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Photographer Instruction Manual For: A Multicenter Masked Study to compare analysis of the detection program IDx-DR against Standard of Care Clinical Examination by Ophthalmologists to Differentiate Levels of Diabetic Retinopathy and Diabetic Macular Edema. Introduction This study will compare grading of diabetic retinopathy and diabetic macular edema determined by an ophthalmologist’s examination, a Reading Center’s Evaluation of the digital photographs and a computer detection program analyzing the same photographs. Obtaining excellent images of two fields of the retina in each eye is critical to the success of the study. This manual will describe how to obtain excellent images and then download them onto an internet server called Webscreen, which is available at http://rt5.cceb.med.upenn.edu/idx_home.html Goals of Photography The photographer’s goal is to obtain two high-quality, 45° images of each eye with the Topcon NW 200 fundus camera. The cameras and the Topcon User’s Manual have been shipped to you. One image should be centered on the macula. The other image should show the nasal retina but the entire optic disc should still be visible. This means that the optic disc of the right eye should be on the far left of the image at 9:00 o’clock and the disc in the left eye should be on the far right of the image at 3:00 o’clock. (See figures and examples below. These were taken on a different camera, but they clearly show which areas to capture)

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Photographer Instruction Manual For:

A Multicenter Masked Study to compare analysis of the detection program IDx-DR

against Standard of Care Clinical Examination by Ophthalmologists to Differentiate

Levels of Diabetic Retinopathy and Diabetic Macular Edema.

Introduction

This study will compare grading of diabetic retinopathy and diabetic macular edema

determined by an ophthalmologist’s examination, a Reading Center’s Evaluation of the

digital photographs and a computer detection program analyzing the same

photographs. Obtaining excellent images of two fields of the retina in each eye is critical

to the success of the study. This manual will describe how to obtain excellent images

and then download them onto an internet server called Webscreen, which is available at

http://rt5.cceb.med.upenn.edu/idx_home.html

Goals of Photography

The photographer’s goal is to obtain two high-quality, 45° images of each eye with the

Topcon NW 200 fundus camera. The cameras and the Topcon User’s Manual have

been shipped to you. One image should be centered on the macula. The other image

should show the nasal retina but the entire optic disc should still be visible. This means

that the optic disc of the right eye should be on the far left of the image at 9:00 o’clock

and the disc in the left eye should be on the far right of the image at 3:00 o’clock. (See

figures and examples below. These were taken on a different camera, but they clearly

show which areas to capture)

Right Eye

Macula Centered Nasal Field

Left Eye

Macula Centered Nasal Field

The following images were not taken with the Topcon Camera that will be used in the

study, but they do show the required photographic fields.

Right Macula Centered. Example taken

with a different camera type to show the

area to image

Right Nasal Field (disc should be slightly

lower at 9:00). Example taken with a

different camera type to show the area

to image

Left Macula Centered. Example taken

with a different camera type to show the

area to image

Left Nasal Field (disc should be closer to

edge of photo and IOL reflection).

Example taken with a different camera

type to show the area to image

Excellent macula centered OD. Example

taken with a different camera type to

show the area to image

Excellent nasal retina OD. Example

taken with a different camera type to

show the area to image

Excellent macula centered OS. Example

taken with a different camera type to

show the area to image

Excellent nasal retina OS. Example

taken with a different camera type to

show the area to image

In order to capture the nasal field you will have to switch to the cameras external fixation

target. The best way to capture the images would be to take the right eye with the

internal fixation for the macula and then switch to the external fixation and direct the

patients gaze to get the nasal field. Then take the nasal field of the left eye with the

external fixation and switch back to the internal fixation and capture the macula.

Often you will have to take more than 2 photographs of each eye. You should check

the quality and positioning of the photographs while the patient is in the chair so you can

take additional images if necessary.

You should then pick out the best macula centered image of each eye and the best

nasal retina image of each eye and enter them on Webscreen. (Instructions on how to

access Webscreen and enter images are given below) This means for each subject,

you will enter four images. You should use the study ID given to you by the Study

Coordinator or Investigator. You may, of course, keep images on your image system for

later use by the doctors.

Trouble Shooting Looking at Common Problems and Solutions

Eyelashes visible

Camera lens needed cleaning. You recognize that it is not in the eye because different pictures have the spot in the same location.

If the lens is dirty please take the necessary

steps to carefully clean it, then retake the

photograph following normal procedures.

These two problems can be solved by simply retaking the photographs following the normal procedures.

Patient not centered

Flash setting too low

Either pull camera base completely

towards you and start over OR

While zoomed into Retina move camera

side to side (using base) and up and down

(twisting joystick) until the white dot is in

the center of the image.

[Note: to get one white dot you need to

push the camera base in or out slightly

until the two white dots become one]

Using controls on Left side of joystick you can

increase (+) or decrease (-) the Flash Setting, or

reset it to the default setting, then Retake photo.

Decrease

Increase

Reset to Default

Camera too close to eye.

Pull base of camera slightly away from

eye until two white spots appear

Pull base slowly away from eye until

two white spots become one spot,

this indicates the Right Distance From

The Eye

Note: may need to center the white spot

by twisting joystick to move camera up

and down, or slightly moving base side to

side to get the spot in middle of screen

Camera too far away.

Push base of camera slightly towards the eye

until two white spots appear.

Continue to push base slowly towards eye until

two white spots become one spot

this indicates the

Right Distance From The Eye

Note: may need to center the white spot by

twisting joystick to move camera up and down,

or slightly moving base side to side to get the

spot in middle of screen

In order to ensure the images you capture on the screen of the camera are what the final images will look like, you will need to use the image quality knobs to adjust the screen values to match what you see on your computer. The best way to do this is to take a test picture of a fundus and use it to calibrate the camera. Below are the baseline settings to try and adjust as you need with the test images.

Bad focus

Turn Focusing Knob Turn on split

switch to help

gauge focus.

Turn the Black Focusing Knob until the image

becomes clear.

To Help Gauge Focus: turn on the ‘split switch’

by clicking the button indicated above. As you

turn the focusing knobs these two lines should

line up to form a straight line indicating the

image is in focus.

Using Webscreen to Submit Images to the Reading Center Make sure you have your id and login handy. Turn on the Topcon camera and computer and remove the lens cover. Open a web browser and go to: http://rt5.cceb.med.upenn.edu/idx_home.html

Click on the “IDx Webscreen Image Management System” link to access the Webscreen site.

Enter your ID and Login in the appropriate boxes (see arrows) and click Login

If you entered these properly you will be logged in and see the following:

In order to make images, and submit them, click on “Take images” You will see the following screen.

DO NOT PRESS ENTER

Fill out ID and Alphacode (twice)

Do Not press Enter

After filling in, click on Select OD and OS images. You will see the following box:

Now you can take images (If help is needed see Taking Photographs above). The photos will show in the box as follows

Once you have taken the first photograph the box will look like this:

This is where you can view the subject code and photographs. Once images have been taken:

- Low Quality Images: simply select all that you do NOT want (careful not to select the ones you want to keep) and push DELETE on the keyboard - High Quality Images: if you have the four required ones, simply select all that you want to send and click submit

Once you have submitted the images it may take from a few seconds or quite a bit longer to display a confirmation screen. Please wait until you get either an error message or hopefully, a screen indicating the images have been received. You can repeat the process for a new patient by simply Re-Clicking Taking and Submitting Photos. [Note: if the Patient Info/Image screen doesn’t come up on the first click, just re-click until it appears. This is a common occurrence.]

Selected image shown

You may select an image by clicking on it in the bottom black box. Here the Right image is selected (as it has a white box around it) and the Left image is Not Selected.

You may also view ALL images that have been taken -From Today: Select pull down menu from image box, select TODAY -From Clinic: Select pull down menu from image box, select ALL

You should enter the macula centered photograph followed by a nasal field photograph of the right eye. The fields and locations of the macula and optic disc have been described and shown in the first part of this manual. Next you should enter the macula centered and nasal field photography of the left eye. Contact Information for Questions/Problems: Webscreen Problems: [email protected]; 215-573-4623 Topcon NW 200 Problems: Brice Critser, [email protected], 319-621-1129 Photographic Protocol/Reading Center: Dr. Ebenezer Daniel, [email protected]