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Appendix

2660021169012 Rev. A 2017-12

CIRRUS HD-OCT User Manual

C-10

The data was taken on a total of 26 eyes for the Wide Angle to Angle scan and 27 eyes for
the HD Angle scan measured by three operators on three CIRRUS 5000 devices and by a
single operator on the Visante OCT. The first qualified CIRRUS scan from any of the three
CIRRUS 5000 devices was used for comparison with the first qualified Visante scan.

Table 7 shows the results of the repeatability and reproducibility analyses for CIRRUS
CIRRUS 5000. Table 8 shows the mean difference between CIRRUS 5000 and Visante OCT.
Negative differences mean that the measurement on CIRRUS is smaller than the Visante
OCT.

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Summary of Contents for CIRRUS HD-OCT 500

Page 1: ...2660021156446 B2660021156446 B CIRRUS HD OCT User Manual Models 500 5000 ...

Page 2: ...nited States and or other countries Windows Windows Media Windows Server and Microsoft are either registered trademarks or trademarks of Microsoft Corporation in the United States and or other countries Mac OS iMac iPad and QuickTime are either registered trademarks or trademarks of Apple Inc in the United States and or other countries All other trademarks used in this document are the property of...

Page 3: ...S Compliance 1 12 2 Introduction Intended Use 2 1 Indications for Use 2 1 Usage 2 1 Intended Operator Profile 2 2 Demographic 2 2 Occupational Skills 2 2 Job Requirements 2 2 Data Analyst Profile 2 3 Demographic 2 3 Occupational Skills 2 3 Job requirements 2 3 Subject Profile 2 3 Installation and Setup 2 3 User Documentation 2 4 Accessing PDF Versions 2 4 Organization 2 4 Instruction Conventions 2...

Page 4: ...gory Registration 4 4 Edit Categories 4 5 Delete Categories 4 5 Archive Setup and Selection 4 6 Set up a CIRRUS HD OCT Archive 4 6 Change The Current Archive 4 8 Set Preferences 4 8 Archive Synchronize 4 8 Archive Alerts 4 8 Normative Data Settings 4 9 DICOM Archive 4 9 Display Options 4 10 IPv4 IPv6 4 11 Preventive Maintenance Service Notifier 4 11 User Login Logout 4 12 User Login 4 12 User Logo...

Page 5: ...levation 5 11 Precautions 5 11 Patient Instructions 5 12 Of Special Note for Anterior Scans 5 12 6 Acquiring Scans Overview of Scan Types 6 1 Posterior Segment Scans 6 2 CIRRUS OCT Angiography 6 2 Angiography Scan 6 2 Montage Angio Scan 6 2 ONH Angiography Scan 6 2 Macula 6 3 Macular Cube 200x200 6 3 Macular Cube 512x128 6 3 Optic Nerve 6 3 Optic Disc Cube 200x200 6 3 Integration 6 4 Macular and O...

Page 6: ...6 16 Guidelines for Pachymetry Scan Acquisition 6 17 Anterior Segment 5 Line Raster Scan 6 18 Guidelines for Anterior Segment 5 Line Raster Scan Cornea Acquisition 6 19 Acquire Screen and Controls 6 19 Acquire Screen Toolbar 6 20 Available Scans List 6 20 Scan Organizer 6 21 Iris Viewport 6 22 Scan Position Montage 6 22 6x6 mm Montage Angio Scan 6 22 8x8 mm Montage Angio Scan 6 23 Fundus Viewport ...

Page 7: ... 4 Create Scan Custom 8 4 Posterior Segment 8 6 Macular Thickness Analysis 8 6 Fovea Location 8 6 ETDRS Position 8 7 ILM RPE Layers 8 8 Slab Overlay ILM RPE Thickness Map 8 8 Additional Features 8 10 Macular Change Analysis 8 11 Manual Selection 8 12 Macular Registration 8 13 Synchronized Data Review 8 16 XML Export 8 16 Macular Thickness OU Analysis 8 16 Advanced RPE Analysis 8 17 RPE Elevation C...

Page 8: ...In HD Images Analysis 8 50 Epithelial Thickness 8 51 In Pachymetry Analysis 8 51 Central Corneal Thickness CCT Measurement 8 52 Angle Measurements 8 53 In HD Angle Analysis 8 53 In Anterior Chamber Analysis 8 54 In Wide Angle to Angle Analysis 8 55 Specialized and Integrative Visualization Tools 8 55 High Definition Images Analysis 8 55 Change the Displayed Scan Line 8 57 Image Display Options But...

Page 9: ...rfusion 9 12 Foveal Avascular Zone FAZ 9 12 AngioPlex Metrix Measurements 9 16 Overlay Options 9 17 ETDRS Options 9 18 Angiography and ONH Angiography Change Analysis 9 19 Previous Scan 9 20 Options Bar 9 21 Toggle Icon 9 21 ONH Overlay and Angio Metrix Bar 9 22 Selected Scan 9 22 AngioPlex Metrix in Change Analysis 9 22 ONH RNFL Thickness 9 23 OCT Angiography Change Manual Selection 9 23 AngioPle...

Page 10: ...port 11 9 XML Export from Analysis Screens 11 9 Values Exported Macular Thickness Analysis 11 10 Values Exported ONH and RNFL OU Analysis 11 11 Export Values Macular Change Analysis 11 12 Values Exported Guided Progression Analysis 11 13 Values Exported Ganglion Cell OU Analysis 11 14 Values Exported Advanced RPE Analysis 11 15 Advanced Export 11 16 Dat Files of ILM RNFL Thickness Maps 11 16 Txt P...

Page 11: ...nce 13 3 Measurement Units 13 3 14 Legal Notices Software Copyright 14 1 Software License Agreement 14 1 Acknowledgment 14 2 A Normative Data Results Overview A 1 RNFL and Macula Normative Databases Diversified A 1 Inclusion and Exclusion Criteria A 2 Inclusion Criteria A 2 Exclusion Criteria A 2 Data Collection A 3 Scan Selection Criteria A 3 Database Population A 3 Data Analysis A 4 Age Coeffici...

Page 12: ...RUS Ganglion Cell Analysis Normative Ranges A 21 Age A 22 Ethnicity A 22 Axial Length and Refractive Error A 23 Data Analysis A 23 Conclusion A 24 Asian Normative Database4 A 24 Overview A 24 Introduction A 24 Inclusion and Exclusion Criteria A 25 Inclusion Criteria A 25 Exclusion Criteria A 25 Data Collection A 26 Scan Selection Criteria A 26 The Asian Dataset A 27 Normative Database Analyses A 2...

Page 13: ...rs B 15 Study 5 Anterior Segment Accuracy Repeatability and Reproducibility B 19 Benchtop Scanning Accuracy Repeatability and Reproducibility B 19 CIRRUS HD OCT Repeatability in Measuring Central Corneal Thickness B 19 Performance of CIRRUS HD OCT RNFL Analysis B 20 Study 6 CIRRUS OCT Angiography B 22 References B 22 C CIRRUS HD OCT Repeatability and Reproducibility of Anterior Scan Measurements S...

Page 14: ...ability and reproducibility of Wide Angle to Angle and HD Angle scan measurements in subjects with glaucoma including repeatability reproducibility and comparison to Visante C 9 Purpose C 9 Data Collection C 9 Inclusion Criteria C 9 Exclusion Criteria C 9 Data Analysis C 9 ...

Page 15: ... and cautions are found throughout the instructions for use Symbols and Labels Warning Caution Note Must Follow Instructions for Use Stand by Fuse Direct Current Type B applied parts Manufacturer Authorized European Community Representative Serial number Catalog number part number Model number Conforms to applicable European Directive s CE Mark with identification number of DQS accredited Notified...

Page 16: ...er storage devices etc the complete system must comply with the system requirements in standard IEC 60601 1 This standard requires the usage of an Isolation Transformer to power the non medical peripheral device s if located within 1 5 m from the patient If the peripheral device is located outside the patient environment beyond 1 5 m and is connected to the instrument a separation device must be u...

Page 17: ...ilation could potentially lead to heat build up which could cause component failure and or fire CAUTION Users are not authorized to dismantle except to remove the rear cover or modify the CIRRUS HD OCT hardware To transport the instrument outside the office you must consult with a Zeiss service technician CAUTION Avoid tipping Do not use the instrument on an uneven or sloped surface Also do not ro...

Page 18: ...ent using a visible light source during the previous 24 hours This will apply particularly if the eye has been exposed to retinal photography This medical device has no user adjustable intensity settings for light incident on the retina nor does it produce UV radiation or short wavelength blue light CAUTION The appliance coupler is the main disconnect device of the instrument Position the instrume...

Page 19: ...he complete system to ensure compliance to the applicable IEC 60601 1 requirements CAUTION The instrument operator must not attempt to touch the patient and the peripheral device simultaneously WARNING This instrument may cause ignition of flammable gases or vapors Do NOT use in the presence of flammable anesthetics such as nitrous oxide or in the presence of pure oxygen WARNING The instrument its...

Page 20: ...practitioner CAUTION Do not reconfigure system components on the table nor add non system devices or components to the table nor replace original system components with substitutes not approved by Zeiss Such actions could result in failure of the table height adjustment mechanism instability of the table tipping and damage to the instrument and injury to operator and patient CAUTION Do not use the...

Page 21: ...ON In case of an emergency disconnect the appliance coupler from the back of the instrument When the power cord is connected to the instrument the green light on the power switch will start flashing When the power switch is pressed the light will change to solid green and the entire instrument will be powered Networking Safety WARNING When networking the CIRRUS HD OCT use only network cables with ...

Page 22: ...nd This cable is included in the accessory kit shipped with the instrument WARNING To directly connect a printer to the CIRRUS HD OCT using a network patch cord UTP cable only use an unshielded RJ 45 connector Use of a shielded network patch cord will ground the printer through the CIRRUS HD OCT which could result in electrical shock to the patient and or examiner It could also invalidate the syst...

Page 23: ...ks including viruses and worms that could disable your system or adversely affect its performance Internet connectivity enables third party software software drivers and updates to be downloaded to your system either automatically or intentionally Installation of any unapproved software including drivers could degrade the performance of the instrument and or lead to corrupted diagnostic or therape...

Page 24: ...rding networking of the CIRRUS HD OCT instrument Refer to the CIRRUS OCT Installation Guide for all additional information on network connectivity Electromagnetic Compatibility EMC WARNING The use of accessories transducers and cables other than those specified may result in increased emissions or decreased immunity of the equipment WARNING The CIRRUS HD OCT should not be used adjacent to or stack...

Page 25: ...c Discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be t...

Page 26: ...fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Note 1 At 80 MHz and 800 MHz the higher frequency applies Note 2 These guidelines may not apply in all situations Electr...

Page 27: ...atabase of normal subjects The CIRRUS Asian Normative Database is a quantitative tool for the comparison of these measurements to a database of normal subjects of Asian descent The CIRRUS HD OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including but not limited to macular holes cystoid macular edema diabetic retinopathy age related macula...

Page 28: ...Photographer Non certified Assistant Occupational Skills Must possess all of the following skills Computer literate Basic knowledge of the eye Ability to work with elderly patients and those with disabilities Job Requirements Must be able to perform all of the following operations Power on the unit and log on Enter find and modify patient identifying data Clean surfaces that contact patient Positi...

Page 29: ... to perform the following requirements Training and certification as required by governing bodies to interpret the analysis in the treatment of ophthalmic diseases or other eye related medical issues Subject Profile CIRRUS shall be used on all adults in need of diagnostic evaluation of the eye including patients with the following disabilities or challenges Wheelchair user Very low or not measurab...

Page 30: ...ncludes the following Installation Guide User Manual this manual Release Notes User documentation has been written to train use and serve as a reference for proper installation network access operation scanning and data analysis The User Manual is delivered in PDF format but you may request a hardcopy manual at any time Training is offered by Zeiss in the use of CIRRUS Such training does not inclu...

Page 31: ...r comparison during patient assessment In addition instructions and information are provided to ensure that data is safely managed and that the system is properly maintained Instruction Conventions Click means left click except where right click is specified Chains of menu items are indicated with the use of the symbol between items For example File Exit directs you to select Exit in the File menu...

Page 32: ...User Documentation 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 2 6 ...

Page 33: ...Integrated Video monitor with chin on the Chinrest head against the Head Rest and selected eye looking into the Imaging Aperture This procedure is discussed in detail in Chapter 5 Clinical Workflow 1 Motorized Patient Alignment Unit 6 Integrated Video Monitor 11 Keyboard 2 Dual Chinrest with Automatic Right Left Sensors 7 Connectors USB network etc and labels under rear cover 12 System Power Switc...

Page 34: ...the upper right on the ID Patient screen 2 If archiving is set to occur upon shutdown see Archive Synchronize on page 4 8 the system will prompt you to archive This is true in both Native and DICOM Archive modes cáÖìêÉ PJO êÅÜáîÉ mêçãéí aá äçÖ Ó k íáîÉ êÅÜáîÉ jçÇÉ Execute the desired option to advance to the Exit Dialog 3 When you archive or close the Archive dialog see above the Exit Dialog will ...

Page 35: ...tions called Review Stations or upgrade software on your CIRRUS HD OCT instrument Licensed Applications The CIRRUS HD OCT instrument is delivered with the following basic licenses All Posterior Segment Scans Analyses except OCT Angiography Anterior segment 5 line raster Anterior Segment Cube 512x128 Access to the following options depends on the licenses purchased with the CIRRUS HD OCT instrument...

Page 36: ... the clinician will be returned to the previous Acquire Screen See Chapter 7 Scan Quality Check for a full description of Quality Check Screens Analysis Screen Following scan acquisition and acceptance data is reviewed on the Analysis Screen The exact layout of the Screen is determined by the Analysis type selected See Chapter 8 Analysis for a complete discussion of Analysis Screen cáÖìêÉ PJQ foor...

Page 37: ...ain to the way in which the screen is used An overview of these items are shown here however additional options may become available during scan acquisition and analysis and are described in the relevant chapters elsewhere The CIRRUS Toolbar appears above all of the 4 main CIRRUS screens shown in Figure 3 4 Access to information shown on the current screen as well as a set of menus Records Edit To...

Page 38: ...atient records through the DICOM server ID Patient mode Search Worklist Patients Opens the Modality Worklist dialog allowing you to set parameters for patient search through the DICOM server ID Patient mode Import Exams Opens the Import Options dialog to import a CIRRUS export database or to select specific patients to import ID Patient mode Export Exams Opens the Export Options dialog where you c...

Page 39: ...e current patient to view and or edit the record ID Patient mode with a patient selected Merge Two Patients Opens the Patient Merge dialog where you can select two patient records to merge ID Patient mode Delete Patient Generates a confirmation prompt asking user if they wish to delete the selected or opened patient record from the database ID Patient mode with a patient selected Move Scan Opens t...

Page 40: ...certain events and identifies them by date time and User ID See Log Files on page 11 17 Admin mode Change My Password Enables you to change the password for the current user Always except for admin user Options Enables access to the following options Always Categories Enables you to create edit or delete categories which you can apply to patient records and search with ID Patient mode Institution ...

Page 41: ...l instrument status is communicated by the color The colors have the following meanings Green means OK or normal The instrument is functioning normally Keyboard Mouse Shortcuts Displays a categorized listing of keyboard shortcut keys and mouse functions Always On Line Manual Opens the CIRRUS User Manual PDF Always License Registration Enables you to register a license through the License Registrat...

Page 42: ...ontinuing to the login screen Also the system prompts you to clear archived exam data Red Critically low hard disk space When hard disk space is critically low the Acquire button is disabled You must clear a sufficient amount of hard disk space by clearing archived exams to continue If there are insufficient archived exams to be cleared you must first archive exams and then clear them You cannot c...

Page 43: ...the DICOM features may not actually be available even though the Status Indicator is green indicating that you are connected to DICOM If this occurs check the DICOM Gateway Configuration IP address see the CIRRUS HD OCT Models 500 5000 Installation Guide and ensure that the IP address is set to 127 0 0 1 Red Networking and search errors are reported along with recommendations for resolution ...

Page 44: ...Software 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 3 12 ...

Page 45: ...d managing patient workflow is discussed in Chapter 5 Clinical Workflow Institution Setup It is not necessary but highly recommended that the person assigned as the CIRRUS Administrator set up information that uniquely identifies your institution whether office clinic or hospital To Specify your Institution name and add a logo if desired 1 From the Toolbar click Tools Options Institution Edit The ...

Page 46: ...mp Use Browse to navigate to the graphic file of your choice The selected file will appear in the Preview pane which is 150 pixels square 1 9 cm or 0 75 inches square at 200 pixels inch and will be stretched or constrained to fit it The graphic will then appear in these proportions on analysis reports though in a smaller size 5 Click Save to save your changes and exit the dialog or click Close to ...

Page 47: ...g CIRRUS HD OCT records the user name under which each scan is acquired it displays the current user next to the Logout link at upper right Register New Staff 1 From the Toolbar Toolbar Options on page 3 5 select Tools Options Users The Staff Registration dialog box will appear as shown in Figure 4 3 2 Click New The New Staff dialog box appears cáÖìêÉ QJP kÉï pí ÑÑ aá äçÖ 3 Edit the staff registra...

Page 48: ...elete medical staff records follow these steps 1 In the Staff Registration dialog select a staff record and click Delete A dialog will ask you to confirm your choice cáÖìêÉ QJQ çåÑáêã pí ÑÑ aÉäÉíáçå aá äçÖ 2 Click OK to confirm deletion or click Cancel to cancel deletion You cannot delete a staff record if there are any references to it in exam data If you try to delete it a dialog appears and so ...

Page 49: ...aces You may enter an optional description 4 Click Save The new category now will be available to place patients in it Edit Categories NOTE You cannot edit categories created at another institution 1 In the Category Registration dialog Figure 4 5 select a category and click Edit The Category Edit dialog appears See Figure 4 6 2 In the Name and Description fields edit the category as desired 3 Clic...

Page 50: ...ve from a Review Station in instrument mode Set up a CIRRUS HD OCT Archive 1 From the CIRRUS HD OCT instrument obtain the name and location of the shared folder on the Network File Server that will be used to archive your data see Chapter 4 of the CIRRUS HD OCT Installation Guide 2 Log in as a CIRRUS operator 3 From the Toolbar select Records Archive Management The Archive Registration dialog box ...

Page 51: ... part of the field 5 If you want to be able to identify this archive location via a distinct descriptor specify it in the Descriptor field up to 85 characters 6 Click Browse next to the Path field to find and select the shared archive folder on the network file server 7 Select Mark as Current if you want to begin using this archive location 8 Click Save to register the new archive The new archive ...

Page 52: ...It is possible to select one neither or both Start up and Shutdown When finished selecting your preferences click OK to save your changes and exit or click Cancel to exit without saving The options are described below Archive Alerts By default the system alerts you to the presence of unarchived exams upon shutdown and asks if you want to archive them Should you choose neither archive checkbox the ...

Page 53: ...l Asian Normative Database license the Diversified normative database is used and the Normative Data Settings tab is not shown DICOM Archive Select Records Preferences to access the Preferences dialog and then select the DICOM Archive tab In DICOM Archive Mode the available options are shown in Figure 4 12 Checked options are the defaults uncheck a checkbox to deselect an option When finished clic...

Page 54: ... This functionality enables exporting image files from the instrument or CIRRUS Review Software in a standard DICOM format for viewing on a remote station See Transferring Images in OPT IOD and OP IOD Formats on page 11 5 and FORUM DICOM or Native Environment on page 11 1 for more information With this option enabled you may choose the desired prompt option Send Without Prompt Prompt Before Sendin...

Page 55: ...s option allows you to select the desired Internet Protocol version as shown in Figure 4 15 The default is IPv4 Consult your IT professional before changing this cáÖìêÉ QJNR mêÉÑÉêÉåÅÉë fmîQ L fmîS Preventive Maintenance Service Notifier The service notifier displays the next Preventive Maintenance date during software startup from 14 days before service is due until Field Service completes the sc...

Page 56: ...aá äçÖ Select a user name from the drop down list and enter the corresponding password to access the system software Note that passwords are case sensitive No user names appear in the drop down list until user accounts are created NOTE It is strongly recommend that you create individual user accounts for each staff member who acquires or analyzes scans and that staff members routinely logout to se...

Page 57: ...em always returns to the ID Patient screen NOTE The Logout button is not available on the Acquisition or Analysis screens To logout of the application from those screens you must click Finish or ID Patient to return to the ID Patient screen Automatic Logout You can configure Windows to go into sleep hibernate or hybrid mode after a specified time has elapsed without user input and can also require...

Page 58: ...User Login Logout 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 4 14 ...

Page 59: ...e floaters away from the region of interest by asking the research subject to look up down and from side to side Minimize corneal opacities by realigning the pupil Daily Tasks Start of Day Each day that the CIRRUS HD OCT system is to be used the following steps must be followed 1 Start the CIRRUS HD OCT instrument 2 Wait for the system check to complete If the system check passes with a non critic...

Page 60: ...rrently retrieved patients This is the default screen that appears following system start and login You can identify a patient using any of the three tabs provided or you can query archived data to display a list of patients scheduled for exams see Chapter 11 Data Management The ID Patient screen has three tabs These are discussed in the sections that follow Once you identify the patient click Acq...

Page 61: ...elect Normative database of interest from the Normative Data drop down list For information on CIRRUS HD OCT normative databases see Appendix A Normative Data Results cáÖìêÉ RJO pÉäÉÅíáåÖ íÜÉ kçêã íáîÉ a í Ä ëÉ 6 Enter the Patient Refractive Error optional You may enter the refractive error in spherical equivalents Diopters for each eye on the patient demographic entry screen if desired During sca...

Page 62: ...Save button will not be enabled Find Existing Patients To search a database or DICOM archive for a patient by name or ID 1 Select the Find Existing Patient tab from the Patient screen Basic Screens on page 3 3 The ID Patient screen will appear as shown in Figure 5 4 2 Type in the patient s last name and or Patient ID in the fields in the upper portion of the screen 3 Click Search The record will a...

Page 63: ...of additional search criteria as discussed in full below Advanced Search Click Advanced Search if you want to search for patients using additional parameters besides those provided in the basic search screen For example you can search on Scan Type for a patient to bring up all the particular scan types associated with the patient using Advanced Search See Find Existing Patients on page 5 4 The Adv...

Page 64: ...ÉÅáÑáÉÇ ÅêáíÉêá Ñçê íÜÉ é íáÉåí ëÉ êÅÜK 1 Using the available fields enter or select search parameters and then click Search See Data Management on page 11 1 for information on the Obscured ID field NOTE The following parameters are disabled in Advanced Search when in DICOM Archive mode Obscured ID Gender Category Age at time of exam years Exam Protocol Use Import Date Exclude Obscured Patient Zei...

Page 65: ... to the ID Patient screen 3 After you select patients click OK The selected patients will appear in the patient list where you started 4 Select the patient of interest The Acquire and Analyze buttons at the bottom of the screen will be activated Add or Remove Categories for Existing Patient Records Categories are created by the System Administrator see System Administration on page 4 1 Once patien...

Page 66: ... aá äçÖ 4 Add the categories of interest to the patient record or Remove them 5 Click Save View Today s Patients To select patients who have either been scheduled to be scanned or have been scanned today DICOM mode only select the View Today s Patients Figure 5 8 tab cáÖìêÉ RJU sáÉï qçÇ óÛë m íáÉåíë í Ä çÑ íÜÉ fa m íáÉåí ëÅêÉÉå ...

Page 67: ...ver and has more than one visit scheduled today a study selection dialog Figure 5 9 asks the user to select the desired visit from the list cáÖìêÉ RJV m íáÉåí píìÇó pÉäÉÅíáçå Çá äçÖ Patient ID Search Conflicts When two patients one saved in DICOM Archive and one saved in a local database have the same Patient ID and Issuer of Patient ID CIRRUS considers them to be the same patient regardless of na...

Page 68: ...ize for CIRRUS HD OCT is 2 mm This can usually be achieved without dilation If dilation is performed on a subject for an exam we recommend that dilation be used on subsequent visits if quantitative comparisons will be made Dilation should not directly affect the quantitative measurements but it may affect them indirectly by allowing more variability in how the OCT beam enters the eye Although such...

Page 69: ...paration on page 5 10 on a patient the patient must wait until the prior scan has been selected and the chinrest motions are complete before placing their head in the chinrest Reducing the amount of time the patient spends in the chinrest improves patient comfort Optional Eyelid Elevation To get a scan unobstructed by the eyelids especially for vertical scans you may find it necessary to tape the ...

Page 70: ...plied instruct the research subject to blink and then open eyes wide during acquisition Of Special Note for Anterior Scans Ensure the corneal scans are centered on the corneal vertex Instruct the patient to fixate on the center of the fixation target even though it may not appear to be in focus The internal fixation target is centered For all anterior segment scans the patient sees the green fixat...

Page 71: ...o the forehead glides more easily across it during X Y movements of the chinrest The video image of the eye is clearest when the Z alignment is correct 5 Instruct the Patient to relax after capture 6 After the capture is complete instruct the subject to relax but maintain chinrest position while the technician reviews the scan 7 If necessary repeat steps 4 through 6 above until the technician is s...

Page 72: ...Patient Preparation 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 5 14 ...

Page 73: ...T Anterior Segment Scan Acquisition Anterior Chamber Scan Anterior Segment Cube Scan 512x128 HD Angle Scan HD Cornea Scan Pachymetry Scan Wide Angle to Angle Scan Anterior Segment 5 Line Raster Scan Posterior Segment Scan Acquisition CIRRUS OCT Angiography Angiography Scan 3x3 6x6 8x8 Montage Angio Scan 6x6 8x8 ONH Angiography Scan 4 5x4 5 Macula Macular Cube Scan 200x200 512x128 Macula and Optic ...

Page 74: ...mages with detailed vasculature To image vascular flow each B scan in the scan pattern is repeated several times consecutively Comparisons of contrast on consecutive B scans in the same location reveal some areas with contrast change over time and some areas with constant contrast Temporal contrast change in a specific location is thought to be due to erythrocyte motion and hence indicates a vesse...

Page 75: ...can The Macular Cube 512x128 is the default scan Compared to the 200x200 this scan has greater resolution in each line from left to right but the lines are spaced further apart giving less resolution from top to bottom This scan can be used to measure macular thickness corneal thickness for anterior segment scans and create a 3 D image of the data Optic Nerve The scan used for viewing the optic ne...

Page 76: ... the post processing tools available for scan analysis Chapter 8 Analysis provide tools for RNFL and Ganglion cell layer estimation which provide the earliest warnings of glaucoma and other neuro ophthalmic conditions Cube scans are the most common acquisition types and are used as the basis for the largest number of CIRRUS HD OCT analyses see Table 8 1 Depending on your requirements you can speci...

Page 77: ...een the HD 1 20x single line and multi line scanning click the Toggle Spacing button located below the fundus image The toggle button remains available until the Single Line scan pattern is moved in the acquisition window To move the scan pattern and keep the button active switch to 5 Line mode before moving the scan pattern and then switch back to Single Line mode If you move the Single Line patt...

Page 78: ...n HD image that is optimized in the region that is of interest for a particular scan To switch between EDI and standard scanning mode select the EDI checkbox below the fundus image Anterior Segment Scans Scan Preparation Instrument Imaging Process When an anterior segment scan is selected or external lens mounted The LSO illumination of the retina is turned off The internal fixation target is cent...

Page 79: ...can length is not adjustable Rotation and line spacing are adjustable for the Anterior Segment 5 Line Raster scan Rotation is adjustable for the HD Angle HD Cornea Anterior Chamber and Wide Angle to Angle scans For more information on adjusting scan patterns see Scan Pattern Adjustments on page 6 5 Aligning Scans Corrected for Beam Scanning Geometry and Corneal Refraction Anterior Chamber Wide Ang...

Page 80: ...CT automatically detects the lens adjusts lens positioning and displays the scans that require the lens in the scan list Select the scan from the scan list for the eye you want to scan Anterior Chamber Scan Chamber View This scan generates a wide field speckle reduced raster scan of the anterior chamber at a depth of 5 8 mm with higher contrast than the Anterior Segment 5 Line Raster scan It uses ...

Page 81: ...page 6 6 The Acquire screen displays the position of the Anterior Chamber scan pattern on the live iris image The OCT B scan image on the right displays the cornea and mirror image of the scan The Anterior Chamber scan requires the Anterior Chamber external lens cáÖìêÉ SJP ÅèìáêÉ ëÅêÉÉåI åíÉêáçê Ü ãÄÉê ïáíÜ çêåÉ åÇ jáêêçê fã ÖÉë çêêÉÅíäó äáÖåÉÇ Guidelines for Anterior Chamber Scan Acquisition Atta...

Page 82: ... much as possible without letting the cornea images touch the iris images The correct position of the scan is shown in Figure 6 3 Three incorrectly aligned images are shown in Figure 6 4 one with the iris touching the cornea one with the cornea too close and one with an off center image that obscures the eye lens cáÖìêÉ SJQ cêçã äÉÑí íç êáÖÜíW áêáë íçìÅÜáåÖ ÅçêåÉ I åçí ÅÉåíÉêÉÇI ÅçêåÉ íçç ÅäçëÉ An...

Page 83: ...use scroll wheel to center the scan on the corneal vertex with the anterior chamber visible in the B scan viewport to center the scan between the gray bars on either side of the B scan display as shown in Figure 6 5 If the patient s cornea is perfectly centered a strong reflection from the anterior cornea can produce bright artifacts in the HD Cornea display Figure 6 6 The scan alignment should be...

Page 84: ...and greatest detail of the iridocorneal angle Wide Angle to Angle and Anterior Chamber scans may also be used for anterior chamber angle analysis All three scans have an angle measurement tool see In HD Angle Analysis on page 8 53 The HD Angle and Wide Angle to Angle scans also have an iridocorneal IC angle tool to measure iridocorneal angle features see Angle Measurements on page 8 53 This scan a...

Page 85: ... until the iris is in clear focus and make coarse adjustments with the X Y controls to move the chinrest until the corneoscleral junction is in view Use the mouse scroll wheel to bring the angle into view on the B scan centering it in the lower quadrant of the B scan viewport and maximizing exposure of the cornea If the angle recess in the B scan appears shadowed by the sclera move the scan slight...

Page 86: ...es the Cornea external lens The HD Cornea Scan provides the data for the HD Cornea Analysis Corneal Thickness on page 8 43 The Acquire screen displays the position of the HD Cornea scan pattern on the live iris image and displays the OCT image of the scan on the right The HD Cornea scan requires the Cornea external lens cáÖìêÉ SJU ÅèìáêÉ ëÅêÉÉåI ea çêåÉ Guidelines for HD Cornea Scan Acquisition At...

Page 87: ...d speckle reduced raster scan with a depth of 2 9 mm It uses 20 B scans each composed of 1024 A scans and is 15 5mm in length when oriented horizontally The scan is adjustable from 89 to 90 degrees though rotation may reduce the field The scan simultaneously highlights both 0 and 180 degree iridocorneal angles This scan requires the Anterior Chamber external lens The Wide Angle to Angle Scan is us...

Page 88: ...ay area and the anterior of the cornea extending slightly out of the field of view as shown in Figure 6 9 NOTE A strong vertical central reflection line on the B scan indicates the scan is centered on the corneal vertex NOTE For the Wide Angle to Wide Angle scan the iris will be slightly out of focus even when correctly aligned Pachymetry This scan consists of 24 radial scan lines with a scan dept...

Page 89: ...of the fixation target even though it may not appear to be in focus Click the center of the pupil and use the X Y and Z controls to center the scan on the corneal vertex until the cornea is visible in the B scan viewports Align the images in the two B scan viewports by fine adjustment of the X Y controls using the keyboard arrow keys To center both images first center the bottom image with the key...

Page 90: ...the Iris image and has an adjustable line length of 3 6 or 9 mm an adjustable angle of 89 to 90 degree and adjustable spacing from 0 to 1 25 mm in increments of 0 025 mm It is used as the basis for HD Images Analysis High Definition Images Analysis on page 8 55 The Acquire screen displays the position of the Anterior Segment 5 Line Raster scan pattern on the live iris image The OCT B scan images o...

Page 91: ...nce a patient is in your database see Patient Records on page 5 2 for new and existing patient protocol and the patient is selected the Scan button at the bottom of the Patient Screen becomes active Pressing Scan brings up the Acquire Screen Figure 6 12 from which all operations for scanning from CIRRUS are conducted The Scan Screen for all but the Montage Angio scan consists of the 5 main portion...

Page 92: ...e is currently being scanned and to the far right are a set of menus Only Tools is of interest during acquisition A discussion of the other items in the Tool Bar can be found in Toolbar Options on page 3 5 Toolbar options specific to scan acquisition include Live Fundus Overlay Color OCT F9 allows you to switch between color and grayscale globally for all viewports Color OCT is the default Live OC...

Page 93: ...r The Scan Organizer is accessed from the Toolbar by selecting Tools Scan Organizer in ID Patient mode NOTE You cannot access the Scan Organizer from Review Software When Scan Organizer is selected the dialog shown in Figure 6 15 below appears All your licensed scans will appear in the left column If your institution only uses certain scans select the scans of interest Select the right arrow and t...

Page 94: ... by clicking the Iris Viewport as well as manual controls both on screen and via the keyboard X Y These controls will adjust the chinrest and forehead rest so that the eye is properly aligned for the OCT scan Start by using the mouse to change depth mouse wheel or move left to right Once you ve aligned the target as well as possible using the mouse controls use the manual controls are to fine tune...

Page 95: ...mouse on location s you want to use However you can click Done after 1 scan is acquired 8x8 mm Montage Angio Scan The 8x8 mm Montage workflow includes 5 scans at different positions and the fixation moves 5 times The initial scan location for this type of scan is Central C and the scan progression and fixation target automatically flows in the following sequence Superior Nasal SN Superior Temporal...

Page 96: ...ency slider is active when a saved scan image overlay is present which occurs when you are using a prior scan Prior scan will appear as a selectable link as shown in the margin If your patient has been scanned previously selecting this option will open up a small screen with a list of the patient s previous scans Once you select a previous scan the location of that scan will appear as a live link ...

Page 97: ...lignment tool that is locked in position relative to the scan pattern the alignment tool moves when you move the scan pattern and vice versa This tool is designed to be placed over the optic disc to assist in accurately repeating scan pattern placement for future scans of the same eye For macular scans placing the alignment tool over the optic disc results in the scan center being within 1 mm of t...

Page 98: ... a value to adjust the angle in the ranges of 0 to 360 degrees Values entered from 91 to 269 are automatically transposed 180 degrees to correspond with scan direction The default 0 degree position is horizontal For Length depending on the scan you can select 3 6 or 9 mm For line Spacing depending on the scan you can select between 0 00 and 1 25 mm in increments of 0 025 mm Enhanced Depth Imaging ...

Page 99: ...se for posterior scans by hovering over the fundus image the mouse cursor will turn into a and dragging the scan pattern box area to another position Hover the mouse over the fixation target icon the mouse icon will turn into and then click and drag the fixation target to change the center its location to one of 9 pre set locations Right clicking the mouse will bring up an option box that allows y...

Page 100: ... with an adjustable length from 3 mm to 9 mm and an adjustable angle from 0 to 90 degrees To Begin Scan Acquisition 1 Ensure that the Patient is fully prepared for the scan as described in Patient Good Practices on page 5 1 2 Select Acquire The screen will change to indicate the scan types available 3 Select the scan type of interest 4 Ask the patient to hold their gaze and head steady as the chin...

Page 101: ...nt A centering target overlays the video image for posterior segment scans For anterior segment scans a graphical scan pattern appears to show the alignment scan pattern position size shape and orientation see Figure 6 19 above It remains in the center of the image and illustrates the path of the scan beam 12 View the Fundus Viewport just below the Iris Viewport Figure 6 12 or Figure 6 13 dependin...

Page 102: ...scan overlay 16 ISelect Capture An on screen progress bar indicates how the data acquisition is progressing see Tracking and Repeat Scans on page 6 32 Acquisition time depends on the fixation stability of the eye If the instrument has difficulty tracking the progress bar stalls and the user will have the option to either realign the eye or to turn tracking off see Troubleshooting FastTrac on page ...

Page 103: ...dvance to the Montage Scan Quality Check screen NOTE If only 1 scan is performed the application treats and saves the scan as a single Angiography scan TIP For curved retinas peripheral scans Turn off z monitoring Do not change centering of b scan during acquisition If only 1 scan is performed the application treats and Set Up for Maximum Image Quality Iris image Center the iris image within the p...

Page 104: ...to the Acquire screen When you are finished acquiring scans click Finish in the Acquire screen You will return to the ID Patient screen Tracking and Repeat Scans Repeat Scans CIRRUS HD OCT contains automatic and manual functions to repeat scan setup and alignment during follow up patient visits Repeat scans are separated into two types Auto Repeat available if you have saved the same scan type for...

Page 105: ...sing settings from the current visit is more efficient The patient has difficulty or is unpredictable in maintaining head position In this instance the repeat scan may be very different from the current position If you do not want the chinrest and ocular lens to move from the currently aligned position when switching to another scan type you can select the Prior Scan link to use previous scan sett...

Page 106: ... the user does not wish to track to a prior scan this function can be turned off by clicking this button which will turn from green to gray 1 Follow the same alignment steps as for a non tracked scan 2 Ensure the B scans are centered Click the up and down arrows or use the mouse scroll wheel to make fine adjustments to center the scan Clicking the Optimize or Center buttons automatically adjusts t...

Page 107: ...cans on page 6 32 7 When the border around the Capture button is green the scan can be performed with FastTrac Click Capture During FastTrac acquisition after clicking Capture a screen appears that shows the scan in progress as shown in Figure 6 20 and provides controls to make adjustments to help complete the scan A tracked scan may take additional time as compared to a non tracked scan During th...

Page 108: ...atients with certain pathologies or anatomical features it may be difficult to ensure centering across all B scans in a cube Cancel the scan On the Acquire Scan screen turn off the monitoring of the Z position Then initiate a new scan with FastTrac Other factors for tracking Iris image scan may not be aimed through the pupil Adjust the scan position in the Iris Viewport Fundus image focus has drif...

Page 109: ...the example above the B scan is too high on the screen If this occurs use the up and down arrows next to the scan window or the mouse wheel to center the scan In this case Figure 6 24 because light is not passing directly through the center of the pupil the fundus image quality is reduced cáÖìêÉ SJOQ mççê cìåÇìë fã ÖÉ nì äáíó ...

Page 110: ...Tracking and Repeat Scans 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 6 38 ...

Page 111: ...opposed to live data In addition the available controls pertain only to data review The Scan Quality Check Screen for all but the Montage Angio scans appears as shown in the Figure 7 1 example cáÖìêÉ TJN nì äáíó ÜÉÅâ pÅêÉÉå Ñçê ìÄÉ pÅ åë Ej Åìä ê ìÄÉ RNOñNOUI c ëíqê ÅF The Scan Quality Check Screen for the Montage Angio scans appears as shown in Figure 7 2 Scans that are not taken are automaticall...

Page 112: ... scans Arrow Keys Enables viewing the acquired Montage Angio scans Red X Indicates that this acquired scan was unable to be montaged Gray Circular Arrow IIf you hover over the thumbnail after previously acquiring a scan it will turn gray This change indicates that it can be selected to be retaken When you click on the thumbnail the arrow will turn green indicating that the scan has been selected t...

Page 113: ... less than 6 are generally unacceptable In these cases the indicator color will be red For signal strengths of 6 or higher the signal strength is acceptable and the indicator color will be green Click the Information button for additional suggestions on how to obtain better signal strength NOTE The Scan Quality Check Screen for Anterior Segment scans does not show the Signal Strength indicator For...

Page 114: ...rallel to the front of the cube and the side of the cube respectively The X slice parallel to the front of the cube top viewport is also known as the fast B scan because this is the direction in which each line of A scans is acquired extremely quickly in milliseconds This is the direction of a horizontal line scan in first generation OCT The Y slice parallel to the side of the cube middle viewport...

Page 115: ... same from end to end Signal strength should be 6 or greater Check for Saccades and Banding FastTrac minimizes but does not completely eliminate the possibility of saccades For cube scans the operator should review the OCT Fundus image to ensure there are minimal saccades and no saccades through the area of interest macula for example A saccade can be detected by discontinuities in the appearance ...

Page 116: ...ted below the RPE If the retinal tissue is captured too low in the axial field of view of the scan then the algorithm will not produce a good result because there will not be enough sub RPE pixels to create good contrast See Figure 7 4 below for an example of a scan with the retina too low for acceptable detection of sub RPE illumination If you obtain an image like this it is advisable to retake t...

Page 117: ... Figure 7 5 shows an example of an image with poor signal quality throughout the image In these cases the B scan usually looks dark or blurry as well Because of this sensitivity CIRRUS OCT Angiography can occasionally show dark spots that are not a result of capillary dropout but rather due to poor local signal as shown in Figure 7 5A This can occur due to floaters or other media opacities One way...

Page 118: ... from light that passes through the moving blood cells and returns to be detected This creates a signal that is below the original motion but caused by the motion and therefore is always found posterior to the original signal Figure 7 6A and B are en face images showing the superficial and deeper retinal layers SRL and DRL for a normal subject The larger vessels that appear similar in the two imag...

Page 119: ...udes vasculature very similar to the overlying SRL There are two potential ways to determine whether a signal is due to decorrelation tails or due to motion in the layer observed One is the characteristic of the vasculature itself even if it is disrupted A typical normal eye demonstrates that the deeper retinal layer Figure 7 6E has a different characteristic appearance than the superficial retina...

Page 120: ...iform layer and any bright signal detected at this location is likely due to ordinary inner retinal vasculature cáÖìêÉ TJT î ëÅìä ê oÉíáå ä i óÉê Ñêçã å åÖáçÖê éÜó PñP ëÅ å ëÜçïáåÖ ÄêáÖÜí êÉ íÜ í áë åçí ëëçÅá íÉÇ ïáíÜ é íÜçäçÖáÅ ä ÑäçïK qÜÉ _JëÅ å ÄÉäçï EíÜêçìÖÜ íÜÉ äçÅ íáçå ïÜÉêÉ íÜÉ Üçêáòçåí ä ÄäìÉ äáåÉ ééÉ êëF ÇÉãçåëíê íÉë íÜ í íÜÉ ëÉÖãÉåí íáçå áë åçí ÅçêêÉÅíäó é ëëáåÖ íÜêçìÖÜ íÜÉ çìíÉê êÉíáå ä...

Page 121: ...ornea especially within the area where the measurement caliper is to be placed NOTE CCT measurements may be easier to obtain on HD Cornea or Anterior Chamber scans The following conditions may affect the ability to obtain a good corneal image for CCT measurements 1 Inability of the patient to maintain fixation including patients with poor visual acuity 2 Excessive corneal reflection resulting from...

Page 122: ...Criteria for Image Acceptance 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 7 12 ...

Page 123: ...metry Scan Pachymetry including Epithelial Thickness Maps Wide Angle to Angle Scan Wide Angle to Angle Anterior Segment 5 Line Raster Scan HD Images Posterior Segment Scan Acquisition Analysis CIRRUS OCT Angiography Angiography Scan 3x3 6x6 8x8 Montage Angio Scan 6x6 8x8 ONH Angiography Scan 4 5x4 5 See CIRRUS OCT Angiography on page 9 1 Macula Macular Cube Scan 200x200 512x128 Macular Thickness M...

Page 124: ...y right clicking on the scan image see Figure 8 1 cáÖìêÉ UJNoáÖÜíJÅäáÅâ çå åó ëÅ å áã ÖÉ íç ÄêáåÖ ìé íÜÉ ääçï ÄäÉ ãÉåì çéíáçåë Ñçê íÜ í å äóëáë íóéÉK NOTE Not all of these options are available for every analysis The menu options available are determined by the scan type Options are described in detail where relevant in the sections which follow Visualization Macular Cube Scan 200x200 512x128 or O...

Page 125: ...on page 4 9 Adjusting Slab Locations To adjust slab offset do one of the following Use the slice navigation arrows to drag the bottom boundary up or down With the mouse pointer anywhere on the screen except on the B scan use the mouse scroll wheel Enter a value in the Offset field below the image or click the up or down arrows To adjust slab thickness do one of the following Drag the top boundary ...

Page 126: ...te a Global Custom Preset 1 Following the steps for adjusting slab locations Adjusting Slab Locations on page 8 3 determine the location of the new slab preset of interest 2 Select one of the 2 Custom squares following the set of Preset Custom views If you have not created a custom view previously the square will be blank If you have previously created a custom view your previous view will contain...

Page 127: ...last custom view you create 4 Select Save and your Custom slab view will be saved for the current patient scan NOTE If you change values in any of the standard presets these values will not change when you save the analysis However if you change values while a Custom view is selected and save the analysis you will have saved new values for the Custom view and thus your previous view in that Custom...

Page 128: ...rrespond to the color coded side bar scale on the right The colors denote Macular thickness in micrometers μm cáÖìêÉ UJP j Åìä ê qÜáÅâåÉëë å äóëáë Fovea Location This feature is active in Macular Thickness Analysis Figure 8 3 Macular Change Analysis Figure 8 7 Ganglion Cell Analysis Ganglion Cell OU Analysis on page 8 22 Advanced RPE Analysis Advanced RPE Analysis on page 8 17 1 Exam date OD and O...

Page 129: ...vea In such a case the reported fovea will be wrong In both of these cases the user can set the fovea manually The most common pathologic conditions that can cause failure of the fovea finding algorithm are those that cause the greatest disturbance of the foveal architecture such as AMD and macular edema as well as epiretinal membranes and other vitreoretinal interface disorders where the vitreore...

Page 130: ...e back to their original positions over the ETDRS Grid position Now move the slice navigators to a new position as shown in Figure 8 4 The ETDRS Grid position does not change nor does the thickness grid position Select to align the ETDRS Grid position with the slice navigators Select to move the ETDRS Grid and the slice navigators back to their original location To save the new fovea position for ...

Page 131: ...the ETDRS grid appear below the grid In this figure the Fovea is located at the intersection of slice 253 and 64 The colors of the ILM RPE color bar represent the depth in micrometers ranging from 0 blue to 350 white in increments of 17 5 µm for each bar cáÖìêÉ UJR fijÓomb qÜáÅâåÉëë j é Thickness map Color bar representing depth in micrometers ...

Page 132: ...ion images may be enlarged to a full screen view The slice navigators will be set to slice 256 and 64 with the Macular Cube 512x128 or will be set to slice 100 and 100 with the Macular Cube 200x200 scan To return to the standard resolution scans re select the High Res Images button or move either the X or Y slice navigator to a different position Edit Layers button Click Edit Layers to open the Ed...

Page 133: ...ges to open them in full screen Double click a full screen image to return to normal view or click the Back button When using the Zoom or Brightness Contrast feature on the ONH and RNFL OU or RNFL Thickness analysis screens do not click and drag the mouse inside the circle on the Fundus image This will cause the circle to move to a different location on the image Macular Change Analysis Selecting ...

Page 134: ... screen select the scan date and the scan you wish to use as the more current scan the scan information that appears on the right side of the screen 2 Select Macular Change Analysis Manual Selection from the far right column 3 A list of eligible scans will appear in a dialog box see Figure 8 8 4 Click the scan you wish to include in the analysis A green checkmark will appear next to the selected s...

Page 135: ...ge due to the patient s eye being rotated from one session to another is also accounted for in the registration Areas of the current image that do not overlap with the prior image are not included in the final registered image This causes the thickness map and the Fundus image on the right to display a black border around the outside edge s of each view The size of the border depends on how much t...

Page 136: ...to the original registration click Cancel NOTE If you or another user have changed the fovea location for any exam while carrying out Macula Thickness Analysis and the result has been saved then that will be the fovea location will be loaded No Registration When No Registration is applied the initial location of the ETDRS grid center for both scans is taken from the value for the previous scan The...

Page 137: ... does not correspond to the first image when the two images were registered to each other Registration Successful The Registration Succeeded message along with the green flag indicate that the two chosen images did register reliably A red flag appears if the registration fails This could be caused by weak signal strength poor alignment opacities large differences in the scan areas or larger differ...

Page 138: ...urrent thickness minus prior thickness in micrometers at each pixel location The difference map has a different color scale to represent the thickness change This color map is indicated to the right Warmer colors indicate an increase in the thickness cooler colors indicate a decrease in thickness The transparency slider beneath each overlay can be adjusted as required to enhance the image XML Expo...

Page 139: ...ss Analysis allowing analysis of disturbances in the RPE Identification and measurement of elevations in the RPE and areas of sub RPE illumination may be helpful in managing age related macular degeneration including advanced forms where atrophy of the RPE is present Two separate screens are available screen 1 RPE elevation and the sub RPE illumination results shown separately as en face images Fi...

Page 140: ...evations The RPE elevation measurements can be affected by the presence size or extent of geographic atrophy choroidal neovascularization extensive epiretinal membrane vitreomacular traction cáÖìêÉ UJNO Çî åÅÉÇ omb å äóëáë Ó pÅêÉÉå N 1 2 3 4 5 6 7 8 1 RPE Elevation Map overlaid on Fundus image 2 Circles on the RPE Elevation Map centered on the fovea location 3 Transparency adjustment for RPE Eleva...

Page 141: ... Values below this threshold are not included in the area and volume calculations In some cases drusen may be observed in color Fundus photographs that are not seen in the Advanced RPE Analysis because either the drusen does not represent any elevation or because the drusen is accompanied by an elevation that does not meet the minimum threshold for detection Only small shallow drusen are likely to...

Page 142: ...ìÄÓomb pÉÖãÉåí íáçå aá äçÖ 2 Use one of the available edit tools shown clockwise at left to modify the segmentation boundaries Pencil Click and drag to draw with fine detail Floodfill Adds gross detail To fill in a full lesion draw the boundary of the lesion with the pencil tool or the floodfill tool click the floodfill icon and then click the lesion to fill it in Eraser Removes gross detail To re...

Page 143: ...since the previous scan The volume of RPE elevations as well as the area and distance of the sub RPE illumination around and from the Fovea respectively are shown If no sub RPE illumination is seen in the circle the value shown is 0 0 A warning message will appear if the 5 mm circle extends outside of the scan window or if the scan is too low in the B scan window Advanced RPE Analysis may occasion...

Page 144: ...icate thinner than all but 5 of normals while a thickness table shows average and minimum thickness within the elliptical annulus Sectors in the lower portion of the screen divide the elliptical annulus of the Thickness Map into 6 regions 3 equally sized sectors in the superior region and 3 equally sized sectors in the inferior region The slice navigator in the Vertical B scan is used to adjust to...

Page 145: ...e fovea location and evaluate if the location is correct cáÖìêÉ UJNS çãé êÉ ÅÉåíÉêÉÇ ÑçîÉ EäÉÑíF ïáíÜ å ìåÅÉåíÉêÉÇ îáÉï E í êáÖÜíFK qÜÉ ÅÉåíÉêÉÇ ÑçîÉ ëÜçïë ÅäÉ ê éáåéçáåí í íÜÉ ÅÉåíÉêK ë ëççå ë íÜÉ ÑçîÉ áë åç äçåÖÉê ÅÉåíÉêÉÇI íÜÉ ÅÉåíÉê ÄÉÖáåë íç Éñé åÇ åÇ ÉäçåÖ íÉK cáÖìêÉ UJNT fÑ íÜÉ ÑçîÉ áë åçí ÅÉåíÉêÉÇI íÜÉ î äìÉë Ñçê íÜÉ ãáåáãìã íÜáÅâåÉëë ïáää ÄÉÖáå íç ÅÜ åÖÉK lÄëÉêîÉ áå íÜÉ ÑáÖìêÉ ÄçîÉI íÜ í ...

Page 146: ...ided Progression Analysis on page 8 38 do not use thickness maps or cubes with clear segmentation errors or where the fovea is far from the center of the selected Cube scan NOTE The GCA algorithm was tested on patients with glaucoma but not other ocular conditions The performance of this algorithm on patients with glaucoma and concomitant retinal disease or retinal disease by itself involving the ...

Page 147: ...slabs from which you can quickly select The depths of each preset slab has been chosen to represent posterior layers of interest as shown in Table 8 2 Additionally you may create your own custom preset by specifying a region of interest that once created is available for analysis across all patients This option is described further in Create Global Custom on page 8 4 1 Show Hide Fundus Image 2 Fun...

Page 148: ... Zone It follows the RPE contour and is elevated slightly to put it at the level of the IS OS Ellipsoid Zone Disturbances to the IS OS Ellipsoid Zone show as dark areas Upper 44 μm above the RPE layer Lower 22 μm above the RPE layer Choroid Highlights Choroidal vasculature It is placed below the RPE Fit at the general level of Haller s Layer deep in the choroid Since choroid thickness can vary fro...

Page 149: ...shown in the En Face Report indicates the ILM and RPE through the use of white dashed lines For this preset it is not possible to move the magenta segmentation lines above or below the bounding lines of the retina Figure 1 Mid retina slab showing upper and lower bounds delineated by the white dashed lines ...

Page 150: ...kness RNFL Symmetry five optic disc parameters 11 Left and right eye neuro retinal rim thickness 3 Toggles ONH slice indicator 12 Transparency slider 4 RNFL thickness map with optic disc and cup masks 13 Move purple circle to select a different center 5 B scan extracted from RNFL Calculation Circle 14 4 mm B scan extracted from ONH radial spoke 6 Average RNFL thickness along Calculation Circle for...

Page 151: ...w and red normal distribution percentiles The green color of the normative data is not applied because most super pixels would be green for normal patients and the green color might obscure the anatomical detail in the underlying OCT fundus image Any region that is not red or yellow falls within or above normal limits A region that is yellow is thinner than all but 5 of normals A region that is re...

Page 152: ...enter based on the age matched normative samples Therefore when you change the position of the Calculation Circle you change the specific super pixel in the normative data against which each super pixel in the exam data is compared NOTE When the temporal RNFL is very thin or entirely absent the RNFL algorithm may show an artificial thickening of the RNFL in this area If the temporal RNFL appears t...

Page 153: ...H Normative Databases For completeness please refer to RNFL and ONH Normative Databases on page A 15 for an explanation of the application of the RNFL Normative Database to these elements Advanced Export Click on the Advanced Export button on the ONH AND RNFL OU ANALYSIS screen to export and store ILM RNFL thickness maps as DAT files and txt files of Neuro retinal Rim Thickness and RNFL Thickness ...

Page 154: ...changes in several clinical factors including optic nerve head appearance and visual fields GPA only refers to change in the Nerve Fiber Layer or GCL IPL thickness assessed by statistical analysis of certain CIRRUS parameters Such changes in thickness may or may not be related to clinically relevant changes GPA is not meant to diagnose Diagnosis is the responsibility of the practitioner who should...

Page 155: ...ars are loaded If there are fewer than 4 scans loaded or if there is less than two years between the first baseline and the current scan no rate of change analysis will be provided NOTE Linear regression fits the data to a linear model assuming that the measurements are independent and normally distributed and that variability does not depend on the size of the measurement If the observed measurem...

Page 156: ...er and circle are used for all other scans There are three curves two for the current baseline exams shown in gray labeled B1 and B2 and one for the most recent examination shown in blue labeled C for current The profile analysis identifies moderate focal thinning in the RNFL thickness by comparing observed change in the RNFL Thickness Profiles to test retest variability and then looking for insta...

Page 157: ...lculating a trend over time cáÖìêÉ UJOO îÉê ÖÉ okci qÜáÅâåÉëë åÇ lke ìéÓíçÓaáëÅ o íáç dê éÜë For RNFL GPA four graphs can be seen as shown in Figure 8 22 1 A graph of the overall average thickness trend from the CIRRUS RNFL Calculation Circle for each exam 2 A graph of Average Cup to Disc Ratio Note that Possible Loss orange color coding and Likely Loss red color coding are associated with a posit...

Page 158: ...ession The summary box reports progressive change as one of Possible Loss yellow Likely Loss red or Possible Increase lavender Possible Loss means progressive loss has been detected once Likely Loss means it has been confirmed by consecutive follow up examinations Shown below are examples of summary box displays The yellow checkmarks in the RNFL Thickness Map Progression and RNFL Thickness Profile...

Page 159: ...ou may access this page by selecting the ONH toggle button The GPA summary box also includes a colored checkmark whenever Possible Loss Likely Loss or Possible Increase has been detected using the Average Cup to Disc Ratio Note that ACDR increases as the thickness of RNFL decreases Therefore Possible Loss of RNFL is indicated by an increase in ACDR and thus Possible Loss is checked when an there i...

Page 160: ...áçå å äóëáë 1 2 3 6 5 7 4 1 Ganglion Cell Guided Progression Analysis is selectable for any Macular Cube scan 2 Thickness Map Color Legend 3 Progressive Ganglion Cell Change shown as Thickness Maps 4 Previous two normal GC thickness maps 5 Ganglion Cell thickness change shown quantitatively 6 Overall avg Rate of Change of Ganglion Cell layer 7 GCL IPL Summary ...

Page 161: ... determined by averaging the top 3 sectors in Figure 8 15 91 6 3 The graph of the Total Inferior Thickness is determined by averaging the bottom 3 sectors in Figure 8 15 67 3 NOTE Do not use GCL Guided Progression Analysis with thickness maps or cubes with clear segmentation errors or where the fovea is far from the center of the scan If the annulus is simply off center return to the Ganglion Cell...

Page 162: ...een confirmed by consecutive follow up examinations Shown below is an example of a summary box display The yellow checkmark by GCL IPL Thickness Map Progression indicates Possible Loss while the red checkmark by the GCL IPL Thickness progression indicates Likely Loss Were any improvement indicated a lavender checkmark would appear beside one of the two progression options Ganglion Cell Guided Prog...

Page 163: ...ng the Chamber Area Measurement and the Value in mm2 is displayed to the right of the iris image A small image of the mirrored corneal image that is not processed is also displayed A mirror artifact indicating an area of data that is poorly resolved and inverted in the axial direction is often detectable While it is possible to hide the mirror artifact in most parts of the image it will invariably...

Page 164: ...seudophakia drag the base line to the pupillary plane The measurements will appear on the OCT image and a summary of the measurements will appear in a table above the OCT image Figure 8 27 below shows the ACD Tool placed correctly at the angles and the anterior surface of the lens cáÖìêÉ UJOT åíÉêáçê ÅÜ ãÄÉê å äóëáë ëÅêÉÉå ïáíÜ íÜÉ a íççä ÅçêêÉÅíäó éä ÅÉÇ íç ãÉ ëìêÉ äÉåë î ìäí åÇ åÖäÉÓíçÓ åÖäÉ Çáë...

Page 165: ...onality Right click the tool once it is placed on the image and the Caliper Size Entry popup will appear as shown to the left and in Figure 8 28 Using these added functions you can type in a specific length of interest and or lock the length of the caliper Corneal Thickness Performance studies see Tables 1 2 4 and 5 in Appendix C CIRRUS HD OCT Repeatability and Reproducibility of Anterior Scan Mea...

Page 166: ... foorp eaJl q m ÅÜóãÉíêó å äóëáë ëÅêÉÉå View Dropdown Located in the upper left quadrant of the Pachymetry Analysis Screen is a dropdown menu labeled View The view screen options shown to the left may be selected from the dropdown menu Pachymetry Map is the default The additional options are described below View and Mark Corneal Thickness Locations Move the mouse over any point on the Pachymetry m...

Page 167: ...r corresponding to 5 mm and the outer ring corresponding to a diameter of 7 mm The zone grid is centered on the corneal vertex The X shows the location of the vertex The white dot on each map in Figure 8 29 shows the location of minimum corneal thickness This value is also reported in the data table The values S I are calculated by subtracting the average value in the I sector at the specified dis...

Page 168: ...v A 2017 12 CIRRUS HD OCT User Manual 8 46 cáÖìêÉ UJPM qÜÉ béáíÜÉäá ä qÜáÅâåÉëë j éë êÉ ÅÅÉëëÉÇ Ñêçã íÜÉ m ÅÜóãÉíêó å äóëáë ëÅêÉÉå Äó ëÉäÉÅíáåÖ áí Ñêçã íÜÉ sáÉï ÇêçéÇçïå äáëí áå íÜÉ ìééÉê äÉÑí èì Çê åí çÑ íÜÉ ëÅêÉÉå EPF áå Figure 8 29K ...

Page 169: ...lysis screen to change the screen so that both the Pachymetry thickness maps and the Epithelial thickness maps are shown as shown in Figure 8 31 cáÖìêÉ UJPN pÉäÉÅíáåÖ ää j éë Ñêçã íÜÉ sáÉï ÇêçéÇçïå äáëí áå íÜÉ ìééÉê äÉÑí èì Çê åí çÑ íÜÉ ëÅêÉÉå ïáää ÅÜ åÖÉ íÜÉ Çáëéä ó íç ëÜçï ÄçíÜ íÜÉ m ÅÜóãÉíêó j éë EqçéF åÇ íÜÉ béáíÜÉäá ä qÜáÅâåÉëë j éë E_çííçãFK ...

Page 170: ...t in the upper right quadrant of the Pachymetry Analysis screen 1 in Figure 8 29 The anterior surface of the cornea is highlighted with a green line and the posterior surface of the cornea is highlighted with a red line Figure 8 32 Bowman s Layer is highlighted with a yellow line To view a thumbnail in full screen double click on the thumbnail image Double click again to return to the thumbnail vi...

Page 171: ...n the Anterior Chamber Analysis Viewport Figure 8 25 The measurements will appear on the OCT image and a summary of the measurements will appear in a table above the OCT image See Using Anterior Chamber Analysis on page 8 42 for a complete description of the use of the ACD and Add Angle tool In Anterior Segment Cube Analysis The Anterior Segment Analysis screen Figure 8 34 for the Anterior Segment...

Page 172: ...åíÉêáçê pÉÖãÉåí å äóëáë Ó çêåÉ qÜáÅâåÉëë In HD Images Analysis When you select an Anterior Segment 5 Line Raster scan from the Analysis screen scan list the High Definition Images analysis for that scan is automatically displayed cáÖìêÉ UJPR eáÖÜ aÉÑáåáíáçå fã ÖÉë å äóëáë Ó çêåÉ qÜáÅâåÉëë ...

Page 173: ... and select Epithelial Thickness Maps cáÖìêÉ UJPS qÜÉ m ÅÜóãÉíêó å äóëáë ëÅêÉÉå ëÜçïë íÜÉ béáíÜÉäá ä qÜáÅâåÉëë j éë ïÜÉå íÜ í çéíáçå áë ëÉäÉÅíÉÇ Ñêçã íÜÉ sáÉï ÇêçéÇçïå äáëí Epithelial Thickness Data Tables As with the Pachymetry maps the data tables displayed below the Epithelial maps contain thickness measurements for the zones shown on the thickness maps Minimum average and maximum thickness mea...

Page 174: ... the Caliper button and align the Caliper vertically against the magenta slice navigator on the horizontal scan 3 The center of the cornea can be identified by moving the scan navigators throughout the entire scan volume and noting how the scans appear to move up and down within the box The apical area being closest to the instrument lens will have the highest scans By using the Caliper as a refer...

Page 175: ...ue only based on the refractive index of the cornea It is not calibrated for other tissue types NOTE The Anterior Scan Cube 512x128 is initially be displayed in the High definition mode Click the Show hide high resolution images button to allow scrolling through the cube images or move a slice navigator to a different slice NOTE For the Anterior Segment 5 Line Raster scan only the ruler and revers...

Page 176: ... corneal endothelium 4 Adjust point F AOD 750 Iris Endpoint to touch the iris 5 Adjust point D AOD 500 Iris Endpoint to touch the iris 6 Adjust point B Scleral Spur Iris Endpoint to touch the iris In Anterior Chamber Analysis 1 Select Add Left Angle Tool or Add Right Angle Tool above the main viewport of the Anterior Chamber Analysis screen 2 Place point A of the Angle Tool at the scleral spur 3 A...

Page 177: ... Analysis In addition to providing a wide view image of the anterior chamber angle tools and calipers are provided with the Wide Angle to Angle Analysis to allow angle measurement as shown in Figure 8 28 Specialized and Integrative Visualization Tools High Definition Images Analysis For all raster scans High Definition Images is the only available analysis When you select a high definition raster ...

Page 178: ...on the screen NOTE The enhancement process combines data from multiple line scans Registration of these line scans may result in reduced data at the edges of the images which may show up as a thin darker region with a sharp edge This is a natural result of the enhancement process but should only occur at the extreme edges of the image NOTE By default all raster line scans are displayed in grayscal...

Page 179: ...he fundus image NOTE For HD 5 Line scans all thumbnails are visible on the screen Image Display Options Buttons The following display options buttons can be found above scan image on The High Definition Analysis screen Right click the image to bring up additional menu options Image Tool Use to Do this Display either the previous image used to track the current image left arrow or the current image...

Page 180: ...oss Hair scans in the same window Reset fovea location which will update the data table and the ETDRS grid thickness measurements Reset peripapillary RNFL circle location which updates the RNFL and ONH analysis Turn on and off the segmentation lines Turn on and off the disc and cup boundaries and fovea indicator 1 Show hide fundus lines icon 2 Macular Thickness Map 3 OCT fundus image 4 ETDRS grid ...

Page 181: ...le ONH RNFL thickness map from either an optic disc cube or macular cube scan GC IP layer thickness map from a selected macular cube scan ILM RPE layer thickness map from a selected macular cube scan The default PanoMap view shows both an RNFL deviation map as well as a deviation map with GC IP layer thickness The RNFL deviation map includes the RNFL extraction circle 1 Information about the macul...

Page 182: ...pond with normative data Sector map for GC IP layer thicknesses colored to correspond with normative data Table summary of parameters for Ganglion Cell Inner Plexiform Layer average thickness and minimum thickness colored to correspond with normative data Table summary of parameters for ONH and RNFL average thickness Superior RNFL Thickness and Inferior RNFL Thickness values colored to correspond ...

Page 183: ...arker pixels and low transparency for brighter pixels These settings enables the user to see through darker tissue The slider reduces or increases the transparency for all pixels by the same percentage For example setting the slider at 50 sets all pixels to 50 of their original value When Use Same Transparency for all Pixels is checked all pixels will share the same transparency value regardless o...

Page 184: ...og below cáÖìêÉ UJQQ pÜçï pÉííáåÖë aá äçÖ Use the checkboxes to show and hide surfaces and the volumes between or below surfaces You can show or hide the cube boundary lines and show or hide the view from the top or bottom of the box The default settings are shown in the figure above Clip Selector Clip Selector allows you to select the whole cube or one of the four niches of the cube Once you sele...

Page 185: ...n the View Settings dialog Light Direction Adjust To adjust the light direction grab the red and green spheres with the mouse and move the mouse left to right The arrow icon indicates the light source direction Greyscale Mode Use this button to toggle between color and grayscale Animation There are three options for creating animations Animation Editor Movie Recording and AutoRecord Keyframes Thes...

Page 186: ... make changes to the animation start over from the first step 5 To save your recorded animation click Save or Save as Movie Save saves the animation in a CIRRUS specific format which can only be viewed using a CIRRUS HD OCT Instrument or CIRRUS Review Software Save as Movie saves the animation in a format that can be viewed with standard movie players such as Windows Media Player or QuickTime Play...

Page 187: ...w that recording is in progress 2 Perform activities rotating moving slicing A message appears on the screen that shows the feature is auto recording 3 Click Stop AutoRecord to finish recording the animation Two buttons become active Clear Auto Recording and PlayEdit AutoRecording To play back edit and save 1 Click Play Edit AutoRecording to play back or edit what you recorded The Auto Generated A...

Page 188: ... Use the slider to zoom in or out on the image Straighten Volume Data cáÖìêÉ UJQV sçäìãÉ píê áÖÜíÉå aá äçÖ This function allows you to adjust the surface of the scan to be horizontal in those cases where the retina is highly tilted Click Auto Straighten to automatically correct the image The slider controls number field and up down arrows are used to manually correct the image by adjusting the X a...

Page 189: ...arent Surfaces Checking the Transparent Surfaces checkbox allows you to view ILM RNFL or RPE as transparent surfaces Use the sliders to adjust the transparency level NOTE When you use Transparent Surfaces the image will have lower resolution Reset Click Reset to return the image to its default settings Click Save Exam to save the 3D View Settings on page 8 61 for this exam ...

Page 190: ...ove is for a Macular Cube 512x128 The upper left viewport shows the saved Fundus image with an optional en face scan overlay The other three viewports show cross sectional scan images in three planes Thinking of the data as a cube the viewports show the data in planes parallel to the side of the cube Y plane lower left viewport the front of the cube X plane upper right viewport and the top of the ...

Page 191: ...an images which are cross sections slices the layers appear as colored lines that trace the anatomical feature on which they are based The ILM is represented by a white line the RPE by a black line and the RPEfit line is magenta in color These lines are also known as segmentation lines You can customize the colors used to display each of these lines as explained below These layers serve as the bas...

Page 192: ...terior line handle moves both lines of the slab together to reposition it in the scan image The resulting slab image you see represents an average signal intensity value for each A scan location through the selected depth of the slab The drop down options ILM RPE and RPEfit are variations of the slab When you select any of these you view the slab of selected thickness you can adjust it as above re...

Page 193: ...ts you make while they are present Delete Measurements button Click Delete to delete the currently selected measurement lines You can select lines in more than one image at a time To deselect a line click anywhere on the same image but off the line Show Hide Layers button Click Layers to hide or show the colored lines indicating the layers ILM RPE and RPEfit Configure Layers button Click Configure...

Page 194: ...ents apply simultaneously to all X Y and Z slices on screen in OCT viewports or as the fundus overlay If two Z slabs are on screen one as the fundus overlay and one in the lower right viewport Brightness Contrast and Color adjustments made on either slab will apply to both Between the fundus image and its overlay Brightness Contrast and Color operate independently Right click one or the other to a...

Page 195: ... These methods are described in the sections which follow Table 9 1 CIRRUS OCT Angiography CIRRUS OCT Angiography Montage Angio and ONH Angiography Analysis The CIRRUS OCT Angiography Analysis screen Figure 9 1 Montage Angio Analysis screen Figure 9 2 and ONH Angiography Analysis screen Figure 9 3 are used for the Angiography Analysis option in CIRRUS OCT For all CIRRUS OCT Angiography Analysis op...

Page 196: ...ë ãéäÉ áã ÖÉ ïáíÜ ëëçÅá íÉÇI ëÉäÉÅí ÄäÉ áã ÖÉ îáÉïë For the Montage Angio Analysis screen Figure 9 2 the middle viewport 2 shows the CIRRUS OCT Montage Angio image while the middle right viewport shows the individual panes of the Montage image and will change depending where you click the cursor in the middle viewport Finally for the ONH Angiography Analysis screen Figure 9 3 the top middle viewpo...

Page 197: ...169012 Rev A 2017 12 Overview 9 3 cáÖìêÉ VJO foorp l q jçåí ÖÉ åÖáç ë ãéäÉ áã ÖÉ ïáíÜ ëëçÅá íÉÇI ëÉäÉÅí ÄäÉ áã ÖÉ îáÉïë cáÖìêÉ VJP foorp l q lke åÖáçÖê éÜó áã ÖÉ ïáíÜ ëëçÅá íÉÇI ëÉäÉÅí ÄäÉ áã ÖÉ îáÉïë 1 10 4 11 12 13 1 9 2 3 6 7 4 5 8 ...

Page 198: ...ary is the ILM and the inner boundary is offset above the ILM by 300 μm Superficial Superficial retinal layer slab The inner surface is the ILM layer segmented in the same manner as CIRRUS HD OCT structural images such as Macular Cube 512x128 The outer surface is an approximation of the inner plexiform layer IPL which is estimated by the following equation ZIPL ZILM 70 TILM OPL Where ZIPL is the b...

Page 199: ...orrelation tail signals Exudates or migrated RPE may cause there to be artifacts in different layers This issue should be uncommon in the outer retina but it can occur The segmentation and flow and intensity B scans should be examined carefully if there is abnormal appearing vasculature in the Avascular slab NOTE This preset is not available for ONH Angiography Choriocapillaris The inner surface i...

Page 200: ...reset is defined as follows Top ILM Bottom RNFL NOTE This preset is only available for ONH Angiography These slab en face definitions should be considered reasonable starting points especially for normal eyes but the inner and outer boundaries can be offset by grabbing magenta lines and shifting them in the B scans Furthermore the slabs will not appropriately illustrate the vasculature of interest...

Page 201: ...ll overlay the data lying above the RPE and green will overlay data lying below the RPE Segmentation Lines Selecting this option adds the dashed magenta lines to the segment viewport lower left 1 Select Edit 2 Left click the mouse at an end where the triangle is of one of the lines and hold down the mouse button to move it This will change the offset and define a new slab These changes will be ref...

Page 202: ...y will remove projection artifacts such as decorrelation tails from the images Once the check box is selected it remains so until unchecked For more information refer to CIRRUS OCT Angiography Acceptance Criteria on page 7 7 Overlays The appearance of the Overlay for Angiography looks like the example margin graphic on the left The appearance of the Overlay for ONH Angiography looks like the examp...

Page 203: ...e 9 22 This option is not available for Montage Angio RNFL Thickness Map ONH Angiography Analysis uses Item 6 Figure 9 3 for the RNFL Thickness option ONH Outer Region ONH Angiography Analysis uses Item 7 Figure 9 3 for the Outer Region option This option indicates the blood flow intensity and area of flow Perfusion The total area of perfused vasculature per unit area in a region of interest ROI F...

Page 204: ...gure 9 3 Montage Angio Image Item 10 in the Montage Angio represents the Montage Angio image of all scans taken Montage Angio Both Option Item 11 in Figure 9 2 represents a toggle option to show the Angio or Structure option in which to view the Montage In addition you can choose the Both option that provides a view of both Angio and Structure as shown in Figure 9 4 cáÖìêÉ VJQ jçåí ÖÉ åÖáç _çíÜ lé...

Page 205: ...äÉÅíÉÇ Ñêçã íÜÉ åÖáçÖê éÜó å äóëáë ëÅêÉÉåI íÜÉ åÖáçmäÉñ jÉíêáñ ïáää ééÉ êK Select the Superficial preset see Presets CIRRUS OCT Angiography Presets on page 9 4 from the OCT Angiography Analysis screen for 3x3 and 6x6 scans only to bring up tools for observing and measuring vessel density and or capillary perfusion For ONH Angiography see Figure 9 3 Measuring capillary non perfusion or impaired cap...

Page 206: ...ay is applied to the segmented FAZ area Values for the total calculated Area Perimeter and Circularity of the FAZ are shown in the AngioPlex Metrix view and described in Table 9 3 Name Description Units Vessel Density Vessel Density is defined as the total length of perfused vasculature per unit area in a region of measurement It is measured in units of inverse millimeters Vessel density can be th...

Page 207: ...thin the boundary of the FAZ mm2 FAZ Perimeter The length of the boundary of the FAZ mm FAZ Circularity How similar the boundary of the FAZ is to a circle Values range from 0 to 1 A value of 1 means the FAZ forms a perfect circle while a value near zero means that the boundary of FAZ is very different from a circle An FAZ can result in a low circularity for a number of reasons including but not li...

Page 208: ...w you to draw your own FAZ outline if desired The drawn FAZ outline must be a single closed shape The drawing tool has several features to aid in drawing a single closed shape such as automatically connecting the end point to the beginning point ending when two parts of the boundary intersect and discarding extra closed shapes created by the auto complete function When the drawing is completed the...

Page 209: ... identified a FAZ it will be outlined as shown below on the left If the automatic FAZ algorithm has not been able to identify the FAZ the message shown below on the right will appear 2 If a FAZ has been found and you wish to edit it select Edit from the FAZ in the AngioPlex Metrix box The message shown below will appear 3 Holding the left mouse button down draw a FAZ outline ...

Page 210: ...ity values for selected regions are shown both in the AngioPlex Metrix table see Item 3 above and when selected in the ETDRS grid with values shown in the individual sectors Table 9 4 and Table 9 5 on the following pages illustrate each of the graphic options provided by the AngioPlex Metrix In addition the ETDRS grid if enabled can be moved and or recentered based on the Slice Navigator position ...

Page 211: ...CIRRUS HD OCT User Manual 2660021169012 Rev A 2017 12 Overview 9 17 Overlay Options Table 9 4 Overlay options available for visualizing vessels and perfusion as well as FAZ shape and size ...

Page 212: ...017 12 CIRRUS HD OCT User Manual 9 18 ETDRS Options Table 9 5 ETDRS Overlays can show values for either vessel density or perfusion ETDRS Grid with Vessel Density Values ETDRS Grid ETDRS Grid with Perfusion Density Values ETDRS Grid ...

Page 213: ... 8 allows you to compare two Angiography scans from a patient s history to visualize changes in retinal vasculature capillary density and perfusion FAZ size and geometry cáÖìêÉ VJU foorp l q åÖáçÖê éÜó Ü åÖÉ å äóëáë ëÅêÉÉå For a change analysis of Montage Angio individual scan images use the CIRRUS OCT Angiography Change Analysis screen Figure 9 8 as well 1 2 4 5 ...

Page 214: ...shown and described on page xxx select the toggle icon Item 3 in the upper right hand area of the screen cáÖìêÉ VJV lke åÖáçÖê éÜó Ü åÖÉ å äóëáë Previous Scan Any AngioPlex scan acquired for the same patient and the same eye during a visit prior to the currently selected scan may be used as the Previous Scan The data from the selected scan will populate the scan images on the left side of the Chan...

Page 215: ...it is the only slab preset from which AngioPlex Metrix see AngioPlex Metrix on page 9 7 selections can be made However any preset can be chosen for visual inspection of possible changes in vasculature For ONH Angiography change analysis RPC is the default preset for change analysis AngioPlex presets are discussed in detail in CIRRUS OCT Angiography Presets on page 9 4 and the algorithms used for t...

Page 216: ...on provides visual control of prior scans Transparency is relative to the Map and Trace overlays Show Grid Shows hides the circle with the quadrants from the view The values shown display the P and F numbers Selected Scan The Selected Scan is the scan you had selected from the scan list prior to selecting Angiography Change Analysis The date of the exam is shown above the scan images AngioPlex Met...

Page 217: ...e top of the analysis screen select the scan date and the scan you wish to use as the more current scan the scan information that appears on the right side of the screen 2 Select Angiography Change Analysis Manual Selection from the far right column 3 A list of eligible scans will appear in a dialog box see Figure 9 10 4 Click the scan you wish to include in the analysis A green checkmark will app...

Page 218: ...Encoded Combination of the above three layers with the following coding SRL Red DRL Green Avascular Blue Combination of the three above Whole Retina Slab Inner Boundary ZILM Outer Boundary ZRPE ZRPEfit 70 μm VRI Inner Boundary ZIVRI ZILM 300μm Outer Boundary ZILM Table 9 4 Layers in a typical normal eye demonstrates that the deeper retinal layer has a different characteristic appearance than the s...

Page 219: ...ayer Inner boundary ZIPL Outer boundary ZOPL ZRPEfit 110μm Avascular Slab Inner Boundary ZOPL Outer Boundary ZIS OS ZRPEfit 70μm Choriocapillaris Slab Inner Boundary ZCCIB ZRPEfit 29 μm Outer Boundary ZCCOB ZRPEfit 49 μm Table 9 4 Layers in a typical normal eye demonstrates that the deeper retinal layer has a different characteristic appearance than the superficial retinal layer ...

Page 220: ... μm ORCC Inner Boundary ZOPL ZRPEfit 110 μm Outer Boundary ZChOB ZRPEfit 115 μm RPE RPE Fit Inner Boundary ZRPE Outer Boundary ZRPEfit Sub RPE Inner Boundary ZRPE Outer Boundary ZRPE 49 μm Table 9 4 Layers in a typical normal eye demonstrates that the deeper retinal layer has a different characteristic appearance than the superficial retinal layer ...

Page 221: ...H Angiography Change Analysis Image Registration Both Automatic Registration and Manual Registration are available for ONH Angiography in CIRRUS The process parallels the registration process found in Macular Registration on page 8 13 Refer to the section for more details ...

Page 222: ...Overview 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 9 28 ...

Page 223: ...rint icon in the upper right corner of the Analysis screen The Standard Print Options Drop down List will appear as shown in Figure 10 1 cáÖìêÉ NMJN eçîÉê çîÉê íÜÉ mêáåíÉê áÅçåI íç êÉîÉ ä íÜÉ pí åÇ êÇ mêáåí léíáçåë aêçéJÇçïå iáëíK Five options are available from any given analysis screen as shown in Figure 10 1 Print No Preview Opens a standard printer dialog box Print Preview Opens the Report Pre...

Page 224: ... mêÉîáÉï ëÅêÉÉåK oÉéçêí mêÉîáÉï ëÅêÉÉåë êÉ ÅÅÉëëÉÇ Ñêçã íÜÉ mêáåí mêÉîáÉï çéíáçå çÑ íÜÉ ÇêçéJÇçïå äáëí ÅÅÉëëÉÇ Ñêçã íÜÉ p îÉ áÅçåI ë ÇáëÅìëëÉÇ áå Standard Print Options on page 10 1 ÄçîÉK Reports are comprised of a header the main window which contains analysis data and a footer Report headers include the following information Patient Name Patient ID Technician Name Institution Patient names IDs e...

Page 225: ...for the alteration is printed in the Comments box at the bottom of the page If alterations are eventually deleted that date time stamp in the Comments box is also deleted from the next report The mini Toolbar at the top left of the Report Review screen provides the same print options as described in the previous section In addition if you select the Save icon from this location you may also select...

Page 226: ...default options may not always provide all the information required To accommodate this you can specify additional information in connection with certain analyses that will then appear on the selected Report as an additional s page s These analysis related special options for reports are specified as follows 1 From the Toolbar Toolbar Options on page 3 5 select Options Print Configuration The wind...

Page 227: ...Multi slice Parameters tab Figure 10 5 When the Macula Multi Slice option is selected reports generated from macula cube scans will include images of the central fast B scan and adjacent B scans Such reports include four fast B scans per page Selecting the number of B scans to display and the spacing between them determines how many pages the report will be cáÖìêÉ NMJR j Åìä jìäíáÓpäáÅÉ m ê ãÉíÉêë...

Page 228: ...een Moving the ETDRS Grid to a different position on the Macular Thickness Analysis screen creates a different set of images on this report If the radial pattern is positioned such that a portion of the radial lines go outside the scan boundary then no OCT data appears For example in the report below the top left hand slice has a black edge on the left where no data appears Advanced Visualization ...

Page 229: ...nclude an overlay For OCT images the companion Fundus image has an overlay that highlights the position of the slice or slab For Fundus images with an overlay the companion text box describes the overlay characteristics In the Tagged Images dialog you have the following options Deselect images All checkboxes are selected by default Uncheck a checkbox to deselect its image and exclude it from the r...

Page 230: ...s Report Options The report for ONH and RNFL Thickness Analysis includes all the information shown on the Analysis Screen plus a second page the Patient Education Page You can turn this option on and off by going into Tools Print Configuration ONH Print Options see Figure 10 7 cáÖìêÉ NMJT qÜÉ lke mêáåí léíáçåë í Ä áå mêáåíçìí çåÑáÖìê íáçå The first page of the ONH and RNFL Thickness Report include...

Page 231: ...áÅâåÉëë Normative Data Details Report If you click the blue icon button you can select Print Preview or Export to DICOM A PRINT PREVIEW screen displays the Normative Data Details Report as shown in Figure 10 9 The report can be printed from the PRINT PREVIEW screen Each eye will print on a separate page for an OU Printout ...

Page 232: ... scans thumbnails of the scan lines and a single larger image of the selected scan line for HD 1 Line 20x HD 5 Line and 5 Line Raster scans If EDI was used to acquire the scan the note Acquired using enhanced depth mode is displayed in the Comments field of the report For analysis you can print the selected line single page or print all lines multiple pages When Print All Lines Multiple Lines is s...

Page 233: ...e larger format window Guided Progression Report Options The Guided Progression Analysis GPA report has three report options Summary report Latest Scan report Parameters Summary Table report The GPA report is configurable to print a single page or two pages with either the Summary or Latest Scan Only report as the default single page or first page of a two page report The Parameters Summary Table ...

Page 234: ... two page GPA report It displays the baseline exam maps latest exam map past exam maps corresponding OCT Fundus images indicating the location of the cup and disc boundaries and a table that summarizes RNFL and ONH parameter data for Baseline 1 Baseline 2 and Current exams How to Read the GPA Report Verify Data Quality Verify the images Discard or retake images with poor registration and or poor s...

Page 235: ... of RNFL thinning due to a change in therapy This leveling off would be a good time to update the Baseline images This will allow GPA to flag change from this new point in time instead of having the summary flags continuously checked off due to thinning that occurred at an earlier less stable time Statistical Significance Guided Progression Analysis compares an observed change with its expected te...

Page 236: ...sing Confirmation to Improve Specificity In order to increase the specificity of the measurement over multiple visits CIRRUS also requires that statistically significant change from Baseline be observed for at least two pairs of measurements when only three measurements are available and for at least three pairs of measurements when four or more measurements are available In this case CIRRUS will ...

Page 237: ...splays the Normative Data Details Report as shown below The report can be printed from the Print Preview screen Macula Thickness Normative Data Details Report The Normative Data Details Report displays the parameters of the analysis in the units measured and as a percentile from the normative database In addition the report displays the result minus the reproducibility limit as well as the result ...

Page 238: ...e Summary ONH and RNFL OU Analysis RNFL Thickness Analysis NOTE ONH and RNFL OU Analysis and RNFL Thickness Analysis reports will print two pages of the Normative Data Details Report as these reports are OU reports two eyes NOTE The Normative Data Details Report is only available for the Diversified Database The Normative Data Details Report is not available for a patient for whom the Asian Normat...

Page 239: ...seful because it runs on top of the DICOM protocol and specifically designed for the exchange of data modalities within configurations of Zeiss instruments This simplifies the review of patient data when such data has been compiled as a result of multiple screenings of various types on more than one instrument Whether or not you have a FORUM enabled DICOM system or you are running in Native mode y...

Page 240: ...ata only if it was created on a later date than the data already imported This prevents overwriting of newer patient data with older Import Export Native Mode To export data 1 If you are exporting to removable media insert the media into its drive If not skip to the next step 2 From the Toolbar Toolbar Options on page 3 5 with the Patient Screen Basic Screens on page 3 3 open select Records Export...

Page 241: ...h to export in the middle area of the Export Options dialog Figure 11 1 page 11 2 labeled Search for Patient Exams to Export You can search for patients by Last Name Patient ID Category or Exam Date range Select the desired options and click Search The Results lists shows the patients matching all search criteria used You may also search and export a single exam For more search options click Advan...

Page 242: ...rt volume exists on the selected destination path a user message appears to confirm the following selected options for the exam export See Figure 11 3 cáÖìêÉ NNJP bñéçêí sçäìãÉ äÉêí pÅêÉÉå Increment This option adds the exported exams to the existing exported volume on the same destination path Overwrite This deletes the existing exported volume at the same destination path location and a new expo...

Page 243: ...US HD OCT instrument see FORUM DICOM Mode on page 11 5 FORUM DICOM Mode Transferring Images in OPT IOD and OP IOD Formats This function allows the export of image files from the instrument or CIRRUS Review Software in a standard DICOM format for viewing on a remote station NOTE This option is not available for the Optic Disc Cube scan and both Anterior Segment scans Terms IOD Information Object De...

Page 244: ...elect Finish at the end of an analysis there is the choice to Archive Now or to wait until later The duration of the image transfer can vary depending on the system the network connection and other factors NOTE If you are adding the FORUM Data Management system to your practice and plan to migrate existing data to the FORUM Archive consult with Zeiss regarding options for creating and migrating fi...

Page 245: ... exam within the range selected The default date range is for the current date To enable searching for all dates check the All Dates checkbox AE Title Read from the Equipment Edit dialog Figure 4 2 Any changes to AE Title do not affect the AE Title of this instrument It is only for use in searching for patients Modality For the CIRRUS instrument is OPT Other options are provided for searching purp...

Page 246: ... select the desired patient s then click Save Repeat this step until all desired patients are added to the local database 5 Click Done to close the Modality Worklist window The application returns to the same tab that was previously selected on the main window before worklist search Once the operation is complete click the View Today s Patients tab on the ID Patient screen to see the patients impo...

Page 247: ...Analysis are exported in batch To initiate the batch XML export in ID patient mode select Records Export Exams to open the Export Options dialog Figure 11 7 cáÖìêÉ NNJT uji bñéçêí XML Export from Analysis Screens The following CIRRUS HD OCT analyses allow XML export of specific values as described in the sections which follow Macular Thickness Analysis ONH and RNFL OU Analysis Macular Change Analy...

Page 248: ...êçã j Åìä ê qÜáÅâåÉëë å äóëáë 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Index XML File Label Index XML File Label Index XML File Label 1 LAST_NAME 9 SITE 17 Z_CENTER 2 FIRST_NAME 10 OPERATORNAME 18 Z_OUTERSUPERIOR 3 PATIENT_ID 11 SIGNALSTRENGTH 19 Z_INNERSUPERIOR 4 GENDER 12 FOVEA_Y 20 Z_INNERRIGHT 5 BIRTH_DATE 13 FOVEA_X 21 Z_OUTERRIGHT 6 VISIT_DATE 14 ILMRPECENTRAL 22 Z_I...

Page 249: ...screen Figure 11 9 are exported to a XML file The labels of these values in the XML file are listed in the table below the figure cáÖìêÉ NNJV s äìÉë bñéçêíÉÇ Ñêçã lke åÇ okci lr å äóëáë Where Field 10 is the nasal quadrant which will appear on the right in the report for the right eye OD and on the left for the left eye OS Field 12 is the temporal quadrant which 1 2 3 4 5 6 7 8 9 10 11 12 13 Index...

Page 250: ... the XML file are listed in the table below cáÖìêÉ NNJNM s äìÉë bñéçêíÉÇ Ñêçã j Åìä ê Ü åÖÉ å äóëáë NOTE Fields 5 9 7 and 11 are exported exactly as they are shown on the screen As an example field 5 Z_INNERRIGHT refers to the inner right hand sector as seen on the screen Thus for the right eye OD it is the Inner Nasal sector For the left eye OS it is the Inner Temporal Sector 1 2 3 4 5 6 7 8 9 10...

Page 251: ... button The values labeled in the Guided Progression Analysis screen Figure 11 11 are exported to a XML file The labels of these values in the XML file are listed in the table below cáÖìêÉ NNJNN s äìÉë bñéçêíÉÇ Ñêçã dìáÇÉÇ mêçÖêÉëëáçå å äóëáë 1 2 3 4 5 6 Index XML File Label Index XML File Label Index XML File Label 1 DATE_TIME 3 SIGNAL_STRENGTH 5 SUPERIOR_THICKNESS 2 SERIAL_NUMBER 4 OVERALL_THICK...

Page 252: ...upper right of the annulus for the left eye OS Field 6 is the nasal superior sector which appears to the upper right of the annulus for the right eye OD and to the upper left of the annulus for the left eye OS Field 7 is the temporal inferior sector which appears to the lower left of the annulus for the right eye OD and to the lower right of the annulus for the left eye OS Field 9 is the nasal inf...

Page 253: ...e The labels of these values in the XML file are listed in the table below cáÖìêÉ NNJNP s äìÉë bñéçêíÉÇ Ñêçã Çî åÅÉÇ omb å äóëáë 4 1 2 3 5 6 7 Index XML File Label Index XML File Label 1 DATE_TIME 5 VOLUME_OF_RPEELEVATIONSFIVEMMCIRCLE 2 AREA_OF_RPEELEVATIONSTHREEMMCIRCLE 6 AREA_OF_SUBRPE_ILLUMINATION 3 AREA_OF_RPEELEVATIONSFIVEMMCIRCLE 7 CLOSEST_DISTANCE_TO_FOVEA 4 VOLUME_OF_RPEELEVATIONSTHREEMMCI...

Page 254: ...tinal Rim Thickness and RNFL Thickness are saved to txt files by clicking on the Advanced Export button on the ONH and RNFL OU Analysis screen The files are plain text files The neuro retinal rim thickness values at 180 points each point representing 2 degrees are saved Furthermore the RNFL thickness values at 256 points each point representing 1 41 degrees are saved in the files For both profiles...

Page 255: ...y date time and User ID Log on log off Display of analysis data Creation modification deletion of data Import export of data from removable media Receipt transmission of data from to an external connection network for example Remote service activity The events are automatically recorded in up to 5 audit files of 5 Mb each When the maximum limit for files and file size is reached the CIRRUS overwri...

Page 256: ...Log Files 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 11 18 ...

Page 257: ...e everywhere in your office If not there may be a localized power outage in your office or a general power outage in your neighborhood If so proceed to Step 2 2 Is the instrument power cord plugged in at both ends If not plug in the cord and try to power up the instrument If Using the Optional Power Table If you are using the optional power table the instrument is powered through it Check the foll...

Page 258: ...cated just above the rear cover of the instrument To gain access to the label showing the serial number remove the rear cover To remove the rear cover depress the two snaps at its top edge cáÖìêÉ NOJNW oÉãçîáåÖ oÉ ê çîÉê A small label indicates the month and year of manufacture in MMYYYY format for example 042013 Routine Cleaning The forehead and chinrests and to a lesser extent the imaging apertu...

Page 259: ...07672 listed in User Replacement Accessories on page 12 5 Apply a small amount of the camera lens cleaner to the dry lens wipe and gently clean the lens If a patient s eye inadvertently contacts any part of the imaging aperture or an external lens clean the imaging aperture or the external lens before proceeding with the examination CAUTION Wipe gently and carefully to avoid scratching the instrum...

Page 260: ...lacing the filter CAUTION When dusting of the instrument or table is necessary use a dry non linting soft cloth Do not use aerosols as these can penetrate the instrument covers and damage the instrument CAUTION When the instrument covers or table require cleaning or disinfecting wipe with a non linting cloth or wipe dampened only not dripping wet with water or alcohol Wipe dry with a clean and sof...

Page 261: ...tion Device External 3197519005000 Occluding Sleeve for Fixation Device 3013509052000 Red Fixation Lamp 2660021124008 Ocular Lens Cover 2660021158407 Cornea Lens Models 500 5000 2660021158406 Anterior Chamber Lens Models 500 5000 2660021150088 Anterior Segment Calibration Tool 2660100061991 Top Fan Filter 2660100006566 Alcohol Wipes 2660100007672 Camera Lens Cleaner 2660100007673 Camera Lens Wipes...

Page 262: ...vides this tool with each instrument It contains fragile parts that must be maintained in their original position for the test measurements to be accurate CAUTION Handle the Verification Test Tool carefully to avoid dropping Damage to the Verification Test Tool can affect test results If you drop the tool it is recommended that you do not use it for testing Immediately contact Zeiss customer servi...

Page 263: ...Click Auto Focus to get a clearer image of the cross hair test pattern Use the focus arrows if your system does not have Auto Focus activated Besides focus other adjustments usually are not necessary although possible 4 Click Capture and then select OD or OS in the Select Eye dialog that appears The Review screen appears automatically NOTE Pay no attention to the image appearance nor to the signal...

Page 264: ...6 Select the Performance Verification patient again and click Analyze 7 In the Analysis screen select the scan you just saved 8 Select Macular Thickness Analysis in the right hand column cáÖìêÉ NOJQ mÉêÑçêã åÅÉ sÉêáÑáÅ íáçå å äóëáë pÅêÉÉå fåáíá ääó 9 When the scan loads select OCT Fundus in the Overlay drop down menu 10 Set the Transparency slider to zero Select OCT Fundus overlay Set Transparency...

Page 265: ...f the target The alignment target is in the center of the cross hair The white cross defines the acceptable range of alignment between the fundus image and the OCT scan image as explained below NOTE When the blue and magenta lines are correctly centered you may find it difficult to see where they cross because the scan lines are nearly as thick as the lines that comprise the central cross Drag tri...

Page 266: ...he very center This way they should cross in the center of the circle which is the alignment target cáÖìêÉ NOJS _äìÉ åÇ j ÖÉåí iáåÉë ÉåíÉêÉÇ çå äáÖåãÉåí q êÖÉí 13 Click Back at upper right or double click anywhere to exit full screen mode 14 Move the Transparency slider to 100 transparent and double click again to make the fundus image appear full screen Now you are ready to evaluate the test Chan...

Page 267: ...of the fundus image and the OCT scan image is within the acceptable range Some examples of pass conditions appear below cáÖìêÉ NOJT bñ ãéäÉë çÑ m ëë çåÇáíáçåë Failure Condition Fail After changing the Transparency to 100 if one or both scan line indicators pass clearly within the black portion of the center the system fails the check Some examples of failure conditions appear below Pass both lines...

Page 268: ... between a marginal pass and a failure The center cross hair defines a stringent range of tolerance Therefore you should confirm a failure only if the scan line indicators lie wholly within the center of the cross hair pattern To confirm your observation you should switch back to 0 Transparency If your observation is confirmed initially you should remove and re install the test tool to ensure it i...

Page 269: ...speed 68k A scans sec Model 500 Model 5000 A scan depth 2 0 mm in tissue 1024 points Axial resolution 5 μm in tissue Transverse resolution 15 μm in tissue Model 500 and Model 5000 Anterior Segment Cube 512x128 Anterior Segment 5 Line Raster Anterior Chamber HD Angle Scan HD Cornea Pachymetry Scan Wide Angle to Angle A scan depth 2 0 mm in tissue 1024 points 2 0 mm in tissue 1024 points 5 8 mm in t...

Page 270: ...OCT scan Optical source Superluminescent diode SLD 840 nm Superluminescent diode SLD 750 nm Optical power Nominal 600 60 μW at the cornea Safety shutoff power maximum 825μW at cornea 1 5 mW at the cornea Field of view 36 degrees W x 22 degrees H 36 degrees W x 30 degrees H Frame rate 1 7 Hz 20 Hz Transverse resolution 45 μm in tissue 25 μm in tissue Model 500 and Model 5000 Methodology CCD camera ...

Page 271: ...120V systems 50 60Hz 5A Line and Neutral are fused Fuse rating N A Electrical rating 230V Single Phase 220 240V systems 50 60 Hz 2 5A Line and Neutral are fused Convenience Receptacle output ratings N A Temperature transport and storage 40º to 70º C Relative humidity transport and storage 10 to 100 including condensation Atmospheric pressure transport and storage 500 hPa to 1060 hPa Temperature op...

Page 272: ...Electrical Physical and Environmental 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual 13 4 ...

Page 273: ...on transferable and non assignable license to use and display this Software on a single CIRRUS HD OCT under the terms of this License If the CIRRUS HD OCT on which You use the Software is a multi user system this License covers all users on that single system 2 The license is granted solely for the use of Your own internal computing requirements and does not grant You any right title or ownership ...

Page 274: ...ay not include any software or software licensee transfers You may not sublicense rent or lease the Software 6 Zeiss warrants the operation of the Software only with the operating system for which it was designed Use of the Software with an operating system other than that for which it was designed will not be supported by Zeiss Zeiss does not claim that the software provided is free from defects ...

Page 275: ...lling the subjects in the study Subjects were given a complete ophthalmic examination that included the following tests Distance visual acuity Perimetry using the Humphrey 24 2 SITA Standard threshold test bilaterally Any defects found were verified with a second test Goldmann applanation tonometry Keratometry Axial length measurement using an IOLMaster Slit lamp examination of the anterior segmen...

Page 276: ...L defect in either eye Presence of amblyopia in either eye Previous laser or incisional surgery Any active infection of anterior or posterior segments Evidence of diabetic retinopathy diabetic macular edema or other vitreo retinal disease Systemic History of diabetes leukemia AIDS uncontrolled systemic hypertension dementia or multiple sclerosis A life threatening or debilitating disease Current o...

Page 277: ...ring image acquisition resulting in a saccade that was within the central 80 of the scan area Area of data loss greater than 10 at the edge of the scan area Presence of floater s obscuring macular area on Macular Cube scans or measurement circle on Optic Disc Cube scans In practice clinicians and operators should quantitatively and qualitatively review scans before comparing them to the CIRRUS RNF...

Page 278: ...RUS HD OCT RNFL and macular thickness parameters adjusted by age Subject s age is considered as a clinically important factor for the RNFL and macular thickness measurements For each fitted regression model the residuals were derived for each eye by subtracting estimated expected mean reading ET age0 from the measured or observed reading Obs age0 In other words residual Obs age0 ET age0 The goal w...

Page 279: ...ed by the subjects in the population comprising the normative database but was not used as a variable in constructing the RNFL and macula normative databases Figure A 1 Figure A 2 and Figure A 3 display scatter plots for RNFL Summary Parameters versus age along with the fitted regression lines These demonstrate that the RNFL summary parameters decrease gradually as the age increases cáÖìêÉ JN îÉê ...

Page 280: ...sÉêëìë ÖÉ Description of Macular Scan Parameters Used in CIRRUS HD OCT CIRRUS Macular Scan parameters were derived from the Early Treatment Diabetic Retinopathy Study ETDRS Grid below Central Subfield Retinal Thickness Average thickness of the retina in a disk shaped region of 1 mm diameter centered on fovea Region 1 ...

Page 281: ...nt of an annulus centered on the fovea with inner 3 mm diameter and outer 6 mm diameter Regions 6 7 8 and 9 Outer Superior Subfield Region 6 Outer Inferior Subfield Region 8 Outer Temporal Subfield Region 9 in OD Region 7 in OS Outer Nasal Subfield Region 7 in OD Region 9 in OS In addition these normative values were also established for the 6 mm x 6 mm square area scanned Average Retinal Thicknes...

Page 282: ...the average macular thickness for all subfields along with the fitted regression line Figure A 6 displays a scatter plot for the average macular volume for all subfields along with the fitted regression line These demonstrate that the central subfield has almost no dependence on age but the remaining subfields decrease very gradually when the age increases cáÖìêÉ JQ îÉê ÖÉ j Åìä qÜáÅâåÉëë sÉêëìë Ö...

Page 283: ...hese normative databases to compare individual patient measurements to those acquired in a normal population Optic Nerve Head Normative Database Diversified The CIRRUS HD OCT Optic Nerve Head Normative Database was collected to provide normative data for use with Optic Nerve Head ONH and RNFL OU Analysis module Post hoc analysis was performed on the Optic Disc 200x200 cube scan originally acquired...

Page 284: ...nal Strength of 5 or lower Large eye motion during image acquisition resulting in a saccade that was within the central 80 of the scan area Area of data loss greater than 10 at the edge of the scan area Presence of floater s obscuring macular area on Macular cube scans or measurement circle on Optic Disc cube scans Scans were reviewed again after processing with the optic nerve head analysis algor...

Page 285: ...unt differences that may be present due to age ethnicity axial length refraction optic disc area or signal strength In multiple regression analysis we found that optic disc area and age were the two parameters with the greatest effect on the remaining ONH parameters Based on R2 values disc area explains as much as 40 of the variability in some parameters while age explains no more than 5 All other...

Page 286: ...ic 1 Indian and 2 mixed ethnicity As expected subjects of African descent had the largest discs on average 1 93 0 33 mm2 while those of European descent had the smallest 1 68 0 30 mm2 p 0 001 There was no statistically significant difference among different ethnicities with respect to the Rim Area p 0 16 The Cup to Disc Ratio Average and Vertical as well as the Cup Volume showed differences among ...

Page 287: ... than 2 5 mm2 or smaller than 1 3 mm2 then normative limits are not applied because not enough data is available in the database to determine the limits In this case the area behind the number or the NR plot is shown as gray In addition Average and Vertical C D Ratios less than or equal to 0 25 will be shown as gray Conclusion The CIRRUS HD OCT optic nerve head normative database was created using...

Page 288: ...2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual A 14 Report The elements shown in the analysis screen in Figure A 7 are presented in a report as well as shown below cáÖìêÉ JT lke åÇ okci lr å äóëáë oÉéçêí ...

Page 289: ... Circle as follows The thinnest 1 of measurements fall in the red area Measurements in red are considered outside normal limits red 1 outside normal limits The thinnest 5 of measurements fall in the yellow area or below 1 yellow 5 suspect 90 of measurements fall in the green area 5 green 95 The thickest 5 of measurements fall in the white area white 95 NOTE Clinicians must exercise judgment in the...

Page 290: ...ckness RNFL Symmetry RNFL Clock Hours RNFL Quadrants RNFL Thickness graph Age Grey shading does not apply to RNFL measurements The thickest 5 of measurements fall in the white area white 95 90 of measurements fall in the green area 5 green 95 The thinnest 5 of measurements fall in the yellow area or below 1 yellow 5 suspect The thinnest 1 of measurements Measurements in red are considered outside ...

Page 291: ... Measuring Central Corneal Thickness on page B 19 If you click the blue icon button you can select Print Preview or Export to DICOM A Print Preview screen displays the Normative Data Details Report as shown in Figure A 9 below The report can be printed from the Print Preview screen Each eye will print on a separate page for an OU Printout See Normative Data Details Reports on page 10 15 for more i...

Page 292: ...Appendix 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual A 18 cáÖìêÉ JV kçêã íáîÉ a í aÉí áäë oÉéçêí ...

Page 293: ...S HD OCT Ganglion Cell Normative Database was collected to provide normative data for use with The Ganglion Cell Analysis module and presents information on the thickness of the ganglion cell plus inner plexiform layer Post hoc analysis was performed on the Macular Cube 200x200 and Macular Cube 512x128 cube scans originally acquired for Macular retinal thickness normative data to determine the typ...

Page 294: ...rmine the normal range of Ganglion Cell Analysis parameters The normative database does not have subjects with refractive errors outside the 12 00 D to 8 00 D range Therefore the analysis below should be applied with caution to subjects with refractive errors outside the 12 00 D to 8 00 D range Scan Selection Criteria The scans were reviewed for image quality as part of the original study One best...

Page 295: ...annulus The minimum is selected because the thinnest portion of the ganglion cell plus inner plexiform layers in the perifoveal region is considered likely to indicate damage to the ganglion cells Results The descriptive statistics for Ganglion Cell Analysis parameters based on 282 normal eyes are reported in Table A 3 below Table A 3 Normal Values for CIRRUS Ganglion Cell Analysis Measurements in...

Page 296: ...áÅâåÉëë ë cìåÅíáçå çÑ ÖÉK Ethnicity The ethnicity breakdown of the Ganglion Cell Analysis is as follows 43 Caucasians 24 Asians 18 African American 12 Hispanic 1 Indian and 2 mixed ethnicity There are statistically significant differences among them in GCL IPL thickness as shown in the table below for Average GCL IPL Thickness Table A 4 Ethnicity Breakdown of the Ganglion Cell Analysis Results rev...

Page 297: ...ed as a clinically important factor for the ganglion cell plus inner plexiform layer thickness measurements For each fitted regression model the residuals were derived for each eye by subtracting the estimated expected mean reading ET age0 from the measured or observed reading Obs age0 In other words residual Obs age0 ET age0 The goal was to predict the 100x th percentiles NL normative limit of th...

Page 298: ...o be the default unless you manually select another database for that specific patient For details on how to select or change the normative database see the Add New Patients on page 5 2 Introduction The Asian Normative Database was developed using sites located in Japan China and India The Asian normative data was collected and analyzed in a manner identical to the collection of the diversified da...

Page 299: ...s measurement using ultrasound pachymetry Subjects were grouped into six categories by subject age 18 29 30 39 40 49 50 59 60 69 and 70 80 It should be noted that this normative database does not have any subject younger than 19 years old or older than 79 years old Inclusion and Exclusion Criteria Inclusion and exclusion criteria for enrollment in the study were as follows Inclusion Criteria Males...

Page 300: ...mits and MD and PSD 5 probability level Data Collection 315 subjects were qualified as normal subjects and enrolled in this study for the RNFL Database and for the Macula Normative Database For the RNFL Normative Database each eye was scanned three times with the Optic Disc Cube 200x200 scan For the macula normative database each eye was scanned three times with the Macular Cube 200x200 scan and t...

Page 301: ...Analysis Normative Databases are adjusted only by age not by ethnicity or any other parameter The normative limits provided for comparisons of individual data to the normative database do not take into account differences that may be present due to ethnicity axial length refraction optic disc area or signal strength Normative Database Analyses From these scans the normative databases for RNFL Macu...

Page 302: ...d traveling superior nasal inferior and back to temporal or TSNIT RNFL Symmetry correlation coefficient between left eye TSNIT profile and right eye TSNIT profile Age Coefficient RNFL Thickness Analysis of subject demographics determined that expected thickness was dependent upon age although the effect was small and sometimes positive slightly increasing thickness with age Thus age correction is ...

Page 303: ...ied on page A 1 Figure A 16 displays a scatter plot for the Central Subfield retinal thickness average versus age along with the fitted regression line Figure A 17 displays a scatter plot for the average macular thickness for all subfields along with the fitted regression line These demonstrate that the central subfield has almost no dependence on age but the remaining subfields decrease very grad...

Page 304: ...e annulus can be seen in Figure A 12 All Ganglion Cell Analysis parameters decrease slowly with age Figure A 18 below shows the average GCL IPL thickness within the measurement annulus as a function of age cáÖìêÉ JNU îÉê ÖÉ d i H fmi qÜáÅâåÉëë E ãF sÉêëìë ÖÉ It should be noted that although the age effect was statistically significant the R2 coefficient of determination of the simple regression mo...

Page 305: ...ubjects less than 5 had discs smaller than 1 3 mm2 Disc area showed no dependence on subject age Classifying disc size as small medium or large has been previously done see example Spaeth but typically the sizing was based on a vertical diameter measured from the slit lamp By measuring the disc area we consider all meridians Table A 7 serves as a very general size classification guide based on div...

Page 306: ...011 per year R2 0 011 p 0 03 for vertical CD Ratio Optic Disc Area The distribution of disc area for the normative database eyes is discussed in the paragraph above Note that 90 of disc areas were between 1 3 mm2 and 2 5 mm2 Therefore normal limits will not be well defined for this population outside of those disc sizes and are not applied gray is shown for not applicable instead of the usual colo...

Page 307: ... to Disc Ratio on Disc Area was found to depend on the size of the disc For this reason quantile regression was used rather than linear regression to set the limits on the ONH parameters with respect to Disc Area This is a method whereby the slope and offset are independently fit for each limit See Artes and Crabb3 for a description of quantile regression Conclusion The CIRRUS HD OCT Asian RNFL ma...

Page 308: ...Appendix 2660021169012 Rev A 2017 12 CIRRUS HD OCT User Manual A 34 ...

Page 309: ...he accuracy and precision of the CIRRUS HD OCT retinal thickness segmentation algorithms and 2 to evaluate the agreement between the resulting measurements and similar measurements made on Stratus OCT A secondary objective of the study was to evaluate the effectiveness of data registration on repeatability Methods Data Collection This was a prospective non randomized multi center study Subjects 18...

Page 310: ...ween scans Each subject also underwent a Stratus Fast Macula scan of the study eye Data Analysis Accuracy was assessed by having 14 trained clinicians perform hand segmentations of selected B scans from a single scan of each type from each subject Layers segmented by CIRRUS HD OCT were compared to the hand segmentations Agreement of the CIRRUS HD OCT analysis with Stratus OCT was assessed by compa...

Page 311: ...etic Retinopathy 40 42 95 2 86 6 98 4 41 42 97 6 90 0 99 5 VRI Disorder 27 28 96 4 85 5 99 2 25 28 89 3 76 0 95 5 Other Retinal Disease 44 51 86 3 76 5 92 4 46 52 88 5 79 2 93 9 Macular Edema 27 28 96 4 85 5 99 2 27 29 93 1 82 2 97 7 No Retinal Disease 37 37 100 0 93 2 100 40 40 100 0 93 7 100 Category 200x200 512x218 n N 95 CI n N 95 CI AMD 68 70 97 1 91 7 99 1 73 74 98 6 94 2 99 7 Diabetic Retin...

Page 312: ...hows the same eye scanned and segmented on CIRRUS HD OCT Although the retinal tissue has the same vertical extent thickness in both 1 AMD 0 200 400 600 800 0 200 400 600 800 Central Subfield measured on Stratus um Central Subfield measured on Cirrus um 2 Diabetic Retinopathy 0 200 400 600 800 0 200 400 600 800 Central Subfield measured on Stratus um Central Subfield measured on Cirrus um 3 VRI Dis...

Page 313: ...n the retinal thickness found by each instrument Furthermore because the integrity of the layers sought varies with pathology the mean difference between instruments varies with pathology as can be seen in Table B 4 Even after the mean difference has been accounted for there is a residual difference that can be seen in the standard deviation of the difference reported in the last column of Table B...

Page 314: ...e reference point for subfield average thickness calculations These repeatability improvements are shown in Table B 6 It is important to note that the algorithm to find the fovea may fail in certain disease cases as is shown in Table B 7 The user should always review the location of the fovea and adjust it as necessary see Fovea Location on page 8 6 for instructions on how to do this Repeatability...

Page 315: ...bility Limit is the upper 95 limit for the difference between repeated results For this study two scans were acquired per subject during a single visit on a single system by a single operator at one of four sites ISO 5725 1 and ISO 5725 6 Repeatability limit 2 8 Repeatability SD N Mean SD CSMT μm for CIRRUS 4 0 MTA CSMT Repeatability Standard Deviation μm CIRRUS 3 0 MTA CIRRUS 4 0 MTA with fovea p...

Page 316: ...n ILM and RPE Segmentation to the Retinal Segmentation Algorithm of the CIRRUS HD OCT ARVO 2008 poster 4240 2 M Chang M Durbin M Weiland U Schmidt Erfurth G Gregori N Bressler Repeatability of retinal thickness measurements using CIRRUS HD OCT Spectral Domain Technology ARVO 2008 poster 4253 3 W Geitzenauer C Kiss M Durbin T Abunto M Wieland N Bressler G Gregori U Schmidt Erfurth Comparing Retinal...

Page 317: ...512x128 scans on the fellow eye from the same CIRRUS HD OCT instrument by three operators for a total of 9 scans The repeatability standard deviation SD is the square root of the random variance component The reproducibility SD is the square root of the sum of all contributions to variance except subject variance The repeatability limit is 2 8x repeatability SD The reproducibility limit is 2 8x th...

Page 318: ...rithm Table B 9 Repeatability and Reproducibility of Area of Sub RPE Illumination Manually Edited Scan Repeatability Reproducibility Repeatability SD mm2 Repeatability Limita mm2 Reproducibility SD mm2 Reproducibility Limitb mm2 CVc 200x200 Scan 0 8887 2 4885 0 9450 2 6460 12 5 512x128 Scan 0 8683 2 4313 1 0317 2 8889 15 8 a Repeatability Limit is the upper 95 limit for the difference between repe...

Page 319: ...f the Closest Distance to Fovea Manually Edited Scan Repeatability Reproducibility Repeatability SD mm Repeatability Limita mm Reproducibility SD mm Reproducibility Limitb mm 200x200 Scan 0 0739 0 2070 0 0762 0 2133 512x128 Scan 0 1247 0 3492 0 1257 0 3520 a Repeatability Limit is the upper 95 limit for the difference between repeated results Per ISO 5725 1 and ISO 5725 6 Repeat ability Limit 2 8 ...

Page 320: ...ariability Subjects assigned to Phase 2 of the study underwent the following series of CIRRUS HD OCT scans using only CIRRUS Unit 1 Three operators acquired the scans on each subject the following study measures were acquired Three acceptable Macular Cube 200x200 scans on one eye from one CIRRUS HD OCT instrument by three operators for a total of 9 scans Three acceptable Macular Cube 512x128 scans...

Page 321: ...than that of the 3 mm circle 0 0288 vs 0 0235 mm3 The repeatability and reproducibility limits will affect the ability to determine when measurements have changed due to a change in pathology as opposed to random variability Repeatability Reproducibility Repeatability SD mm2 Repeatability Limita mm2 Reproducibility SD mm2 Reproducibility Limitb mm2 CVc 200x200 Scan 3mm Circle 0 1295 0 3626 0 1568 ...

Page 322: ...epeatability Reproducibility Repeatability SD mm3 Repeatability Limita mm3 Reproducibility SD mm3 Reproducibility Limitb mm3 CVc 200x200 Scan 3mm Circle 0 0117 0 0327 0 0122 0 0341 15 2 5mm Circle 0 0098 0 0275 0 0106 0 0298 8 3 512x128 Scan 3mm Circle 0 0074 0 0206 0 0084 0 0235 12 0 5mm Circle 0 0088 0 0245 0 0103 0 0288 11 4 a Repeatability Limit is the upper 95 limit for the difference between...

Page 323: ...vely The repeatability of the minimum thickness measurement was notably lower than the rest of the parameters this is expected as the minimum thickness is a more variable measurement from subject to subject depending upon disease severity Among the ONH parameters the disc area measurement had the largest repeatability limit 0 1506 mm2 and the smallest repeatability limit was the cup volume measure...

Page 324: ...6857 1 7330 4 8525 1 5 Inferior GCL IPL Thickness 0 9962 2 7894 1 1907 3 3339 1 2 Temporal Inferior GCL IPL Thickness 0 8196 2 2948 0 9177 2 5696 1 0 ONH Parameters Average Cup to Disc Ratio 0 0136 0 0380 0 0242 0 0679 5 4 Vertical Cup to Disc Ratio 0 0243 0 0681 0 0302 0 0846 7 1 Disc Area mm2 0 0538 0 1506 0 0942 0 2637 5 4 Rim Area mm2 0 0420 0 1177 0 0619 0 1733 4 7 Cup Volume mm3 0 0065 0 018...

Page 325: ... glaucoma 20 as moderate glaucoma and 19 as severe glaucoma The mean age of the included subjects was 66 9 years with a range from 43 to 89 years The repeatability SD and limits for the GCA parameters are shown in Table B 16 1 Derived from Mwanza JC Chang RP Budenz DL Durbin MK Gendy MG Ski W Feauer WJ Reproducibility of Peripapillary Retinal Nerve Fiber Layer Thickness and Optic Nerve Head Parame...

Page 326: ... 1 6 Inferior GCL IPL Thickness 1 0677 2 9896 1 6 Temporal Inferior GCL IPL Thickness 1 0488 2 9367 1 6 Moderate Glaucoma Average GCL IPL Thickness 0 7661 2 1352 1 2 Minimum GCL IPL Thickness 1 1132 3 1169 2 1 Temporal Superior GCL IPL Thickness 1 3433 3 7611 2 1 Superior GCL IPL Thickness 1 8238 5 1065 2 9 Nasal Superior GCL IPL Thickness 0 8209 2 2986 1 2 Nasal Inferior GCL IPL Thickness 0 8341 ...

Page 327: ...ubject was imaged 3 times during a single visit on each of three CIRRUS OCT instruments by one operator Phase II enrolled 22 subjects and was designed to determine inter operator variability wherein each subject was imaged three times during a single visit by each of three operators Phases I and II enrolled different subjects The CIRRUS HD OCT repeatability and reproducibility are shown in Table B...

Page 328: ... CIRRUS RNFL thickness measurements The repeatability and reproducibility including effects of multiple visits and multiple instruments along with the coefficient of variability are shown in Table B 20 on page B 21 Similar results were also found in an independent study which reported a coefficient of variability of 1 5 in normal subjects and 1 6 in patient eyes2 2 Vizzeri G Weinreb RN Gonzalez Ga...

Page 329: ...jects Mean Thickness μm Repeatability SD μm Reproducibility SD μm Repeatability Limita μm Reproducibility Limitb μm Average 93 1 1 33 1 35 3 72 3 78 Temporal 64 6 2 03 2 05 5 68 5 74 Superior 118 8 3 42 3 45 9 58 9 66 Nasal 68 6 2 19 2 24 6 13 6 27 Inferior 123 6 3 01 3 14 8 43 8 79 Clock hour 1 113 6 4 84 5 05 13 55 14 14 Clock hour 2 84 3 4 7 4 74 13 16 13 27 Clock hour 3 56 4 2 43 2 56 6 80 7 1...

Page 330: ...ckness measurements using Orbscan II Visante ultrasound and Pentacam pachymetry after laser in situ keratomileusis for myopia J Cataract Refract Surg 2007 33 1177 1182 3 Zhao PS Wong TY Wong WL Saw SM Aung T Comparison of central corneal thickness measurements by visante anterior segment optical coherence tomography with ultrasound pachymetry Am J Ophthalmol 2007 Jun 143 6 1047 9 4 Bechmann M Thie...

Page 331: ... with corneal pathology The subjects ranged in age from 25 to 69 years CIRRUS HD OCT Anterior Chamber scans to measure CCT ATA ACD and Pachymetry scans were taken in the Normal Cornea and Corneal Pathology groups For the Post LASIK group only the Pachymetry scans yielding nine measurement zones were taken Visante OCT Anterior Segment Single scans were taken in the Normal Cornea and Corneal Patholo...

Page 332: ...h normal corneas in the study eye Subjects who had undergone LASIK in the study eye Blindness or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images Post LASIK Group Subjects who had undergone prior refractive and corneal surgery except LASIK in the study eye Subjects who had LASIK less than 2 weeks or more than 24 weeks prior to the day of data collection...

Page 333: ... 8 2 674 7 486 0 484 3 218 9 011 0 582 Inner Superior 557 9 3 399 9 518 0 609 4 261 11 930 0 764 Inner Inferior 541 9 2 714 7 598 0 501 3 306 9 257 0 610 Inner Temporal 532 5 1 870 5 237 0 351 2 085 5 837 0 392 Outer Nasal 588 9 4 061 11 370 0 690 4 739 13 268 0 805 Outer Superior 599 7 4 786 13 402 0 798 6 897 19 312 1 150 Outer Inferior 572 4 3 511 9 830 0 613 5 326 14 912 0 930 Outer Temporal 5...

Page 334: ... Temporal 527 9 2 867 8 027 0 543 3 837 10 742 0 727 Outer Nasal 594 3 4 496 12 589 0 756 5 298 14 835 0 891 Outer Superior 606 5 5 534 15 495 0 912 6 185 17 319 1 020 Outer Inferior 572 5 4 233 11 851 0 739 8 945 25 046 1 563 Outer Temporal 556 2 3 821 10 699 0 687 4 792 13 418 0 862 All statistics are estimated from two way random effect ANOVA model with random effects opera tor device eye and i...

Page 335: ... 9 197 25 752 1 576 Outer Superior 580 2 6 972 19 522 1 202 8 915 24 963 1 537 Outer Inferior 560 4 5 560 15 568 0 992 9 557 26 760 1 705 Outer Temporal 530 0 7 294 20 424 1 376 7 382 20 670 1 393 All statistics are estimated from two way random effect ANOVA model with random effects opera tor device eye and interaction between operator device and eye Mean Intercept of the ANOVA model Repeatabilit...

Page 336: ... 1 3 9 1 4 0 1 4 0 347 19 5 16 9 Inner Superior 45 558 7 36 4 558 0 35 4 0 7 11 6 2 8 4 2 0 692 22 5 23 9 Inner Inferior 45 541 9 32 6 542 8 34 9 0 9 6 8 2 9 1 1 0 372 14 5 12 6 Inner Temporal 45 533 0 32 9 537 9 32 4 4 9 6 9 6 9 2 8 001 18 7 8 9 Outer Nasal 45 589 2 33 8 598 2 36 3 9 1 13 8 13 2 4 9 001 36 6 18 5 Outer Superior 44 601 7 39 4 606 3 41 3 4 6 22 7 11 5 2 3 0 183 50 1 40 8 Outer Infe...

Page 337: ... 4 0 10 1 7 8 0 2 0 038 24 1 16 1 Inner Superior 30 559 4 67 2 563 2 71 0 3 9 14 9 9 4 1 7 0 165 33 6 25 9 Inner Inferior 30 534 6 62 7 536 3 58 9 1 8 13 5 6 8 3 3 0 479 28 7 25 2 Inner Temporal 30 528 9 63 7 535 1 64 8 6 2 8 6 9 4 3 0 001 23 4 11 0 Outer Nasal 29 593 9 59 6 607 7 63 6 13 8 14 1 19 1 8 4 001 42 0 14 4 Outer Superior 29 607 1 85 1 618 8 85 5 11 7 13 9 17 0 6 4 001 39 5 16 1 Outer I...

Page 338: ...Scan Type CIRRUS Visante Difference 95 CI 95 LOA Parameter N Mean SD Mean SD Mean SD Mean Difference p value Mean Difference Pachymetry Center 40 465 6 44 3 463 7 44 8 1 8 6 1 0 1 3 8 0 064 10 3 13 9 Inner Nasal 40 515 8 39 8 515 8 38 9 0 0 14 7 4 7 4 7 1 000 29 4 29 4 Inner Superior 40 509 5 39 6 515 6 39 4 6 2 13 6 10 5 1 8 0 007 33 4 21 1 Inner Inferior 40 500 6 39 1 499 2 39 2 1 4 10 8 2 1 4 9...

Page 339: ...were compared separately with the corresponding measurements taken on the Visante OCT The study enrolled 27 subjects ranging in age from 43 to 77 years the mean was 62 years The study population consisted of glaucoma suspects and those with established glaucoma The severity of the disease ranged from mild to severe All enrolled subjects had a variety of angle configurations ranging from Grade II t...

Page 340: ...nd by a single operator on the Visante OCT The first qualified CIRRUS scan from any of the three CIRRUS 5000 devices was used for comparison with the first qualified Visante scan Table 7 shows the results of the repeatability and reproducibility analyses for CIRRUS CIRRUS 5000 Table 8 shows the mean difference between CIRRUS 5000 and Visante OCT Negative differences mean that the measurement on CI...

Page 341: ...0 048 10 764 0 022 0 061 13 786 TISA 750 Nasal 0 281 0 023 0 065 8 305 0 034 0 095 12 085 AOD 500 Nasal 0 461 0 053 0 148 11 496 0 066 0 185 14 332 AOD 750 Nasal 0 621 0 054 0 151 8 699 0 075 0 211 12 162 SSA Nasal 39 186 2 772 7 762 7 074 3 638 10 188 9 285 AC Angle Nasal 38 282 2 517 7 048 6 575 3 433 9 612 8 968 TISA 500 Temporal 0 161 0 020 0 057 12 685 0 026 0 072 16 033 TISA 750 Temporal 0 2...

Page 342: ... 665 5 065 0 488 0 019 14 107 8 554 Temporal 26 35 255 18 767 38 573 18 385 3 318 6 493 5 940 0 695 0 015 16 304 9 669 HD Angle Nasal 27 37 677 17 408 39 974 19 074 2 297 8 411 5 625 1 030 0 168 19 119 14 525 Temporal 27 37 141 19 649 36 767 18 295 0 374 5 934 1 974 2 722 0 746 11 495 12 243 N is the number of eyes with measurements Difference CIRRUS Visante 95 confidence interval CI for mean diff...

Page 343: ...gio 6 2 ONH Angio 6 2 Animation Editor 8 63 Anterior Segment 5 Line Raster Custom scan pattern 6 15 Guidelines for cornea acquisition 6 19 Anterior Segment Cube 512x128 Scan analysis 8 49 Anterior Segment Scans Fixation target 5 12 6 6 HD Angle 6 6 Instrument Imaging Process 6 6 Scan Review 7 11 Archive Archive Management 3 6 Archive Now 3 6 4 8 11 6 Auto Archive 4 10 Preferences 4 8 Retrieve Arch...

Page 344: ...nectivity Status 3 11 DICOM Retrieve 3 6 DICOM Workflow For Modality Worklist 11 7 Dirty lens 6 32 8 21 Distribution of Normals A 16 DRL Slab 9 4 E EDI 6 6 6 26 Edit Categories 4 5 Edit Layers button 8 10 Edit Segmentation dialog 8 10 Edit Staff Records 4 4 Electromagnetic Compatibility EMC 1 10 En face 6 26 7 5 8 17 8 20 8 68 8 69 Scan overlay 8 68 Encryption 1 4 Enhance button 6 28 Enhanced Dept...

Page 345: ... Exams 3 6 3 7 Imported data Data Integrity 11 2 Patient Privacy 11 1 Privacy and Data Integrity Features 11 1 Inner limiting membrane ILM 8 69 Institution Edit 3 8 Institution Logo add to printouts 4 2 Instrument Status 3 10 Internet Connectivity Risks 1 9 Internet protocol versions 3 6 4 11 Iris Illumination dimmed 5 12 6 6 Iris Viewport Click to center pupil 6 29 K Keyboard Mouse Shortcuts 3 9 ...

Page 346: ... Data Details Report 10 15 Normative Database Asian A 24 Optic Nerve Head A 9 O Obscuration ID 11 1 Obscured Patients 11 1 11 3 OCT Angiography Current View References 9 8 Remove Projections 9 8 Omit Patient Identifiers 11 1 11 3 ONH and RNFL OU Analysis Deviation from Normal Map 8 29 RNFL Data Table 8 31 RNFL Thickness Map 8 29 TSNIT Thickness Graphs 8 30 ONH Angio Example Screen 9 2 ONH Angio An...

Page 347: ...work Activities 1 9 Protective Packing Symbols 1 1 Q Quality Check Screen for Montage Scans 7 2 R Rapid Refresh View 6 27 Rate of Change 8 33 Rear Connectors Illustrated 12 2 Red status 3 10 Refractive error 5 3 6 24 Registration Review button 8 15 Repeat Scan dialog 6 30 Replacement Accessories 12 5 Requisition Procedure ID number 11 8 Reset 7 3 Retinal Layers 8 24 Retinal pigment epithelium RPE ...

Page 348: ...strument 3 10 Network 3 10 Red 3 10 Yellow 3 10 Status area 3 9 Status color 3 9 Status components 3 10 Stock Print 10 15 Sub RPE Preset 9 6 Symbols and Labels 1 1 T Tag All button 10 7 Tag for print 10 6 Tagged Images Button 8 72 10 6 TeleService 3 9 Test eye See Verification Test Tool Text Convention 2 5 Thickness Slab 9 4 Today s Patients List 5 9 Top Fan Filter 12 3 Track to Prior button 6 34 ...

Page 349: ...3 USB 3 1 13 3 User Manual Online 3 9 Organization 2 4 Users 3 8 4 3 V Verification check 12 6 Verification Test Tool 12 6 Version information 3 9 View Licenses 3 9 View Today s Patients Tab 5 8 W Whole Eye Slab 9 6 Whole Retina Slab 9 6 Wide Angle to Angle Guidelines for acquisition 6 16 Windows Automatic Update 1 9 4 3 X XML Export 11 9 Y Yellow status 3 10 Z Zip format 11 3 Z offset 6 28 ...

Page 350: ...CIRRUS HD OCT User Manual 2660021169012 Rev A 2017 12 I 8 ...

Page 351: ...CIRRUS HD OCT User Manual 2660021169012 Rev A 2017 12 ...

Page 352: ...25 557 4101 info zeiss com med www zeiss com med Carl Zeiss Meditec AG Goeschwitzer Strasse 51 52 07745 Jena Germany Phone 49 36 41 22 03 33 Fax 49 36 41 22 01 12 info zeiss com med www zeiss com med 2660021169012 Rev A 2017 12 CIRRUS HD OCT Models 500 5000 User Manual Specifications subject to change without notice ...

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