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DRCR.net OCT-A Optovue AngioVue Procedure Manual 2.0 9-19-16

DRCR.net Image Acquisition Protocol

Optical Coherence Tomography Angiography (OCT-A) Using: Optovue AngioVue

Version 2.0

September 19, 2016

DRCR.net OCT-A Optovue AngioVue Procedure Manual 2.0 9-19-16 of 19

Table of Contents Optovue OCT Angiography (OCT-A) Overview ...................................................................................................... 3

OCT-A Technician Certification ............................................................................................................................... 5

2.1 Overview .................................................................................................................................................................. 5

2.2 Patient Management ................................................................................................................................................. 5

Scan Acquisition: Steps to Acquire OCT Angiography Scans .................................................................................. 8

3.1 AngioVue Scan ........................................................................................................................................................ 8

3.2 Scan Optimization .................................................................................................................................................. 10

Exporting ................................................................................................................................................................. 16

4.1. Renaming Subjects prior to Export ..................................................................................................................... 16

4.2 Exporting Data Files .............................................................................................................................................. 16


Version History Version Author Approver Effective Date Revision Description

1.0 Adam Glassman Lee Jampol 28 July 2016 Initial version of document

2.0 Adam Glassman Cindy Stockdale 19 September 2016

Optovue will certify imagers; exports should be uploaded not zipped, formatting fixes and minor clarifications added

1. Optovue OCT Angiography (OCT-A) Overview

a. Machine: Optovue Avanti XR AngioVue

b. Certification for OCT-A imaging is not required at this time

c. Scan Type:

˗ Two scan settings on the macula: 3x3 mm scan and 6x6 mm scan centered on the

fovea. Each scan setting should include both x-fast AND y-fast images.

˗ One scan setting for the optic nerve: 4.5x4.5 centered on the optic nerve. The scan

for the 4.5x4.5 should include both x-fast AND y-fast images.

d. Select the PATIENT window from the main menu. Select an existing patient or add a new

patient.

e. Click the Scan button to go to the SCAN window.

f. In the SCAN window, select the patient eye to be scanned; Both/OU or Right/OD or

Left/OS.

g. If the DRCR network protocol has been created on your device, click the protocol – the list

of required scans should appear in the patient’s window.

• If the DRCR network protocol has not been created on your specific device, check

all the AngioVue OCT Angiography scans that need to be captured. Then in the

completed scan window, all selected scans will be displayed with capture number

labeled beside.

h. To start a selected scan, use the mouse to double click any selected scan from the

completed scan window.

i. In the new version of eye tracking software, “Eye Alignment” pop up window will show up.

j. Adjust table height to accommodate the subject comfortably as needed.


k. Have the subject place his/her chin into the correct chin cup with forehead leaning against

the forehead rest

l. Align eye to be scanned vertically with the canthus mark on the side of the chin rest

assembly

m. Ask the patient to look at the fixation target, a blue dot in the red field.

n. Center the video image on the pupil and move the scan head towards the patient,

controlling it so that the video image passes through the pupil. Carefully advance until the

fundus come into view. Figures below show the progression of views as you move the scan

head forward. The box (the scanning region) on the right panel can also be dragged to the

location to best center the image provided the Follow-Up box is unchecked. This is

particularly important for patient with eccentric fixation.

o. Adjust the working distance between the scan head and the patient eye to optimize the

video image. Optimized fundus images should show Optic nerve head clearly visible and

fundus image is illuminated evenly from edge to edge.

p. When the video image is optimized, click “Auto Adjust” button in the new tracking

software (or “Auto All” button) to adjust Polarization, Z offset, and Focus.

q. The enface OCT image as well as the line scan OCT image will show up in two different

windows.

r. Use the mouse wheel to adjust the line OCT image between the two red lines with correct

orientation.

s. If the SSI indicator is not green, adjust the Z axis, Focus or P-Motor functions until the SSI

indicator is green.

t. Capture image - click the joystick button or the on screen green check mark (Once the

joystick button or green check mark is clicked do not try to adjust the live OCT image by

moving the station in and out)

u. When the 1st OCT Angiography has been captured, a pop-up window will show up and ask

if you want to continue to the 2nd MCT (OCT Angiography) scan. At this step, the


technician should check the image quality and decide to “Continue” or “Rescan” the 1st

scan one more time.

v. If the 1st scan quality is fine, click “Continue” button.

w. Capture image - click the joystick button or the on screen green check mark

x. When the 2nd OCT Angiography is captured, a pop up window will ask if you want to

continue to the MCT processing and save. At this step, the technician should check the

image quality and decide to “Continue and Save” or “Rescan” the 2nd scan one more time.

y. When the 2nd scan quality is fine, click “Continue and Save” button.

z. Please review the OCT Angiography image again. If a scan has poor saturation or is of poor

quality, have the subject blink or apply artificial tears, and repeat the scan. The Signal

Strength (SSI) should be above 50. If the SSI is below 30, the RTVue will not save the data.

aa. All images will be exported via the DRCR.net uploader

Further clarification regarding any information included in this document may be obtained by

contacting the DRCR.net Coordinating Center [email protected] or 813-975-8690.

OCT-A Technician Certification

2.1 Overview

Initially certification will not be required prior to collecting images. However, technicians will be

required to send images to Optovue for review. Each technician who will be using AngioVue OCTA

in DRCR.net trials will send images from two normal eyes and two eyes from a person with

diabetes to Optovue at [email protected]. In the future, technician certification may be

required.

2.2 Patient Management

a. Manage Patient Information

The system application opens by default to the PATIENT window.


Figure 1 PATIENT Window Items

Figure 1 Legend:

1. PATIENT tab (highlighted)

2. Basic or Advanced Search area

3. Selected patient in list and on title bar

4. Patient list

5. Patient Detail area

6. Visit list (for selected patient)

7. Scan list (for selected visit)

8. Review button

9. OD and OS Retina OverVue buttons

10. Scan button

11. Edit button

12. Add Patient button

13. Advanced or Basic Search link

Use the PATIENT window to create, find, select, edit and delete patients, visits and scans, and to

initiate scanning or scan review. Features of the PATIENT window help you enter patient

information in advance, preview today’s scheduled patients, and search for patients using a

specified date range or other search criteria. The PATIENT list displays search results.

b. Add a New Patient

To add a new patient, click the Add Patient button. The Add New Patient dialog appears, as

shown in Figure 2.


Figure 2 Add New Patient Dialog

1. Required fields are in bold. Enter the required information and enter other information as

desired. You must enter the birth date in the indicated format.

2. Use the Optional area to enter:

˗ Physician: Use the down arrow to select one or more physicians to associate with

this patient, or select Add New to enter a new physician name and associate it with

this patient.

˗ Operator: Use the down arrow to select one or more operators to associate with

this patient, or select Add New to enter a new operator name and associate it with

this patient.

˗ Visit Comment: Enter desired comments for this patient.

3. Note: You can also create, edit and delete physicians, operators or diseases by selecting

Physician, Operator or Disease from the Database Management menu.

4. Use the Disease Category area to associate one or more user-defined diseases with this

patient. Once they are created, you can search for patients by disease category. To create

disease categories, click Add New to display the Disease Category Editor dialog, enter a

disease name and click OK.

5. When you finish entering information for the new patient, click Save to save the new

patient and close the dialog, or click Scan to initiate scanning for this new patient. Click

Cancel to discard entered information and close the dialog.

a. Edit Patient Information

1. To edit patient information, select the patient name from the Patient list and click the Edit

button. The Edit Patient/Visit Info dialog appears.

2. Edit the fields as desired.


3. Click Save to save your changes.

4. Click Cancel to discard the edits and close the dialog.

Figure 3 Edit Patient Dialog

Scan Acquisition: Steps to Acquire OCT Angiography Scans

Note: We recommend you clean the chinrest and forehead rest between patients with a

disinfectant. For example, wipe with an isopropyl alcohol pad or with another germicide using a

clean cloth.

3.1 AngioVue Scan

1. Scan Window (older models may have different view)

a. From the PATIENT window, select an existing patient or add a new patient, then click the Scan

button to go the SCAN window (Fig. 4)

2. Scan Parameters

a. In the SCAN window, select the patient eye to be scanned. Both/OU is selected by default.

To change, click the Right/OD or Left/OS button.


Figure 4 Scan Selection Options

b. Select the AngioVue OCT Angiography scan type, Angio Retina 3x3 mm, Angio Retina 6x6

mm, and Angio Disc 4.5mm scans. When you finish your selections, click the Scan button

to begin scanning. Ensure that both the x-fast and y-fast images are obtained for

each of the 3 scan settings above.

a. A scanning protocol can also be created to use in the future by clicking Database

Management => Protocol => Add. Once a scanning protocol is created it can be

used by selected the Scan Selection tab

c. During the follow up scanning, the operator should repeat any previous scan for a patient

by double-clicking on the scan name in the Scans list of the PATIENT window.

d. Position the patient correctly as follows:

˗ Chin on the system chin rest with teeth together

˗ Forehead against the forehead rest

˗ Eye to be scanned aligned vertically with the canthus mark on the side of the

forehead and chin rest assembly.

˗ Ask the patient to look at the fixation target, a blue dot in the red field.

e. Center the video image on the pupil and move the scan head towards the patient,

controlling it so that the video image passes through the pupil. Carefully advance until the

fundus comes into view. The figure below shows the progression of views as you move the

scan head forward.


Figure 5 Video Image Progression as Scanner Approaches Eye

f. Alternate view for some AngioVue models, from Scan Selection menu bar select AngioVue

Retina scan and 3D Clinical under the Retina category and Select AngioVue Disc under

Nerve Fiber Layer. When prompted select 3x3 mm and 6x6 mm for the retina scan and 6x6

mm for the disc scan.

Figure 6 SCAN Selection

3.2 Scan Optimization

a. Adjust the working distance between the scan head and patient eye to optimize the video

image. Optimized fundus images and optic disc images should be illuminated evenly from

edge to edge.


Note: For fundus imaging, make sure to set the working distance first. If a live OCT scan appears in

the scan window, do not stop forward movement of the camera until you achieve a good infrared

(IR) video image of the fundus.

Figure 7 Optimize Working Distance

b. When the video image is optimized, Click Auto Adjust to optimize scan signal strength and

image quality.

IR video image showing scan

pattern overlay

En face image


A. B.

Figure 8 Auto Adjust

Options:

A. Pop-up window appearing when aligning the IR image.

B. Permanent button.

˗ Auto Adjust executes Auto Z, Auto F and Auto P in combination. Auto All also tries to place

the scan image in the target area between the red dashed lines. Figure 8 shows an

example of a scan centered vertically. If the scan is not between the red dashed lines but

visible in the window, click once in the scan window and scroll the mouse wheel to bring

the OCT scan between the red dashed lines. This image is also upside down. This means

that the working distance is too close. In this case the joystick should be pulled back and

Auto Adjust repeated so the scan is right side up.

Figure 9 Example of Scan Centered Vertically

c. On the right side of each live scan, a green bar indicates a good signal strength index (SSI)

value. To capture the scan, either press the joystick button or click the checkmark button

. Once you click the joystick button or the on screen green check mark. Do not try to

adjust the live OCT image by moving the station in / out / left / right.

Green bar shows good

signal strength


d. After the first scan capture (fast X), review the scan images for quality and completeness.

Then continue to capture the fast Y scan, click the Continue button.

Figure 10 Review Fast X scan (lower left) and Rescan or Continue

and Capture OCT Angiography Fast Y Scan

e. To capture the Fast Y scan, either press the joystick button or click the checkmark button

.

f. After the second scan capture (fast Y), review the scan images for quality and

completeness.

g. When both scans don’t have black lines, click the Continue and Save button.


Figure 11 Review OCT Angiography Fast Y Scan (upper right) and Rescan

or Save Both Scans

h. After the MCT merge the fast X and fast Y OCTA scans, the final OCT Angiography scan

image is ready to review. The scan will be saved in the patient’s file.

Figure 12 Review complete OCTA images


i. When you are done one scanning, continue to capture other OCT Angiography scans for the

patients.

3. Follow-up Mode

Figure 13 Follow-up and Tracking Mode Buttons

Follow-up mode is on when its checkbox is checked, and off when it is unchecked (see Figure ).

When you are repeating a scan done on a previous visit for this patient, you can use Follow-up to

repeat the scan location and rotation of the previous scan. Repeat scans using Follow-up cannot

be moved or rotated. Turning Follow-up off allows you to move or rotate the scan. Follow-up

mode does not take into account changes in fixation relative to the previous scan.

Note: You may have to guide the patient’s fixation to achieve alignment of the scan to the

previous visit.

In Follow-up mode, the cross-hair on the IR image is red if alignment is not correct, and green

when alignment is correct. The capture button turns green only when the cross-hair is green,

indicating correct alignment. If you want to scan a different location, turn off follow-up mode.

NOTE: Sometimes even with correct alignment, cross hair remains red if signal to noise ratio is

poor. In this case there is no choice but to turn off FOLLOWUP mode.

4. Tracking Mode

Tracking helps to maintain scan placement when the patient blinks or moves their eye. Tracking is

on when its checkbox is checked, and off when it is unchecked.

A good IR image of the fundus is important when tracking is on, because the system tracks image

details to maintain scan placement. Figure 16 below shows examples of good and poor IR fundus

images.

Figure 14 Good IR Image (Left) and Poor IR Image (Right)


The capture button turns green only when a good fundus image is present. A small green cross on

the IR image indicates good tracking, and a red cross indicates poor tracking. During scan capture,

a small progress bar at bottom left shows scan progress. If scan capture takes longer than

expected because tracking is on, you can turn tracking off during scan capture, and the system

captures remaining scans with tracking off.

Exporting

4.1. Renaming Subjects prior to Export

a. Identifying subject information must be anonymized before sending to the FPRC.

˗ Select Patient tab and Edit.

˗ Enter anonymized information using the following format and select Save.

Last Name: Study Name

First Name: Subject #

Date of Birth: 1/1/1900

4.2 Exporting Data Files

a. Navigate to top left corner TOOLBAR > File > Data Transfer > Output Data

b. A window will appear as seen below. Select destination to save the export.


c. Create a new folder on the desktop by right clicking and selecting “New” > “Folder.” Name

the new folder according to the labeling convention, click “Save”

d. A new screen will appear. To search for the correct subject, enter their name in the

“Search” area (circled in red below). Then select “Search.”


e. A list of patients that meet the search criteria will appear on the left side of the screen.

Find the subject and select the correct visit date.

f. Since patient names and identifiers are not in the OCT machine but patients are named

based on study and site number, do not select ‘anonymous’ on the export since this will

re-name the patient.


g. Select “Start Output.

h. The following screen will pop up if the export has successfully completed. Select “OK.”

i. Select “Save and Exit.”

You should see the following contents when you open the folder to which you exported the

patient data. Upload the folder with all three contents through the DRCR.net Upload Application.

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