1. Training and Certification
BCVA Examiner
Training and Certification
Lilly BDAD Clinical Trial
© 2009 The EMMES Corporation

2. Training Objectives Review Examination Lane set up
Train in protocol methods of performing the following tasks:
ETDRS Refraction
ETDRS Visual Acuity
Completion of Worksheets related to the above tasks
Review responsibilities
Review certification requirements

3. Examination Lane

4. Exam Lane Requirements
4 meter space
ETDRS light box
ETDRS Charts R, 1, & 2
Trial lens set
With – 0.37 lens
Jackson Cross Cylinders
0.25, 0.50, 1.00
Trial frames
Meter stick
Primary & spare light tubes
With fenestrated sleeves
Burn-in & change documentation
-0.37
Animation:
➙ Activates the first bullet
Each ➙ activates the next bullet
No fade – screen will have all needed equipment.
NOTE: This is animated only in the BCVA PPT as you will not go through the detailed exam lane information given in the monitor PPT.

5. Examination Lane
Established sites have the examination lane already configured
Lane requirements are covered in the EMMES training manual
Examination lane certification is granted by:
EMMES certifier during EMMES site visit
Grandfathering
From Sponsor’s previous clinical trial
From previous EMMES site visit

6. Refraction

7. Refraction Acceptable baselines:
Phoropter
Autorefractor
Retinoscopy
Lensometry
Last visit Refraction in trial frames
Sphere and Cylinder
Final refinement must be done using trial lenses in trial frames and the Jackson Cross Cylinder (JCC)
Animation:
Phoropter appears soon after slide
➙ Autorefractor appears
➙ Retinoscope appears
➙ Lensometer appears, then glasses
➙ Woman appears
➙ Women appear, then JCC a few seconds later

8. Trial Lens Set Loose spherical and cylindrical lenses
Used for ETDRS refraction and visual acuity measurement
Plus and minus power spherical lenses
Cylinders may be plus, minus, or both

9. -0.37 Sphere Additional lens needed in Lilly BDAD Study
- 0.37
Additional lens needed in Lilly BDAD Study
Not usually included in trial lens set and may need to be ordered separately
Site must obtain this lens before start of study

10. Jackson Cross Cylinder
Used to check for axis and power of cylinder
Site must have JCC in three powers:
0.25
0.50
1.00

11. Trial Frames Must be comfortable for the subject to wear
Must be in good repair with no broken or missing parts
Several types are available
Trial lenses are inserted into lens cells for refraction and visual acuity measurement

12. Technique

13. Refraction For visual acuity of 20/80 or better
Start with and spherical lenses
Start with cylinder at axis 180o
If using minus cylinder, begin with at axis 90o
For visual acuity worse than 20/80
Use higher diopter power spheres and cylinders
Refer to BCVA Guidelines sheet for each step
Step 1: Initial sphere power
Step 2: Cylinder – axis and power
Step 3: Final sphere power

14. Initial Sphere

15. Refraction Use Chart R Begin with right eye Refine: Chart R
Initial sphere
Cylinder (axis and power)
Final sphere

16. Sphere
Ask subject to read smallest line they are able to see on Chart R as a starting point
Select beginning lens from BCVA Guidelines based on this reading
As vision improves with addition of lenses, use lens appropriate for the vision at each point during testing

17. Refraction Ask subject if lens makes the letters
Chart R
Ask subject if lens makes the letters
Better
Worse
No Different
Do not say “Better 1 or 2”

18. Push Plus
“Push Plus” – determine highest plus or least minus that produces minimal blur
Offer sphere and give sphere as long as it is “Better” or “No Different”
Once sphere is “Worse”
Ask subject to read smallest line they are able to read
Necessary as when minus is offered, subject must earn minus by reading more letters on the chart

19. Offer Minus Offer -0.37 minus sphere
- 0.37
Offer minus sphere
If “Better,” subject must earn minus by reading at least one more letter
If earned, give sphere
Continue to offer sphere until “Worse” or “No Different”

20. Offer Plus
After minus has been offered, earned, and adjusted – that is, “worse” or “no different”
Offer again and ask if “Better, Worse, or No Different”
Offer and give plus until plus is “Worse”
Always end up offering plus

21. Refraction at 1 Meter Refract both eyes at 4 meters
If fewer than 4 letters are read at 4 meters, move subject to 1 meter
Carefully measure with 1 meter stick
Add sphere to distance refraction
Remember to take this out when recording refraction worksheet
Both eyes are refracted at 4 meters before moving subject to 1 meter

22. Cylinder

23. Cylinder
Do not estimate the cylinder or use only the spherical refraction
Use cylinder from autorefractor or retinoscopy as a starting point
It must be refined and finalized using the Jackson Cross Cylinder
Use JCC power according to BCVA Guidelines
Refine cylinder axis and cylinder power
Animation is automatic

24. JCC Flips and Rotates JCC with power dots JCC with power lines
White & green are plus power
Red is minus power

25. Axis Refinement

26. Instructions to Subject
For axis refinement, instruct the subject to find the smallest line read comfortably and concentrate on a round letter one line above
Smallest line read
Instruct subject to concentrate here
No animation

27. Axis Refinement
When refining the cylinder axis, follow the handle of the JCC
Offers plus and minus power 45o from beginning axis alignment
- 1.00

28. Axis Refinement
If working in minus cylinder, “chase” the minus line or dot
Rotate the lens axis 5 – 15o
- 1.00

29. Axis Refinement
Now place the JCC with handle at the new axis and continue to flip, asking “Better 1 or 2, or about the same”
Continue to chase the prefered line or dot
- 1.00

30. Axis Refinement
Continue to rotate the axis and the JCC according to the subject’s responses
It may be necessary to use smaller degree changes as the end point gets closer or if there is high cylinder power
- 1.00

31. Axis Refinement
As long as the response is a number, continue to flip the JCC to refine the axis
Correct axis has been determined when the subject’s response is “about the same”
Cylinder axis must be determined before determining the correct cylinder power

32. Power Refinement

33. Instructions to Subject
For power refinement, instruct the subject to find the smallest line read comfortably and concentrate on a round letter on that line
Smallest line read
Instruct subject to concentrate here
No animation

34. Power Refinement
When refining the cylinder power, follow the power dots or power lines
Offers plus and minus power on the refined axis
- 1.00

35. Power Refinement
Continue to offer power and exchange trial lens until subject’s response is “about the same”
Correct power has now been determined
Animation is automatic
- 1.25
- 1.50

36. Spherical Equivalent
Once 0.50 diopter of cylinder has been added or subtracted, adjust the sphere by 0.25 of opposite power
-0.50 cylinder added: give sphere
-0.50 cylinder taken away: give sphere
Adjust the sphere as you go – do not wait until the cylinder power is fully determined

37. Refraction – Cylinder
If there is established cylinder from last Refraction:
Refine axis using Jackson Cross Cylinder
Follow the handle of the JCC
Refine power using JCC
When checking cylinder, the choices given the subject are:
“Better 1 or 2 or about the same”

38. Cylinder If cylinder is unknown:
Test for astigmatism by placing a cylinder first at 180o and then at 90o if the first choice is not satisfactory (or at 90o if working in minus cylinder)
Refine the axis and power with Jackson Cross Cylinder (JCC)
Follow the color line or dot of the cylinder you are working in
Move the axis 5o – 15o or smaller increments as axis is refined

39. Final Sphere Refinement

40. Final Sphere
Ask subject to read smallest line they are now able to see on Chart R
Select refinement lens from BCVA Guidelines based on this reading
As vision improves with addition of lenses, use lens appropriate for the vision at each point during testing
Animation is automatic

41. Refraction – Final Sphere
Offer and ask if “Better, Worse, or No Different”
Offer and give plus until plus is “Worse”
Check visual acuity before offering minus
Offer sphere and give if minus is better and more letters are read
Offer to finish Refraction
If final sphere changes by ≥ 0.50 diopter, re-check the cylinder axis and power

42. Visual Acuity

43. Points of Note Always test the right eye first
Use Chart 1 for the right eye
Use Chart 2 for the left eye
If < 20 letters are read correctly, the subject must be tested at 1 meter
Add sphere to distance refraction
If the subject must be moved to 1 meter, both eyes should be tested at 4 meters before moving the subject to 1 meter
Animation:
➙ Chart 1 expands (medium speed)
➙ Chart 2 expands (medium speed)

44. Points of Note
Give the subject detailed instructions before testing begins
Start at the upper left corner – read left to right
There are no numbers – only letters
Animation is automatic
Read slowly – one letter per second
It is acceptable and encouraged to guess letters
Corrections should be made before going on to the next letter

45. ETDRS Charts 10 alphabet letters Sloan letters Random order
Same degree of difficulty for each letter

46. Points of Note If subject loses their place on the chart
Verbally orient place
By row number from the top of the chart
Do not ask for row lower than 3rd or 4th
By horizontal lines on the chart
Do not
Repeat the last line read
Point to the chart 1 2 3
Animation:
➙ Numbers 1, 2, 3 appear
➙ Arrows to horizontal lines appear

47. BCVA Examiner Responses
Do not stop the subject if they give an incorrect response
Do not comment as the subject responds
“OK” or “yes” should not be said after each letter, nor should nods or other gestures be made
Once the examiner does not respond, the subject knows they have given an incorrect response
Testing must be completely unbiased on the part of the BCVA examiner

48. Subject Questions
If the subjects asks if it is a certain letter, the BCVA examiner should ask them to choose the letter they think it is
If the subject attempts to skip letters – “the third letter looks like...,” the BCVA examiner should immediately stop them and ask them to begin with the first letter on the left

49. Points of Note Encourage the subject to read as far as possible
Do not allow subject to quit easily
Ask subject to guess letters on next line
Allow subject the opportunity to guess any letter they may confuse with a number or another letter
Urge subject to pick one letter

50. Points of Note Corrections
Subject may not go back and correct a letter once they have read the next letter
Subject may correct before going to next letter
Stop the subject immediately if they read letters too quickly or if they say a number
This will give them the opportunity to correct before going to the next letter

51. Skipped Lines
If it is obvious that the subject has skipped a line, the BCVA examiner should:
Stop the testing
Re-orient the subject to the correct line
Ask the subject to read that line
Continue with the testing as if the subject had not skipped a line (i.e. – this is the only time a subject is permitted to go back as it is technically not a correction but an omission)

52. Head Position
The subject may be permitted to turn his or her head to fixate eccentrically, provided the fellow eye is adequately occluded
The trial lens occluder may not be adequate for this
A tissue or eye patch may be needed
If patch used, it should be loose enough so that subject can keep both eyes open (even though one is occluded)
Always use at 1 meter

53. When to Stop
Visual acuity testing is stopped only when the subject convinces the examiner that they can read no more letters on the ETDRS chart
It is not stopped when the subject misses two letters on a line as in some other clinical trials

54. Visual Acuity – Right Eye
Chart 1
Tested at 4 meters
Start with the right eye; occlude the left eye
Place Chart 1 in light box
Other charts should be out of view

55. Visual Acuity – Left Eye
Chart 2
Tested at 4 meters
Remove occluder lens from left eye; occlude right eye
Remove Chart 1
Put it out of view
Place Chart 2 in light box

56. Visual Acuity Testing
Subjects unable to read at least 20 letters at 4 meters (either eye):
Seat subject 1 meter from the chart and carefully measure the distance from the front of subject’s eye in a straight line to the front of the chart
Add sphere to Refraction
Test again
Both eyes should be tested at 4 meters before moving subject to 1 meter

57. Visual Acuity Testing Remove Chart 2 from view Testing is complete
Chart R only may be displayed in the light box between screenings
Testing is complete
Score worksheets
Check to ensure that worksheet is completely and accurately filled out
Check addition for Visual Acuity score

58. Worksheet: Refraction
Record the 4 meter (distance) refraction on the worksheet for each eye
If any field has no power, insert zeros
If refraction was performed at 1 meter, remember to take out the sphere added for 1 meter testing when recording the refraction

59. VA Worksheet Completion
All letters read correctly should be clearly and individually circled
Letters read incorrectly or letters subject was unable to read should be left blank
Lines the subject attempted to read but had no correct answers should have a “0” total
No letters read on a line should have a “0” total
Animation is automatic

60. Visual Acuity Worksheets
Right Eye
Left Eye
Animation is automatic – does not fade.

61. Scoring Worksheet C Z R H S 5 O N 4 D K V 2

62. Worksheet Example

63. Worksheet Example

64. Worksheet Example

65. Worksheet Example

66. Snellen Equivalent
To the left of the circled responses is the “Snellen Acuity Equivalent”
Smallest line with one or fewer incorrectly read letters
Line will have a score of 4 or 5
Enter this in the “Visual Acuity Score” section
Animation:
➙ Vertical arrows will appear from top, followed by vertical ovals
➙ Vertical arrows and ovals fade. Arrow to smallest line with a score of 4 or 5, followed by horizontal oval – these do not fade
➙ Arrow to score line, followed by horizontal oval – these do not fade

67. Corrections All worksheet or CRF corrections should be uniform:
Single line through error
Correction inserted
If necessary, use the margin for explanation or clarification
Date
Initials (or sign name)
Oct EK

68. Common Errors
VA score ends in a line where all 5 letters were read correctly
May indicate the subject was not encouraged to read more letters
Crossing out letters not circled
Not circling letters consistently or individually
Not counting circled letters in individual rows correctly

69. Common Errors
Not testing subject at 1 meter if fewer than 20 letters were correctly read at 4 meters
Do not assume they would read all 30 letters at 1 meter
Not adding sphere when subject is moved to 1 meter
Not testing both eyes at 4 meters before moving subject to 1 meter

70. Site Responsibilities

71. Site Equipment
It is the site’s responsibility to obtain all required equipment and supplies before an EMMES site visit
Equipment procurement information is given in the EMMES training manual sent to each site

72. Exam Lane Configuration
The Study Coordinator (or other designated individual) at the site is responsible for setting up the exam lane prior to an EMMES site visit
Exam lane cannot be fully certified until all equipment is obtained, in place, and required documentation is in place
If site has “action items” – these must be satisfied
documentation is acceptable

73. Exam Lane Changes
Any changes to the exam lane should be reported to the monitor by the site
New or changed lane must be certified before study subjects may be screened
Changes include:
Relocation of exam lane to another room or building
Painting or color change which may affect lighting
Newly-installed room lighting which may affect light measurement of charts

74. Examiner
Certification

75. BCVA Examiner Certification
Earned during an EMMES site visit or by being grandfathered from another active EMMES certification
BCVA examiner may not screen study subjects until full certification is granted by EMMES
A certification number is assigned by EMMES and will be effective throughout the study for that BCVA examiner
Certification Letter issued by EMMES
Should be kept in study binder

76. BCVA Examiner Certification
It is the Study Coordinator’s responsibility to ensure sufficient number of BCVA examiners are certified at site
If BCVA examiners need to be certified by EMMES, Study Coordinator should:
Contact monitor – they will assess needs at the site and any other sites in the general area or country
Site Visit Request will be sent to EMMES – EMMES will contact site to schedule site visit

77. Grandfathering
It is the Study Coordinator’s responsibility to submit the Certification Affidavit required to grandfather a BCVA examiner into the Lilly BDAD study
Grandfathering is not automatic – the required paperwork must be submitted to EMMES
BCVA examiner may not screen study subjects until grandfathered

78. 401 North Washington Street
EMMES Contacts
Eva Karlsson, COT:
Ophthalmic Trainer/Certifier – Lead Point
Lisa Motta:
Lead Administrative Coordinator
The EMMES Corporation
401 North Washington Street
Rockville, MD U.S.A.
Phone:
Fax:

79. Questions?
T H A N K Y O U

80. R 1 2