SPECTRALIS Glaucoma Module, 3, en USadelabdelshafik.website/002-postgraduates-material/course...

SPECTRALIS®

Glaucoma Module PremiumEdition

User ManualSoftware Version 6.7

November 2016© Heidelberg Engineering GmbHArticle No. 97467-004 INT.AE16

© Heidelberg Engineering GmbH

Corporate HeadquartersHeidelberg Engineering GmbHMax-Jarecki-Str. 869115 Heidelberg/GermanyTelephone: +49 (0) 6221 64 63 0Fax: +49 (0) 6221 64 63 62

AustraliaHeidelberg Engineering Pty Ltd404 Albert St.East Melbourne 3002VictoriaTelephone: +61 (396) 392 125Fax: +61 (396) 392 127

UKHeidelberg Engineering Ltd.55 MarlowesHemel HempsteadHertfordshire HP1 1LETelephone: +44 (0) 1442 502 330Fax: +44 (0) 1442 242 386

SwitzerlandSymed Medical Systems GmbHAlte Winterthurerstrasse 888309 Nürensdorf/SwitzerlandTelephone: +41 (0) 44 8887 020Fax: +41 (0) 44 8887 024

Email: [email protected]: http://www.HeidelbergEngineering.com

Table of contents1 Preface................................................................................. 4

1.1 Symbols used in this Document................................... 41.2 Intended Use................................................................ 61.3 Compatibility................................................................. 61.4 E-learning..................................................................... 7

2 Terms and Definitions........................................................ 83 Workflow............................................................................ 114 Anatomic Positioning System......................................... 12

4.1 Defining the Anatomic Map......................................... 124.2 Redefining Anatomic Landmarks................................ 194.3 Activating Anatomic Maps.......................................... 20

5 Acquiring Images.............................................................. 225.1 Presets........................................................................ 225.2 Acquiring Images........................................................ 22

6 Analyzing Images.............................................................. 266.1 Symbols...................................................................... 266.2 Progression Series..................................................... 266.3 Confirming Segmentation........................................... 276.4 Reviewing APS information........................................ 286.5 Analyzing BMO-based Minimum Rim Width............... 296.5.1 “BMO Rim Analysis” Tab......................................... 306.5.2 “BMO Overview” Tab.............................................. 366.5.3 “Progression” Tab................................................... 396.6 Analyzing Peripapillary Retina Nerve Fiber Layer

Thickness.................................................................... 436.6.1 “RNFL Thickness” Tab............................................ 436.6.2 “Thickness Map” Tab.............................................. 476.7 Analyzing the Posterior Pole....................................... 47

7 Reference Database.......................................................... 497.1 BMO-MRW Reference Database................................ 497.2 RNFL Thickness Reference Database....................... 51

8 Reports.............................................................................. 558.1 “Minimum Rim Width Analysis” Report...................... 558.2 “BMO Overview” Report............................................ 568.3 “Glaucoma Overview” Report.................................... 578.4 “Minimum Rim Width & RNFL Analysis Single Exam

Report” ....................................................................... 588.5 “MRW, RNFL & Asymmetry Analysis Single Exam”

Report......................................................................... 598.6 “MRW, RNFL & Visual Field Structure Function Map”

Report......................................................................... 618.7 “Progression Analysis” Report................................... 62

9 Troubleshooting................................................................ 649.1 Error Messages Image Acquisition............................. 649.2 Error Messages “Progression” Tab............................ 65

10 Index................................................................................... 66

Table of contents

© Heidelberg Engineering GmbH, Article No. 97467-004 INT 3

1 PrefaceThis user manual serves as a reference guide for softwaremodules from Heidelberg Engineering. Read the entire usermanual to gain a full understanding of the software. It is notnecessary to read all the chapters in chronological order. Beginwith a topic of interest. Follow the links and references included inthe text for guidance to other chapters.

If you have any further questions on the SPECTRALIS software,hardware specifications, HEYEX, or operating the software in anetwork 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 DocumentThis chapter describes the definition, formatting, and symbols usedin this document.

The code of, for example, the heyex.ini file is identified bymonospaced typeface, for example DefaultDevice=1.

Cross-references are identified by parentheses and a black arrow(°), for example: ( “Cross-references”, p. 4).

Examples are identified by a gray background over the entirewidth of the page.

Examples

Elements of the graphical user interface like buttons, windownames, or file names are identified by quoted “italic” font, forexample “Next” .

Keys are identified by their symbol, for example + .

Lists are used for structuring information and are marked by redsquares:

▪ List entry▪ List entry

Code

Cross-references

Elements of the graphical userinterface

Keys

Lists

Preface

Symbols used in this Document

1

© Heidelberg Engineering GmbH, Article No. 97467-004 INT4

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 are used for supporting the reader in completing a taskand are marked by red triangles:

Step 1. Step 2.

Safety messages are indicated by symbols in this document. Theyare marked by a signal word and a safety alert symbol indicatingthe category of the hazard.

WARNING!Warning indicates a hazardous situation which, if notavoided, could result in death or serious injury.

CAUTION!Caution with the safety alert symbol indicates ahazardous situation which, if not avoided, couldresult in minor or moderate injury.

NOTICE!Notice is used to address practices not related topersonal injury.

This symbol indicates helpful hints for using thedevice and software.

Embedded safety messages are integrated into the step of theprocedure 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?

Menu paths

Procedures

Safety messages

Embedded safety messages

Preface

Symbols used in this Document

1


Information available on websites is identified by underlined text,for example http://www.heidelbergengineering.com. Click on theURL to open the corresponding website.

1.2 Intended UseThe SPECTRALIS is a non-contact ophthalmic diagnostic imagingdevice. It is intended for:

▪ viewing the posterior segment of the eye, including two- and three-dimensional imaging

▪ cross-sectional imaging (SPECTRALIS HRA+OCT andSPECTRALIS 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 managementof 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 aschanges in the eye that result from neurodegenerative diseases.The SPECTRALIS OCT Angiography software is indicated as anaid in the visualization of vascular structures of the retina andchoroid.The SPECTRALIS HRA+OCT and SPECTRALIS OCT includereference databases for measurements of retinal layer and opticnerve head anatomy, which are used to quantitatively comparemeasurements in the human retina and optic nerve head to valuesfound in normal subjects.

1.3 CompatibilityThe following software versions are required to run theSPECTRALIS 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

Start HEYEX and select “Help ► About” in the menu bar of thedatabase window.The “About Heidelberg Eye Explorer” window is displayed.

Check the installed modules. Click “OK” to close the window.

URL

Installed modules

Preface

Compatibility

1


1.4 E-learningThe Interactive Video Tutorial offers a quick introduction to the newfeatures and functions of the SPECTRALIS Glaucoma ModulePremium Edition. It also provides self-tests that allow you toassess your knowledge about the use of the software withouthaving access to a SPECTRALIS device. Use the innovative, self-educational tool to learn at your own pace whenever and whereveryou would like.The Interactive Video Tutorial is available in English, German,Spanish, French, Portuguese, Italian, Turkish and Chinese.To download the full version, go tohttp://e-learning.he-academy.com.

Preface

E-learning

1


2 Terms and DefinitionsThis chapter defines the abbreviations and terms used in thisdocument.

An anatomic landmark is a distinct point of reference of theanatomy, which is identified for the examined eye. With APS, twofixed anatomic landmarks are located, the fovea and the Bruch'smembrane opening center.

The anatomic map consists of the anatomic landmarks and theanatomic landmark image.

Anatomic Positioning System; the APS uses the anatomiclandmarks to automatically position OCT scans.

The baseline image is the first image of a progression series.

Bruch's membrane

Bruch's Membrane Opening

Bruch's Membrane Opening based Minimum Rim Width

Bruch's Membrane Opening Center

Corneal Curvature

Choroid

confocal Scanning Laser Ophthalmoscopy

External Limiting Membrane

False negatives

Fovea-to-BMO-center axis; with APS, scans are automaticallyaligned relative to the patient's individual Fovea-to-BMO-centeraxis.

A follow-up image is an image that has been acquired after thebaseline image. It is part of the progression series.

False positives

Anatomic landmark

Anatomic map

APS

Baseline image

BM

BMO

BMO-MRW

BMOC

C-Curve

CHO

cSLO

ELM

FN

FoBMOC

Follow-up image

FP

Terms and Definitions2


Ganglion Cell Layer

Heidelberg Edge Perimeter

Heidelberg Eye Explorer

High resolution mode; if you select HR as the scan resolutionmode, images are acquired with a higher spatial scan resolutionbut with a low scan rate. HR acquires more data points over alonger time period and requires more time and space for datastorage.

High speed mode; if you select HS as the scan resolution mode,images are acquired at a faster rate but will be of a lowerresolution. HS is optimized for fast image acquisition with a highframe rate and reduced data storage.

Internal Limiting Membrane

Inner Nuclear Layer

Inner Plexiform Layer

Optical Coherence Tomography

Optic nerve head

The ONH-RC scan pattern combines a radial scan and threeconcentric circle scans centered on the ONH with APS.

Outer Nuclear Layer

Outer Plexiform Layer

Posterior pole

Peripapillary retina

First Photoreceptor Layer

Second Photoreceptor Layer

Retinal Nerve Fiber Layer

GCL

HEP

HEYEX

HR

HS

ILM

INL

IPL

OCT

ONH

ONH-RC

ONL

OPL

PPole

PPR

PR1

PR2

RNFL

Terms and Definitions 2


Retinal Nerve Fiber Layer Thickness

Retinal pigment epithelium

A segmentation line marks and belongs to either a certain retinalstructure (ILM, PR1, PR2, RPE, BM) or the outer boundary of aretinal or sub-retinal layer (RNFL, GCL, IPL, INL, OPL, ONL,CHO). Each segmentation line is named by the structure or layer towhich it belongs. For example, the segmentation line along theboundary between GCL and IPL is named "GCL"; and the GCLthickness is given by the distance between the two segmentationlines named "RNFL" and "GCL".

The four blue markers on the OCT image in the acquisition windowindicate the Sweet Spot. This is the recommended area to placethe structure of interest for the best OCT image quality. For normalOCT acquisitions, the Sweet Spot is located in the upper third ofthe OCT image.

Visual field

RNFLT

RPE

Segmentation lines

Sweet Spot

VF

Terms and Definitions2


3 Workflow

Workflow 3


4 Anatomic Positioning SystemImage acquisition using the Anatomic Positioning System (APS)ensures that OCT images are acquired at fixed and known retinallocations relative to certain retinal anatomical landmarks, such asthe fovea and the BMO center.

4.1 Defining the Anatomic Map

WARNING!Wrong classification results may be caused byimprecisely defined anatomic landmarksIf the anatomic landmarks are not defined correctly,classification results may be wrong. Wrongclassification results may lead to wrong diagnosticconclusions which may result in wrong therapeuticapproaches.

The APS proposes the position of the anatomiclandmarks. Double-check the positions of theanatomic landmarks and correct them, if necessary.

The anatomic map is the basis for positioning APS scans andneeds to be defined prior to the first examination. The definition ofthe 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 imagewill then be the baseline image of a progression series. After imageacquisition, check and confirm the BMO segmentation.

For APS definition, the “C-Curve” values entered in the“Eye Data” dialog box are critical as these values affect theabsolute 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 andthe flat corneal curvature values.

The “C-Curve” value is fixedYou cannot change the “C-Curve” value for anexisting progression series.

If you want to update the “C-Curve” value because it is wrong orfor a patient who underwent invasive surgery, you have to re-defineanatomic landmarks and start a new progression series. For furtherinformation on re-defining anatomic landmarks, please refer to( Chapter 4.2 “Redefining Anatomic Landmarks”, p. 19). Forfurther information on entering or updating the patient's eye data,please refer to the SPECTRALIS User Manual.

Switch on the device. Prepare the device.

Importance of C-Curve

Preparing the examination

Anatomic Positioning System

Defining the Anatomic Map

4


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 resultsmay deviate from actual values.

Click “OK” to confirm.

If you do not change the C-Curve values from the preset valueof 7.7 mm, a message will be displayed asking to verify that bothC-Curve values are correct. Measurements will only be accurate ifthe 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 areswitched 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 acquisitionwindow 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 theleft-right recognition of the camera.

Open the “Application&Structure” drop-down list and select“Glaucoma” as the application.



4


Select an APS preset, for example “ONH-RC” .The nasal fixation light is automatically switched on, “IR” isautomatically selected as the acquisition mode, and “HS” isautomatically 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 twosection images. In the upper part of the OCT section, thecorresponding section images of the vertical line of the red + isdisplayed. In the lower part of the OCT section, the correspondingsection images of the horizontal line of the red + is displayed(Fig. 1). In the lower part of the OCT section, the OCT image iscropped either on the left side or on the right side depending on theexamined eye. This crop is due to the 15° scan protruding theimage border in the cSLO image.

Ask the patient to look at the fixation light during the examination.

Fig. 2: Aligning the cSLO image

Move the camera slightly to the left or the right and turn the joystickso that the bright spot is centered in the cSLO image (Fig. 2). Ifyour device is a SPECTRALIS HRA+OCT, try to avoid pivoting thecamera head.

Aligning the camera



4


Move the camera slowly towards the patient’s eye until an evenly-illuminated cSLO image is displayed (Fig. 2).L WARNING! Careless movement of the camera might injurethe patient's eye. Adjust the camera carefully. Check the distancebetween the lens and the patient’s eye continuously.

If the cSLO image has dark edges (Fig. 2), move the cameracloser to the patient's eye.

If the cSLO image is too dark in the upper part, turn the joystickcounterclockwise to move the camera down.

If the cSLO image is too dark in the lower part, turn the joystickclockwise to move the camera up.

If the cSLO image is too dark on the right side (Fig. 2), move thecamera to the left.

If the cSLO image is too dark on the left side (Fig. 2), move thecamera to the right.

If the cSLO image is well-illuminated but out of focus, turn thefocus knob and adjust the patient's refraction so that the vesselsand the cSLO image are sharply displayed.L WARNING! Incorrect classification results may be causedby incorrect focus settings during image acquisition.Classification results may be incorrect if the calculation is based onincorrect refraction values. Incorrect classification results may leadto incorrect diagnostic conclusions which may result in incorrecttherapeutic 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 brightnesscontrol is selected, turn until the image is illuminated correctly.

If your device is a SPECTRALIS OCT, the manual imagebrightness control is not available.For further information on manual and automatic image brightnesscontrol, please refer to the SPECTRALIS User Manual.

Fig. 3: Aligning the OCT image

Move the camera slowly towards the patient’s eye until the OCTimage is displayed in the Sweet Spot .

Aligning the OCT image



4


If the bar above the OCT image is red , move the camera slowlyback from the patient's eye until the bar displays a gray scale.

In some medical cases, for example posterior vitreousdetachment, it is possible that the bar above the OCT image mayremain red even though the OCT image is properly aligned. Checkthe OCT image for high image contrast and high image resolution.

If the OCT image is upside down , move the camera slowly backfrom the patient's eye until the OCT image is displayed correctly.

If the OCT image is pivoted horizontally or the image contrastvaries in the OCT image, move the camera slightly left or right bymeans of the joystick until the OCT image is aligned correctly andthe image contrast is evenly high.

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 theacquisition window. ART Mean is automatically switched on. Theprogression bar increases as the fovea is being detected.

Keep the hands on the device and readjust the camera as needed.

If the fovea has been detected, “Confirm Fovea Position” blinks inthe “Scan” section. In the cSLO image, the red + has turned blue.In the OCT images, blue dashed lines indicate the position of thefovea. If the fovea cannot be detected or the detection timed out,the + in the cSLO image stays red and the dashed lines in the OCTimages 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 thefovea position.

Go to the OCT images and click on the thinnest part of the retinaindicating the fovea position.

Depending on the area that is selected in one of the OCTimages, the already correct foveal position in the other OCT imagemay become invalid again. In several cases it might be possiblethat the manual detection of the fovea needs to be repeatedseveral times.If the fovea position has been detected correctly, the red + turnsblue in the cSLO image and the red dashed lines turn blue in theOCT images.

Alternatively, click “Back” to re-start the automatic detection of thefovea.

Click “Confirm Fovea Position” .The position of the fovea is confirmed. Now the BMO needs to bedetected.

Step 1 - Detecting the foveaposition

Step 2 - Confirming the foveaposition



4


If the fovea position is confirmed, “Start BMO Detection” blinks inthe “Scan” section. ART Mean is still active. In the cSLO image, ared X is displayed at the estimated BMO center position.

If the red X is not positioned near the estimated BMO center, drag-and-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 theOCT section you will see the corresponding section image of theaxis from the lower left to the upper right of the red X in the cSLOimage. In the lower section you will see the corresponding sectionimage of the axis from the upper left to the lower right of the red Xin the cSLO image (Fig. 4).

Adjust the camera so that the cSLO image is well illuminated, theimage contrast is evenly high, and the OCT image is ashorizontally 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 beingdetected.

Keep the hands on the device and readjust the camera as needed.

Step 3 - Detecting the BMO centerposition



4


If the BMO center has been detected, “Confirm BMO Position”blinks in the “Scan” section. The red X has turned blue. If the BMOcenter cannot be detected or the detection timed out, the X in thecSLO image stays red and the dashed lines in the OCT images arealso 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 BMOcenter cannot be detected, drag-and-drop the blue vertical linesindicating the Bruch's Membrane Opening in the OCT window tothe desired position (Fig. 5). The vertical lines correspond to thecircles on the X in the cSLO image.

If the BMO center has been detected incorrectly, drag-and-drop thered 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 theproper location of the endpoint in the other OCT image. It might bepossible that the manual detection of the Bruch's Membrane endneeds to be repeated several times.If the BMO center position has been detected correctly, the red Xturns blue in the cSLO image and the red dashed lines turn blue inthe OCT images.

If the blue X is positioned so that blood vessels hide the Bruch'sMembrane in the OCT image, click or to rotate the blue X.

Alternatively, click “Back” to re-start the automatic detection of theBMO 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 aredisplayed. 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 ARTMean settings for the radial scan and for the circle scans aredisplayed.

Step 4 - Confirming the BMO centerposition



4


If your device is a SPECTRALIS HRA+OCT, press “Acquire” onthe touch panel. If your device is a SPECTRALIS OCT, press thebutton on the joystick briefly.The image acquisition starts using the selected preset. The smalllive images are displayed again. If you selected the ONH-RCpreset, the radial scan is acquired. ART Mean counts to 25 frames.Then, the three circle scans are acquired. ART Mean counts to 100frames.

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 aredisplayed in the image viewing window in the form of imagethumbnails. The baseline image is marked with indicating theunconfirmed baseline examination. The next step is to confirm theBMO segmentation.

Please confirm the BMO segmentation right afterthe image acquisitionIf the distance between the scan center and theBMOC is greater than 100 μm,Heidelberg Engineering recommends repeating thebaseline image acquisition before the patient leavesthe examination room. Otherwise, the patient mightneed an additional visit for re-examining a baselineimage.

For further information on confirming the BMO segmentation,please refer to ( Chapter 6.3 “Confirming Segmentation”, p. 27).

To close the analysis window, click . In the image viewing window, the image thumbnail is marked with

.

4.2 Redefining Anatomic LandmarksIf the distance between the scan center and the BMO center isgreater than 100 μm in a follow-up image, Heidelberg Engineeringrecommends redefining the anatomic landmarks. With these newanatomic landmarks, a new progression series will be created.

If you redefine the anatomic landmarks, newlyacquired OCT images will not be comparable toalready acquired imagesFor the new Anatomic Map, a new baseline imagewill be created. The already existing progressionseries will be closed.

Select the desired patient file and start a new examination.

The acquisition window opens. After initializing, turns to .

Acquiring the baseline image

Confirming the BMO segmentation

Exiting the Confirmation


Redefining Anatomic Landmarks

4


Press either on the touch panel or click in the acquisitionwindow.A high tone is audible when the scanners and the laser areswitched 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 OCTimages 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 animage.This image will then be the baseline image of a new progressionseries. The already existing baseline image will be closed. Thebaseline image of the closed progression series will be markedwith . The follow-up images of the closed progression series willbe marked with .

Confirm the BMO segmentation ( Chapter 6.3 “ConfirmingSegmentation”, p. 27).The redefined anatomic landmarks and the anatomic map areactivated.

4.3 Activating Anatomic MapsA patient file may contain several anatomic maps for the followingreasons:

▪ You redefined an anatomic map during an examination instead ofusing an already existing anatomic map.

▪ You confirmed a BMO segmentation and defined a new anatomicmap.

▪ You imported E2E files containing anatomic maps.You can reactivate existing anatomic maps in order to continue theexisting progression series, and you can activate the anatomicmap of imported E2E files to continue the imported progressionseries.

Please note that the following procedure assumesthe presence of two different anatomic maps.

Images acquired with the active anatomic map are marked with or . Images acquired with the inactive anatomic map aremarked 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 toactivate the anatomic map.The analysis window opens.


Activating Anatomic Maps

4


Select “APS ► Activate Anatomic Map” in the menu bar.The anatomic map of the currently selected image is activated. Theimage 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).


Activating Anatomic Maps

4


5 Acquiring Images5.1 Presets

Scan pattern 24 radialscans

3 circlescans

Volume Volume Circle Volume

Scan size Length 15° Diameter3.5 mm,4.1 mm,4.7 mm

30° x 25° 30° x 15° Diameter12°

15° x 15°

Center position ofscan pattern

BMOC BMOC Fovea Fovea adjustable adjustable

Orientation of linear sectionimages

Centralscan onFoBMOCaxis

– Parallel toFoBMOCaxis

Perpendicular toFoBMOCaxis

– adjustable

# section images 24 3 61 19 1 73

Distance between sectionimages

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 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 acquisitionwindow.A high tone is audible when the scanners and the laser areswitched on. The camera starts and the cSLO image is displayed.

turns to .

Starting the examination

Acquiring Images

Acquiring Images

5


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 acquisitionwindow 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 theleft-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 isautomatically switched on. In the cSLO image, the BMO center andthe fovea position are automatically identified. If the anatomiclandmarks are not identified automatically, they have not yet beendefined. Please refer to ( Chapter 4.1 “Defining the AnatomicMap”, p. 12) and follow the instructions for defining anatomiclandmarks. In the OCT image, the BMO center is marked by adashed line.

Ask the patient to look at the fixation light during the examination.

Fig. 6: Aligning the cSLO image

Move the camera slightly to the left or the right and turn the joystickso that the bright spot is centered in the cSLO image (Fig. 6). Ifyour device is a SPECTRALIS HRA+OCT, try to avoid pivoting thecamera head.

Move the camera slowly towards the patient’s eye until an evenly-illuminated cSLO image is displayed (Fig. 6).L WARNING! Careless movement of the camera might injurethe patient's eye. Adjust the camera carefully. Check the distancebetween the lens and the patient’s eye continuously.

If the cSLO image has dark edges, move the camera closer to thepatient's eye.

If the cSLO image is too dark in the upper part, turn the joystickcounterclockwise to move the camera down.

If the cSLO image is too dark in the lower part, turn the joystickclockwise to move the camera up.

Aligning the camera

Acquiring Images

Acquiring Images

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If the cSLO image is too dark on the right side, move the camera tothe left.

If the cSLO image is too dark on the left side, move the camera tothe right.

If the cSLO image is well-illuminated but out of focus, turn thefocus knob and adjust the patient's refraction so that the vesselsand the cSLO image are sharply displayed.L WARNING! Incorrect classification results may be causedby incorrect focus settings during image acquisition.Classification results may be incorrect if the calculation is based onincorrect refraction values. Incorrect classification results may leadto incorrect diagnostic conclusions which may result in incorrecttherapeutic 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 brightnesscontrol is selected, turn until the image is illuminated correctly.

If your device is a SPECTRALIS OCT, the manual imagebrightness control is not available.For further information on manual and automatic image brightnesscontrol, please refer to the SPECTRALIS User Manual.

Fig. 7: Aligning the OCT image

Move the camera slowly towards the patient’s eye until the OCTimage is displayed in the Sweet Spot .

If the bar above the OCT image is red , move the camera slowlyback from the patient's eye until the bar displays a gray scale.

In some medical cases, for example posterior vitreousdetachment, it is possible that the bar above the OCT image mayremain red even though the OCT image is properly aligned. Checkthe OCT image for high image contrast and high image resolution.

If the OCT image is upside down , move the camera slowly backfrom the patient's eye until the OCT image is displayed correctly.

If the OCT image is pivoted horizontally or the image contrastvaries in the OCT image, move the camera slightly left or right bymeans of the joystick until the OCT image is aligned correctly andthe image contrast is evenly high.

Aligning the OCT image

Acquiring Images

Acquiring Images

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If your device is a SPECTRALIS HRA+OCT, press “Acquire” onthe touch panel. If your device is a SPECTRALIS OCT, press thebutton on the joystick briefly.The image acquisition starts. ART Mean is automatically switchedon. The small live images are displayed in the lower section of theacquisition window. The progression bar increases as the ARTMean counts the preset number of frames.

Images can be acquired before ART Mean reaches theadjusted number of frames.

Watch the small live images for an even illumination and properorientation 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 sectionimages are acquired. ART Mean is automatically switched off.

To acquire several images, press “Acquire” or the button on thejoystick again.

To examine the left eye, move the camera to the right.In the “Settings” section, “OS” is automatically selected. Realignthe camera and repeat the previous steps.

Click “Save images” in the menu bar.

If you have acquired multiple images and did not close theacquisition window over a longer period, click “Save images” toprevent data loss in case of PC and/or hardware problems.

To switch off the camera, press on the touch panel or click inthe 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 inthe form of image thumbnails.

Review the images.

Acquiring images with ART Mean

Quitting the examination

Acquiring Images

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6 Analyzing Images6.1 Symbols

The image thumbnails displayed in the image viewing window aremarked 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

indicates a baseline image acquired with an APS scan. Theanatomic map is activated and the BMO segmentation is not yetconfirmed.

indicates a follow-up image. The anatomic map isdeactivated.

Example

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, pleaserefer to ( Chapter 6.3 “Confirming Segmentation”, p. 27).

6.2 Progression SeriesAfter you have defined the anatomic landmarks and acquired abaseline image, all images acquired using APS presets willautomatically form a progression series.

In the “Glaucoma” application, the reference set on a baselineimage cannot be changed by the “Set reference” function. Thereference stays on the baseline image. If you want to re-set areference, re-define the anatomic landmarks and acquire a newbaseline image using APS presets. Please note that this will start anew progression series and newly acquired OCT images will notbe comparable to already acquired images. For further informationon re-defining anatomic landmarks, please refer to ( Chapter 4.2“Redefining Anatomic Landmarks”, p. 19).

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 nolonger affect progression results.

You can include each follow-up image that has previously beenexcluded into a progression series.

In order to include an image into a progression series, right-click animage thumbnail marked with in the image viewing window.The context menu opens.

References

Excluding images from aprogression series

Including images into aprogression series

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Progression Series

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Select “Progression ► Ex/Include”.The image is included into the progression series and will affectprogression results.

For further information on progression series, please refer to theSPECTRALIS User Manual.

6.3 Confirming SegmentationAfter you have acquired an image with the ONH-RC preset, theBMO segmentation needs to be confirmed.

In the image viewing window, double click an image thumbnailmarked with or .You will receive a message indicating that the volume data iscalculated. Then, you will receive a message indicating that theminimum rim is being calculated. Please note that these processesmay 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 segmentationhas not yet been confirmed. Below the OCT image, isdisplayed.

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 tothe SPECTRALIS User Manual.

Click to confirm both, the BMO segmentation and theILM segmentation.

Once the segmentation of the BMO locations is confirmed, the trueBMO center is defined as the geometric center of the confirmed 48individual BMO points. This BMO center can differ from the scancenter identified during the Anatomic Map definition. For correctanalysis of BMO-MRW and RNFLT, it is important that the distancebetween the scan center and the BMOC is not more than 100 μm.

If the distance between the scan center and the BMOC is≤ 100 μm and the User Account Management is enabled, yourconfirmation is accepted without querying your user name. If theUser Account Management is disabled, a dialog will prompt you toenter your user name.

Enter your name and click “OK” to confirm.Your confirmation is accepted.

Confirming the segmentation

Distance between scan center andBMOC

Distance between scan center andBMOC ≤ 100 μm

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If the distance between the scan center and the BMOC is> 100 μm, a window is displayed offering the options “Set BMOcenter as new scan center (Recommended)” and “Continue withdisplaced scan center” .Heidelberg Engineering recommends selecting “Set BMO centeras new scan center (Recommended)” whenever possible. Theanatomic map with displaced landmarks will be deactivated. Theimage thumbnail will be marked with . A new, correctedanatomic map will be automatically created. Acquire a new image( 5 “Acquiring Images”, p. 22).Only consider selecting “Continue with displaced scan center” inthe following cases:

▪ It is not feasible or too difficult to reexamine the patient. This mightbe the case due to lack of cooperation, due to the patient’s medicalconditions such as strong nystagmus, or if the patient does notagree to a repeat examination.

▪ Long-term monitoring is planned, and you consider comparabilityover time more important than accuracy of the individualclassification results.The displaced anatomic landmarks will be accepted and used foridentifying the BMO center and the fovea in follow-upexaminations.

Click to close the analysis window.

The image thumbnail is marked with or .

6.4 Reviewing APS informationThe information about the APS is logged. If you want to review thisinformation, 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

Distance between scan center andthe BMOC > 100 μm

Closing the analysis window

Analyzing Images

Reviewing APS information

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6.5 Analyzing BMO-based Minimum Rim WidthMeasurement of BMO-based minimum rim width is performed fromradial section images centered at the center of Bruch’s membraneopening. The location of BMO is identified in each of the radialsection images. The BMO-MRW is then measured as the shortestdistance from each identified BMO point to the internal limitingmembrane.

Analyzing Images

Analyzing BMO-based Minimum Rim Width

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6.5.1 “BMO Rim Analysis” Tab

Fig. 8: “BMO Rim Analysis” tab

Patient informationMenu barTool bar with follow-up controlcSLO image ( 6.5.1.1 “cSLO Image”, p. 30)OCT image ( 6.5.1.2 “OCT Image”, p. 31)Zoom and pan modeBMO-MRW classification chart with overallclassification ( 6.5.1.3 “BMO-MRWClassification Chart”, p. 32)Switching between the cSLO image and animported fundus image ( 6.5.1.4 “SwitchingBetween the cSLO Image and an ImportedFundus Camera Image”, p. 33)

Zoom and pan modeReference database ( 7.1 “BMO-MRWReference Database”, p. 49)Y-scale functionsSegmentation EditorEditing BMO points ( 6.5.1.7 “Editing the BMOPoints”, p. 35)BMO-MRW diagram ( 6.5.1.5 “BMO-MRWDiagram”, p. 33)Image informationBMO segmentation confirmation ( 6.3“Confirming Segmentation”, p. 27)

6.5.1.1 cSLO ImageThe red dots superimposed on the cSLO image indicate the BMOpoints as identified in the individual section images. The followingthree display options can be selected:

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Fig. 9: Display options

BMO points and section image positionsdisplayedBMO points displayedOCT section image positions displayed

When you open the analysis window, the BMO points and the OCTsection image position are displayed (Fig. 9).

To show and hide the BMO points and the white lines indicating thestandard 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 baror press on the keyboard.

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.

In the lower right corner of the cSLO image, the BMO area isdisplayed. The BMO area is used for reference data adjustment.

6.5.1.2 OCT ImageRed dots indicate the identified BMO points; the red line indicatesthe internal limiting membrane. The blue arrows extending from theBMO points to the ILM indicate the shortest distance from BMO toILM. 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).

Standard sectors

BMO area

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6.5.1.3 BMO-MRW Classification ChartThe 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 correspondingpercentiles of the normal distribution, adjusted for the age of theexamined subject and the BMO area of the examined eye.

For example, a value of 11% (the 11th percentile of the normaldistribution) means that 11% of the eyes in the referencedatabase have BMO-MRW values of this size or smaller. Pleaserefer to ( 7.1 “BMO-MRW Reference Database”, p. 49) for thesize, demographics, and clinical characteristics of the referencedatabase cohort.

Example

The pie chart is color-coded according to this percentile, to indicatewhether a sector is classified as follows:

▪ A green sector represents the range above the 5th percentile of theBMO-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 5th percentile butabove the 1st percentile of the BMO-MRW distribution across theeyes in the reference database. This range is considered as“borderline” .

▪ A red sector represents the range below the 1st percentile of theBMO-MRW distribution across the eyes in the reference database.This range is considered as “outside normal limits” .

The text and color-coding of the bar below the pie chart indicatethe 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 areclassified as “borderline” but none as “outside normal limits” .

▪ A red bar indicates that one or more sectors or global are classifiedas “outside normal limits” .For further information on the size, demographics, and clinicalcharacteristics of the reference database cohort, please refer to( 7.1 “BMO-MRW Reference Database”, p. 49).

Color-coding

Overall classification result

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The following further information is displayed in the BMO-MRWclassification chart :

▪ “C-Curve” value▪ Distance between scan center and BMO center as calculated from

all radial scans indicated by “∆ BMOC” . This value is onlydisplayed if the BMO segmentation has been confirmed.

6.5.1.4 Switching Between the cSLO Image and an Imported Fundus Camera ImageThis functions allows for switching between the display of the cSLOimage and an imported fundus camera image which isautomatically aligned to the cSLO image. The imported funduscamera image should be a 45° or 30° image with the optic disc inits center.

If the fundus camera image does not meet thesespecifications, or if you select a different image type,the alignment of the fundus camera image to thecSLO image might fail and the fundus camera imagewill not be displayed properly.

For further information on importing images, please refer to theImage 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 onecSLO image, one of the fundus camera images is automaticallyselected, based on the following criteria:

▪ If a fundus camera image was dragged into the lightbox, this imageis 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 DiagramThe BMO-MRW diagram displays the following information:

▪ The BMO-MRW profile measured along the optic disccircumference.

▪ The normal range of BMO-MRW.The black line indicates the measured BMO-MRW. In a follow-upexamination, the baseline values are displayed as a gray curve.The horizontal axis represents the position along the optic disccircumference in degrees, with 0° located at the fovea-to-BMO-center axis (temporal) and the angle increasing clockwise for aright eye and counter-clockwise for a left eye. That is, thesequence is temporal to superior to nasal to inferior to temporal.The vertical axis represents the measured BMO-MRW in μm.

C-curve and distance between scancenter and BMO center

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Fig. 10: Incorrect segmentation identified in BMO-MRW diagram

If you recognize isolated peaks in the black and gray curves of theBMO-MRW diagram (Fig. 10), the BMO segmentation might beincorrect.

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).

The following three range bands are displayed in the BMO-MRWdiagram:

▪ The green band represents the range between the 5th and the 95th

percentile of the BMO-MRW distribution across the eyes in thereference database. This range is considered as “within normallimits” . The green line within this green band represents the meanBMO-MRW of the eyes in the reference database (50th percentile).

▪ The red band represents the range below the 1st percentile of theBMO-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 5th percentile butabove the 1st percentile of the normal distribution. This range isconsidered as “borderline” .The range bands are adjusted for the age of the examined subjectand for the BMO area of the examined eye. For further informationon the size, demographics, and clinical characteristics of thereference database cohort, please refer to ( 7.1 “BMO-MRWReference Database”, p. 49).

The classification results “Borderline” and “Outsidenormal limits ” do not necessarily indicate thatmeasured values relate to disease states.Likewise, the classification result “Within normallimits” does not necessarily indicate that disease iscompletely ruled out.

CAUTION!Clinicians must exercise judgment in theinterpretation of the reference dataFor any particular measurement, note that 1 out of20 eyes in the reference database (5%) will fallbelow the green range, and 1 out of 20 eyes in thereference database (5%) will fall above the greenrange.

Color-coding

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CAUTION!Always take the patient’s disk size and racial andethnic descent into account when interpretingclassification resultsClassification results for very small and very largediscs may not be as reliable as results for discs ofaverage size.Classification results may not be reliable for patientswhose racial and ethnical descent differ from thosein the reference database. For easy identification inthe software and on reports, classification results arealways displayed together with the used referencedatabase.

6.5.1.6 Confirming the BMO SegmentationIf the BMO segmentation has not been confirmed, isactive. 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 inthe cSLO image, the BMO-MRW diagram, and theBMO-MRW classification will be updatedsimultaneously.

If you edit the BMO points, your changes will not onlyaffect a single point but also the computed BMOcenter. As a result, the changes will affect the fovea-to-BMO-center axis angle, as well as the averagemeasurement results in all sectors.

If you edit the BMO points of an already confirmedexamination, you have to re-confirm the BMOsegmentation. For further information, please refer to( Chapter 6.3 “Confirming Segmentation”, p. 27).

Select a patient file containing OCT examinations and open it inthe analysis window.

Open the “BMO Rim Analysis” tab.

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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-and-

drop 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 OCTimage.

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 thatthis 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 torecalculate Bruch's Membrane Opening. All manual changes willbe lost.

Click “OK” to confirm. To quit the BMO points editing, click or press on the

keyboard.

6.5.2 “BMO Overview” TabThe “BMO Overview” tab provides an overview of the optic nervehead anatomy around Bruch's Membrane Opening. Radial OCTsection images at twelve equidistant locations around the optic discmargin are shown.

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Fig. 12: “BMO Overview” tab

Patient informationMenu barTool bar with follow-up controlOCT images with BMO-MRW ( 6.5.1.2 “OCTImage”, p. 31)cSLO image ( 6.5.1.1 “cSLO Image”, p. 30)Reference database ( 7.1 “BMO-MRWReference Database”, p. 49)Switching between the cSLO image and animported fundus camera image ( 6.5.1.4“Switching Between the cSLO Image and anImported Fundus Camera Image”, p. 33)

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6.5.2.1 OCT Image


Arrow indicating BMO-MRWILM segmentation line

The measured BMO-MRW is indicated by an arrow extending fromBMO to ILM. Each arrow is color-coded (Fig. 13) as follows toindicate whether the measured BMO-MRW is within or outside thenormal limits:

▪ Green = “within normal limits”▪ Yellow = “borderline”▪ Red = “outside normal limits”

If an arrow is color-coded white, the sector cannot be classifieddue to missing data of ILM or BMO segmentation.

To show or hide the BMO-MRW in the OCT images, press onthe keyboard (Fig. 13).

To show or hide the ILM in the OCT images, press on thekeyboard (Fig. 13).

6.5.2.2 cSLO Image

Fig. 14: cSLO image and OCT image

White lines superimposed indicating locations of the twelveOCT imagesOCT image and corresponding cSLO image marked with *

White lines superimposed on the cSLO image (Fig. 14) indicatethe locations of the twelve OCT images . The red dots are theBMO points as identified in the corresponding OCT images (Fig. 14).

Display options

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The top central OCT image (Fig. 14) and its correspondingwhite line on the cSLO image (Fig. 14) are marked with a * . The* may be difficult to see if the underlying structure is very bright.


Show BMO pointsHide 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” TabThe “Progression” tab is only available for ONH-RC scans andcircle scans.

Display options

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Fig. 16: “Progression” tab

Patient informationMenu barTool bar with follow-up control ( 6.5.3.1“Follow-up Control”, p. 40)Image quality bar ( “Examinations”, p. 41)Zoom and pan modeOCT imageY-scale functions

Control elementscSLO imageReference database ( 7.1 “BMO-MRWReference Database”, p. 49)Progression chart ( 6.5.3.2 “ProgressionChart”, p. 40)Image informationSector diagram ( “Sector diagram”, p. 42)

6.5.3.1 Follow-up ControlIn the “Progression” tab, the function to quickly switch between theimages of the progression series is replaced by clicking the desiredgray data point. The corresponding cSLO image and the OCTimage are displayed. Below the horizontal axis of the progressionchart ( 6.5.3.2 “Progression Chart”, p. 40), a small gray arrowindicates the currently selected examination.

6.5.3.2 Progression ChartFor circle scans, the chart shows the measured RNFL thicknessover time. For ONH-RC scans, the progression chart shows eitherthe measured BMO-MRW over time or the measured RNFLthickness over time. Select one of the following structures to bedisplayed below the chart:

▪ “BMO-MRW”▪ “RNFLT 3.5 mm”

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▪ “RNFLT 4.1 mm”▪ “RNFLT 4.7 mm”

If multiple images have been acquired in a progression series onthe same day, the last acquired image of this day is taken forprogression analysis. If you exclude the last acquired image in anexamination tab from the progression series, the previouslyacquired image from this day is automatically taken for progressionanalysis.Each gray data point in the progression chart marks anexamination. 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 barshows the mapping from quality values to gray shading. Thecurrently selected examination is marked with a circle on the imagequality bar. Below the circle, the image quality value is displayed.Please note that the image quality information is only displayed ifglobal “G” has been selected in the sector diagram ( “Sectordiagram”, p. 42).If you hover with the mouse cursor over a data point, theexamination date is displayed on the horizontal axis and the valuefor BMO-MRW in μm or RNFL thickness in μm is displayed on thevertical axis. The BMO-MRW values correspond to the valuesshown in the “BMO Rim Analysis” tab. The RNFL thickness valuescorrespond 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 classificationchart, please refer to ( 6.6.1.3 “Peripapillary RNFLT ClassificationChart”, p. 44).If you click a gray data point, the corresponding cSLO image andthe selected OCT image are displayed. Below the progressionchart, a small gray arrow indicates the currently selectedexamination.

The change of BMO-MRW and RNFL thickness with time isestimated and predicted by linear regression in terms of ordinaryleast squares. The blue regression line shows the linearapproximation from the given data and a five-year trend.The legend in the bottom right of the diagram shows the followingresults 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 normalage decrease with the alternative of a faster decrease than normal.The p-value estimates the likelihood to observe a similar or evenmore extreme slope by chance alone. A small p-value (<0.05)suggests that a systematic change, i.e., disease progression islikely to be present. A large p-value means that there is lessevidence that a true change has taken place.

Examinations

Regression analysis

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P-values are often misinterpreted. A small (“statistically significant”)p-value does not automatically mean that there is a clinicallyrelevant change. In a large series of high-quality images, evensmall and clinically unimportant changes may become statisticallysignificant. A large (“not statistically significant”) p-value does notexclude the possibility that a clinically important change hasoccurred. This is particularly important if only few images, orimages of poor quality are available for analysis.If only one or two examinations exist, neither the blue regressionline nor regression analysis results are displayed. If three to fourexaminations exist, the blue regression line is dashed but noregression analysis results are displayed. Full regression analysisresults are only displayed, if the progression series consists of fiveor more included examinations.The gray lines mark the confidence interval of the regression linewith a confidence level of 95%.

The following three range bands are displayed in the progressionchart:

▪ The white band represents the range above the 5th percentile ofthe BMO-MRW / RNFLT distribution across the eyes in thereference database. This range is considered as “within normallimits” .

▪ The yellow band represents the range below the 5th percentile butabove the 1st percentile of the BMO-MRW / RNFLT distributionacross the eyes in the reference database. This range isconsidered as “borderline” .

▪ The red band represents the range below the 1st percentile of theBMO-MRW / RNFLT distribution across the eyes in the referencedatabase. This range is considered as “outside normal limits” .The green line represents the mean BMO-MRW of the eyes in thereference database.The range bands are adjusted for the subject’s age and theexamined eye’s BMO area.

You can display the progression information globally (G) and foreach 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 informationdisplayed in the progression chart changes according to yourselection.

Color-coding

Sector diagram

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6.6 Analyzing Peripapillary Retina Nerve Fiber Layer Thickness6.6.1 “RNFL Thickness” Tab

Fig. 17: “RNFL Thickness” tab

Patient informationMenu barTool bar with follow-up controlcSLO imageOCT imagePeripapillary RNFLT classification chart andoverall classification ( 6.6.1.3 “PeripapillaryRNFLT Classification Chart”, p. 44)

Pan modeReference database ( 7.2 “RNFL ThicknessReference Database”, p. 51)Y-scale functionsSegmentation EditorRNFL thickness profile graph ( 6.6.1.4 “RNFLThickness Profile Graph”, p. 45)Image information

6.6.1.1 cSLO ImageIn the lower right corner of the cSLO image, the diameter of thecurrently selected circle scan and the BMO area of the examinedeye are displayed.

6.6.1.2 OCT ImageIn the OCT image, the segmentation lines for the ILM and theRNFL are indicated. The RNFL thickness is measured along thecircular scan and compared to the reference database ( 7.2“RNFL Thickness Reference Database”, p. 51).

Analyzing Images

Analyzing Peripapillary Retina Nerve Fiber Layer...

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6.6.1.3 Peripapillary RNFLT Classification ChartThe peripapillary RNFLT classification chart represents theclassification 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 ofthe six standard sectors compared to older software versionsbefore 6.0:

▪ The sector limits proposed by Garway-Heath are used (Garway-Heath et al., Mapping the Visual Field to the Optic Disc in NormalTension Glaucoma Eyes, 2000, American Academy ofOphthalmology).

▪ The origin (0°) of the peripapillary angular coordinate has beenchanged in the RNFLT classification chart to correspond to theanatomical axis between fovea and BMOC.

The differences of the standard sector definitions are shown in thefollowing 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 beanalyzed using the Garway-Heath or the legacysector definitions, and Garway-Heath sectors will beused by default. Images acquired with the RNFLpreset can be analyzed with legacy sector definitionsonly.

In order to switch between the Garway-Heath and the legacysectors, select “Options ► Preferences ► Glaucoma Options” inthe 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 averageRNFL thicknesses in μm for each sector and global. Thepercentage numbers in parentheses are the correspondingpercentiles of the normal distribution, adjusted for the age of theexamined subject and BMO area of the examined eye.

Analyzing Images


6


For example, a value of 11% (the 11th percentile of the normaldistribution) means that 11% of the eyes in the referencedatabase have RNFL thickness values of this size or thinner.

Example

For further information on the size, demographics, and clinicalcharacteristics of the reference database cohort, please refer to( 7.2 “RNFL Thickness Reference Database”, p. 51).

The pie chart is color-coded according to this percentile, to indicatewhether a sector is classified as follows:

▪ A green sector represents the range above the 5th percentile of theRNFLT distribution across the eyes in the reference database. Thisrange is considered as “within normal limits” .

▪ A yellow sector represents the range below the 5th percentile butabove the 1st percentile of the RNFLT distribution across the eyesin the reference database. This range is considered as“borderline” .

▪ A red sector represents the range below the 1st percentile of theRNFLT distribution across the eyes in the reference database. Thisrange is considered as “outside normal limits” .

The text and color-coding of the bar below the pie chart indicatethe 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 meanare 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 clinicalcharacteristics of the reference database cohort, please refer to( 7.2 “RNFL Thickness Reference Database”, p. 51).

6.6.1.4 RNFL Thickness Profile GraphThe 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 afollow-up examination, the baseline values are displayed as a graycurve.The horizontal axis represents the position along the optic disccircumference in degrees, with 0° located at the fovea-to-BMO-center axis (temporal) and the angle increasing clockwise for aright eye and counter-clockwise for a left eye, i.e., the sequence istemporal to superior to nasal to inferior to temporal. The verticalaxis 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 afactor of 4.

Color-coding

Overall classification results

Analyzing Images


6


The following three range bands are displayed in the RNFLthickness profile graph:

▪ The green band represents the range between the 5th and the 95th

percentile of the RNFLT distribution across the eyes in thereference database. This range is considered as “within normallimits” . The green line within this green band represents the meanRNFLT of the eyes in the reference database (50th percentile).

▪ The yellow band represents the range below the 5th percentile butabove the 1st percentile of the normal distribution. This range isconsidered as “borderline” .

▪ The red band represents the range below the 1st percentile ofRNFLT distribution across the eyes in the reference database. Thisrange is considered as “outside normal limits” .The range bands are adjusted for the age of the examined subjectand for the BMO area of the examined eye.For further information on the size, demographics, and clinicalcharacteristics of the reference database cohort, please refer to( 7.2 “RNFL Thickness Reference Database”, p. 51).

The classification results “Borderline” and “Outsidenormal limits ” do not necessarily indicate thatmeasured values relate to disease states.Likewise, the classification result “Within normallimits” does not necessarily indicate that disease iscompletely ruled out.

CAUTION!Always take the patient’s disk size and racial andethnic descent into account when interpretingclassification resultsClassification results for very small and very largediscs may not be as reliable as results for discs ofaverage size.Classification results may not be reliable for patientswhose racial and ethnical descent differ from thosein the reference database. For easy identification inthe software and on reports, classification results arealways displayed together with the used referencedatabase.

CAUTION!Clinicians must exercise judgment in theinterpretation of the reference dataFor any particular measurement, note that 1 out of20 eyes in the reference database (5%) will fallbelow the green range, and 1 out of 20 eyes in thereference database (5%) will fall above the greenrange.

Color-coding

Analyzing Images


6


6.6.2 “Thickness Map” TabThe “Thickness Map” tab is only available for images acquiredwith the “PPoleH” , “PPoleV” , and the “ONH” presets. For furtherinformation on this tab, please refer to the SPECTRALIS UserManual.

Fig. 18: “Thickness Map” tab

Patient informationMenu barTool bar with follow-up controlcSLO image with thickness map overlay, ETDRSgrid, and color scale“Average Thickness” and “Retina Thickness”graph of the reference examinationZoom and pan modeTransparency of the overlay

OCT imageLayer and grid selectionSegmentation Editor“Average Change” graph and Macula Index“Retina Thickness Change” graphImage information“Average Thickness” and “Retina Thickness”graph of the current examination

6.7 Analyzing the Posterior PoleThe “Posterior Pole” tab is only available for images acquired withthe “PPoleH” preset. For further information on presets, pleaserefer to ( 5.1 “Presets”, p. 22). For further information on this tab,please refer to the SPECTRALIS User Manual.

Analyzing Images

Analyzing the Posterior Pole

6


Fig. 19: “Posterior Pole” tab

Patient informationMenu barTool bar with follow-up controlcSLO image with overlay and color scale“Hemisphere Asymmetry” and “RetinaThickness” graph of the reference examinationZoom and pan modeTransparency of the overlay

OCT imageLayer and grid selectionSegmentation Editor“Retina Thickness Change” graphImage information“Hemisphere Asymmetry” and “RetinaThickness” graph of the current examination

Analyzing Images

Analyzing the Posterior Pole

6


7 Reference Database7.1 BMO-MRW Reference Database

The BMO-MRW reference database includes 246 eyes (123 righteyes and 123 left eyes) of 246 normal subjects (109 male and 137female) of European descent with mean age of 52.2 years (range20 to 87 years). Subjects were enrolled in a prospective, multi-center, observational study. Included subjects had healthy eyeswithout prior intraocular surgery (except cataract surgery or Lasik)and without clinically significant vitreal, retinal or choroidaldiseases, diabetic retinopathy, or disease of the optic nerve, nohistory of glaucoma, intraocular pressure ≤21 mmHg, bestcorrected visual acuity ≥0.5, refraction between +6 and -6 diopters,astigmatism ≤2 diopters, normal visual field with GlaucomaHemifield Test and Mean Deviation within normal limits, clinicallynormal appearance of optic disc with normal appearingneuroretinal rim with respect to color and shape.BMO-MRW reference data was acquired and analyzed relative tothe fovea-to-BMO-center axis, to ensure accurate and consistentpositioning of the BMO-MRW profiles across eyes.The age- and BMO area-adjusted BMO-MRW normal distributionpercentiles were computed. The distribution percentiles are used todetermine whether an examined eye has measures within oroutside the normal range.The reference database is limited by its sample size (246 eyes of246 subjects), the covered age range (20 to 87 years), the coveredrange of optic disc size (BMO area 1.0 to 3.4 mm2; 8 cases withBMO area >2.5 mm2), the covered range of refraction (+6 to -6diopters), and European ethnicity.

CAUTION!Consider the reference database limitationsdescribed above when examining subjects whosecharacteristics differ from those included in thereference database.

BMO-MRW decreases with increasing age and with increasingBMO area. To take this into account, the reference database isadjusted for age and BMO area in a multiple linear regressionmodel. As a result, the percentiles of the normal distribution usedfor the classification depend on the patient's age and the eye’sBMO area.The BMO-MRW value ri that corresponds to a certain normaldistribution percentile i for a subject of given age and BMO area,and the normal distribution percentile pr that corresponds to ameasured value of BMO-MRW for a subject of given age and BMOarea, are computed as follows:

The ith age- and BMO area-adjusted percentile of BMO-MRW ri fora subject with age a and BMO area b is given by

.The age- and BMO area-adjusted percentile pr corresponding to ameasured BMO-MRW r for a subject with age a and BMO area b isgiven by ,

Composition

Adjustment for age and for BMOarea

Reference Database

BMO-MRW Reference Database

7


▪ = mean BMO-MRW in the reference database (age- and BMOarea-adjusted)

▪ σr = 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▪ sra = slope of the regression of BMO-MRW versus age▪ srb = 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 asfollows:

▪ Mean age = 52.17 years▪ Mean BMO area = 1.781 mm2

The means , standard deviations σr, and slopes sra and srb forBMO-MRW global and in the six standard sectors temporal (T),temporal-superior (TS), temporal-inferior (TI), nasal (N), nasal-superior (NS), and nasal-inferior (NI) are listed in the followingtable:

[μm] σr [μm] sra [μm/year] srb [μm/mm2]

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 followingtables show the values of the 1st and the 5th percentiles of BMO-MRW for the global average and the averages in the standardsectors, for a 45 years old subject with a small BMO area(1.5 mm2), and for a 65 years old subject with a large BMO(2.5 mm2).

Reference Database

BMO-MRW Reference Database

7


BMO-MRW, age 45 years, BMO area 1.5 mm2

1st percentile [μm] 5th 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 mm2


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 DatabaseThe RNFLT reference database includes 218 eyes (111 right eyesand 107 left eyes) of 218 normal subjects (94 male and 124female) of European descent with mean age of 51.5 years (range20 to 87 years). Subjects were enrolled in a prospective, multi-center, observational study. Included subjects had healthy eyeswithout prior intraocular surgery (except cataract surgery or Lasik)and without clinically significant vitreal, retinal or choroidaldiseases, diabetic retinopathy, or disease of the optic nerve, nohistory of glaucoma, intraocular pressure ≤21 mmHg, bestcorrected visual acuity ≥0.5, refraction between +6 and -6 diopters,astigmatism ≤2 diopters, normal visual field with GlaucomaHemifield Test and Mean Deviation within normal limits, clinicallynormal appearance of optic disc with normal appearingneuroretinal rim with respect to color and shape.RNFLT reference data was acquired and analyzed relative to thefovea-to-BMO-center axis, to ensure accurate and consistentpositioning of the BMO-MRW profiles across eyes. The age- andBMO area-adjusted RNFLT normal distribution percentiles werecomputed. The distribution percentiles are used to determinewhether an examined eye has measures within or outside thenormal range.The RNFLT reference database includes reference data for RNFLthickness along peri-papillary circle scans with 3.5 mm, 4.1 mm,and 4.7 mm diameter.

Composition

Reference Database

RNFL Thickness Reference Database

7


The reference database is limited by its sample size (218 eyes of218 subjects), the covered age range (20 to 87 years), the coveredrange of optic disc size (BMO area 1.0 to 3.4 mm2; 8 cases withBMO area >2.5 mm2), the covered range of refraction (+6 to -6diopters), and European ethnicity.

CAUTION!Consider the reference database limitationsdescribed above when examining subjects whosecharacteristics differ from those included in thereference database.

RNFL thickness in normal subjects decreases slightly withincreasing age and with decreasing BMO area. To take this intoaccount the reference database is age-adjusted and BMO area-adjusted based on multiple linear regression. As a result, thepercentiles of the normal distribution used for the classificationdepend on the patient's age and the eye's BMO area.

The RNFLT value ri that corresponds to a certain normaldistribution percentile i for a subject of given age and BMO area,and the normal distribution percentile pr that corresponds to ameasured value of RNFLT for a subject of given age and BMOarea, are computed as follows:

The ith age- and BMO area-adjusted percentile of RNFLT ri is givenby .The age- and BMO area-adjusted percentile pr corresponding to ameasured RNFLT r for a subject with age a and BMO area b isgiven by , .

▪ = mean RNFLT in the reference database (age- and BMO area-adjusted)

▪ σr = 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▪ sra = slope of the regression of RNFLT versus age▪ srb = 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

distributionMean age and mean BMO area in the reference database are asfollows:

▪ Mean age = 51.51 years▪ Mean BMO area = 1.773 mm2

The means , standard deviations σr, and slopes sra and srb forRNFLT global and in the six standard sectors temporal (T),temporal-superior (TS), temporal-inferior (TI), nasal (N), nasal-superior (NS), and nasal-inferior (NI) are listed in the followingtables for circle diameters 3.5 mm, 4.1 mm and 4.7 mm:

Adjustment for age and for BMOarea

Reference Database


7


RNFLT (3.5 mm circle diameter)


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 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 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 followingtables show the values of the 1st and the 5th percentiles of theaverage RNFLT (3.5mm diameter circle) global and in the standardsectors, for a 45 years old subject with a large BMO area(2.5 mm2), and for a 65 years old subject with a small BMO area(1.5 mm2).

Reference Database


7


RNFLT (3.5 mm circle diameter), age 45 years, BMO area 2.5 mm2


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 mm2


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

Reference Database


7


8 ReportsThe reports described in this chapter are available in addition tothe standard SPECTRALIS reports. For all information ongenerating, customizing, and printing reports, as well as exportingreports as image files, please refer to the SPECTRALIS UserManual.

Please select the following report options in the “Print SpectralisReport” window. The software will remember these settings andapplies 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 astwo images.

Reports with thicknessmaps

“Thickness Map” Select the desired layer from the drop-down list.

Reports with PosteriorPole maps

“Posterior Pole Map” Select the desired layer from the drop-down list.

Reports with circle scansof ONH-RC examinations

“Circle” Select the desired size of the circlescan from the drop-down list.

Reports with progressionseries

▪ “Parameter”▪ “Sector”

▪ Select either “Minimum Rim Width”or the desired size of the circle scan.

▪ Select the desired sector from thedrop-down list.

8.1 “Minimum Rim Width Analysis” Report

Required examinations ONH-RC scans

Options The report is also available as an OU report.

Note ▪ On this report, only the cSLO image can be displayed, not the importedfundus camera image.

▪ BMO-MRW diagram always uses the Garway-Heath definition of thestandard sectors ( “Standard sector definitions”, p. 44).

Reports

Minimum Rim Width Analysis Report

8


Fig. 20: “Minimum Rim Width Analysis” report

Patient data, diagnosis and commentsOCT images with BMO-MRWcSLO image with overlayBMO-MRW diagram, BMO-MRW classificationchart, and overall classification ( 6.5.1 “ “BMORim Analysis” Tab”, p. 30)Reference database ( 7.1 “BMO-MRWReference Database”, p. 49)Space for notes

8.2 “BMO Overview” Report


Note ▪ 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 displayedon the report.

Reports

BMO Overview Report

8


Fig. 21: “BMO Overview” Report

Patient data, diagnosis and commentscSLO image with overlaysOCT images with BMO-MRWReference database ( 7.1 “BMO-MRWReference 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 bothimage thumbnails. Then, release and right-click a selected imagethumbnail. The report will then be listed in the “Print Spectralis Report”window.

Reports

Glaucoma Overview Report

8


Fig. 22: “Glaucoma Overview” report

Patient data, diagnosis and commentscSLO image with superimposed scan pattern“Hemisphere Asymmetry” graphcSLO image with thickness map grid and colorscaleReference database ( 7.1 “BMO-MRWReference Database”, p. 49)MRW diagram, BMO-MRW classification chart,and overall classification ( 6.5.1 “ “BMO RimAnalysis” Tab”, p. 30)

RNFLT diagram, peripapillary RNFLTclassification chart, and overall classification( 6.7 “Analyzing the Posterior Pole”, p. 47)“Average Thickness” graphGCL thickness mapSpace for notes

8.4 “Minimum Rim Width & RNFL Analysis Single Exam Report”


Note ▪ The BMO-MRW diagram always uses the Garway-Heath definition of thestandard sectors ( “Standard sector definitions”, p. 44).

▪ The RNFLT classification chart uses the sectors selected in the“Glaucoma Options” .

Reports

Minimum Rim Width & RNFL Analysis Single Exam Re...

8


Fig. 23: “Minimum Rim Width & RNFL Analysis Single Exam Report”

Patient data, diagnosis and commentsBMO overviewOCT image of the APS radial scanBMO-MRW diagramBMO-MRW classification chart with overallclassification

Reference database ( 7.1 “BMO-MRWReference Database”, p. 49)OCT image of the APS circle scanRNFLT diagramRNFLT classification chartSpace for notes

8.5 “MRW, RNFL & Asymmetry Analysis Single Exam” Report

Required examinations 1 ONH-RC scan and 1 PPoleH scan

Note To generate the report, add the ONH-RC scan and the PPoleH scan to thelightbox.

Reports

MRW, RNFL & Asymmetry Analysis Single Exam Report

8


Fig. 24: “MRW, RNFL & Asymmetry Analysis Single Exam” report

Patient data, diagnosis and commentsOCT image of the APS scanRNFLT diagramBMO-MRW diagramRNFLT and BMO-MRW classification charts withoverall classificationReference database ( 7.1 “BMO-MRWReference Database”, p. 49)

cSLO image with thickness map grid and colorscaleOCT imageThickness profile graph“Average Thickness” and “HemisphereAsymmetry” graphsSpace for notes

Reports

MRW, RNFL & Asymmetry Analysis Single Exam Report

8


8.6 “MRW, RNFL & Visual Field Structure Function Map” Report

Required examinations 1 ONH-RC scan and 1 HEP visual field examination performed using a24-2 or 30-2 testing pattern

Note ▪ If you generate the report and multiple visual field examinations exist, the“Choose Companion Exam” dialog box is displayed where availablevisual field examinations are listed. Select the desired visual fieldexamination from the list and click “OK” to confirm.

▪ The combined SPECTRALIS & HEP Visual Field report is only availablefor examinations that have taken place within a six month interval. If theexaminations have a time difference of 90 days or more, the time spanbetween the OCT examination and the visual field examination ishighlighted in red on the report.

Reports

MRW, RNFL & Visual Field Structure Function Map ...

8


Fig. 25: “MRW, RNFL & Visual Field Structure Function Map” report

Patient data, diagnosis and commentsExamination datesSPECTRALIS cSLO imageSPECTRALIS RNFLT diagramSPECTRALIS BMO-MRW diagramStructure-Function-Map HEP and RNFLReference database ( 7.2 “RNFL ThicknessReference Database”, p. 51)

HEP VF “Grayscale” with color codingHEP VF “Total Deviation” with color codingHEP VF “Pattern Deviation”HEP information on duration, FP Count, FNCount, fixation losses, global indices andreliabilityStructure-Function-Map HEP and BMO-MRWSpace for notes

8.7 “Progression Analysis” Report

Required examinations Progression series of ONH-RC scans

Reports

Progression Analysis Report

8


Fig. 26: “Progression Analysis” report

Patient data, diagnosis and commentsMRW progression chart

Reference databaseSpace for notes

Reports

Progression Analysis Report

8


9 Troubleshooting9.1 Error Messages Image Acquisition

The following messages can be displayed in the status bar of theacquisition window.

Message Cause Remedy

“Confirm baseline segmentationbefore follow-up acquisition!”

BMO segmentation has not beenconfirmed.

Confirm the BMO segmentationright after baseline imageacquisition

“Adjust the camera for scanningat the fovea, then press the "Start"button or "Acquire".”

Anatomic landmark definition hasbeen started. An APS preset hasbeen selected.

Start the fovea detection ( “Step1 - Detecting the foveaposition”, p. 16).

“Please wait for automatic fovealocalization to complete...”

The fovea is being detected. Wait until the Fovea is detected.

“Position invalid. Please markfovea position in both OCTimages.”

The fovea could not be detected. Define the fovea manually( “Step 2 - Confirming the foveaposition”, p. 16).

“Please check/correct foveaposition in both OCT images andpress "Confirm".”


“Automatic fovea localizationfailed. Please define manuallyusing the markers in the OCTimages.”


“Automatic fovea localizationfailed to complete. Please definemanually using the markers in theOCT images.”


“Adjust the camera for scanningat the ONH, then press the "Start"button or "Acquire".”

The fovea has been detected.Now, start BMO center detection.

Start the BMO center detection( “Step 3 - Detecting the BMOcenter position”, p. 17).

“Please wait for automatic BMOcenter localization to complete...”

BMO center is being detected Wait until the BMO center isdetected.

“Automatic BMO centerlocalization failed. Please definemanually using the BM endpointmarkers in the OCT images.”

The BMO center could not bedetected.

Define the BMO ends manually( “Step 3 - Detecting the BMOcenter position”, p. 17).

“Automatic BMO centerlocalization failed to complete.Please define manually using theBM endpoint markers in the OCTimages.”



“Position invalid. Please reviewthe BM endpoint markers in theOCT images.”



“Please check/correct the BMOcenter location (using the BMendpoint markers) and press"Confirm".”



Troubleshooting

Error Messages Image Acquisition

9


Message Cause Remedy

“APS: Anatomic landmarkdefinition completed.”

Anatomic landmarks have beendetected successfully.

Acquire the baseline image( “Acquiring the baselineimage”, p. 19).

“APS: Anatomic landmarkdefinition aborted on user.”

Anatomic landmark definition hasbeen canceled.

Repeat anatomic landmarkdefinition ( 4.1 “Defining theAnatomic Map”, p. 12).

“APS: Anatomic landmarkdefinition aborted! Please restartAPS definition.”

Anatomic landmarks definition hasbeen canceled.

Repeat anatomic landmarkdefinition ( 4.1 “Defining theAnatomic Map”, p. 12).

9.2 Error Messages “Progression” TabFault description Cause Remedy

“Potential outlierdetected”

This warning message is displayed, if data of oneor more examinations do not conform to the rest ofthe progression data. The gray data pointsindicating the respective examinations areencircled.

Check the segmentation of theseexaminations and modify thesegmentation, if necessary.

“Invalid datafound”

This error message is displayed, if the layersegmentation or BMO segmentation of one ormore examinations is missing or invalid. Therespective examination is not displayed in theprogression chart.

Please check the progressionseries for invalid data.

“Unconfirmeddata found”

For ONH-RC scans, this error message isdisplayed, if you have not yet confirmed the BMOsegmentation for all data points. Data points withunconfirmed BMO segmentation are marked by anorange encircling.

▪ Select the respective data pointin the progression chart.

▪ Open the “BMO Rim Analysis”tab and confirm the BMOsegmentation.

“Insufficient dataavailable”

This error message is displayed, if not enoughexaminations are included in the progression toallow a statistical analysis.

Acquire at least five images ondifferent days to get reliableprogression information.

Troubleshooting

Error Messages Progression Tab

9


10 IndexAAnatomic landmarks............................................. 12

APS information.............................................. 28BMOC detection.............................................. 12Defining anatomic landmarks.......................... 12Fovea detection.............................................. 12Redefining anatomic landmarks...................... 19

Anatomic map...................................................... 12Acquiring the baseline image.......................... 12Defining anatomic landmarks.......................... 12

BBaseline image..................................................... 12

Confirmed APS............................................... 26Deactivated anatomic map............................. 26Unconfirmed APS........................................... 26

BMO center confirmation date............................. 28BMO center confirmation location........................ 28BMO center confirmed by.................................... 28BMO-MRW

Reference database........................................ 49BMO Overview tab

Overview of the anatomy around BMO........... 36BMO Overview Tab

Minimum rim width.......................................... 38Bruch's Membrane opening

Editing the end points..................................... 35Reset............................................................... 35Undo all changes............................................ 35

CC-Curve................................................................ 12Confirmed APS.................................................... 26Corneal curvature................................................. 12FFollow-up image

Confirmed APS............................................... 26Deactivated anatomic map............................. 26Excluding imaged from a progression series.. 26Including images into a progression series..... 26Unconfirmed APS........................................... 26

Fundus camera imageImage registration........................................... 33

GGarway-Heath sectors

Thickness profile............................................. 44

LLandmark definition date...................................... 28Landmark definition location................................ 28Landmarks defined by.......................................... 28Legacy sectors

Thickness profile............................................. 44MMean corneal radius............................................. 12Minimum rim width

Classification................................................... 38Color-coding.................................................... 38

OOCT images

Thickness map................................................ 47ONH-RC............................................................... 22PPeripapillary RNFLT

Classification................................................... 44Peripapillary RNFL thickness

RNFL thickness graph.................................... 45Peripapillary RNFL Thickness

Reference Database....................................... 51PPoleH................................................................. 22PPoleV................................................................. 22Presets................................................................. 22

ONH................................................................ 22ONH-RC.......................................................... 22PPoleH............................................................ 22PPoleV............................................................ 22RNFL............................................................... 22

Progression chart................................................. 40Color-coding of the range bands..................... 42Data points...................................................... 41Image quality................................................... 41Regression analysis........................................ 41Sector diagram................................................ 42

Progression series............................................... 26References...................................................... 26

P-value................................................................. 41RReference database

Adjustment for age and for BMO area...... 49, 52BMO-MRW...................................................... 49

Index10


Regression analysisConfidence interval......................................... 41Confidence level............................................. 41No regression analysis results are displayed.. 41P-value............................................................ 41Regression line............................................... 41Regression line is dashed............................... 41

Regression analysis results................................. 41Regression line.................................................... 41

Regression line is dashed............................... 41TThickness map

Analysis window.............................................. 47

Thickness profileGarway-Heath sectors.................................... 44Legacy sectors................................................ 44Peripapillary RNFLT classification.................. 44RNFL thickness graph.................................... 45

UUnconfirmed APS................................................. 26Unconfirmed data................................................. 26

Index 10



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