Model 11-WIN Users Manual
Contents
1. nix asi nisl V cns n b RR 17 APPENDIX GE m 18 PP EIN di 19 APPENDIX a 21 APPENDIX rec ere er e En Duc uie Il EU Uu EUH acie iiri Ecc rc 22 APPENDIX cim 23 EVA Users Manual Model 11 WIN docx Page 2 of 24 System Setup MODEL HIGHLIGHTS e Model 11 WIN is the laptop version of the EVA Tester e Able to display letters down to 20 6 e Windows based system that uses Wi Fi for communication e System controlled using an Apple iPod Touch e Sleep option to make monitor dark without turning it off e System uses a Dell Latitude laptop with a footprint of approximately 15 wide by 10 deep e Test results are stored as encrypted files per HIPAA requirements 1 SYSTEM DESCRIPTION The Electronic Visual Acuity EVA Tester uses an Apple iPod Touch to communicate with a Windows based computer Stimuli are high contrast black and white letters with luminance of 85 to 105 cd m and contrast of 98 The system can present single letters or lines of letters Single letters are framed with crowding bars around the letter For lines of letters five 5 letters are displayed for sizes smaller than 20 200 a decreasing number of letters is displayed as letter size increases With a 15 6 inch LCD LED monitor at 1920 x 1080 pixels the system is capable of displaying letters from 22. 1 Connect the iPod to the white USB charging cable and plug USB end into laptop Connect Wireless Router as shown in Figures 2 5 e Plug small end of Micro USB Cable into wireless router Figure 3 left e Plug large end of Micro USB Cable into wall plug Figure 3 right e Plug yellow Ethernet cable into yellow port LAN on wireless router Figure 4 e Plug other end of Ethernet cable into back of laptop Figure 1 Plug laptop and wireless router power cords into the power strip and then plug the power strip into a wall outlet 6 Attach the plastic ruler to the back of the monitor with the Velcro strip 7 Insert the Model 1 1 WIN Flash Drive in a USB port as shown in Figure 2 8 Turn the laptop on by pressing the power button Figure 2 The 10 computer will go through start up boot sequence When start up is complete the monitor will display the splash screen with the calibration square in the center Configure E ETDRS and ATS HOTV MUST be configured before initial use a Press the Home button on the iPod round button below screen b The passcode is the last four digits of the Tower ID For example if the Tower ID is T000123 the passcode is 0123 c Tap the EVA icon at the bottom of the screen EVA Users Manual Model 11 WIN docx Page 6 of 24 System Setup d Tap Configure Studies at the top right of the screen e Tap Set E ETDRS and check boxes for studies in which your site
3. a pretest 2 If response is correct letter at next smallest logMAR level is presented and testing continues sequentially with one letter per logMAR level through 20 20 until there is an incorrect response 3 If starting point was 20 100 and response is incorrect at either 20 100 or 20 80 screening is restarted at 20 400 4 starting point is 20 400 and response is incorrect at either 20 400 or 20 320 screening is restarted at 20 800 e If 20 800 is missed 20 800 becomes the starting level for phase Phase I Starting 2 logMAR levels above the missed level in Screening the smallest logMAR level at which 3 of 3 or 3 of 4 letters are correctly identified is determined 1 Up to 4 single letters are sequentially presented 2 logMAR levels above the level missed in screening e Exception if 20 20 was correct in Screening phase starts at 20 30 e Exception if 20 800 or 20 640 was missed in Screening phase starts at 20 800 2 If first tested level is failed testing continues at sequentially larger logMAR levels until a level is passed e If 20 800 is failed phase ends the Reinforcement phase is omitted and 20 800 is retested in phase Il 3 Iffirst tested level is passed testing continues at sequentially smaller logMAR levels until a level is failed Reinforcement Phase In order to get the child whose attention is drifting back on track 3 letters larger than the phase threshold are sequentially presented 1 Starting le
4. and optionally for other identifiers such as patient ID andtest date These codes are displayed on the iPod with the test result and can be used during data entry to confirm the data is entered correctly If it is necessary to view the codes for a previous test select the appropriate icon on the EVA Application screen on the iPod and select the study for which the test was done Tap View Previous Tests and tap either View by Date or View by Patient ID Select the patient ID and the test resultsand codes will be displayed EVA Users Manual Model 11 WIN docx Page 10 of 24 Configure Studies 7 CONFIGURE STUDIES The Configure Studies program selects studies or non study that will use the E ETDRS and ATS HOTV vision testing programs For example if a site is participating in the DRCRnet and PEDIG studies Configure Studies is set to display those studies when E ETDRS testing is used You must use the Configure Studies program to set up the E ETDRS and ATS HOTV programs before initial use 1 On iPod tap Configure Studies icon in upper right corner 2 Tap Set E ETDRS and check boxes for studies at your site Select Non Study if your EVA Tester is also used for non study patients 3 Tap Done 4 If your site uses ATS HOTV for children under age 7 tap Set ATS HOTV and repeat steps 2 and 3 5 Tap Exit to leave configuration 8 PRINTING OPTIONS Your study may have an option to create a printable file with the results of a te
5. is participating Select Non Study if your EVA Tester is also used for non study patients f Tap Done g If your site uses ATS HOTV for children under age 7 tap Set ATS HOTV select your studies and Non Study if needed tap Done h Tap the Exit to leave configuration 11 Confirm testing distance is 3 meters 118 inches from the patient to the monitor screen The EVA Tester is ready to use Refer to Section 6 for patient testing procedures IMPORTANT A Model 11 WIN flash drive is required for this EVA Tester Usable flash drives are labeled 11 WIN Do NOT use flash drives intended for other models Figure 1 View of the back of the EVA PC Ethernet port Power Cord EVA Users Manual Model 11 WIN docx Page 7 of 24 Monitor Calibration Figure 2 Wireless Router Parts USB Ports on Wireless Router left and Wall plug right Micro Full size USB USB port port Ethernet cable Micro USB cable Wireless Wall plug Router Figure 3 Figure 5 Wireless Router Assembled Figure 4 Ethernet ports on Wireless Router EVA Users Manual Model 11 WIN docx Page 8 of 24 Monitor Calibration 5 MONITOR CALIBRATION The EVA monitor must be correctly calibrated for valid testing The calibration square is the image displayed on the EVA splash screen Two monitor calibration checks are performed at regular intervals 1 size calibration check to confirm lette
6. the Retrieve Data Flash Drive to your coordinating center If the files are emailed include your Project DRCR PEDIG etc and Site Number in the subject line 10 SHUT DOWN THE EVA TESTER To shutdown the EVA PC use the PC Power application on the iPod You can also press and quickly release the power button and the PC will safely shut itself down Do NOT press and hold the power button or system will crash and require several minutes to restart EVA Users Manual Model 11 WIN docx Page 12 of 24 Frequently Asked Questions 11 EVA VISUAL ACUITY TESTING APPLICATIONS 11 1 E ETDRS Visual Acuity Test The Electronic Early Treatment of Diabetic Retinopathy E ETDRS is a visual acuity testing program for subjects 7 years of age or older It was developed to provide a visual acuity letter score comparable to the ETDRS chart testing score The E ETDRS Visual Acuity Testing protocol consists of an initial screening phase to obtain an approximation of the visual acuity threshold followed by a testing phase to obtain the visual acuity score Details of the E ETDRS algorithm and an example are included in Appendix E The E ETDRS application displays the test result as a letter score number of letters correctly identified and as a Snellen approximation Also displayed are validation codes for the test result patient ID and test date These codes can be used to validate correct entry when the data are entered into a case report form T
7. 0 20 400 Show letter at DEI ee EDS oe Correct each successively smaller C t 20 100 20 50 20 25 20 12 until either a level until inn ss OEC Show a 20 800 miss or 20 12 correct or 20 400 correct letter Letter missed Letter Missed Show letter 2 levels up from missed level i e level smaller than last correct level Incorrect Correct Show letter at each successive Show letter at each successively larger level until correct response smaller level until a miss or 20 12 or 20 800 is shown correct Screening score is Incorrect last correct level or 20 800 if last letter shown is 20 800 Screening score is 20 800 Threshold Phase To start the letter pool consists of letters from 2 levels the level of the screening phase score and one level smaller Each letter presentation is randomly selected from the active pool of letters with the stipulation that every third letter must be from the largest level in the active letter pool A level remains in the active pool until 5 letters are tested at the level A new level is added to the active letter pool when a letter from the largest level in the pool is missed one level larger is added to the letter poolt b A letter from the smallest level in the pool is correct one level smaller is added to the letter poolt Testing continues until an upper logMAR level with 5 of 5 letters correct and a lower logMAR level with 0 of 5 letters correct are determined and 5 let
8. 0 800 1 6 logMAR to 20 6 0 5 logMAR at a test distance of 3 meters Letter size corresponds to the logMAR progression of the ETDRS charts The iPod communicating with the PC wirelessly via Wi Fi provides instructions to the technician and displays the letter that is being shown on the monitor For the automated tests ATS HOTV E ETDRS the size and sequence of letter presentations is determined from a computer algorithm based on the subject s responses EVA Users Manual Model 11 WIN docx Page 3 of 24 System Setup 2 DEFINITIONS AND SYSTEM COMPONENTS 2 1 Definitions EVA PC The laptop PC used for the EVA Tester Also referred to as the Tower EVA Tester All components of the EVA Tester including laptop iPod programs on the PC and communication between the iPod and PC iPod The Apple iPod Touch that is used as the controller for the EVA Tester Program Flash Drive Portable memory device used to start the EVA Tester and store encrypted test results The flash drive must be inserted in a USB port for the tester to start Retrieve Data Flash Drive Flash drive with EVA program to download test data from EVA hard drive when requested by a study coordinating center Splash Screen The initial screen when EVA starts up A white square outlined in black is displayed in the middle of the screen with EVA written underneath Used for monitor calibration Tower ID Unique identifier used to configure wireless connectio
9. EVA USER S MANUAL MODEL 1 1 WIN TESTING REQUIREMENTS SIZE CALIBRATIO ide ime Wh y one eye a ary such that your eye MINANCE CALIBRATION p and place sensor on Do NOT allow the sensor to 1 area n Manual Revised December 2012 EVA Users Manual Model 11 WIN docx Page 1 of 24 Table of Contents CONTENTS 1 SYSTEM DESCRIPTION iicsiciccskserckcscire cinxit tuttbesi n cosl ctu rhe ibo rn irt dnce 3 2 DEFINITIONS AND SYSTEM COMPONENTS eerte traten tn tnntentn tens 4 TIPS FOR SUCCESSFUL 6 Ae SYSTEM SETUP aiiis tici otim ir enar ra Glam E ini ci dlc CERE Rd rar cem 6 5 MONITOR CALIBRATION REIR PER RECUERDAN ERU 9 6 USING THE TESTER icri par panca oun iu ud blc ccn 10 7 CONFIGURE STUDIES 4icnticiticckcienr mide enr dera 11 B PRINTING OPTIONS disci ecd t Du pic ipaa DU Ru LU nir DN HR t DD DEG a 11 9 RETRIEVE STUDY DATA bond nda 11 10 SHUT DOWN THE EVA TESTER iiid rid Rud 12 11 EVA VISUAL ACUITY TESTING 13 12 FREQUENTLY ASKED idc ccn arai 15 18 COMMON ERRORS sientan
10. METER Mastech LX1330B LCD Screen Photo Sensor Important e Your EVA Tester MUST display the calibration image with a white square inside a black frame as shown at right If you do not have this image contact your coordinating center Do NOT continue with calibration e Allow monitor to warm up for at least 10 minutes e Be sure other lights are off in the room when you take light meter readings Procedure ON OFF Switch Confirm that all other lights are off in the room 1 Confirm monitor has been warming up for at least 10 minutes 2 Display the EVA splash screen 3 Turn the light meter on by pressing the POWER button If battery icon is displayed on the LCD screen replace the 9V battery EVA 4 Confirm the light meter screen displays only the word Lux on bottom right If other items are displayed turn the meter off then on again to clear the display Calibration Square on Splash Screen EVA Users Manual Model 11 WIN docx Page 19 of 24 Appendix B Light Meter Instructions 5 Press the Range button once 6 Remove the sensor protective cover and place the side with the white circle see image above on the white area in the center of the EVA calibration square Do NOT allow the sensor to touch non white areas 7 The display will return the lux value of the monitor screen Confirm that the displayed value falls within the range specified on your light meter label If the displayed value
11. at didn t come with the EVA Tester can use it 4 What program version is my EVA Tester running iPod Questions 1 use the Palm PDA from a previous EVA model How can I find which program version is installed on my EVA Tester What do do if cannot find the EVA program on my iPod KR W N need to look up a previous score for a patient How do do that System Questions 1 How much space do need to properly operate the EVA Tester The system is calibrated for a 3 meter 118 inches testing distance from the patient to the front of the monitor screen You will need approximately 11 feet from the patient to the back of the laptop 2 Why does the testing distance need to be 3 meters For standardized testing of visual acuity in a clinical trial it is best to have the same testing distance at all clinical sites since visual acuity can vary with testing distance It was therefore decided to have a fixed test distance of 3 meters even if this means that the EVA Tester must be wheeled into position when it is used to test a study patient 3 have an LCD monitor that didn t come with the EVA Tester can use it No EVA Testers are carefully calibrated and validated with specific hardware Any variation of this hardware could cause the testing to be invalid EVA Users Manual Model 11 WIN docx Page 15 of 24 Frequently Asked Questions 4 What program version is my EVA Tester running The program version
12. d 20 40 letters 20 50c 20 40m 20 50c 20 40m 20 50m 2 Because a 20 50 letter was missed add 20 63 to the letter mix so now have letters of 20 40 20 50 and 20 63 intermixed 20 63c 20 50c 20 40c 3 Because 20 40 was correct add 20 32 to the letter mix mix is now 20 32 20 40 20 50 and 20 63 20 32m 20 63c 20 63c 20 50m 4 Five letters at 20 50 have been tested so it drops out of the mix mix is now 20 32 20 40 and 20 63 20 63c 20 40c 20 32m 20 40m 5 Five letters at 20 40 have been tested so it drops out of the mix mix is now 20 32 and 20 63 20 32m 20 32m 20 63c 6 Five letters at 20 63 have been tested so it drops out of the mix mix is now 20 32 only 20 32m 7 Five letters at 20 32 have been tested there are no letters left in the mix so test is over Test summary 20 63 5 5 correct 20 50 3 5 correct 20 40 2 5 correct 20 32 0 5 correct Letter Score 10 number of letters correctly identified 55 5 times the number of lines above larger than 20 63 and through 20 800 65 Snellen Approximation logMar to Snellen conversion for 65 letters 20 50 EVA Users Manual Model 11 WIN docx Page 23 of 24 20 12 Correct Appendix E E ETDRSO Visual Acuity Test Protocol Electronic ETDRS E ETDRS Visual Acuity Testing Protocol Algorithm Screening Phase In each step one letter is shown at each logMAR level Show 20 400 letter Correct Incorrect Show 1 in 3 level 20 20
13. d patients being screened for the study Data entry of the patient ID and technician ID is required results are identified by the patient ID and stored on both the Program Flash Drive and on the hard drive 11 3 Chart An application that can be used for manual vision testing Displays individual letters or lines of letters using either the HOTV or Sloan letter set 11 4 PC Power An application to shut down restart or sleep the EVA PC A Shutdown This option turns the EVA PC off Use this if you want to power off the system or if you need to unplug it B Restart This option restarts the EVA PC You may be asked to do this in the course of troubleshooting C Sleep This option displays a black image covering the entire screen You can use this option when you need to use the room while the EVA Tester is not in use without turning off the EVA PC and or monitor IMPORTANT The Model 11 WIN EVA Tester has been equipped with a Sleep feature that darkens the screen without turning the monitor off If you use the Sleep feature you do NOT need to let the monitor warm up again before use You should always perform calibration checks before testing EVA Users Manual Model 11 WIN docx Page 14 of 24 Frequently Asked Questions 12 FREQUENTLY ASKED QUESTIONS System Questions 1 How much space do need to properly operate the EVA Tester 2 Why does the testing distance need to be 3 meters 3 have an LCD monitor th
14. for your EVA Tester is located on the bottom of the splash screen iPod Questions 1 Can use the Palm PDA from a previous EVA model No The 11 WIN model EVA Tester is completely new and requires the Apple iPod Touch to access the Wi Fi signal PDAs from previous EVA models used Bluetooth to communicate with the PC 2 How can I find which program version is installed on my EVA Tester Tap the Configure Studies icon the version is displayed on the bottom of the iPod screen 3 What do do if cannot find the EVA program on the iPod If you cannot find the EVA program scroll once to the left and type Safari in the search bar Select Safari from the list below In the address bar type 192 168 250 1 and tap Go Tap the middle button 52 and then tap Add to Home Screen Name the new icon EVA 4 need to look up a previous score for a patient How do I do that There are two ways to view previous patient test results by patient and by date On the iPod select the appropriate study for the patient tap Continue Tap View Previous Tests Tap View by Date or View by Patient Select the appropriate date or Patient ID for previous results When completed tap Done three times to exit to the View Previous Tests menu EVA Users Manual Model 11 WIN docx Page 16 of 24 13 COMMON ERRORS 1 Cannot Open EVA See Figure 1 Check to make sure all devices are on and EVA is at the Calbration Square Sometimes the EVA Tester takes a minute t
15. he E ETDRS application includes study versions for use in specified clinical studies These study versions MUST be used for study patients and patients being screened for the study Data entry of the patient ID and technician ID is required results are identified by the patient ID and stored on both the Program Flash Drive and on the hard drive 11 2 ATS HOTV Visual Acuity Test The ATS HOTV is the electronic version of the Amblyopia Treatment Study Visual Acuity Testing protocol that was developed to facilitate the standardization of visual acuity testing in clinical trials of pediatric eye disease involving children in the three to less than 7 years old range In brief the ATS HOTV consists of the presentation of single surrounded optotypes letters H O T and V in 4 steps a screening phase a first threshold determination Phase reinforcement phase and a second threshold determination Phase Il Details of the ATS HOTV algorithm are included in Appendix D The ATS HOTV application displays the test result as a Snellen value Also displayed are validation codes for the test result patient ID and test date These codes can be used to validate correct entry when the data are entered into a case report form EVA Users Manual Model 11 WIN docx Page 13 of 24 Frequently Asked Questions The ATS HOTV application includes study versions for use in specified clinical studies These study versions MUST be used for study patients an
16. is below the specified range increase brightness leave the monitor on for 10 minutes and then recheck with the light meter recommend increasing brightness in 5 increments 8 When finished with light meter calibration replace the protective cover to avoid damage when not in use EVA Users Manual Model 11 WIN docx Page 20 of 24 Appendix C iPod Instructions APPENDIX C iPod Instructions Apple iPod Touch 4G 16GB Sleep wake Home EVA Users Manual Model 11 WIN docx Page 21 of 24 Appendix D ATS HOTVO Visual Acuity Test Protocol APPENDIX D ATS HOTVO Visual Acuity Test Protocol Single letters with surround bars letter width from the letter are presented in four phases screening phase first threshold determination reinforcement and phase II second threshold determination e n phase and phase 11 up to four single letters are sequentially presented at each logMAR level that is tested e level is considered to be passed if 3 of 3 or 3 of 4 letters are correct and failed if 2 letters at a level are missed e Testing of a level stops as soon as criteria are met for either pass or fail Screening Phase Starting from either 20 100 or 20 400 single letters in sequential descending logMAR sizes are shown until one is missed 1 Tester selects 20 100 or 20 400 size letter to present as starting point depending on the expectation of visual acuity level based on previous testing or
17. n between the iPod and EVA PC Printed on a label attached to the EVA PC example 1000001 Validation Codes Encrypted values for the test result and optional identifiers used during data entry to validate that information is correctly entered EVA Users Manual Model 11 WIN docx Page 4 of 24 System Setup 2 2 System Components EVA Model 11 WIN uses Wi Fi communication between the PC and the iPod The shipment should include the components listed below EVA PC Laptop Computer with Tower ID sticker attached Power Cord for Laptop Computer Apple iPod Touch iPod USB Charging Cable Program Flash Drive Light Meter Plastic Ruler Tape Measure Model 11 WIN Program Flash Drive Surge Protector Cart Optional EVA Users Manual Model 11 WIN docx Page 5 of 24 System Setup 3 TIPS FOR SUCCESSFUL USE Keep the iPod battery charged by reattaching to the USB charging cable plugged into the EVA after each use Use only flash drives with Model 11 WIN on the label To shut down the EVA PC use either the PC Power button on the iPod or press and quickly release the power button on the EVA PC Do NOT press and hold the EVA PC power button or the system may take longer to boot the next time 4 SYSTEM SETUP Follow these instructions to set up the 11 WIN EVA Tester ls 2 3 Place the laptop on the cart provided or your own cart Plug laptop power supply cord into the computer as shown in Figure
18. n which high validity and test retest reliability were demonstrated Moke PS Turpin AH Beck RW et al A computerized method of visual acuity testing adaptation of the amblyopia treatment study visual acuity testing protocol Am J Ophthalmol 2001 132 903 14 Overview The E ETDRS Visual Acuity Testing Protocol consists of an initial screening phase to obtain an approximation of the visual acuity threshold and then a testing phase to obtain the visual acuity score The protocol is summarized below The complete algorithm is depicted in the figure that follows Letters are displayed with surround bars one full letter width from the letter The E ETDRS testing protocol Screening phase With single letter presentations determines smallest logMAR level at which a letter is correctly identified Testing phase Starts testing letters by intermixing letter sizes of screening phase score and one level smaller Test progress If a letter is missed at a level one level larger is added to the testing mix if a letter is correct at a level one level smaller is added to the testing mix Acuity Tests 5 letters at each level until smallest level with 5 5 correct and the smallest determination level with 0 5 correct are determined Example IN THE FOLLOWING EXAMPLE C CORRECT AND M MISSED Screening 20 400c 20 200c 20 100c 20 50c 20 25m 20 40m Score 20 50 Test progress 1 Start by intermixing 20 50 an
19. o start broadcasting the WiFi signal EVA Users Manual Model 11 WIN docx Common Errors Cannot Open EVA could not be it could conr Figure 1 Page 17 of 24 Appendix A Monitor Adjustment Instructions APPENDIX A Monitor Adjustment Instructions These instructions describe how to adjust the 11 WIN laptop display to conform to luminance specifications Refer to the instructions for the laptop model included with your system NOTE Size cannot be adjusted on these monitors If the calibration square is incorrect contact Jaeb Center EVA Support do not proceed with EVA testing If the brightness or size do not calibrate correctly contact Jaeb EVA Support for assistance Dell Latitude E5530 7 Home 4 1 tnd 0 insert To Adjust Brightness 1 Hold down the Fn key on the keyboard 2 Press the up arrow on the keyboard to increase brightness 3 Press the down arrow on the keyboard to decrease brightness EVA Users Manual Model 11 WIN docx Page 18 of 24 Appendix B Light Meter Instructions APPENDIX B Light Meter Instructions The light meter is used to calibrate the computer monitor that you use for visual acuity determinations CRITICAL NOTE Effective May 2012 EVA Testers only use a digital light meter See below for photographs and instructions to identify and correctly use your light meter YOU MUST USE THE CORRECT PROCEDURE FOR VALID TEST RESULTS DIGITAL LIGHT
20. ration checks before testing EVA Users Manual Model 11 WIN docx Page 9 of 24 Using the EVA Tester 6 USING THE EVA TESTER 6 1 Perform Visual Acuity Testing Follow these instructions to perform visual acuity testing with the EVA Tester 1 2 3 Confirm test distance is 3 meters 118 inches from the monitor Insert the Model 11 WIN Flash Drive into a USB port Power the EVA PC Perform size and luminance calibration checks on the monitor screen to the position of the patient s face Confirm florescent lighting is not used in the exam room Dim incandescent lighting is recommended Turn iPod on The iPod screen should display test icons E ETDRS ATS HOTV etc If the icons are not displayed tap the EVA icon Tap an icon to start a program EETDRS and ATS HOTV Testing a For study patient select protocol e g DRCRnet PEDIG etc For non study patient select Non Study Tap Continue b Tap New Test c Confirm Date and Time are correct If not tap Change Time enter the correct date and time and tap Save d Tap Start Test verify testing distance and calibration tap Continue e If necessary choose a protocol or select Screening ID not yet assigned and tap Continue Note Screening option is not available for DRCRnet and PEDIG f Follow directions on iPod screen to perform test 6 2 Validation Codes The EVA vision test results include encrypted values for the score
21. rs are accurately displayed and 2 luminance calibration check to confirm the monitor screen is sufficiently bright for testing Procedures to check calibration on your monitor are as follows 5 Size Calibration 1 Display the EVA splash screen The outlined square in the middle of the screen is used for size calibration Each side of the square should be 114 mm in length 2 Complete the following steps on the top and left side of square a Place a ruler with millimeter scale against side of the square Confirm the length of the side is 114 mm IMPORTANT When viewing use only one eye and adjust your head as necessary so your eye is directly on line with side b If the either side is not 114 mm contact EVA Support at the Jaeb Center for assistance 5 2 Luminance Calibration For correct testing the white area of the calibration square should be at least 95 cd m The corresponding lux values are on the EVA Splash Screen See Appendix B for instructions and photos IMPORTANT 1 Allow monitor to warm up at least 10 minutes 2 Turn room lights OFF and follow instructions in Appendix B for your light meter 3 If needed adjust brightness setting as described in Appendix A IMPORTANT The Model 11 WIN EVA Tester has been equipped with a Sleep feature that darkens the screen without turning the monitor off If you use the Sleep feature you do NOT need to let the monitor warm up again before use You should still perform calib
22. st The EVA Tester cannot be connected to a printer but the printable file is placed on the Program Flash Drive so you can take it to another computer for printing These features are only available if approved by the study coordinating center 1 Auto Print This feature automatically stores an unencrypted raw text file copy of the Test Results on the Program Flash Drive in a folder named Print 2 View Previous Test Print This feature adds a Print button to the View Previous Tests display Clicking Print stores an unencrypted raw text file copy of the Test Results on the Program Flash Drive in a folder named Print 9 RETRIEVE STUDY DATA Periodically your coordinating center may want to download stored test data from the PC hard drive They will send you a Retrieve Data Flash Drive to download the data and return to the coordinating center 1 Ensure the EVA Tester is at the Calibration Square 2 Leave the Program Flash Drive plugged in and insert Retrieve Data Flash Drive in another USB port 3 The data retrieval will start and you will see a message stating that the EVA PC will shut down when the retrieval is complete 4 When the EVA PC shuts down remove the Retrieve Data Flash Drive EVA Users Manual Model 11 WIN docx Page 11 of 24 Retrieve Study Data 5 Use the same Retrieve Data Flash Drive on each Model 1 1 WIN EVA Tester at your site repeating steps 1 4 6 After retrieving data from all 11 WIN EVA Testers mail
23. ters are tested on all levels in between the upper and lower logMAR levels Visual acuity score is the number of letters correctly identified during threshold testing plus 5 letters for each logMAR line above the upper logMAR level through 20 800 The screening phase uses the letters V R K and D The threshold phase uses the same 5 letters from the Sloan letter set that appear on the original ETDRS charts for right and left eyes Unless screening score was 20 12 in which case letter pool consists of only 20 12 letters TUnless 20 800 letter is missed Unless 20 10 is correct 1 20 10 becomes part of the active letter pool it will be the lower logMAR level EVA Users Manual Model 11 WIN docx Page 24 of 24
24. vels larger than the level missed in phase 1 3 successively smaller single letters are presented e Exception if the level failed in phase is 20 500 or 20 640 3 20 800 letters are shown for reinforcement e Note the reinforcement phase responses do not contribute to the visual acuity score and even if the responses are incorrect the test proceeds to phase ll Phase II The last level missed in Phase is retested and if passed testing continues until a level is failed 1 Up to 4 single letters are sequentially presented at the last level missed in phase 2 If the level is failed testing stops 3 If the level is passed testing continues at sequentially smaller logMAR levels until a level is failed Final Visual Acuity Score The visual acuity score is the smallest logMAR level passed in Phase or Phase Il logMAR levels Snellen equivalents 20 800 20 640 20 500 20 400 20 320 20 250 20 200 20 160 20 125 20 100 20 80 20 63 20 50 20 40 20 32 20 25 20 20 20 16 20 12 EVA Users Manual Model 11 WIN docx Page 22 of 24 Appendix E E ETDRSO Visual Acuity Test Protocol APPENDIX E E ETDRSO Test Protocol The EVA runs a visual acuity testing program called E ETDRSO Electronic Early Treatment of Diabetic Retinopathy The program has been developed to provide a visual acuity letter score that is comparable to the ETDRS chart testing score During development of the E ETDRS protocol a study was conducted i
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