SPECTRALIS Glaucoma Module Premium Edition User Manual Software Version 6.7 November 2016 Heidelberg Engineering GmbH Article No. 97467-004 INT.AE16
Corporate Headquarters Heidelberg Engineering GmbH Max-Jarecki-Str. 8 69115 Heidelberg/Germany Telephone: +49 (0) 6221 64 63 0 Fax: +49 (0) 6221 64 63 62 Australia Heidelberg Engineering Pty Ltd 404 Albert St. East Melbourne 3002 Victoria Telephone: +61 (396) 392 125 Fax: +61 (396) 392 127 UK Heidelberg Engineering Ltd. 55 Marlowes Hemel Hempstead Hertfordshire HP1 1LE Telephone: +44 (0) 1442 502 330 Fax: +44 (0) 1442 242 386 Switzerland Symed Medical Systems GmbH Alte Winterthurerstrasse 88 8309 Nürensdorf/Switzerland Telephone: +41 (0) 44 8887 020 Fax: +41 (0) 44 8887 024 Email: info@heidelbergengineering.com Internet: http://www.heidelbergengineering.com Heidelberg Engineering GmbH
Table of contents Table of contents 1 Preface... 4 1.1 Symbols used in this Document... 4 1.2 Intended Use... 6 1.3 Compatibility... 6 1.4 E-learning... 7 2 Terms and Definitions... 8 3 Workflow... 11 4 Anatomic Positioning System... 12 4.1 Defining the Anatomic Map... 12 4.2 Redefining Anatomic Landmarks... 19 4.3 Activating Anatomic Maps... 20 5 Acquiring Images... 22 5.1 Presets... 22 5.2 Acquiring Images... 22 6 Analyzing Images... 26 6.1 Symbols... 26 6.2 Progression Series... 26 6.3 Confirming Segmentation... 27 6.4 Reviewing APS information... 28 6.5 Analyzing BMO-based Minimum Rim Width... 29 6.5.1 BMO Rim Analysis Tab... 30 6.5.2 BMO Overview Tab... 36 6.5.3 Progression Tab... 39 6.6 Analyzing Peripapillary Retina Nerve Fiber Layer Thickness... 43 6.6.1 RNFL Thickness Tab... 43 6.6.2 Thickness Map Tab... 47 6.7 Analyzing the Posterior Pole... 47 7 Reference Database... 49 7.1 BMO-MRW Reference Database... 49 7.2 RNFL Thickness Reference Database... 51 8 Reports... 55 8.1 Minimum Rim Width Analysis Report... 55 8.2 BMO Overview Report... 56 8.3 Glaucoma Overview Report... 57 8.4 Minimum Rim Width & RNFL Analysis Single Exam Report... 58 8.5 MRW, RNFL & Asymmetry Analysis Single Exam Report... 59 8.6 MRW, RNFL & Visual Field Structure Function Map Report... 61 8.7 Progression Analysis Report... 62 9 Troubleshooting... 64 9.1 Error Messages Image Acquisition... 64 9.2 Error Messages Progression Tab... 65 10 Index... 66 Heidelberg Engineering GmbH, Article No. 97467-004 INT 3
1 Preface Symbols used in this Document 1 Preface This user manual serves as a reference guide for software modules from Heidelberg Engineering. Read the entire user manual to gain a full understanding of the software. It is not necessary to read all the chapters in chronological order. Begin with a topic of interest. Follow the links and references included in the text for guidance to other chapters. If you have any further questions on the SPECTRALIS software, hardware specifications, HEYEX, or operating the software in a network please refer to the following applicable documents ( Applicable documents, p. 4): Applicable documents Article No. Document 230087 SPECTRALIS Product Family User Manual 230006 SPECTRALIS Hardware Manual 230088 HEYEX User Manual 97509 HEYEX Networking and Administrator Guide 1.1 Symbols used in this Document This chapter describes the definition, formatting, and symbols used in this document. Code The code of, for example, the heyex.ini file is identified by monospaced typeface, for example DefaultDevice=1. Cross-references Cross-references are identified by parentheses and a black arrow ( ), for example: ( Cross-references, p. 4). Examples Examples are identified by a gray background over the entire width of the page. Elements of the graphical user interface Elements of the graphical user interface like buttons, window names, or file names are identified by quoted italic font, for example Next. Keys Keys are identified by their symbol, for example +. Lists Lists are used for structuring information and are marked by red squares: List entry List entry 4 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Preface 1 Symbols used in this Document Menu paths Menu paths in the software are identified by quoted italic font. Each menu item is separated by a black triangle u, for example File Save as. Procedures Procedures are used for supporting the reader in completing a task and are marked by red triangles: Step 1. Step 2. Safety messages Safety messages are indicated by symbols in this document. They are marked by a signal word and a safety alert symbol indicating the category of the hazard. WARNING! Warning indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION! Caution with the safety alert symbol indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE! Notice is used to address practices not related to personal injury. This symbol indicates helpful hints for using the device and software. Embedded safety messages Embedded safety messages are integrated into the step of the procedure when they should be followed. L CAUTION! This is an embedded safety message of the type "Caution". The embedded safety message includes the use of a signal word, the safety alert symbol, and the message. This is an embedded safety message of the type "Note". Safety messages answer the following questions: What is the hazard? What are possible consequences of not avoiding the hazard? How should the hazard be avoided? Heidelberg Engineering GmbH, Article No. 97467-004 INT 5
1 Preface Compatibility URL Information available on websites is identified by underlined text, for example http://www.heidelbergengineering.com. Click on the URL to open the corresponding website. 1.2 Intended Use 1.3 Compatibility The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device. It is intended for: viewing the posterior segment of the eye, including two- and threedimensional imaging cross-sectional imaging (SPECTRALIS HRA+OCT and SPECTRALIS OCT) fundus imaging fluorescence imaging (fluorescein angiography, indocyanine green angiography; SPECTRALIS HRA+OCT, SPECTRALIS HRA) autofluorescence imaging (SPECTRALIS HRA+OCT, SPECTRALIS HRA and SPECTRALIS OCT with BluePeak) performing measurements of ocular anatomy and ocular lesions. The device is indicated as an aid in the detection and management of various ocular diseases, including: age-related macular degeneration macular edema diabetic retinopathy retinal and choroidal vascular diseases glaucoma The device is indicated for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. The SPECTRALIS OCT Angiography software is indicated as an aid in the visualization of vascular structures of the retina and choroid. The SPECTRALIS HRA+OCT and SPECTRALIS OCT include reference databases for measurements of retinal layer and optic nerve head anatomy, which are used to quantitatively compare measurements in the human retina and optic nerve head to values found in normal subjects. The following software versions are required to run the SPECTRALIS Glaucoma Module software version 6.7: Heidelberg Eye Explorer (HEYEX) software version 1.9, or higher SPECTRALIS Acquisition Module (AQM) software version 6.7, or higher SPECTRALIS Viewing Module (VWM) software version 6.7, or higher Installed modules Start HEYEX and select Help About in the menu bar of the database window. The About Heidelberg Eye Explorer window is displayed. Check the installed modules. Click OK to close the window. 6 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Preface 1 E-learning 1.4 E-learning The Interactive Video Tutorial offers a quick introduction to the new features and functions of the SPECTRALIS Glaucoma Module Premium Edition. It also provides self-tests that allow you to assess your knowledge about the use of the software without having access to a SPECTRALIS device. Use the innovative, selfeducational tool to learn at your own pace whenever and wherever you would like. The Interactive Video Tutorial is available in English, German, Spanish, French, Portuguese, Italian, Turkish and Chinese. To download the full version, go to http://e-learning.he-academy.com. Heidelberg Engineering GmbH, Article No. 97467-004 INT 7
2 Terms and Definitions 2 Terms and Definitions This chapter defines the abbreviations and terms used in this document. Anatomic landmark An anatomic landmark is a distinct point of reference of the anatomy, which is identified for the examined eye. With APS, two fixed anatomic landmarks are located, the fovea and the Bruch's membrane opening center. Anatomic map The anatomic map consists of the anatomic landmarks and the anatomic landmark image. APS Anatomic Positioning System; the APS uses the anatomic landmarks to automatically position OCT scans. Baseline image The baseline image is the first image of a progression series. BM Bruch's membrane BMO Bruch's Membrane Opening BMO-MRW Bruch's Membrane Opening based Minimum Rim Width BMOC Bruch's Membrane Opening Center C-Curve Corneal Curvature CHO Choroid cslo confocal Scanning Laser Ophthalmoscopy ELM External Limiting Membrane FN False negatives FoBMOC Fovea-to-BMO-center axis; with APS, scans are automatically aligned relative to the patient's individual Fovea-to-BMO-center axis. Follow-up image A follow-up image is an image that has been acquired after the baseline image. It is part of the progression series. FP False positives 8 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Terms and Definitions 2 GCL Ganglion Cell Layer HEP Heidelberg Edge Perimeter HEYEX Heidelberg Eye Explorer HR High resolution mode; if you select HR as the scan resolution mode, images are acquired with a higher spatial scan resolution but with a low scan rate. HR acquires more data points over a longer time period and requires more time and space for data storage. HS High speed mode; if you select HS as the scan resolution mode, images are acquired at a faster rate but will be of a lower resolution. HS is optimized for fast image acquisition with a high frame rate and reduced data storage. ILM Internal Limiting Membrane INL Inner Nuclear Layer IPL Inner Plexiform Layer OCT Optical Coherence Tomography ONH Optic nerve head ONH-RC The ONH-RC scan pattern combines a radial scan and three concentric circle scans centered on the ONH with APS. ONL Outer Nuclear Layer OPL Outer Plexiform Layer PPole Posterior pole PPR Peripapillary retina PR1 First Photoreceptor Layer PR2 Second Photoreceptor Layer RNFL Retinal Nerve Fiber Layer Heidelberg Engineering GmbH, Article No. 97467-004 INT 9
2 Terms and Definitions RNFLT Retinal Nerve Fiber Layer Thickness RPE Retinal pigment epithelium Segmentation lines A segmentation line marks and belongs to either a certain retinal structure (ILM, PR1, PR2, RPE, BM) or the outer boundary of a retinal or sub-retinal layer (RNFL, GCL, IPL, INL, OPL, ONL, CHO). Each segmentation line is named by the structure or layer to which it belongs. For example, the segmentation line along the boundary between GCL and IPL is named "GCL"; and the GCL thickness is given by the distance between the two segmentation lines named "RNFL" and "GCL". Sweet Spot The four blue markers on the OCT image in the acquisition window indicate the Sweet Spot. This is the recommended area to place the structure of interest for the best OCT image quality. For normal OCT acquisitions, the Sweet Spot is located in the upper third of the OCT image. VF Visual field 10 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Workflow 3 3 Workflow Heidelberg Engineering GmbH, Article No. 97467-004 INT 11
4 Anatomic Positioning System Defining the Anatomic Map 4 Anatomic Positioning System 4.1 Defining the Anatomic Map Image acquisition using the Anatomic Positioning System (APS) ensures that OCT images are acquired at fixed and known retinal locations relative to certain retinal anatomical landmarks, such as the fovea and the BMO center. WARNING! Wrong classification results may be caused by imprecisely defined anatomic landmarks If the anatomic landmarks are not defined correctly, classification results may be wrong. Wrong classification results may lead to wrong diagnostic conclusions which may result in wrong therapeutic approaches. The APS proposes the position of the anatomic landmarks. Double-check the positions of the anatomic landmarks and correct them, if necessary. The anatomic map is the basis for positioning APS scans and needs to be defined prior to the first examination. The definition of the anatomic map is divided into the following four steps: Step 1 - Detecting the fovea position Step 2 - Confirming the fovea position Step 3 - Detecting the BMO center position Step 4 - Confirming the BMO center position After the anatomic map is defined, acquire an image. This image will then be the baseline image of a progression series. After image acquisition, check and confirm the BMO segmentation. Importance of C-Curve For APS definition, the C-Curve values entered in the Eye Data dialog box are critical as these values affect the absolute measurement results. C-Curve is the radius of curvature of the anterior corneal surface. For an astigmatic eye, it is given by the average of the steep and the flat corneal curvature values. The C-Curve value is fixed You cannot change the C-Curve value for an existing progression series. If you want to update the C-Curve value because it is wrong or for a patient who underwent invasive surgery, you have to re-define anatomic landmarks and start a new progression series. For further information on re-defining anatomic landmarks, please refer to ( Chapter 4.2 Redefining Anatomic Landmarks, p. 19). For further information on entering or updating the patient's eye data, please refer to the SPECTRALIS User Manual. Preparing the examination Switch on the device. Prepare the device. 12 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Anatomic Positioning System 4 Defining the Anatomic Map Prepare the patient. Move the camera to the farthest back position. Click to start HEYEX. Create or select a patient file. To start a new examination, click in the tool bar. The Examination Data dialog box is displayed. Enter the required data and click OK to confirm. The Eye Data dialog box is displayed. Enter the patient's C-Curve value correctly. If the C-Curve standard value 7.7 mm remains unchanged, examination results may deviate from actual values. Click OK to confirm. If you do not change the C-Curve values from the preset value of 7.7 mm, a message will be displayed asking to verify that both C-Curve values are correct. Measurements will only be accurate if the C-Curve values are correct. The acquisition window opens. After initializing, turns to. Press either on the touch panel or click in the acquisition window. A high tone is audible when the scanners and the laser are switched on. The camera starts and the cslo image is displayed. turns to. Turn the filter wheel to the filter wheel position R. If your device is a SPECTRALIS HRA+OCT press OCT on the touch panel and select an OCT acquisition mode, for example IR +OCT. If your device is a SPECTRALIS OCT, click in the acquisition window and select an cslo acquisition mode, for example IR. The OCT acquisition window opens. To examine the right eye, move the camera to the left. In the Settings section, OD is automatically selected due to the left-right recognition of the camera. Open the Application&Structure drop-down list and select Glaucoma as the application. Heidelberg Engineering GmbH, Article No. 97467-004 INT 13
4 Anatomic Positioning System Defining the Anatomic Map Select an APS preset, for example ONH-RC. The nasal fixation light is automatically switched on, IR is automatically selected as the acquisition mode, and HS is automatically selected as the scan resolution. In the cslo image, a red + is displayed. Fig. 1: OCT window divided in two sections The OCT section is automatically vertically divided and shows two section images. In the upper part of the OCT section, the corresponding section images of the vertical line of the red + is displayed. In the lower part of the OCT section, the corresponding section images of the horizontal line of the red + is displayed (Fig. 1). In the lower part of the OCT section, the OCT image is cropped either on the left side or on the right side depending on the examined eye. This crop is due to the 15 scan protruding the image border in the cslo image. Ask the patient to look at the fixation light during the examination. Aligning the camera Fig. 2: Aligning the cslo image Move the camera slightly to the left or the right and turn the joystick so that the bright spot is centered in the cslo image (Fig. 2). If your device is a SPECTRALIS HRA+OCT, try to avoid pivoting the camera head. 14 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Anatomic Positioning System 4 Defining the Anatomic Map Move the camera slowly towards the patient s eye until an evenlyilluminated cslo image is displayed (Fig. 2). L WARNING! Careless movement of the camera might injure the patient's eye. Adjust the camera carefully. Check the distance between the lens and the patient s eye continuously. If the cslo image has dark edges closer to the patient's eye. (Fig. 2), move the camera If the cslo image is too dark in the upper part, turn the joystick counterclockwise to move the camera down. If the cslo image is too dark in the lower part, turn the joystick clockwise to move the camera up. If the cslo image is too dark on the right side camera to the left. If the cslo image is too dark on the left side camera to the right. (Fig. 2), move the (Fig. 2), move the If the cslo image is well-illuminated but out of focus, turn the focus knob and adjust the patient's refraction so that the vessels and the cslo image are sharply displayed. L WARNING! Incorrect classification results may be caused by incorrect focus settings during image acquisition. Classification results may be incorrect if the calculation is based on incorrect refraction values. Incorrect classification results may lead to incorrect diagnostic conclusions which may result in incorrect therapeutic approaches. Always check the correct focus settings. The refraction is displayed as the Focus value in the Settings section of the acquisition window. If the cslo image is overexposed and manual image brightness control is selected, turn until the image is illuminated correctly. If your device is a SPECTRALIS OCT, the manual image brightness control is not available. For further information on manual and automatic image brightness control, please refer to the SPECTRALIS User Manual. Aligning the OCT image Fig. 3: Aligning the OCT image Move the camera slowly towards the patient s eye until the OCT image is displayed in the Sweet Spot. Heidelberg Engineering GmbH, Article No. 97467-004 INT 15
4 Anatomic Positioning System Defining the Anatomic Map If the bar above the OCT image is red, move the camera slowly back from the patient's eye until the bar displays a gray scale. In some medical cases, for example posterior vitreous detachment, it is possible that the bar above the OCT image may remain red even though the OCT image is properly aligned. Check the OCT image for high image contrast and high image resolution. If the OCT image is upside down, move the camera slowly back from the patient's eye until the OCT image is displayed correctly. If the OCT image is pivoted horizontally or the image contrast varies in the OCT image, move the camera slightly left or right by means of the joystick until the OCT image is aligned correctly and the image contrast is evenly high. Step 1 - Detecting the fovea position In the Scan section, Start Fovea Detection blinks. Click either Start Fovea Detection, press Acquire on the touch panel, or press the button on the joystick. The small live images are displayed in the lower section of the acquisition window. ART Mean is automatically switched on. The progression bar increases as the fovea is being detected. Keep the hands on the device and readjust the camera as needed. Step 2 - Confirming the fovea position If the fovea has been detected, Confirm Fovea Position blinks in the Scan section. In the cslo image, the red + has turned blue. In the OCT images, blue dashed lines indicate the position of the fovea. If the fovea cannot be detected or the detection timed out, the + in the cslo image stays red and the dashed lines in the OCT images are also red. Check if the fovea has been detected correctly. If the fovea has been detected incorrectly, drag-and-drop the red + in the cslo image at the thinnest part of the retina indicating the fovea position. Go to the OCT images and click on the thinnest part of the retina indicating the fovea position. Depending on the area that is selected in one of the OCT images, the already correct foveal position in the other OCT image may become invalid again. In several cases it might be possible that the manual detection of the fovea needs to be repeated several times. If the fovea position has been detected correctly, the red + turns blue in the cslo image and the red dashed lines turn blue in the OCT images. Alternatively, click Back to re-start the automatic detection of the fovea. Click Confirm Fovea Position. The position of the fovea is confirmed. Now the BMO needs to be detected. 16 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Anatomic Positioning System 4 Defining the Anatomic Map Step 3 - Detecting the BMO center position If the fovea position is confirmed, Start BMO Detection blinks in the Scan section. ART Mean is still active. In the cslo image, a red X is displayed at the estimated BMO center position. If the red X is not positioned near the estimated BMO center, dragand-drop the red X to the center of the optic nerve head. Fig. 4: OCT window divided in two sections The OCT section is still vertically divided. In the upper part of the OCT section you will see the corresponding section image of the axis from the lower left to the upper right of the red X in the cslo image. In the lower section you will see the corresponding section image of the axis from the upper left to the lower right of the red X in the cslo image (Fig. 4). Adjust the camera so that the cslo image is well illuminated, the image contrast is evenly high, and the OCT image is as horizontally aligned as possible. Check if the quality bar is blue and as long as possible. Either click Start BMO Detection, press Acquire on the touch panel, or press the button on the joystick. The progression bar increases as the BMO center is being detected. Keep the hands on the device and readjust the camera as needed. Heidelberg Engineering GmbH, Article No. 97467-004 INT 17
4 Anatomic Positioning System Defining the Anatomic Map Step 4 - Confirming the BMO center position If the BMO center has been detected, Confirm BMO Position blinks in the Scan section. The red X has turned blue. If the BMO center cannot be detected or the detection timed out, the X in the cslo image stays red and the dashed lines in the OCT images are also red. Check if the BMO center has been detected correctly. Fig. 5: Blue lines indicating BMO If the BMO center has been detected incorrectly or if the BMO center cannot be detected, drag-and-drop the blue vertical lines indicating the Bruch's Membrane Opening in the OCT window to the desired position (Fig. 5). The vertical lines correspond to the circles on the X in the cslo image. If the BMO center has been detected incorrectly, drag-and-drop the red X in the cslo image at the center of the optic nerve head. Go to the OCT images and click on the end of Bruch's Membrane. Adjusting the BMO endpoint in one OCT image may affect the proper location of the endpoint in the other OCT image. It might be possible that the manual detection of the Bruch's Membrane end needs to be repeated several times. If the BMO center position has been detected correctly, the red X turns blue in the cslo image and the red dashed lines turn blue in the OCT images. If the blue X is positioned so that blood vessels hide the Bruch's Membrane in the OCT image, click or to rotate the blue X. Alternatively, click Back to re-start the automatic detection of the BMO center. Click Confirm BMO Position. The position of the BMO center is confirmed. In the cslo image, the selected scan pattern and the fovea-to-bmo-center axis are displayed. The small live images disappear. In the Scan section, the ART Mean settings for the selected APS scan are displayed. For example, if you have selected the ONH-RC preset, the ART Mean settings for the radial scan and for the circle scans are displayed. 18 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Anatomic Positioning System 4 Redefining Anatomic Landmarks Acquiring the baseline image If your device is a SPECTRALIS HRA+OCT, press Acquire on the touch panel. If your device is a SPECTRALIS OCT, press the button on the joystick briefly. The image acquisition starts using the selected preset. The small live images are displayed again. If you selected the ONH-RC preset, the radial scan is acquired. ART Mean counts to 25 frames. Then, the three circle scans are acquired. ART Mean counts to 100 frames. Watch the small live images for an even illumination. Keep the hands on the device and readjust the camera as needed. The image acquisition stops automatically. To close the acquisition window, click. The acquired images are saved. The acquired images are displayed in the image viewing window in the form of image thumbnails. The baseline image is marked with indicating the unconfirmed baseline examination. The next step is to confirm the BMO segmentation. Confirming the BMO segmentation Please confirm the BMO segmentation right after the image acquisition If the distance between the scan center and the BMOC is greater than 100 μm, Heidelberg Engineering recommends repeating the baseline image acquisition before the patient leaves the examination room. Otherwise, the patient might need an additional visit for re-examining a baseline image. For further information on confirming the BMO segmentation, please refer to ( Chapter 6.3 Confirming Segmentation, p. 27). Exiting the Confirmation To close the analysis window, click. In the image viewing window, the image thumbnail is marked with. 4.2 Redefining Anatomic Landmarks If the distance between the scan center and the BMO center is greater than 100 μm in a follow-up image, Heidelberg Engineering recommends redefining the anatomic landmarks. With these new anatomic landmarks, a new progression series will be created. If you redefine the anatomic landmarks, newly acquired OCT images will not be comparable to already acquired images For the new Anatomic Map, a new baseline image will be created. The already existing progression series will be closed. Select the desired patient file and start a new examination. The acquisition window opens. After initializing, turns to. Heidelberg Engineering GmbH, Article No. 97467-004 INT 19
4 Anatomic Positioning System Activating Anatomic Maps Press either on the touch panel or click in the acquisition window. A high tone is audible when the scanners and the laser are switched on. The camera starts and the cslo image is displayed. turns to. Select Setup Redefine Anatomic Landmarks for APS in the menu bar. You will receive a warning message indicating that new OCT images will not be comparable to already acquired images. Click OK to confirm. In the Scan section, Start Fovea Detection blinks. Please follow the steps 1 to 4 for defining anatomic landmarks in ( Chapter 4.1 Defining the Anatomic Map, p. 12) and acquire an image. This image will then be the baseline image of a new progression series. The already existing baseline image will be closed. The baseline image of the closed progression series will be marked with. The follow-up images of the closed progression series will be marked with. Confirm the BMO segmentation ( Chapter 6.3 Confirming Segmentation, p. 27). The redefined anatomic landmarks and the anatomic map are activated. 4.3 Activating Anatomic Maps A patient file may contain several anatomic maps for the following reasons: You redefined an anatomic map during an examination instead of using an already existing anatomic map. You confirmed a BMO segmentation and defined a new anatomic map. You imported E2E files containing anatomic maps. You can reactivate existing anatomic maps in order to continue the existing progression series, and you can activate the anatomic map of imported E2E files to continue the imported progression series. Please note that the following procedure assumes the presence of two different anatomic maps. Images acquired with the active anatomic map are marked with or. Images acquired with the inactive anatomic map are marked with or. For further information on APS symbols, please refer to ( 6.1 Symbols, p. 26). Double-click the image thumbnail for which you would like to activate the anatomic map. The analysis window opens. 20 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Anatomic Positioning System 4 Activating Anatomic Maps Select APS Activate Anatomic Map in the menu bar. The anatomic map of the currently selected image is activated. The image thumbnail marked previously with is now marked with and vice versa. For further information on APS symbols, please refer to ( Chapter 6.1 Symbols, p. 26). Heidelberg Engineering GmbH, Article No. 97467-004 INT 21
5 Acquiring Images Acquiring Images 5 Acquiring Images 5.1 Presets Scan pattern 24 radial scans 3 circle scans Scan size Length 15 Diameter 3.5 mm, 4.1 mm, 4.7 mm Center position of scan pattern Orientation of linear section images Volume Volume Circle Volume 30 x 25 30 x 15 Diameter 12 15 x 15 BMOC BMOC Fovea Fovea adjustable adjustable Central scan on FoBMOC axis Parallel to FoBMOC axis Perpendic ular to FoBMOC axis adjustable # section images 24 3 61 19 1 73 Distance between section images 7.5 0.3 mm 120 μm 240 μm 60 μm # ART Mean 25 100 9 9 100 9 Scan angle cslo image [ ] 30 x 30 30 x 30 30 x 30 30 x 30 30 x 30 30 x 30 Image resolution HR HS HS HR HS HS EDI n/a n/a off off n/a off Fixation light nasal nasal central central nasal nasal Structure ONH PPR Retina Retina PPR ONH 5.2 Acquiring Images Starting the examination Switch on the device. Start HEYEX. Prepare the device. Prepare the patient. Move the camera to the farthest back position. Select a patient file. Start a new examination. The acquisition window is displayed. After initializing,. turns to Press either on the touch panel or click in the acquisition window. A high tone is audible when the scanners and the laser are switched on. The camera starts and the cslo image is displayed. turns to. 22 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Acquiring Images 5 Acquiring Images Turn the filter wheel to the filter wheel position A or R correctly. If your device is a SPECTRALIS HRA+OCT press OCT on the touch panel and select an OCT acquisition mode, for example IR +OCT. If your device is a SPECTRALIS OCT, click in the acquisition window and select an cslo acquisition mode, for example IR. The OCT acquisition window opens. To examine the right eye, move the camera to the left. In the Settings section, OD is automatically selected due to the left-right recognition of the camera. Open the Application&Structure drop-down list and select Glaucoma as the application. Select an APS preset, for example ONH-RC. If you selected the ONH-RC preset, the nasal fixation light is automatically switched on. In the cslo image, the BMO center and the fovea position are automatically identified. If the anatomic landmarks are not identified automatically, they have not yet been defined. Please refer to ( Chapter 4.1 Defining the Anatomic Map, p. 12) and follow the instructions for defining anatomic landmarks. In the OCT image, the BMO center is marked by a dashed line. Ask the patient to look at the fixation light during the examination. Aligning the camera Fig. 6: Aligning the cslo image Move the camera slightly to the left or the right and turn the joystick so that the bright spot is centered in the cslo image (Fig. 6). If your device is a SPECTRALIS HRA+OCT, try to avoid pivoting the camera head. Move the camera slowly towards the patient s eye until an evenlyilluminated cslo image is displayed (Fig. 6). L WARNING! Careless movement of the camera might injure the patient's eye. Adjust the camera carefully. Check the distance between the lens and the patient s eye continuously. If the cslo image has dark edges, move the camera closer to the patient's eye. If the cslo image is too dark in the upper part, turn the joystick counterclockwise to move the camera down. If the cslo image is too dark in the lower part, turn the joystick clockwise to move the camera up. Heidelberg Engineering GmbH, Article No. 97467-004 INT 23
5 Acquiring Images Acquiring Images If the cslo image is too dark on the right side, move the camera to the left. If the cslo image is too dark on the left side, move the camera to the right. If the cslo image is well-illuminated but out of focus, turn the focus knob and adjust the patient's refraction so that the vessels and the cslo image are sharply displayed. L WARNING! Incorrect classification results may be caused by incorrect focus settings during image acquisition. Classification results may be incorrect if the calculation is based on incorrect refraction values. Incorrect classification results may lead to incorrect diagnostic conclusions which may result in incorrect therapeutic approaches. Always check the correct focus settings. The refraction is displayed as the Focus value in the Settings section of the acquisition window. If the cslo image is overexposed and manual image brightness control is selected, turn until the image is illuminated correctly. If your device is a SPECTRALIS OCT, the manual image brightness control is not available. For further information on manual and automatic image brightness control, please refer to the SPECTRALIS User Manual. Aligning the OCT image Fig. 7: Aligning the OCT image Move the camera slowly towards the patient s eye until the OCT image is displayed in the Sweet Spot. If the bar above the OCT image is red, move the camera slowly back from the patient's eye until the bar displays a gray scale. In some medical cases, for example posterior vitreous detachment, it is possible that the bar above the OCT image may remain red even though the OCT image is properly aligned. Check the OCT image for high image contrast and high image resolution. If the OCT image is upside down, move the camera slowly back from the patient's eye until the OCT image is displayed correctly. If the OCT image is pivoted horizontally or the image contrast varies in the OCT image, move the camera slightly left or right by means of the joystick until the OCT image is aligned correctly and the image contrast is evenly high. 24 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Acquiring Images 5 Acquiring Images Acquiring images with ART Mean If your device is a SPECTRALIS HRA+OCT, press Acquire on the touch panel. If your device is a SPECTRALIS OCT, press the button on the joystick briefly. The image acquisition starts. ART Mean is automatically switched on. The small live images are displayed in the lower section of the acquisition window. The progression bar increases as the ART Mean counts the preset number of frames. Images can be acquired before ART Mean reaches the adjusted number of frames. Watch the small live images for an even illumination and proper orientation of the OCT image. Keep the hands on the device and readjust the camera as needed. The image acquisition stops automatically as soon as all section images are acquired. ART Mean is automatically switched off. To acquire several images, press Acquire or the button on the joystick again. To examine the left eye, move the camera to the right. In the Settings section, OS is automatically selected. Realign the camera and repeat the previous steps. Click Save images in the menu bar. If you have acquired multiple images and did not close the acquisition window over a longer period, click Save images to prevent data loss in case of PC and/or hardware problems. Quitting the examination To switch off the camera, press on the touch panel or click in the acquisition window. turns to. To quit the examination and close the acquisition window, click. The acquired images are saved. The acquisition window closes. The acquired images are displayed in the image viewing window in the form of image thumbnails. Review the images. Heidelberg Engineering GmbH, Article No. 97467-004 INT 25
6 Analyzing Images Progression Series 6 Analyzing Images 6.1 Symbols The image thumbnails displayed in the image viewing window are marked with the following symbols. Baseline image Follow-up image Image acquired with an APS preset Anatomic map is deactivated BMO segmentation is not yet confirmed Manually closed progression series Example indicates a baseline image acquired with an APS scan. The anatomic map is activated and the BMO segmentation is not yet confirmed. indicates a follow-up image. The anatomic map is deactivated. After image acquisition, image thumbnails are marked with indicating that the BMO segmentation has not yet been confirmed. For further information on confirming BMO segmentation, please refer to ( Chapter 6.3 Confirming Segmentation, p. 27). 6.2 Progression Series After you have defined the anatomic landmarks and acquired a baseline image, all images acquired using APS presets will automatically form a progression series. References In the Glaucoma application, the reference set on a baseline image cannot be changed by the Set reference function. The reference stays on the baseline image. If you want to re-set a reference, re-define the anatomic landmarks and acquire a new baseline image using APS presets. Please note that this will start a new progression series and newly acquired OCT images will not be comparable to already acquired images. For further information on re-defining anatomic landmarks, please refer to ( Chapter 4.2 Redefining Anatomic Landmarks, p. 19). Excluding images from a progression series You can exclude each image from a progression series. In order to exclude an image from a progression series, right-click an image thumbnail marked with in the image viewing window. The context menu opens. Select Progression Ex/Include. The image is excluded from the progression series and will no longer affect progression results. Including images into a progression series You can include each follow-up image that has previously been excluded into a progression series. In order to include an image into a progression series, right-click an image thumbnail marked with in the image viewing window. The context menu opens. 26 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Confirming Segmentation Select Progression Ex/Include. The image is included into the progression series and will affect progression results. For further information on progression series, please refer to the SPECTRALIS User Manual. 6.3 Confirming Segmentation After you have acquired an image with the ONH-RC preset, the BMO segmentation needs to be confirmed. In the image viewing window, double click an image thumbnail marked with or. You will receive a message indicating that the volume data is calculated. Then, you will receive a message indicating that the minimum rim is being calculated. Please note that these processes may take up to one minute. The analysis window opens and the BMO Rim Analysis tab is displayed. In the Minimum Rim Width chart you will receive a message indicating that the segmentation has not yet been confirmed. Below the OCT image, is displayed. Confirming the segmentation Turn the mouse wheel and scroll through the acquired image. In the OCT image, check the position of the red dots indicating the BMO locations and correct them if necessary. For further information on editing the BMO points, please refer to ( Chapter 6.5.1.7 Editing the BMO Points, p. 35). Check the segmentation of the ILM and correct it, if necessary. For further information on the Segmentation Editor, please refer to the SPECTRALIS User Manual. Click to confirm both, the BMO segmentation and the ILM segmentation. Distance between scan center and BMOC Once the segmentation of the BMO locations is confirmed, the true BMO center is defined as the geometric center of the confirmed 48 individual BMO points. This BMO center can differ from the scan center identified during the Anatomic Map definition. For correct analysis of BMO-MRW and RNFLT, it is important that the distance between the scan center and the BMOC is not more than 100 μm. Distance between scan center and BMOC 100 μm If the distance between the scan center and the BMOC is 100 μm and the User Account Management is enabled, your confirmation is accepted without querying your user name. If the User Account Management is disabled, a dialog will prompt you to enter your user name. Enter your name and click OK to confirm. Your confirmation is accepted. Heidelberg Engineering GmbH, Article No. 97467-004 INT 27
6 Analyzing Images Reviewing APS information Distance between scan center and the BMOC > 100 μm If the distance between the scan center and the BMOC is > 100 μm, a window is displayed offering the options Set BMO center as new scan center (Recommended) and Continue with displaced scan center. Heidelberg Engineering recommends selecting Set BMO center as new scan center (Recommended) whenever possible. The anatomic map with displaced landmarks will be deactivated. The image thumbnail will be marked with. A new, corrected anatomic map will be automatically created. Acquire a new image ( 5 Acquiring Images, p. 22). Only consider selecting Continue with displaced scan center in the following cases: It is not feasible or too difficult to reexamine the patient. This might be the case due to lack of cooperation, due to the patient s medical conditions such as strong nystagmus, or if the patient does not agree to a repeat examination. Long-term monitoring is planned, and you consider comparability over time more important than accuracy of the individual classification results. The displaced anatomic landmarks will be accepted and used for identifying the BMO center and the fovea in follow-up examinations. Closing the analysis window Click to close the analysis window. The image thumbnail is marked with or. 6.4 Reviewing APS information The information about the APS is logged. If you want to review this information, follow the procedure: Select a patient file containing APS scans. Double-click an image thumbnail. The analysis window opens. Select APS Info in the menu bar. The following information is displayed: Landmarks defined by : the logged user name is displayed Landmark Definition Date : the date of the anatomic map definition is displayed Landmark Definition Location : the institute where the anatomic map has been defined is displayed BMO Center confirmed by : the logged user name is displayed BMO Center Confirmation Date : the date of confirmation is displayed BMO Center Confirmation Location : the institute where BMO center has been confirmed is displayed 28 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width 6.5 Analyzing BMO-based Minimum Rim Width Measurement of BMO-based minimum rim width is performed from radial section images centered at the center of Bruch s membrane opening. The location of BMO is identified in each of the radial section images. The BMO-MRW is then measured as the shortest distance from each identified BMO point to the internal limiting membrane. Heidelberg Engineering GmbH, Article No. 97467-004 INT 29
6 Analyzing Images Analyzing BMO-based Minimum Rim Width 6.5.1 BMO Rim Analysis Tab Fig. 8: BMO Rim Analysis tab Patient information Menu bar Tool bar with follow-up control cslo image ( 6.5.1.1 cslo Image, p. 30) OCT image ( 6.5.1.2 OCT Image, p. 31) Zoom and pan mode BMO-MRW classification chart with overall classification ( 6.5.1.3 BMO-MRW Classification Chart, p. 32) Switching between the cslo image and an imported fundus image ( 6.5.1.4 Switching Between the cslo Image and an Imported Fundus Camera Image, p. 33) Zoom and pan mode Reference database ( 7.1 BMO-MRW Reference Database, p. 49) Y-scale functions Segmentation Editor Editing BMO points ( 6.5.1.7 Editing the BMO Points, p. 35) BMO-MRW diagram ( 6.5.1.5 BMO-MRW Diagram, p. 33) Image information BMO segmentation confirmation ( 6.3 Confirming Segmentation, p. 27) 6.5.1.1 cslo Image The red dots superimposed on the cslo image indicate the BMO points as identified in the individual section images. The following three display options can be selected: 30 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width Fig. 9: Display options BMO points and section image positions displayed BMO points displayed OCT section image positions displayed When you open the analysis window, the BMO points and the OCT section image position are displayed (Fig. 9). To show and hide the BMO points and the white lines indicating the standard sectors (Fig. 9), select either HRA Image Show BMO Contour in the menu bar or press on the keyboard. To show and hide the OCT section image position (Fig. 9), select either HRA Image Show Scan Positions in the menu bar or press on the keyboard. Standard sectors Solid white lines superimposed on the cslo image (Fig. 9) indicate the following six standard sectors: T temporal (315 to 45 ) TS temporal-superior (45 to 85 ) TI temporal-inferior (275 to 315 ) N nasal (125 to 235 ) NS nasal-superior (85 to 125 ) NI nasal-inferior (235 to 275 ) The dotted white line indicates the fovea-to-bmo-center axis, which defines the 0 position of the optic disc circumference. BMO area In the lower right corner of the cslo image, the BMO area is displayed. The BMO area is used for reference data adjustment. 6.5.1.2 OCT Image Red dots indicate the identified BMO points; the red line indicates the internal limiting membrane. The blue arrows extending from the BMO points to the ILM indicate the shortest distance from BMO to ILM. The length of an arrow equals the BMO-MRW at that location. For further information on editing the BMO points, please refer to ( Chapter 6.5.1.7 Editing the BMO Points, p. 35). Heidelberg Engineering GmbH, Article No. 97467-004 INT 31
6 Analyzing Images Analyzing BMO-based Minimum Rim Width 6.5.1.3 BMO-MRW Classification Chart The BMO-MRW classification chart represents the average BMO- MRW and the classification results for the global average (G), displayed in the center, and the six standard sectors, with 0 defined by the fovea-to-bmo-center-axis: T temporal (315 to 45 ) TS temporal-superior (45 to 85 ) NS nasal-superior (85 to 125 ) N nasal (125 to 235 ) NI nasal-inferior (235 to 275 ) TI temporal-inferior (275 to 315 ) The black numbers are the measured average BMO-MRW in μm. The percentage numbers in parentheses are the corresponding percentiles of the normal distribution, adjusted for the age of the examined subject and the BMO area of the examined eye. Example For example, a value of 11% (the 11 th percentile of the normal distribution) means that 11% of the eyes in the reference database have BMO-MRW values of this size or smaller. Please refer to ( 7.1 BMO-MRW Reference Database, p. 49) for the size, demographics, and clinical characteristics of the reference database cohort. Color-coding The pie chart is color-coded according to this percentile, to indicate whether a sector is classified as follows: A green sector represents the range above the 5 th percentile of the BMO-MRW distribution across the eyes in the reference database. This range is considered as within normal limits. A yellow sector represents the range below the 5 th percentile but above the 1 st percentile of the BMO-MRW distribution across the eyes in the reference database. This range is considered as borderline. A red sector represents the range below the 1 st percentile of the BMO-MRW distribution across the eyes in the reference database. This range is considered as outside normal limits. Overall classification result The text and color-coding of the bar below the pie chart indicate the following overall classification of the examined eye: A green bar indicates that all sectors and global are classified as within normal limits. A yellow bar indicates that one or more sectors or global are classified as borderline but none as outside normal limits. A red bar indicates that one or more sectors or global are classified as outside normal limits. For further information on the size, demographics, and clinical characteristics of the reference database cohort, please refer to ( 7.1 BMO-MRW Reference Database, p. 49). 32 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width C-curve and distance between scan center and BMO center The following further information is displayed in the BMO-MRW classification chart : C-Curve value Distance between scan center and BMO center as calculated from all radial scans indicated by BMOC. This value is only displayed if the BMO segmentation has been confirmed. 6.5.1.4 Switching Between the cslo Image and an Imported Fundus Camera Image This functions allows for switching between the display of the cslo image and an imported fundus camera image which is automatically aligned to the cslo image. The imported fundus camera image should be a 45 or 30 image with the optic disc in its center. If the fundus camera image does not meet these specifications, or if you select a different image type, the alignment of the fundus camera image to the cslo image might fail and the fundus camera image will not be displayed properly. For further information on importing images, please refer to the Image Capture Module User Manual. To switch between the cslo image and the fundus camera image, click. If more than one fundus camera image has been imported for one cslo image, one of the fundus camera images is automatically selected, based on the following criteria: If a fundus camera image was dragged into the lightbox, this image is selected and aligned. The fundus camera image last displayed is selected and aligned. The fundus camera image imported at a day closest to the day of the subject's SPECTRALIS examination is selected and aligned. 6.5.1.5 BMO-MRW Diagram The BMO-MRW diagram displays the following information: The BMO-MRW profile measured along the optic disc circumference. The normal range of BMO-MRW. The black line indicates the measured BMO-MRW. In a follow-up examination, the baseline values are displayed as a gray curve. The horizontal axis represents the position along the optic disc circumference in degrees, with 0 located at the fovea-to-bmocenter axis (temporal) and the angle increasing clockwise for a right eye and counter-clockwise for a left eye. That is, the sequence is temporal to superior to nasal to inferior to temporal. The vertical axis represents the measured BMO-MRW in μm. Heidelberg Engineering GmbH, Article No. 97467-004 INT 33
6 Analyzing Images Analyzing BMO-based Minimum Rim Width Fig. 10: Incorrect segmentation identified in BMO-MRW diagram If you recognize isolated peaks in the black and gray curves of the BMO-MRW diagram (Fig. 10), the BMO segmentation might be incorrect. Check the BMO segmentation and correct it if necessary. For further information on editing the BMO points, please refer to ( Chapter 6.5.1.7 Editing the BMO Points, p. 35). Color-coding The following three range bands are displayed in the BMO-MRW diagram: The green band represents the range between the 5 th and the 95 th percentile of the BMO-MRW distribution across the eyes in the reference database. This range is considered as within normal limits. The green line within this green band represents the mean BMO-MRW of the eyes in the reference database (50 th percentile). The red band represents the range below the 1 st percentile of the BMO-MRW distribution across the eyes in the reference database. This range is considered as outside normal limits. The yellow band represents the range below the 5 th percentile but above the 1 st percentile of the normal distribution. This range is considered as borderline. The range bands are adjusted for the age of the examined subject and for the BMO area of the examined eye. For further information on the size, demographics, and clinical characteristics of the reference database cohort, please refer to ( 7.1 BMO-MRW Reference Database, p. 49). The classification results Borderline and Outside normal limits do not necessarily indicate that measured values relate to disease states. Likewise, the classification result Within normal limits does not necessarily indicate that disease is completely ruled out. CAUTION! Clinicians must exercise judgment in the interpretation of the reference data For any particular measurement, note that 1 out of 20 eyes in the reference database (5%) will fall below the green range, and 1 out of 20 eyes in the reference database (5%) will fall above the green range. 34 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width CAUTION! Always take the patient s disk size and racial and ethnic descent into account when interpreting classification results Classification results for very small and very large discs may not be as reliable as results for discs of average size. Classification results may not be reliable for patients whose racial and ethnical descent differ from those in the reference database. For easy identification in the software and on reports, classification results are always displayed together with the used reference database. 6.5.1.6 Confirming the BMO Segmentation If the BMO segmentation has not been confirmed, is active. You will receive a message in the Minimum Rim Width chart indicating that the segmentation has not yet been confirmed. For further information on confirming the BMO segmentation, please refer to ( Chapter 6.3 Confirming Segmentation, p. 27). 6.5.1.7 Editing the BMO Points If you edit the BMO points, the related information in the cslo image, the BMO-MRW diagram, and the BMO-MRW classification will be updated simultaneously. If you edit the BMO points, your changes will not only affect a single point but also the computed BMO center. As a result, the changes will affect the foveato-bmo-center axis angle, as well as the average measurement results in all sectors. If you edit the BMO points of an already confirmed examination, you have to re-confirm the BMO segmentation. For further information, please refer to ( Chapter 6.3 Confirming Segmentation, p. 27). Select a patient file containing OCT examinations and open it in the analysis window. Open the BMO Rim Analysis tab. Heidelberg Engineering GmbH, Article No. 97467-004 INT 35
6 Analyzing Images Analyzing BMO-based Minimum Rim Width Fig. 11: Editing the BMO points To edit the BMO points, click or press on the keyboard. Hover with the mouse cursor over the OCT image and drag-anddrop the red dots at the end of the arrows to the desired location (Fig. 11). As an alternative, double-click the desired location in the OCT image. The red dots will be marked with m for manual changes. To remove a red dot, right-click it. The context menu opens. Select Remove Point. The red dot is deleted. The letter m is displayed indicating that this point has been removed manually. Click to save your changes. To reset your changes to the last saved position, right-click the red dot. The context menu opens. Select Undo. The red dot will be reset to its last saved position. Click to undo all changes. A message is displayed asking whether you really want to recalculate Bruch's Membrane Opening. All manual changes will be lost. Click OK to confirm. To quit the BMO points editing, click or press on the keyboard. 6.5.2 BMO Overview Tab The BMO Overview tab provides an overview of the optic nerve head anatomy around Bruch's Membrane Opening. Radial OCT section images at twelve equidistant locations around the optic disc margin are shown. 36 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width Fig. 12: BMO Overview tab Patient information Menu bar Tool bar with follow-up control OCT images with BMO-MRW ( 6.5.1.2 OCT Image, p. 31) cslo image ( 6.5.1.1 cslo Image, p. 30) Reference database ( 7.1 BMO-MRW Reference Database, p. 49) Switching between the cslo image and an imported fundus camera image ( 6.5.1.4 Switching Between the cslo Image and an Imported Fundus Camera Image, p. 33) Heidelberg Engineering GmbH, Article No. 97467-004 INT 37
6 Analyzing Images Analyzing BMO-based Minimum Rim Width 6.5.2.1 OCT Image Fig. 13: Display options Arrow indicating BMO-MRW ILM segmentation line The measured BMO-MRW is indicated by an arrow extending from BMO to ILM. Each arrow is color-coded (Fig. 13) as follows to indicate whether the measured BMO-MRW is within or outside the normal limits: Green = within normal limits Yellow = borderline Red = outside normal limits If an arrow is color-coded white, the sector cannot be classified due to missing data of ILM or BMO segmentation. Display options To show or hide the BMO-MRW in the OCT images, press the keyboard (Fig. 13). To show or hide the ILM in the OCT images, press keyboard (Fig. 13). on the on 6.5.2.2 cslo Image Fig. 14: cslo image and OCT image White lines superimposed indicating locations of the twelve OCT images OCT image and corresponding cslo image marked with * White lines superimposed on the cslo image (Fig. 14) indicate the locations of the twelve OCT images. The red dots are the BMO points as identified in the corresponding OCT images (Fig. 14). 38 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width Display options The top central OCT image (Fig. 14) and its corresponding white line on the cslo image (Fig. 14) are marked with a *. The * may be difficult to see if the underlying structure is very bright. Fig. 15: Display options Show BMO points Hide BMO points To show or hide the BMO points in the cslo image, press on the keyboard (Fig. 15). To show or hide the white lines superimposed on the cslo image, press on the keyboard. 6.5.3 Progression Tab The Progression tab is only available for ONH-RC scans and circle scans. Heidelberg Engineering GmbH, Article No. 97467-004 INT 39
6 Analyzing Images Analyzing BMO-based Minimum Rim Width Fig. 16: Progression tab Patient information Menu bar Tool bar with follow-up control ( 6.5.3.1 Follow-up Control, p. 40) Image quality bar ( Examinations, p. 41) Zoom and pan mode OCT image Y-scale functions Control elements cslo image Reference database ( 7.1 BMO-MRW Reference Database, p. 49) Progression chart ( 6.5.3.2 Progression Chart, p. 40) Image information Sector diagram ( Sector diagram, p. 42) 6.5.3.1 Follow-up Control In the Progression tab, the function to quickly switch between the images of the progression series is replaced by clicking the desired gray data point. The corresponding cslo image and the OCT image are displayed. Below the horizontal axis of the progression chart ( 6.5.3.2 Progression Chart, p. 40), a small gray arrow indicates the currently selected examination. 6.5.3.2 Progression Chart For circle scans, the chart shows the measured RNFL thickness over time. For ONH-RC scans, the progression chart shows either the measured BMO-MRW over time or the measured RNFL thickness over time. Select one of the following structures to be displayed below the chart: BMO-MRW RNFLT 3.5 mm 40 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing BMO-based Minimum Rim Width RNFLT 4.1 mm RNFLT 4.7 mm Examinations If multiple images have been acquired in a progression series on the same day, the last acquired image of this day is taken for progression analysis. If you exclude the last acquired image in an examination tab from the progression series, the previously acquired image from this day is automatically taken for progression analysis. Each gray data point in the progression chart marks an examination. The gray shading correlates with the image quality. The image quality ranges from white, indicating bad image quality, to black, indicating excellent image quality. The image quality bar shows the mapping from quality values to gray shading. The currently selected examination is marked with a circle on the image quality bar. Below the circle, the image quality value is displayed. Please note that the image quality information is only displayed if global G has been selected in the sector diagram ( Sector diagram, p. 42). If you hover with the mouse cursor over a data point, the examination date is displayed on the horizontal axis and the value for BMO-MRW in μm or RNFL thickness in μm is displayed on the vertical axis. The BMO-MRW values correspond to the values shown in the BMO Rim Analysis tab. The RNFL thickness values correspond to the values shown in the RNFL Thickness tab. For further information on the BMO-MRW classification chart, please refer to ( 6.5.1.3 BMO-MRW Classification Chart, p. 32). For further information on the peripapillary RNFLT classification chart, please refer to ( 6.6.1.3 Peripapillary RNFLT Classification Chart, p. 44). If you click a gray data point, the corresponding cslo image and the selected OCT image are displayed. Below the progression chart, a small gray arrow indicates the currently selected examination. Regression analysis The change of BMO-MRW and RNFL thickness with time is estimated and predicted by linear regression in terms of ordinary least squares. The blue regression line shows the linear approximation from the given data and a five-year trend. The legend in the bottom right of the diagram shows the following results of the regression analysis: Rate of change for the selected parameter: Slope of BMO-MRW or Slope of RNFLT in μm per year. P-value of a one sided test against the null hypothesis of a normal age decrease with the alternative of a faster decrease than normal. The p-value estimates the likelihood to observe a similar or even more extreme slope by chance alone. A small p-value (<0.05) suggests that a systematic change, i.e., disease progression is likely to be present. A large p-value means that there is less evidence that a true change has taken place. Heidelberg Engineering GmbH, Article No. 97467-004 INT 41
6 Analyzing Images Analyzing BMO-based Minimum Rim Width P-values are often misinterpreted. A small ( statistically significant ) p-value does not automatically mean that there is a clinically relevant change. In a large series of high-quality images, even small and clinically unimportant changes may become statistically significant. A large ( not statistically significant ) p-value does not exclude the possibility that a clinically important change has occurred. This is particularly important if only few images, or images of poor quality are available for analysis. If only one or two examinations exist, neither the blue regression line nor regression analysis results are displayed. If three to four examinations exist, the blue regression line is dashed but no regression analysis results are displayed. Full regression analysis results are only displayed, if the progression series consists of five or more included examinations. The gray lines mark the confidence interval of the regression line with a confidence level of 95%. Color-coding The following three range bands are displayed in the progression chart: The white band represents the range above the 5 th percentile of the BMO-MRW / RNFLT distribution across the eyes in the reference database. This range is considered as within normal limits. The yellow band represents the range below the 5 th percentile but above the 1 st percentile of the BMO-MRW / RNFLT distribution across the eyes in the reference database. This range is considered as borderline. The red band represents the range below the 1 st percentile of the BMO-MRW / RNFLT distribution across the eyes in the reference database. This range is considered as outside normal limits. The green line represents the mean BMO-MRW of the eyes in the reference database. The range bands are adjusted for the subject s age and the examined eye s BMO area. Sector diagram You can display the progression information globally (G) and for each sector (T, TI, TS, N, NI, NS) individually. To call the desired progression information, click either global (G) or the desired sector in the sector diagram. The selected sector is marked with a black outline. The information displayed in the progression chart changes according to your selection. 42 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing Peripapillary Retina Nerve Fiber Layer... 6.6 Analyzing Peripapillary Retina Nerve Fiber Layer Thickness 6.6.1 RNFL Thickness Tab Fig. 17: RNFL Thickness tab Patient information Menu bar Tool bar with follow-up control cslo image OCT image Peripapillary RNFLT classification chart and overall classification ( 6.6.1.3 Peripapillary RNFLT Classification Chart, p. 44) Pan mode Reference database ( 7.2 RNFL Thickness Reference Database, p. 51) Y-scale functions Segmentation Editor RNFL thickness profile graph ( 6.6.1.4 RNFL Thickness Profile Graph, p. 45) Image information 6.6.1.1 cslo Image In the lower right corner of the cslo image, the diameter of the currently selected circle scan and the BMO area of the examined eye are displayed. 6.6.1.2 OCT Image In the OCT image, the segmentation lines for the ILM and the RNFL are indicated. The RNFL thickness is measured along the circular scan and compared to the reference database ( 7.2 RNFL Thickness Reference Database, p. 51). Heidelberg Engineering GmbH, Article No. 97467-004 INT 43
6 Analyzing Images Analyzing Peripapillary Retina Nerve Fiber Layer... 6.6.1.3 Peripapillary RNFLT Classification Chart The peripapillary RNFLT classification chart represents the classification results for the global average of the circle scan (G), which is displayed in the center, and six standard sectors. By default, this SPECTRALIS software uses a different definition of the six standard sectors compared to older software versions before 6.0: The sector limits proposed by Garway-Heath are used (Garway- Heath et al., Mapping the Visual Field to the Optic Disc in Normal Tension Glaucoma Eyes, 2000, American Academy of Ophthalmology). The origin (0 ) of the peripapillary angular coordinate has been changed in the RNFLT classification chart to correspond to the anatomical axis between fovea and BMOC. The differences of the standard sector definitions are shown in the following table. Standard sector definitions Garway-Heath sectors Legacy sectors Limits Width Limits Width T temporal 315 to 45 90 315 to 45 90 TS temporal-superior 45 to 85 40 45 to 90 45 NS nasal-superior 85 to 125 40 90 to 135 45 N nasal 125 to 235 110 135 to 225 90 NI nasal-inferior 235 to 275 40 225 to 270 45 TI temporal-inferior 275 to 315 40 270 to 315 45 0 defined by fovea-to-bmo-center axis horizontal image axis Images acquired with the ONH-RC preset may be analyzed using the Garway-Heath or the legacy sector definitions, and Garway-Heath sectors will be used by default. Images acquired with the RNFL preset can be analyzed with legacy sector definitions only. In order to switch between the Garway-Heath and the legacy sectors, select Options Preferences Glaucoma Options in the menu bar and select either Legacy Sectors or Garway- Heath Sectors. Click OK to confirm. The black numbers in the pie chart are the measured average RNFL thicknesses in μm for each sector and global. The percentage numbers in parentheses are the corresponding percentiles of the normal distribution, adjusted for the age of the examined subject and BMO area of the examined eye. 44 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing Peripapillary Retina Nerve Fiber Layer... Example For example, a value of 11% (the 11 th percentile of the normal distribution) means that 11% of the eyes in the reference database have RNFL thickness values of this size or thinner. For further information on the size, demographics, and clinical characteristics of the reference database cohort, please refer to ( 7.2 RNFL Thickness Reference Database, p. 51). Color-coding The pie chart is color-coded according to this percentile, to indicate whether a sector is classified as follows: A green sector represents the range above the 5 th percentile of the RNFLT distribution across the eyes in the reference database. This range is considered as within normal limits. A yellow sector represents the range below the 5 th percentile but above the 1 st percentile of the RNFLT distribution across the eyes in the reference database. This range is considered as borderline. A red sector represents the range below the 1 st percentile of the RNFLT distribution across the eyes in the reference database. This range is considered as outside normal limits. Overall classification results The text and color-coding of the bar below the pie chart indicate the following overall classification of the examined eye: A green bar indicates that all sectors and global are classified as within normal limits. A yellow bar indicates that one or more sectors or the global mean are classified as borderline but none as outside normal limits. A red bar indicates that one or more sectors or the global mean are outside normal limits. For further information on the size, demographics, and clinical characteristics of the reference database cohort, please refer to ( 7.2 RNFL Thickness Reference Database, p. 51). 6.6.1.4 RNFL Thickness Profile Graph The thickness profile graph displays the following information: The RNFL thickness profile measured along the circular scan. The comparison of the thickness profile to the normal range. The black curve indicates the measured RNFL thickness. In a follow-up examination, the baseline values are displayed as a gray curve. The horizontal axis represents the position along the optic disc circumference in degrees, with 0 located at the fovea-to-bmocenter axis (temporal) and the angle increasing clockwise for a right eye and counter-clockwise for a left eye, i.e., the sequence is temporal to superior to nasal to inferior to temporal. The vertical axis represents the measured RNFL thickness in μm. To stretch or compress the vertical axis scale, click or. The scale can be compressed by a factor of 2 or stretched by a factor of 4. Heidelberg Engineering GmbH, Article No. 97467-004 INT 45
6 Analyzing Images Analyzing Peripapillary Retina Nerve Fiber Layer... Color-coding The following three range bands are displayed in the RNFL thickness profile graph: The green band represents the range between the 5 th and the 95 th percentile of the RNFLT distribution across the eyes in the reference database. This range is considered as within normal limits. The green line within this green band represents the mean RNFLT of the eyes in the reference database (50 th percentile). The yellow band represents the range below the 5 th percentile but above the 1 st percentile of the normal distribution. This range is considered as borderline. The red band represents the range below the 1 st percentile of RNFLT distribution across the eyes in the reference database. This range is considered as outside normal limits. The range bands are adjusted for the age of the examined subject and for the BMO area of the examined eye. For further information on the size, demographics, and clinical characteristics of the reference database cohort, please refer to ( 7.2 RNFL Thickness Reference Database, p. 51). The classification results Borderline and Outside normal limits do not necessarily indicate that measured values relate to disease states. Likewise, the classification result Within normal limits does not necessarily indicate that disease is completely ruled out. CAUTION! Always take the patient s disk size and racial and ethnic descent into account when interpreting classification results Classification results for very small and very large discs may not be as reliable as results for discs of average size. Classification results may not be reliable for patients whose racial and ethnical descent differ from those in the reference database. For easy identification in the software and on reports, classification results are always displayed together with the used reference database. CAUTION! Clinicians must exercise judgment in the interpretation of the reference data For any particular measurement, note that 1 out of 20 eyes in the reference database (5%) will fall below the green range, and 1 out of 20 eyes in the reference database (5%) will fall above the green range. 46 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Analyzing Images 6 Analyzing the Posterior Pole 6.6.2 Thickness Map Tab The Thickness Map tab is only available for images acquired with the PPoleH, PPoleV, and the ONH presets. For further information on this tab, please refer to the SPECTRALIS User Manual. Fig. 18: Thickness Map tab Patient information Menu bar Tool bar with follow-up control cslo image with thickness map overlay, ETDRS grid, and color scale Average Thickness and Retina Thickness graph of the reference examination Zoom and pan mode Transparency of the overlay OCT image Layer and grid selection Segmentation Editor Average Change graph and Macula Index Retina Thickness Change graph Image information Average Thickness and Retina Thickness graph of the current examination 6.7 Analyzing the Posterior Pole The Posterior Pole tab is only available for images acquired with the PPoleH preset. For further information on presets, please refer to ( 5.1 Presets, p. 22). For further information on this tab, please refer to the SPECTRALIS User Manual. Heidelberg Engineering GmbH, Article No. 97467-004 INT 47
6 Analyzing Images Analyzing the Posterior Pole Fig. 19: Posterior Pole tab Patient information Menu bar Tool bar with follow-up control cslo image with overlay and color scale Hemisphere Asymmetry and Retina Thickness graph of the reference examination Zoom and pan mode Transparency of the overlay OCT image Layer and grid selection Segmentation Editor Retina Thickness Change graph Image information Hemisphere Asymmetry and Retina Thickness graph of the current examination 48 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reference Database 7 BMO-MRW Reference Database 7 Reference Database 7.1 BMO-MRW Reference Database Composition The BMO-MRW reference database includes 246 eyes (123 right eyes and 123 left eyes) of 246 normal subjects (109 male and 137 female) of European descent with mean age of 52.2 years (range 20 to 87 years). Subjects were enrolled in a prospective, multicenter, observational study. Included subjects had healthy eyes without prior intraocular surgery (except cataract surgery or Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve, no history of glaucoma, intraocular pressure 21 mmhg, best corrected visual acuity 0.5, refraction between +6 and -6 diopters, astigmatism 2 diopters, normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits, clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape. BMO-MRW reference data was acquired and analyzed relative to the fovea-to-bmo-center axis, to ensure accurate and consistent positioning of the BMO-MRW profiles across eyes. The age- and BMO area-adjusted BMO-MRW normal distribution percentiles were computed. The distribution percentiles are used to determine whether an examined eye has measures within or outside the normal range. The reference database is limited by its sample size (246 eyes of 246 subjects), the covered age range (20 to 87 years), the covered range of optic disc size (BMO area 1.0 to 3.4 mm 2 ; 8 cases with BMO area >2.5 mm 2 ), the covered range of refraction (+6 to -6 diopters), and European ethnicity. CAUTION! Consider the reference database limitations described above when examining subjects whose characteristics differ from those included in the reference database. Adjustment for age and for BMO area BMO-MRW decreases with increasing age and with increasing BMO area. To take this into account, the reference database is adjusted for age and BMO area in a multiple linear regression model. As a result, the percentiles of the normal distribution used for the classification depend on the patient's age and the eye s BMO area. The BMO-MRW value r i that corresponds to a certain normal distribution percentile i for a subject of given age and BMO area, and the normal distribution percentile p r that corresponds to a measured value of BMO-MRW for a subject of given age and BMO area, are computed as follows: The i th age- and BMO area-adjusted percentile of BMO-MRW r i for a subject with age a and BMO area b is given by. The age- and BMO area-adjusted percentile p r corresponding to a measured BMO-MRW r for a subject with age a and BMO area b is given by, Heidelberg Engineering GmbH, Article No. 97467-004 INT 49
7 Reference Database BMO-MRW Reference Database = mean BMO-MRW in the reference database (age- and BMO area-adjusted) σ r = standard deviation of BMO-MRW in the reference database (age- and BMO area-adjusted) = mean age of the subjects in the reference database = mean BMO area of the eyes in the reference database s ra = slope of the regression of BMO-MRW versus age s rb = slope of the regression of BMO-MRW versus BMO area F(Z)= cumulative distribution function of the normal distribution F -1 (p) = inverse of the cumulative distribution function of the normal distribution Mean age and mean BMO area in the reference database are as follows: Mean age = 52.17 years Mean BMO area = 1.781 mm 2 The means, standard deviations σ r, and slopes s ra and s rb for BMO-MRW global and in the six standard sectors temporal (T), temporal-superior (TS), temporal-inferior (TI), nasal (N), nasalsuperior (NS), and nasal-inferior (NI) are listed in the following table: [μm] σ r [μm] s ra [μm/year] s rb [μm/mm 2 ] BMO-MRW Global 336.1 51.63-1.3390-48.795 BMO-MRW T 238.7 42.83-1.0286-35.353 BMO-MRW TS 321.1 59.87-1.4527-40.840 BMO-MRW TI 352.4 60.25-1.5594-23.402 BMO-MRW N 374.2 63.67-1.2828-72.949 BMO-MRW NS 374.2 71.09-1.4747-48.672 BMO-MRW NI 411.6 71.87-1.7216-46.052 As an example for the effect of age and BMO area, the following tables show the values of the 1 st and the 5 th percentiles of BMO- MRW for the global average and the averages in the standard sectors, for a 45 years old subject with a small BMO area (1.5 mm 2 ), and for a 65 years old subject with a large BMO (2.5 mm 2 ). 50 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reference Database 7 RNFL Thickness Reference Database BMO-MRW, age 45 years, BMO area 1.5 mm 2 1 st percentile [μm] 5 th percentile [μm] Global 239 275 Temporal 156 186 Temporal-superior 204 245 Temporal-inferior 230 271 Nasal 256 299 Nasal-superior 233 282 Nasal-inferior 270 319 BMO-MRW, age 65 years, BMO area 2.5 mm 2 1 st percentile [μm] 5 th percentile [μm] Global 164 199 Temporal 100 130 Temporal-superior 134 175 Temporal-inferior 175 217 Nasal 157 201 Nasal-superior 155 203 Nasal-inferior 189 238 7.2 RNFL Thickness Reference Database Composition The RNFLT reference database includes 218 eyes (111 right eyes and 107 left eyes) of 218 normal subjects (94 male and 124 female) of European descent with mean age of 51.5 years (range 20 to 87 years). Subjects were enrolled in a prospective, multicenter, observational study. Included subjects had healthy eyes without prior intraocular surgery (except cataract surgery or Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve, no history of glaucoma, intraocular pressure 21 mmhg, best corrected visual acuity 0.5, refraction between +6 and -6 diopters, astigmatism 2 diopters, normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits, clinically normal appearance of optic disc with normal appearing neuroretinal rim with respect to color and shape. RNFLT reference data was acquired and analyzed relative to the fovea-to-bmo-center axis, to ensure accurate and consistent positioning of the BMO-MRW profiles across eyes. The age- and BMO area-adjusted RNFLT normal distribution percentiles were computed. The distribution percentiles are used to determine whether an examined eye has measures within or outside the normal range. The RNFLT reference database includes reference data for RNFL thickness along peri-papillary circle scans with 3.5 mm, 4.1 mm, and 4.7 mm diameter. Heidelberg Engineering GmbH, Article No. 97467-004 INT 51
7 Reference Database RNFL Thickness Reference Database The reference database is limited by its sample size (218 eyes of 218 subjects), the covered age range (20 to 87 years), the covered range of optic disc size (BMO area 1.0 to 3.4 mm 2 ; 8 cases with BMO area >2.5 mm 2 ), the covered range of refraction (+6 to -6 diopters), and European ethnicity. CAUTION! Consider the reference database limitations described above when examining subjects whose characteristics differ from those included in the reference database. Adjustment for age and for BMO area RNFL thickness in normal subjects decreases slightly with increasing age and with decreasing BMO area. To take this into account the reference database is age-adjusted and BMO areaadjusted based on multiple linear regression. As a result, the percentiles of the normal distribution used for the classification depend on the patient's age and the eye's BMO area. The RNFLT value r i that corresponds to a certain normal distribution percentile i for a subject of given age and BMO area, and the normal distribution percentile p r that corresponds to a measured value of RNFLT for a subject of given age and BMO area, are computed as follows: The i th age- and BMO area-adjusted percentile of RNFLT r i is given by. The age- and BMO area-adjusted percentile p r corresponding to a measured RNFLT r for a subject with age a and BMO area b is given by,. = mean RNFLT in the reference database (age- and BMO areaadjusted) σ r = standard deviation of the RNFLT in the reference database (age- and BMO area-adjusted) = mean age of the subjects in the reference database = mean BMO area of the eyes in the reference database s ra = slope of the regression of RNFLT versus age s rb = slope of the regression of RNFLT versus BMO area F(Z) = cumulative distribution function of the normal distribution F -1 (p) = inverse of the cumulative distribution function of the normal distribution Mean age and mean BMO area in the reference database are as follows: Mean age = 51.51 years Mean BMO area = 1.773 mm 2 The means, standard deviations σ r, and slopes s ra and s rb for RNFLT global and in the six standard sectors temporal (T), temporal-superior (TS), temporal-inferior (TI), nasal (N), nasalsuperior (NS), and nasal-inferior (NI) are listed in the following tables for circle diameters 3.5 mm, 4.1 mm and 4.7 mm: 52 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reference Database 7 RNFL Thickness Reference Database RNFLT (3.5 mm circle diameter) [μm] σ r [μm] s ra [μm/year] s rb [μm/mm 2 ] RNFLT Global 97.8 8.6-0.1872 6.390 RNFLT T 70.5 9.8-0.0502 2.338 RNFLT TS 128.0 19.6-0.1591 11.333 RNFLT TI 148.8 16.9-0.3357 11.783 RNFLT N 81.5 12.5-0.1558 4.035 RNFLT NS 112.0 22.4-0.2718 10.239 RNFLT NI 109.5 21.5-0.3820 7.919 RNFLT (4.1 mm circle diameter) [μm] σ r [μm] s ra [μm/year] s rb [μm/mm 2 ] RNFLT Global 84.2 7.4-0.1474 5.529 RNFLT T 63.3 8.8-0.0471 3.024 RNFLT TS 117.7 16.6-0.1091 11.727 RNFLT TI 133.4 15.0-0.3096 9.949 RNFLT N 68.0 10.1-0.1057 3.385 RNFLT NS 90.2 18.7-0.2090 6.705 RNFLT NI 87.4 17.8-0.3045 5.366 RNFLT (4.7 mm circle diameter) [μm] σ r [μm] s ra [μm/year] s rb [μm/mm 2 ] RNFLT Global 73.9 6.6-0.1188 4.385 RNFLT T 58.3 7.8-0.0368 2.801 RNFLT TS 107.8 14.6-0.0900 10.116 RNFLT TI 119.8 14.0-0.2937 7.768 RNFLT N 58.6 8.5-0.0667 2.497 RNFLT NS 74.4 15.2-0.1860 3.659 RNFLT NI 71.2 14.4-0.2327 4.826 As an example for the effect of age and BMO area, the following tables show the values of the 1 s t and the 5 th percentiles of the average RNFLT (3.5mm diameter circle) global and in the standard sectors, for a 45 years old subject with a large BMO area (2.5 mm 2 ), and for a 65 years old subject with a small BMO area (1.5 mm 2 ). Heidelberg Engineering GmbH, Article No. 97467-004 INT 53
7 Reference Database RNFL Thickness Reference Database RNFLT (3.5 mm circle diameter), age 45 years, BMO area 2.5 mm 2 1 st percentile [μm] 5 th percentile [μm] Global 83.6 89.5 Temporal 49.7 56.4 Temporal-superior 91.7 105.1 Temporal-inferior 120.0 131.7 Nasal 56.3 64.8 Nasal-superior 69.1 84.4 Nasal-inferior 67.8 82.4 RNFLT (3.5 mm diameter circle), age 65 years, BMO area 1.5 mm 2 1 st percentile [μm] 5 th percentile [μm] Global 73.5 79.4 Temporal 46.4 53.1 Temporal-superior 77.2 90.5 Temporal-inferior 101.7 113.2 Nasal 49.2 57.7 Nasal-superior 53.4 68.7 Nasal-inferior 52.5 66.8 54 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reports 8 Minimum Rim Width Analysis Report 8 Reports The reports described in this chapter are available in addition to the standard SPECTRALIS reports. For all information on generating, customizing, and printing reports, as well as exporting reports as image files, please refer to the SPECTRALIS User Manual. Please select the following report options in the Print Spectralis Report window. The software will remember these settings and applies them the next time, you print a report of the same type. Report options Report Option Description Overview reports No. scans per page Enter the number of images per page. Please note that OCT images count as two images. Reports with thickness maps Reports with Posterior Pole maps Reports with circle scans of ONH-RC examinations Reports with progression series Thickness Map Posterior Pole Map Circle Parameter Sector Select the desired layer from the dropdown list. Select the desired layer from the dropdown list. Select the desired size of the circle scan from the drop-down list. Select either Minimum Rim Width or the desired size of the circle scan. Select the desired sector from the drop-down list. 8.1 Minimum Rim Width Analysis Report Required examinations Options Note ONH-RC scans The report is also available as an OU report. On this report, only the cslo image can be displayed, not the imported fundus camera image. BMO-MRW diagram always uses the Garway-Heath definition of the standard sectors ( Standard sector definitions, p. 44). Heidelberg Engineering GmbH, Article No. 97467-004 INT 55
8 Reports BMO Overview Report Fig. 20: Minimum Rim Width Analysis report Patient data, diagnosis and comments OCT images with BMO-MRW cslo image with overlay BMO-MRW diagram, BMO-MRW classification chart, and overall classification ( 6.5.1 BMO Rim Analysis Tab, p. 30) Reference database ( 7.1 BMO-MRW Reference Database, p. 49) Space for notes 8.2 BMO Overview Report Required examinations Note ONH-RC scans This report can only be generated in the BMO Overview tab. Depending on your selection in the BMO Overview tab, either the acquired cslo image or the imported fundus camera image is displayed on the report. 56 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reports 8 Glaucoma Overview Report Fig. 21: BMO Overview Report Patient data, diagnosis and comments cslo image with overlays OCT images with BMO-MRW Reference database ( 7.1 BMO-MRW Reference Database, p. 49) Space for notes 8.3 Glaucoma Overview Report Required examinations 1 ONH-RC scan and 1 PPoleH scan Note To generate this report, press and hold on the keyboard and click both image thumbnails. Then, release and right-click a selected image thumbnail. The report will then be listed in the Print Spectralis Report window. Heidelberg Engineering GmbH, Article No. 97467-004 INT 57
8 Reports Minimum Rim Width & RNFL Analysis Single Exam Re... Fig. 22: Glaucoma Overview report Patient data, diagnosis and comments cslo image with superimposed scan pattern Hemisphere Asymmetry graph cslo image with thickness map grid and color scale Reference database ( 7.1 BMO-MRW Reference Database, p. 49) MRW diagram, BMO-MRW classification chart, and overall classification ( 6.5.1 BMO Rim Analysis Tab, p. 30) RNFLT diagram, peripapillary RNFLT classification chart, and overall classification ( 6.7 Analyzing the Posterior Pole, p. 47) Average Thickness graph GCL thickness map Space for notes 8.4 Minimum Rim Width & RNFL Analysis Single Exam Report Required examinations Note ONH-RC scans The BMO-MRW diagram always uses the Garway-Heath definition of the standard sectors ( Standard sector definitions, p. 44). The RNFLT classification chart uses the sectors selected in the Glaucoma Options. 58 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reports 8 MRW, RNFL & Asymmetry Analysis Single Exam Report Fig. 23: Minimum Rim Width & RNFL Analysis Single Exam Report Patient data, diagnosis and comments BMO overview OCT image of the APS radial scan BMO-MRW diagram BMO-MRW classification chart with overall classification Reference database ( 7.1 BMO-MRW Reference Database, p. 49) OCT image of the APS circle scan RNFLT diagram RNFLT classification chart Space for notes 8.5 MRW, RNFL & Asymmetry Analysis Single Exam Report Required examinations Note 1 ONH-RC scan and 1 PPoleH scan To generate the report, add the ONH-RC scan and the PPoleH scan to the lightbox. Heidelberg Engineering GmbH, Article No. 97467-004 INT 59
8 Reports MRW, RNFL & Asymmetry Analysis Single Exam Report Fig. 24: MRW, RNFL & Asymmetry Analysis Single Exam report Patient data, diagnosis and comments OCT image of the APS scan RNFLT diagram BMO-MRW diagram RNFLT and BMO-MRW classification charts with overall classification Reference database ( 7.1 BMO-MRW Reference Database, p. 49) cslo image with thickness map grid and color scale OCT image Thickness profile graph Average Thickness and Hemisphere Asymmetry graphs Space for notes 60 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reports 8 MRW, RNFL & Visual Field Structure Function Map... 8.6 MRW, RNFL & Visual Field Structure Function Map Report Required examinations Note 1 ONH-RC scan and 1 HEP visual field examination performed using a 24-2 or 30-2 testing pattern If you generate the report and multiple visual field examinations exist, the Choose Companion Exam dialog box is displayed where available visual field examinations are listed. Select the desired visual field examination from the list and click OK to confirm. The combined SPECTRALIS & HEP Visual Field report is only available for examinations that have taken place within a six month interval. If the examinations have a time difference of 90 days or more, the time span between the OCT examination and the visual field examination is highlighted in red on the report. Heidelberg Engineering GmbH, Article No. 97467-004 INT 61
8 Reports Progression Analysis Report Fig. 25: MRW, RNFL & Visual Field Structure Function Map report Patient data, diagnosis and comments Examination dates SPECTRALIS cslo image SPECTRALIS RNFLT diagram SPECTRALIS BMO-MRW diagram Structure-Function-Map HEP and RNFL Reference database ( 7.2 RNFL Thickness Reference Database, p. 51) 8.7 Progression Analysis Report HEP VF Grayscale with color coding HEP VF Total Deviation with color coding HEP VF Pattern Deviation HEP information on duration, FP Count, FN Count, fixation losses, global indices and reliability Structure-Function-Map HEP and BMO-MRW Space for notes Required examinations Progression series of ONH-RC scans 62 Heidelberg Engineering GmbH, Article No. 97467-004 INT
Reports 8 Progression Analysis Report Fig. 26: Progression Analysis report Patient data, diagnosis and comments MRW progression chart Reference database Space for notes Heidelberg Engineering GmbH, Article No. 97467-004 INT 63