Diabetic Retinopathy Clinical Research Network (DRCR.net) UWF Optos 200Tx Imaging Protocol Version 3.0 9/19/16 DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 1 of 14
Table of Contents Background... 3 P200Tx Device... 3 Imaging Protocol... 4 How will the Study Eye be determined?... 5 Image Capture Sequence... 5 Certification Procedures... 8 Image Transfer Procedures... 8 Image Retakes... 9 Examples of Well Captured images... 9 Contact Information:... 10 Cleaning the mirror... 11 Process Description... 11 DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 2 of 14
Version Author Effective Date Revision Description 2.0 Adam Glassman 02/25/2015 Initial Implemented Version 3.0 Adam Glassman 09/19/2016 Removed nasal and temporal steered images from FA procedure Background This imaging protocol will provide you detailed information regarding imaging your diabetic retinopathy study using the Optos system, sending images to the Coordinating Center, image storage and system maintenance. P200Tx Device The Optos P200Tx system is a scanning laser ophthalmoscopes (SLO) containing an ellipsoidal mirror; that scans through one focal point with a SLO, a virtual scanner is created inside the eye allowing majority of retina (82%) including the retinal periphery to be imaged. This results in a 200 image that can be captured through a non-dilated pupil with a resolution of 3000 X 3000 pixels with its smallest resolvable feature at 14 microns. Images can be captured in color composite mode, which uses a red laser (633nm) and a green laser (532nm) to visualize the choroid and the RPE respectively, fluorescein angiography (FA) and AF (FAF) images can also be acquired. FAF images are captured using the green laser wavelength and are not averaged like other systems. The blue laser is used when capturing angiographic images. A series of images is captured as the fluorescein flows through the retinal vessels. Optos technology is designed to operate through a minimum pupil diameter of 2mm. The composite image supports analysis of the retinal image by allowing individual review of the green and red channels information. The Green Channel image contains information from the sensory retina through the pigment epithelium layers of the retina. The Red Channel image contains information from the deeper structures of the retina, from the pigment epithelium through the choroid. DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 3 of 14
Imaging Protocol Following informed consent, each participant will have the following images captured: Color Optomap Plus Images (12 total images - 6 images per eye): 2200 color central fixation Optomap plus images 1 superior steered 200 color Optomap plus image 1 inferior steered 200 color Optomap plus image 1 nasal steered 200 color Optomap plus image* 1 temporal steered 200 color Optomap plus image* * only at baseline visit FA Optomap Images (12 images: 6 per eye*) Early phase (starting at 15 sec) 3 200 central fixation images study eye 3 200 central fixation images fellow eye Late phase (starting at 4 min) DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 4 of 14
1 200 central fixation image study eye 1 200 superior steered image study eye 1 200 inferior steered image study eye followed by 1 200 central fixation image fellow eye 1 200 superior steered image fellow eye 1 200 inferior steered image fellow eye A total of 12 images per subject will be saved and uploaded to Reading Center. *If there is only one study eye, this eye should always be imaged first. If both eyes are study eyes, the right eye is photographed first and then the left eye is imaged. Each digital image must be evaluated to be of adequate quality for submission, according to the study procedures. If photograph quality is judged substandard by the operator, then the imaging should be repeated until a good quality image is obtained. How will the Study Eye be determined? The study eye will be determined by eligibility criteria. A patient may have 2 study eyes. In this case, the right eye should be imaged first and the left eye imaged next Image Capture Sequence 1. Select the Patient List button. 2. Select the New Patient button. 3. Enter in subject information as follows to mask patient information: a) Last Name = STUDY PROTOCOL b) First Name = Participant Study #, Name Code (e.g. 001001, ABC) c) ID = Participant Study # (e.g. 001001) d) Date of Birth = 01/01/1899 All images MUST be acquired using the masked subject information as detailed above. Images should NOT be acquired under MRN# or patient name. 4. Ensure the patient s name is highlighted and then choose OK. 5. Select Optomap Plus and then choose OK. If this patient will also be receiving FA imaging as a part of this protocol select DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 5 of 14
Optomap FA this will start the session with color images 6. Select the Study Eye for the first image. For each subsequent image you will need to select which eye you will image. 7. Position participant with their feet flat on the floor and facing the device 8. Adjust the table height using the bottom button on the hand control. Then align the canthus with the marker on the chinrest using the chinrest adjustment knob. 9. Ensure the chinrest is on the left side to image the Right Eye or the right side to image the Left Eye. 10. Have the participant lean in towards the device with their face at a 45 angle; they should have one eye lined up with the center of the hole and their nose should be facing to the left of the hole. 11. Ask the participant to fixate on the central Green LED. 12. Using the hand controller center alignment and +/- buttons to adjust the instrument until the edge of the ring on the capture monitor is at the edge of the limbus, the central target should be at the center of the pupil. 13. When the participant is positioned correctly, the ring on the monitor will turn from red to green, when the ring is red the central target will indicate whether the patient needs to be closer to (indicated by a + sign in the center) or further away from the device (indicated by a - sign in the center). The green ring is just a guide. It is more important to make sure the iris is centered within the limbus ring correctly. 14. Adjust participant position using the hand controller until satisfied, then capture the image by pressing the button on top of the hand controller. Clicking the capture button again will return you to the capture screen for the same eye, if you use the touchscreen you will need to once again select the eye. DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 6 of 14
15. For the next image switch on the superior eye-steering LED (this LED will be red) and ask the participant to fixate on it. 16. Using the hand controller to move the limbus ring up until it is once again positioned properly around the iris. 17. When the participant s eye is in the proper position press the capture button. 18. After acquisition, press the capture button again to return or select the eye you wish to image and select reset position button. 19. Then switch on the lower inferior eye-steering LED (this LED will be red) and ask the patient to fixate on it. 20. Adjust the device using the hand controller to move the limbus ring down until it is once again positioned properly around the iris. 21. When the participant s eye is in the proper position press the capture button. 22. After acquisition, press the capture button again to return or select the eye you wish to image and select reset position. 23. When the color images have been reviewed, choose the complete session button in the top right hand corner. This will end the session or start the FA session. 24. At this point the Operator should set up for the FA injection. When ready to start the session, select the Study Eye. This will bring up the FA imaging window. 25. Make sure the contrast is set to 15 to begin the imaging session. 26. Position and align the patient to image the study eye. 27. Select the Right Eye or Left Eye button for the study eye. 28. During the transit phase, capture central 200 Optomap fa images. 29. As you begin the injection, press the capture button once. This will start the timer. 30. When the injection is complete, press the capture button again to record injection time. DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 7 of 14
31. Begin taking images at the rate of about an image per second beginning about 15 seconds after the start of the injection. A total of 3 images should be submitted to the Coordinating Center for each eye. 32. As more dye enters the eye the contrast slider may need to be decreased to avoid overexposure to preserve image detail. 33. Move to the non-study eye, adjust the chinrest, and select the appropriate eye. 34. Capture 3 central 200 Optomap fa images of the fellow eye. 35. Return to the study eye, adjust the chinrest, and select the appropriate eye 36. At 4 minutes, Capture 1 central 200 Optomap fa image of the study eye. 37. Capture 1 superior 200 Optomap fa image of the study eye 38. Capture 1 inferior 200 Optomap fa image of the study eye 39. Return to the fellow eye, adjust the chinrest, and select the appropriate eye 40. Capture 1 superior 200 Optomap fa image of the fellow eye 41. Capture 1 inferior 200 Optomap fa image of the fellow eye 42. It is important to remember only 75 images can be captured in a session. After 75 images you will need to start a new session, which will also restart your clock, so this is not recommended. 43. At the end of the session you can review images on the device and edit the session or you can review and edit at the review station. 44. When finished choose the complete session button in the upper right hand corner. This will save the images and they can be viewed at the review station. Certification Procedures A. Optos Training and Certification 1. Technician training and certification will be performed by Optos. Only certified imagers should obtain photos. If you have any questions about certification or ongoing training please contact Dana Keane at Optos (dkeane@optos.com). 2. B. Submitting Certification Scans Certification images should be submitted via email directly to Dana Keane at Optos (dkeane@optos.com). Due to large file size, certification images should be submitted as screenshots of the actual image. Please contact Dana if you require further assistance. Image Transfer Procedures To collect images for upload: 1. Go to C: Optos Data/Images/Primary 2. All images are named Patient ID Date Time Eye Image # 3. Images can be copied directly from here for upload to the Coordinating Center. 4. Images will be uploaded to the Coordinating Center through the DRCR.net Image Uploader application and may be uploaded by operators and/or coordinators. DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 8 of 14
Image Retakes Images that do not meet quality standards will be flagged and you will be contacted to re-image the patient. Additional images can be taken to obtain the best quality and only the best uploaded. Examples of Well Captured images Images will need to have a full 200 view with no clipping of the iris or lens. Lid and lash should be minimized to obscure less than 10 of the field of view. For central images the reader should be able to visualize an unobscured view of the disc and macula with a field of view out to the vortex veins. Central Fixation Images Steered Images Superior field Inferior field DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 9 of 14
Contact Information: Director of Clinical Dana Keane dkeane@optos.com Office: 508-787-1507 Cell: 339-221-1331 Sr Clinical Research Associate Jessica Carnevale jcarnevale@optos.com Office: 508-787-1481 Cell: 774-245-3390 DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 10 of 14
Appendix A Cleaning the mirror Tools Required Suitable powder-free gloves. Flashlight (optional). Q-tips (cotton buds). Opto-Wipe cloths. De-ionized water. Process Description Safety The edges of the main mirror are sharp. Do not touch them. Only clean the area of the main mirror that you can see. Do not put your hand or any cleaning material into parts of the device you cannot see. Dust Do not use lint cloths, tissues or other materials that may create dust, near the scan head. General Cleaning Process This process may be carried out by customers who have been trained by Optos. The surface of the main mirror is very delicate, and must be handled with extreme care. Follow the steps below to remove dust from the mirror surface: 1. Switch on the device and take a normal eye image to assess image quality. Note: When switched on from cold, allow time for the lasers to reach the temperature required for optimum performance. P200MA and P200C devices will require 10 minutes, the P200 will require 15 minutes. 2. Switch off the device. 3. Remove any rings, watches, bracelets, jewelry or other items which may come into contact with the mirror surface. 4. Access the main mirror: i. Detach the head rest from the front of the eye aperture by pulling the pin at the bottom of the head rest down and sliding it completely off of the supporting bracket. ii. Remove the soft face pad from the eye aperture. 5. Put on the powder-free gloves. 6. Using the flashlight, look through the eye aperture and inspect the surface of the mirror for visible dust. Take notice of any smudges or spots. 9. Gather the corners of a clean dry Opto-wipe cloth into a mushroom shape. Use the mushroom ball to gently wipe the mirror. Reach into the eye aperture and carefully wipe the DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 11 of 14
visible surface of the mirror. Starting at one side of the mirror, using single downwards strokes, gently wipe the mirror. Always start from the top of the area you can see. Do not rub the mirror. Dispose of the dirty cloth. 10. Using the flashlight check the mirror again for any remaining smudges or spots. If it appears clean go to step 14 of this procedure. 11. If the main mirror still shows smudges or spots dip a Q-tip or clean dry Opto-wipe in deionized water and rub gently. CAUTION: Take extreme care not to touch anything inside the eye aperture other than the visible mirror surface, and not to drip any water inside the device. 12. Use a clean Opto-wipe cloth to lightly polish out any streaks. NOTE: GENTLE rubbing is essential. It is better to gently rub the spot several times than to rub the spot too hard as this may damage the mirror. 13. Inspect the mirror surface with the flashlight and confirm all contaminants have been removed. Repeat cleaning with the Q-tip if necessary. 14. Remove the gloves. 15. Replace the face pad and head rest. 16. Switch on the device and wait at least 10 minutes for device to warm up to the operating temperature required for optimum performance. Note: An error message may be displayed if capture is attempted before the required temperature has been reached. 17. Take a test eye images to determine if the image quality has been sufficiently improved. DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 12 of 14
Appendix B Operator Competency Assessment Operator: Optos Trainer: Site Name: Device Serial Number: Key Skills YES NO Remarks Does the user understand the safety guidelines? Can the operator use the Capture application and capture good images? Can the operator understand and explain what the device does? Does the user understand the imaging protocol? Can the user capture clinical trial quality images? Can the user archive the system? Does the user know where to get help? Does the user understand how to upload and transmit images to the reading center? Image Quality: Review of 3-5 patient sessions Image Type Acquired Excellent Average Poor Central Gaze Superior Steered Inferior Steered DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 13 of 14
Nasal Steered Temporal Steered Appropriate FA timing Pass Retraining Needed Operator Signature & Date: Optos Trainer Signature & Date: DRCR.net UWF 200 Tx Imaging Protocol V3.0 9-19-15 Final Page 14 of 14