eva user`s manual model 12-win
Contents
1. USER S MANUAL MODEL 12 WIN TESTING REQUIREMENTS SIZE CALIBRATION TEST DISTANCE Use provided ruler to measure the length of each side of the calibration square Use tape measure to confirm the distance from EVA monitor to middle of seat of chair is 3 meters 118 inches Place ruler against side of square Confirm length of side is 114 mm IMPORTANT When viewing use only one eye and move your head as necessary such that your eye 3 meters 118 inches is directly on line with side Warm up monitor for at least 10 minutes 45 minutes for Low Contrast testing Turn light meter on Remove sensor cover and place sensor on center of the calibration square Do NOT allow sensor to touch non white areas Lux value must be 106 or greater Do NOT adjust monitor settings Do NOT adjust monitor settings Monitor is Contact the Jaeb Center if calibration fails calibrated to allow Low Contrast testing ELECTRONIC VISUAL ACUITY The Jaeb Center provides the EVA Tester for research purposes E V http eva jaeb org sene Manual Revised October 2013 EVA Users Manual Model 12 WIN docx Page 1 of 22 Table of Contents CONTENTS De SYSTEM cetreva ttr rn 3 2 DEFINITIONS AND SYSTEM COMPONENTSS rennen 4 3 TIPS FOR SUCCESSFUL acsnesanananadanatanasznndannsacidinaiacnlacni2. are stored as encrypted files per HIPAA requirements e Monitor specially configured and calibrated for Low Contrast IMPORTANT A Model 12 WIN EVA Tester is configured and calibrated for low contrast testing DO NOT adjust the monitor settings If the monitor does not fall within range greater than 106 lux on the provided light meter contact EVA Support at the Jaeb Center 1 SYSTEM DESCRIPTION The Electronic Visual Acuity EVA Tester uses an Apple iPod Touch to communicate with a Windows based computer For normal high contrast testing stimuli are high contrast black 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 low contrast testing stimuli are gray letters with a contrast of either 2 5 or 5 compared to the white background Letters are framed with crowding bars of the same contrast For lines of letters in the Chart application five 5 letters are displayed for sizes smaller than 20 100 a decreasing number of letters is displayed as letter size increases With a 23 6 inch LCD LED monitor at 1920 x 1080 pixels the system is capable of displaying letters from 20 800 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 EVA Users Manual Model 12 WIN docx Page 3 of 22 System Setup The iPod c
3. gray to white The second screen displays a black background with squares that progress from gray to black If the monitor s calibration changes one or more of the squares will not be visible If that occurs technicians are advised to contact the Jaeb Center and to not perform any low contrast testing with the system 10 4 Chart An application that can be used for manual vision testing Chart displays individual letters or lines of letters using HOTV or Sloan letters sets It can also display individual Lea Symbols 10 5 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 12 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 12 WIN docx Page 13 of 22 Frequently Asked Questions 11 FREQUENTLY ASKED QUESTIONS System Ques
4. alibration 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 95 cd m 106 lux on the provided light meter or greater The corresponding lux values are printed on the light meter label See Appendix A for instructions and photos IMPORTANT 1 Allow monitor to warm up a For regular testing the monitor should be on for at least 10 minutes b For Low Contrast testing the monitor should be on for at least 45 minutes 2 Turn room lights OFF and follow instructions in Appendix A for your light meter IMPORTANT The Model 12 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 calibration checks before testing EVA Users Manual Model 12 WIN docx Page 9 of 22 Usi
5. ars 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 Il up to four single letters are sequentially presented at each logMAR level that is tested e A 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 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 If starting point is 20 400 and response is incorrect at either 20 400 or 20 320 screening is restarted at 20 800 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 lette
6. can vary with testing distance It was therefore decided to have a fixed test distance of 3 EVA Users Manual Model 12 WIN docx Page 14 of 22 Frequently Asked Questions 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 4 I use any monitor for Low Contrast testing No Only the monitor that came with your model 12 WIN EVA Tester can be used for Low Contrast testing The monitor is part of the system as a whole The system is carefully calibrated to display the gray levels needed for testing Using a different monitor would result in different gray levels being displayed and would invalidate any results obtained with that system 5 Does it matter if the EVA PC and monitor are stacked or separate The system will work either way Choose the setup that is easiest and most comfortable for you Be sure that you adjust the cart as needed for the correct testing height 6 Where are the keyboard and mouse The EVA Tester does not require a keyboard or a mouse to operate so this equipment is not included The only equipment required is the PC the monitor the router and the iPod 7 How I find out which program version my EVA Tester is r
7. ctive letter pool it will be the lower logMAR level EVA Users Manual Model 12 WIN docx Page 22 of 22
8. d monitor the cart provided or your own cart Plug the HDMI cable into the computer and monitor as shown in Figure 2 Plug PC power supply cord into the computer as shown in Figure 1 Connect the iPod to the white USB charging cable Plug Ethernet cable from yellow LAN port on Router to the Ethernet port on the back of the EVA PC Plug Router power cord into back of Router Plug Monitor PC and Router power cords into the power strip and then plug the power strip into a wall outlet Attach the plastic ruler to the back of the monitor with the Velcro strip Turn monitor on by pressing power button Insert the Model 12 WIN Flash Drive in USB port as shown in Figure 2 Turn the PC on by pressing the power button on the front of the PC The 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 will be the last four digits of the Tower ID For example if the Tower ID is T0001 23 the password will be 0123 c Tap the EVA icon at the bottom of the screen d Tap Configure Studies at the top right of the screen EVA Users Manual Model 12 WIN docx Page 6 of 22 System Setup e Tap Set E ETDRS and check boxes for studies in which your site is part
9. ed 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 II ogMAR 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 12 WIN docx Page 20 of 22 Appendix D E ETDRS Visual Acuity Test Protocol APPENDIX D E ETDRS Test Protocol The EVA runs a visual acuity testing program called E ETDRS 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 in 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
10. een 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 12 WIN docx Page 17 of 22 Appendix 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 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 12 WIN docx Page 18 of 22 Appendix B iPod Diagram APPENDIX B iPod Diagram Apple iPod Touch 5G 16GB Sleep wake 10 44 AM IETDRS ETDRS ZK ETORS CSH ETORS Il vopz E ETDRS E ETDRS PC Power Home EVA Users Manual Model 12 WIN docx Page 19 of 22 Appendix C ATS HOTVO Visual Acuity Test Protocol APPENDIX C ATS HOTVO Visual Acuity Test Protocol Single letters with surround b
11. eening 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 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 pool t 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 letters 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 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 Unless 20 800 letter is missed Unless 20 10 is correct SI 20 10 becomes part of the a
12. icipating 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 5 select your studies and Non Study if needed tap Done h Tap the Exit to leave configuration 14 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 12 WIN flash drive is required for this EVA Tester Usable flash drives are labeled 12 WIN Do NOT use flash drives intended for other models EVA Users Manual Model 12 WIN docx Page 7 of 22 System Setup Figure 1 View of the back of the EVA PC Use for HDMI Use for Use for Power Cord Program Flash iPod cable Ethernet cable Figure 2 View of the back of the Asus monitor Power Cord HDMI EVA Users Manual Model 12 WIN docx Page 8 of 22 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 letters 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 1 Size C
13. 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 ifa 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 and 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
14. n 4 steps a screening phase a first threshold determination Phase 1 reinforcement phase a second threshold determination Phase 1 Details of the ATS HOTV algorithm are included in Appendix C 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 12 WIN docx Page 12 of 22 Low Contrast E ETDRS Visual Acuity Test The ATS HOTV 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 10 3 Low Contrast E ETDRS Visual Acuity Test The Low Contrast E ETDRS uses the same algorithm as the E ETDRS Visual Acuity Test The Low Contrast version of the test allows the user to select from two different low contrast levels 2 596 and 596 The contrast levels represent the percentage of difference in luminance between the foreground letter image and background Two Low Contrast Calibration screens are used to check monitor calibration before low contrast testing The first screen displays a white background with squares that progress from light
15. nasdaantanstanmiantienssinilanasavalanasaaniiat 6 4 SYSTENLSETUDP oid a da 6 5 MONITOR CALIBRATION RA Xo CRM AUR EEUU ca S 9 6 USING THE EVA TESTER DUE DUUGEREKUREA TA Du UELLE E OR AUR 10 7 CONFIGURE STUDIES incra tata Lu AREA Cd a CER HL LE UH 11 B RETRIEVE STUDY DATA iia icicizazaki cua E d Dad Ex aa RR LE EM RR 11 9 SHUT DOWN THE EVA TESTER ku ir 11 10 EVA VISUAL ACUITY TESTING APPLICATIONS rers 12 11 FREQUENTLY ASKED OUEST IONS iiiiidduainix ludit i 14 APPENDIX e M 17 APPENDIX B T M 19 APPENDIX cece aed eae cen cub dicic ed ird dental dae ee i dc 20 APPENDIX S ELLO 21 EVA Users Manual Model 12 WIN docx Page 2 of 22 System Setup MODEL HIGHLIGHTS e Model 12 WIN is a desktop EVA Tester that is also configured to display Low Contrast letters Chart application able to display letters down to 20 6 E ETDRS algorithm available in 596 and 2 596 low contrast levels Windows based system that uses Wi Fi for communication System controlled using an Apple iPod Touch Sleep option to make monitor dark without turning it off System is only 8 deep and 18 to top of monitor when stacked monitor is 22 wide e Test results
16. ne that go to the previous screen and find your Tower ID in the list of networks Tap on it and the iPod will join the network Press the Home button and tap the EVA icon to begin using the EVA Tester EVA Users Manual Model 12 WIN docx Page 16 of 22 Appendix A Light Meter Instructions APPENDIX A 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 should only use a digital light meter See below for photographs and instructions to identify and correctly use your meter YOU MUST USE THE CORRECT PROCEDURE FOR VALID TEST RESULTS DIGITAL LIGHT 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 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 scr
17. ng 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 12 WIN Flash Drive into a USB port see Figure 1 on Page 8 Power on 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 an icon to start a program E ETDRS and ATS HOTV Testing a For study patient select protocol e g DRCRnet PEDIG etc For non study patient select Non Study Tap Next b Tap New Test c Confirm Date and Time are correct If not tap Change Date amp Time enter the correct date and time and tap Save Changes d Tap Next verify testing distance and calibration tap Next e If a Low Contrast test is being performed be sure you can see all ten 10 boxes on each of the Low Contrast Calibration screens If you do not see all 10 boxes contact the Jaeb center do not perform low contrast testing Tap Next f Follow directions on iPod screen to perform test 6 2 Validation Codes The EVA vision test results include encry
18. ommunicating 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 2 DEFINITIONS AND SYSTEM COMPONENTS 2 1 Definitions EVA PC The personal computer sent with the EVA Tester Also referred to as the Tower EVA Tester All components of the EVA Tester including monitor PC 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 Data Retrieval 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 EVA Testing Requirements are displayed with a white square outlined in black in the middle of the screen Used for monitor calibration Router A wireless access point used to manage communication between the EVA PC and the iPod Tower ID Unique identifier used to configure wireless connection between the iPod and EVA PC Printed on a label attached to the EVA PC example 1000001 Valida
19. ous EVA model No The 12 WIN model EVA Tester requires the Apple iPod Touch to access the Wi Fi signal PDAs from previous EVA models used Bluetooth to communicate with the PC 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 4 and then tap Add to Home Screen Name the new icon EVA 12 My iPod won t communicate with the EVA PC What do do Make sure all cords are plugged in firmly It may be best to unplug and plug back in all of the cords to ensure a good connection After checking all cords reboot the EVA PC by pressing the power button on the front After the EVA Splash Screen displays you should be able to connect to the EVA PC Press the Home button and then tap the EVA icon on the iPod Also make sure your iPod is connected to the EVA Tester s network See the answer below for details 13 Someone connected my iPod to another Wi Fi network How do get it to work with the EVA Tester again Press the Home button tap Settings and tap Wi Fi There should be a checkmark next to the network named with your EVA Tester s Tower ID e g T0001 23 If you have connected the iPod to another network you will need to tap the blue arrow at the right side of the screen and tap Forget this network Once you have do
20. ownload 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 Insert Retrieve Data Flash Drive in a USB port Leave the Program Flash Drive plugged in 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 5 Use the same Retrieve Data Flash Drive on each Model 12 WIN EVA Tester at your site repeating steps 1 4 6 After retrieving data from all 12 WIN EVA Testers mail 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 9 SHUT DOWN THE EVA TESTER To shut down 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 12 WIN docx Page 11 of 22 EVA Visual Acuity Testing Applications 10 EVA VISUAL ACUITY TESTING APPLICATIONS 10 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 pro
21. pted values for the score and patient ID test 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 6 3 Viewing a Previous Test 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 appropriate test and the test results including validation codes will be displayed EVA Users Manual Model 12 WIN docx Page 10 of 22 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 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 f 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 RETRIEVE STUDY DATA Periodically your coordinating center may want to d
22. rs 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 3 levels 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 Il Phase 11 The last level missed in Phase is retested and if passed testing continues until a level is failed 1 Upto 4 single letters are sequentially presented at the last level missed in phase 2 If level is failed testing stops 3 the level is pass
23. 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 12 WIN docx Page 21 of 22 Appendix D E ETDRS 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 20 400 Show letter at 20 12 Show letters in 3 level steps e g 20 200 Correct each successively smaller Correct Correct Incorrect Show a 20 800 Correct 20 100 20 50 20 25 20 12 until either a level n l either auntie miss or 20 12 correct or 20 400 correct etter Incorrect Letter missed Letter Missed Show letter 2 levels up from missed level 1 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 last correct level or 20 800 if last letter shown is 20 800 Scr
24. tion Codes Encrypted values for test result and patient identifier used during case report form data entry to validate that information is correctly entered EVA Users Manual Model 12 WIN docx Page 4 of 22 System Setup 2 2 System Components The shipment should include the components listed below EVA PC with Tower ID sticker attached Tape Measure Cart Optional e EVA PC power adaptor e 23 6 LED LCD Monitor e Monitor power adaptor e HDMI cable e Apple iPod Touch e iPod USB charging cable e Wireless router e Router power cord and adaptor e Ethernet cable e EVA Program Flash Drive e Light Meter e Plastic Ruler Note keyboard and mouse are not used with the EVA Tester are not included TESTING REQUIREMENTS SIZE CALIBRATION TEST DISTANCE LUMINANCE CALIBRATION A EVA Users Manual Model 12 WIN docx Page 5 of 22 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 12 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 12 WIN EVA Tester 1 2 Place the an
25. tions UJ 0 ND FS How much space need to properly operate the EVA Tester Why does the testing distance need to be 3 meters have an LCD monitor that didn t come with the EVA Tester can use it I use any monitor for Low Contrast testing Does it matter if the EVA PC and monitor are stacked or separate Where are the keyboard and mouse How find out which program version my EVA Tester is running Why do I have to let the monitor warm up When do it need to look up a previous score for a patient How do do that iPod Questions 10 11 12 13 Can use the Palm PDA from a previous EVA model What do do if cannot find the EVA program on my iPod My iPod won t communicate with the EVA PC What do do Someone connected my iPod to another Wi Fi network How get it to work with the EVA Tester again 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 Since the base of the monitor has a depth of about 6 inches you will need approximately 11 feet from the patient to the back of the monitor 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
26. unning The program version for your EVA Tester is located on the bottom of the splash screen You can also view the version on the iPod by tapping the Configure Studies icon the version is displayed on the bottom of the iPod screen 8 Why do have to let the monitor warm up When do it All EVA Tester monitors need to warm up to achieve display stability For high contrast testing this can be achieved in 10 minutes For Low Contrast testing this requires 45 minutes At that time the monitor s luminance is stable and all optotypes displayed will be consistent The warm up period should be followed any time the monitor is off for longer than a reboot If you need to turn the monitor off to make the lane dark for other use consider using the Sleep function found in the PC Power menu You do not need to wait for the warm up period if the monitor has already warmed up and you used the Sleep function EVA Users Manual Model 12 WIN docx Page 15 of 22 9 need to look up a previous score for a patient How do 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 iPod Questions 10 Can use a Palm PDA from a previ
27. vide 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 D 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 The 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 10 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 i
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