.508.4-39.756.40.990.901.081.4-45.348.21.000.921.08
IT_7_9-8.8-26.69.01.160.831.49-13.9-60.833.01.030.941.12-23.8-78.731.01.040.951.14

Contact Lens Group Agreement

Table 40a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Contact Lens Group (n= 15)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParametermeanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**
C_2-0.41.3-2.92.1-1.72.0-5.62.3-2.11.6-5.21.0
T_2_5-0.21.7-3.63.11.51.5-1.44.51.31.0-0.63.2
ST_2_5-0.11.8-3.63.42.41.4-0.45.32.31.10.34.4
S_2_50.31.3-2.22.83.01.50.15.83.31.40.65.9
SN_2_50.21.4-2.62.92.81.40.15.63.00.91.14.8
N_2_50.41.5-2.73.41.71.3-0.94.32.10.80.63.6
IN_2_50.41.6-2.73.51.21.6-2.04.31.60.9-0.13.3
I_2_50.01.3-2.42.51.21.2-1.23.61.20.7-0.22.6
IT_2_50.01.8-3.63.61.11.6-2.14.21.11.0-0.93.1
T_5_70.12.2-4.14.4-0.12.5-5.14.90.01.4-2.72.8
ST_5_7-0.12.3-4.64.40.62.3-3.95.10.51.0-1.42.4
S_5_70.11.9-3.63.71.42.0-2.45.31.51.0-0.53.4
SN_5_70.21.8-3.43.80.82.0-3.24.81.00.9-0.92.8
N_5_71.01.7-2.34.3-0.81.9-4.52.90.11.0-1.82.1
IN_5_71.21.8-2.24.7-0.81.9-4.52.90.50.9-1.42.3
I_5_70.31.7-2.93.6-0.31.7-3.63.10.10.9-1.81.9
IT_5_70.72.6-4.35.8-0.54.4-9.28.20.23.3-6.46.8
T_7_90.13.0-5.75.81.54.3-6.910.01.63.5-5.38.5
ST_7_9-1.73.4-8.45.04.17.2-10.018.22.45.8-9.013.8
S_7_9-1.73.1-7.84.36.87.8-8.522.25.16.3-7.217.4
SN_7_9-1.32.7-6.54.03.37.5-11.518.02.06.0-9.813.9
N_7_90.42.2-4.04.70.04.2-8.38.30.43.0-5.56.3
IN_7_91.22.3-3.25.6-0.63.6-7.76.60.62.7-4.65.9
I_7_90.02.7-5.35.30.94.4-7.79.40.92.7-4.46.2
IT_7_90.53.4-6.07.1-1.011.9-24.322.4-0.411.2-22.321.5
  • LOA lower bound = mean-1.96xSD

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Table 40b. Deming Regression Analysis between Software and Manual Measurements

Contact Lens Group (n= 15)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParameterinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCl lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
C_2-2.3-12.78.21.040.831.250.4-20.421.31.000.951.046.5-10.123.10.980.951.01
T_2_55.4-3.714.60.890.711.066.2-18.430.70.990.941.04-1.4-21.318.61.010.971.04
ST_2_55.3-2.312.90.890.751.04-1.4-28.926.11.010.951.06-11.5-25.52.61.031.001.05
S_2_52.8-0.56.00.950.891.01-10.7-27.15.61.030.991.06-14.3-32.64.01.031.001.06
SN_2_53.3-0.87.40.940.861.02-6.7-21.68.31.020.991.05-6.3-15.22.51.021.001.03
N_2_55.22.97.60.910.860.95-0.4-7.97.11.000.991.02-5.7-16.65.21.010.991.03
IN_2_52.7-5.410.90.960.791.12-10.1-23.43.11.021.001.05-8.7-16.5-0.91.021.001.03
I_2_51.7-6.19.50.970.811.12-4.3-15.06.41.010.991.03-4.3-13.04.31.010.991.03
IT_2_53.8-6.313.90.930.741.123.6-5.712.80.990.981.01-4.1-18.09.71.010.981.04
T_5_76.4-10.923.80.880.541.219.0-9.727.70.980.951.02-5.9-16.24.51.010.991.03
ST_5_71.6-12.916.00.970.681.254.2-28.136.40.990.931.05-10.4-33.512.61.020.981.06
S_5_72.7-5.711.10.950.781.1110.6-23.544.70.980.921.056.2-23.936.40.990.941.04
SN_5_70.3-6.26.91.000.871.131.4-8.311.11.000.981.02-6.7-30.717.31.010.971.05
N_5_77.53.112.00.870.780.96-5.1-11.21.11.011.001.02-10.3-20.5-0.21.021.001.04
IN_5_75.6-0.811.90.920.801.04-9.3-18.3-0.31.021.001.03-7.0-23.79.71.010.981.04
I_5_7-5.7-11.50.11.111.011.224.0-9.117.20.990.971.024.1-8.416.60.990.971.02
IT_5_76.1-27.039.20.900.261.5332.5-42.0106.90.940.791.0821.4-43.986.70.960.841.08
T_7_92.3-13.117.70.960.651.26-5.6-22.010.81.010.981.04-26.6-38.2-14.91.051.031.07
ST_7_91.6-22.125.40.930.461.4013.0-42.668.60.980.891.08-12.8-51.025.41.020.961.09
S_7_9-6.3-22.910.21.100.771.43-31.8-51.7-11.91.061.031.09-36.3-80.27.51.061.001.13
SN_7_9-2.5-12.17.11.020.841.21-12.1-117.993.71.030.851.20-4.7-121.1111.61.010.831.19
N_7_96.30.212.50.880.771.0020.6-1.943.00.960.931.0020.5-11.452.40.970.921.02
IN_7_9-0.8-8.97.31.040.881.1911.2-31.553.90.980.901.0616.5-26.459.30.970.901.05
I_7_9-9.6-24.85.51.180.901.47-3.4-17.210.41.010.981.0315.75.426.00.980.960.99
IT_7_910.5-16.937.80.810.281.3469.9-86.7226.50.870.581.1659.2-128.8247.20.900.581.22

Dry Eye Group Agreement

Table 41a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Dry Eye Group (n= 18)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParametermeanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound **
C_2-0.31.0-2.31.7-2.41.1-4.5-0.3-2.70.7-4.1-1.3
T_2_5-0.21.6-3.32.81.11.8-2.44.50.80.8-0.62.3
ST_2_5-0.31.8-3.93.22.21.7-1.15.51.91.0-0.13.8
S_2_50.31.5-2.53.22.81.6-0.46.03.11.30.65.6
SN_2_5-0.11.8-3.73.42.82.1-1.47.02.71.10.64.7
N_2_5-0.11.5-3.12.81.91.5-1.14.91.70.70.33.2
IN_2_50.11.6-3.13.21.61.8-1.95.01.60.9-0.13.3
I_2_50.21.8-3.33.71.21.9-2.65.01.41.0-0.63.5
IT_2_50.11.5-2.83.00.51.4-2.33.30.60.8-1.02.2
T_5_70.72.9-5.16.5-1.44.8-10.98.0-0.74.3-9.17.6
ST_5_70.42.7-4.85.60.94.6-8.210.01.33.6-5.88.4
S_5_70.52.3-4.05.01.84.6-7.210.72.34.2-6.010.6
SN_5_70.82.2-3.65.10.02.3-4.44.50.81.5-2.23.8
N_5_70.61.8-3.04.1-0.32.0-4.23.70.31.1-1.82.4
IN_5_71.11.8-2.44.5-0.71.8-4.32.80.30.9-1.42.0
I_5_70.61.9-3.04.30.21.8-3.33.70.80.9-1.02.5
IT_5_70.92.6-4.26.0-0.52.4-5.34.20.32.1-3.74.4
T_7_9-0.24.0-8.07.61.68.2-14.517.81.47.4-13.116.0
ST_7_9-1.53.4-8.25.24.95.6-6.215.93.45.5-7.414.2
S_7_9-2.13.0-7.93.77.49.2-10.725.55.38.3-11.021.6
SN_7_9-0.62.8-6.04.95.311.1-16.527.14.710.0-15.024.4
N_7_90.53.2-5.76.70.14.9-9.69.80.64.2-7.68.8
IN_7_90.43.0-5.46.30.34.1-7.78.40.83.1-5.36.8
I_7_9-0.43.1-6.65.71.63.4-5.18.21.11.8-2.54.7
IT_7_90.43.2-5.96.71.35.6-9.612.21.74.2-6.610.0
  • LOA lower bound = mean-1.96xSD

{40}------------------------------------------------

Image /page/40/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a circular graphic that is orange at the bottom and fades to yellow at the top. The circle is not complete, with a gap at the top left.

Table 41b. Deming Regression Analysis between Software and Manual Measurements

Dry Eye Group (n= 18)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParameterinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
C_2-1.6-6.63.31.020.931.120.6-3.34.40.990.991.00-0.8-13.411.81.000.971.02
T_2_55.30.310.30.890.800.99-5.2-22.011.51.010.981.05-4.0-8.10.21.011.001.02
ST_2_5-0.2-9.79.41.000.811.18-0.2-7.87.41.000.991.020.0-4.95.01.000.991.01
S_2_5-4.1-11.02.81.080.951.222.4-7.412.31.000.981.021.2-9.111.51.000.991.02
SN_2_5-8.6-23.86.61.160.881.448.0-3.319.30.990.971.012.6-5.210.31.000.991.01
N_2_5-10.6-17.7-3.51.201.061.335.8-7.018.60.990.971.020.4-4.04.81.000.991.01
IN_2_5-2.6-11.76.51.050.881.222.0-14.017.91.000.971.03-4.6-11.62.51.011.001.02
I_2_5-3.4-8.92.01.070.961.17-5.7-17.96.41.010.991.04-4.5-10.51.41.011.001.02
IT_2_5-2.1-7.33.01.040.951.14-7.1-11.3-2.81.021.011.02-6.1-14.32.11.011.001.03
T_5_74.0-14.322.20.940.581.295.5-83.594.50.990.811.1630.1-35.895.90.950.831.06
ST_5_7-8.4-38.221.51.170.601.73-34.9-112.642.81.070.921.21-21.3-86.944.31.040.921.15
S_5_7-6.0-22.09.91.130.821.43-25.7-95.043.61.050.921.17-30.0-99.539.41.050.941.17
SN_5_70.6-14.615.81.000.721.295.0-6.016.10.990.971.01-1.7-15.812.41.000.981.03
N_5_7-1.9-13.19.31.050.841.25-2.4-20.716.01.000.971.04-7.3-21.36.81.010.991.04
IN_5_7-0.4-11.010.11.030.831.226.2-2.314.60.990.971.00-3.5-11.44.31.010.991.02
I_5_70.0-11.711.71.010.791.23-6.7-13.60.31.011.001.03-0.2-6.66.21.000.991.01
IT_5_7-1.0-22.220.21.030.641.43-10.8-25.84.21.020.991.051.3-9.311.91.000.981.02
T_7_9-1.5-22.619.51.030.621.43-8.8-99.381.61.020.851.1926.7-25.679.00.960.871.05
ST_7_94.8-8.217.80.880.641.1213.4-16.943.80.990.931.0433.6-9.376.40.950.891.02
S_7_9-4.4-21.312.51.050.731.3724.4-30.379.20.970.891.0610.2-29.750.10.990.941.05
SN_7_92.4-6.411.20.940.781.11-37.8-131.455.91.070.921.23-56.7-157.644.21.090.941.25
N_7_9-8.3-23.36.71.160.891.44-14.3-46.918.41.020.971.08-34.9-61.5-8.21.061.011.10
IN_7_9-7.6-27.111.91.150.781.523.2-13.119.50.990.971.02-13.2-28.72.31.021.001.05
I_7_9-7.6-25.310.11.130.811.452.4-10.415.11.000.981.02-1.3-8.66.01.000.991.02
IT_7_93.1-30.336.50.950.331.57-15.1-42.412.21.030.981.08-1.3-17.114.41.010.981.03

Post-LRS Group Agreement

Table 42a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Post-Laser Refractive Surgery Group (n= 19)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParametermeanSDLOA lower bound*LOA upper bound**meanSDLOA lower bound*LOA upper bound**meanSDLOA lower bound*LOA upper bound**
C_20.41.2-2.12.8-3.91.8-7.4-0.5-3.51.0-5.5-1.5
T_2_51.42.1-2.75.60.32.3-4.24.81.71.4-1.14.6
ST_2_51.12.2-3.35.51.82.4-2.96.52.91.6-0.16.0
S_2_51.12.0-2.85.03.12.1-0.97.24.21.90.57.9
SN_2_50.82.1-3.34.93.12.0-0.86.93.91.41.16.7
N_2_50.71.9-3.14.52.21.9-1.45.92.91.6-0.36.2
IN_2_51.01.8-2.64.61.62.0-2.45.62.61.6-0.65.8
I_2_51.31.7-2.14.71.21.8-2.44.72.51.4-0.35.3
IT_2_51.61.8-1.95.00.22.0-3.84.11.71.5-1.14.6
T_5_71.14.0-6.68.9-1.24.5-10.17.80.01.5-3.02.9
ST_5_70.43.1-5.76.51.14.1-7.19.21.52.1-2.75.7
S_5_71.33.6-5.88.41.24.2-7.09.42.52.0-1.36.4
SN_5_71.42.9-4.37.1-0.63.2-6.95.80.82.7-4.56.1
N_5_71.42.7-3.86.6-0.42.7-5.75.01.11.4-1.63.7
IN_5_71.52.5-3.36.3-0.32.9-6.05.41.21.5-1.84.2
I_5_71.02.9-4.76.71.13.8-6.48.72.11.7-1.25.5
IT_5_70.92.7-4.36.2-0.43.4-7.06.30.61.4-2.33.4
T_7_9-1.34.2-9.46.91.87.5-12.916.50.55.2-9.710.7
ST_7_9-1.04.5-9.97.93.69.5-15.122.32.67.4-11.917.1
S_7_9-0.55.1-10.49.44.213.7-22.731.13.712.6-20.928.3
SN_7_9-0.34.2-8.57.92.57.5-12.217.22.26.7-10.915.3
N_7_91.13.3-5.57.60.75.4-9.911.21.84.3-6.710.2
IN_7_90.33.7-7.07.61.05.9-10.612.61.34.6-7.610.3
I_7_9-0.23.4-6.76.42.05.4-8.512.61.93.8-5.69.3
IT_7_9-0.34.0-8.27.51.95.6-9.112.81.63.7-5.88.9
  • LOA lower bound = mean-1.96xSD

{41}------------------------------------------------

Image /page/41/Picture/0 description: The image contains the logo for Optovue. The logo consists of a stylized orange circle on the left side, with a gap in the upper left quadrant. To the right of the circle, the word "OPTOVUE" is written in gray, sans-serif font. The logo is simple and modern in design.

Table 42b. Deming Regression Analysis between Software and Manual Measurements

Post-Laser Refractive Surgery Group (n= 19)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParameterinterceptinterceptCI lowerinterceptCl upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCl lowerinterceptCl upperslopeslopeCI lowerslopeCl upper
C_2-4.5-8.1-0.91.091.021.15-10.1-17.0-3.21.021.001.03-6.8-11.1-2.51.011.001.02
T_2_5-5.6-14.83.61.120.961.29-2.9-17.111.31.010.981.041.1-7.79.91.000.981.02
ST_2_5-5.1-12.11.81.110.981.24-1.6-9.25.91.010.991.035.1-2.012.11.000.981.01
S_2_5-4.3-12.13.41.100.951.25-2.7-22.617.21.020.971.0610.30.320.30.990.971.01
SN_2_5-5.2-12.62.11.110.971.254.9-22.832.71.000.941.0513.36.320.40.980.971.00
N_2_5-4.6-14.25.01.100.921.274.8-16.526.11.000.951.0411.63.519.80.980.971.00
IN_2_5-2.1-11.37.21.050.891.2124.6-4.353.60.960.891.022.5-4.49.41.000.991.01
I_2_5-4.5-9.50.61.101.011.1911.0-36.258.20.980.881.085.6-2.013.20.990.981.01
IT_2_5-2.6-8.63.41.070.961.18-21.1-75.833.61.050.931.161.8-6.49.91.000.981.02
T_5_7-24.2-54.46.01.470.912.03-14.8-62.232.61.030.931.122.0-9.213.21.000.981.02
ST_5_7-11.6-25.92.61.220.971.48-0.4-22.722.01.000.961.040.7-8.510.01.000.991.02
S_5_7-9.3-17.1-1.41.201.071.34-30.0-67.07.01.060.991.132.9-8.113.81.000.981.02
SN_5_74.0-8.816.80.950.711.19-26.9-53.1-0.71.051.001.102.1-26.130.31.000.951.04
N_5_7-6.3-22.910.31.140.831.46-15.7-49.818.51.030.971.09-0.3-10.39.71.000.991.02
IN_5_7-1.7-12.38.91.060.861.25-8.4-68.051.21.010.911.120.8-8.510.01.000.981.02
I_5_7-14.7-32.43.01.280.961.60-17.8-43.78.01.030.981.085.8-4.316.00.990.981.01
IT_5_7-17.2-40.86.31.330.901.76-57.4-155.140.31.110.911.301.4-11.614.41.000.981.02
T_7_9-1.5-59.957.01.00-0.132.14-10.5-55.934.91.030.951.11-13.7-44.016.61.020.971.07
ST_7_9-5.1-49.038.81.080.211.95-9.6-55.736.51.020.941.10-7.5-44.729.71.020.961.08
S_7_9-32.2-86.221.81.640.522.7516.0-60.692.60.970.831.11-9.2-95.176.81.020.891.15
SN_7_91.5-14.317.40.960.651.283.4-58.265.11.000.891.11-31.4-70.07.21.050.991.11
N_7_9-10.6-26.65.41.220.921.5126.6-15.368.40.950.881.03-32.8-71.15.61.050.991.11
IN_7_91.4-15.418.30.980.671.2945.4-29.8120.60.920.781.05-14.5-32.03.01.031.001.05
I_7_910.6-4.725.80.800.521.08-31.0-74.812.91.070.981.1514.5-2.731.70.980.951.01
IT_7_913.6-17.344.50.730.141.32-49.6-116.016.91.100.971.22-6.8-23.910.21.010.991.04

Keratoconus Group Agreement

Table 43a. Limits of Agreement Analysis between Software and Manual Measurements

Difference (Software vs. Manual), Keratoconus Group (n= 16)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParametermeanSDLOAlowerbound*LOAupperbound **meanSDLOAlowerbound*LOAupperbound**meanSDLOAlowerbound*LOAupperbound**
C_2-0.41.9-4.23.4-3.41.9-7.20.5-3.82.2-8.10.6
T_2_5-0.23.9-7.97.51.33.3-5.27.81.12.6-4.06.2
ST_2_51.03.0-4.96.83.42.9-2.39.24.43.3-2.110.9
S_2_51.02.4-3.75.84.83.1-1.410.95.84.2-2.414.1
SN_2_50.72.6-4.45.74.53.1-1.610.65.24.1-2.813.1
N_2_50.82.4-3.95.63.72.9-2.09.34.53.9-3.212.2
IN_2_50.33.8-7.37.84.04.8-5.413.54.33.4-2.411.0
I_2_5-0.54.6-9.58.61.57.6-13.316.31.05.7-10.212.3
IT_2_5-0.64.3-8.97.8-1.59.7-20.417.4-2.110.5-22.618.4
T_5_70.54.4-8.19.1-2.15.8-13.59.2-1.65.8-13.09.7
ST_5_71.23.5-5.78.21.54.1-6.59.52.83.7-4.610.1
S_5_71.13.1-5.07.23.67.2-10.417.74.86.8-8.518.0
SN_5_71.33.2-4.97.61.86.5-10.914.53.25.4-7.413.8
N_5_71.32.8-4.16.7-0.85.2-11.09.40.55.3-9.810.8
IN_5_71.52.7-3.76.7-0.99.3-19.217.40.610.0-19.120.2
I_5_71.03.8-6.48.4-2.15.8-13.49.3-1.16.2-13.311.1
IT_5_70.74.9-9.010.4-6.512.2-30.517.5-5.811.6-28.516.8
T_7_90.63.6-6.57.74.914.2-22.932.65.513.7-21.432.3
ST_7_90.24.0-7.78.01.911.4-20.424.22.111.3-20.024.2
S_7_90.04.0-7.87.8-1.016.0-32.330.3-1.014.5-29.527.5
SN_7_90.94.7-8.210.02.311.0-19.323.93.29.8-16.022.3
N_7_90.84.3-7.79.2-0.16.1-12.011.80.74.5-8.19.5
IN_7_90.33.8-7.17.70.012.1-23.823.70.310.9-21.221.7
I_7_90.54.2-7.68.75.513.2-20.431.46.012.3-18.130.2
IT_7_90.84.5-8.09.62.318.8-34.639.13.116.8-29.936.1
  • LOA lower bound = mean-1.96xSD

{42}------------------------------------------------

Image /page/42/Picture/0 description: The image shows the text 'K180660' in a simple, sans-serif font. The text is presented in a clear and legible manner. The number appears to be a product or lot number.

Image /page/42/Picture/1 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in gray, sans-serif font. To the left of the word is a semi-circular shape that transitions from orange to yellow. The semi-circle is open on the left side, creating a crescent shape.

Table 43b. Deming Regression Analysis between Software and Manual Measurements

Keratoconus Group (n= 16)
Epithelial ThicknessStromal ThicknessCorneal Thickness
ParameterinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upperinterceptinterceptCI lowerinterceptCI upperslopeslopeCI lowerslopeCI upper
C_2-5.2-8.8-1.71.091.021.16-12.4-16.6-8.11.021.011.03-16.2-27.8-4.71.031.001.05
T_2_5-8.7-26.28.71.170.851.48-5.1-13.53.31.010.991.03-12.3-29.24.51.030.991.06
ST_2_5-5.0-15.25.11.110.941.28-3.2-10.74.41.010.991.03-8.5-25.18.21.020.991.06
S_2_5-0.5-12.911.91.030.791.261.5-5.88.91.000.991.02-6.4-33.620.91.020.971.07
SN_2_5-5.8-27.315.61.120.741.492.0-4.18.11.000.991.01-0.4-36.835.91.010.951.07
N_2_5-4.2-19.210.81.090.831.354.1-3.712.01.000.981.01-2.4-43.739.01.010.941.09
IN_2_5-3.3-10.13.51.060.931.20-0.9-8.97.21.010.991.0215.1-14.444.60.980.921.03
I_2_51.1-36.138.20.970.261.69-0.9-8.16.31.000.991.028.1-27.143.30.990.921.05
IT_2_5-0.3-27.627.01.000.451.54-2.9-10.54.71.010.991.02-32.2-96.432.01.060.941.18
T_5_7-7.1-35.621.31.140.611.68-0.7-22.120.81.000.961.04-21.0-62.720.61.040.961.11
ST_5_7-17.8-43.07.41.360.881.83-4.7-19.09.61.010.981.04-3.1-27.721.61.010.971.05
S_5_7-8.1-50.234.01.170.391.96-20.8-45.53.81.041.001.08-28.5-74.417.41.050.981.13
SN_5_70.8-92.994.51.01-0.692.71-11.2-28.96.41.020.991.05-26.3-62.810.31.050.991.11
N_5_70.4-20.521.21.020.651.39-5.3-23.713.01.010.981.04-15.9-58.727.01.030.961.10
IN_5_74.5-8.017.10.950.731.16-0.4-16.215.41.000.971.03-8.9-80.462.51.020.901.13
I_5_7-7.4-28.113.31.150.791.5111.4-15.137.80.980.931.03-14.0-36.78.71.020.991.06
IT_5_73.7-37.044.30.940.191.706.5-14.427.40.990.941.03-57.1-152.338.01.100.931.26
T_7_95.0-14.023.90.920.571.27-19.8-69.730.11.040.951.134.7-61.871.31.000.891.11
ST_7_95.0-34.244.20.910.131.68-22.5-63.718.81.040.971.124.7-54.563.81.000.901.09
S_7_9-56.6-115.72.52.130.943.32-47.3-113.118.61.080.971.1935.2-42.6113.00.940.821.07
SN_7_913.0-72.398.30.77-0.802.35-5.1-61.451.11.010.921.1015.9-48.480.20.980.881.08
N_7_920.82.539.20.640.320.96-31.6-78.215.01.060.981.1325.8-4.656.20.960.911.01
IN_7_98.3-30.346.90.860.181.53-21.6-38.3-4.91.041.011.0752.4-21.7126.60.920.791.04
I_7_9-1.8-18.414.81.040.761.3210.8-13.134.80.980.941.03-35.6-88.617.31.070.981.16
IT_7_9-3.9-32.624.71.090.581.59-11.8-44.020.31.020.971.08-50.2-102.92.61.091.001.18

Conclusion

The modified Avanti device and its RTVue XR Avanti and RTVue CAM predicate devices are identical in design and intended use. The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices.

§ 886.1570 Ophthalmoscope.

(a)
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.(b)
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.