Ophthalmology Procedures Manual
Ophthalmology Procedures Manual
September 2005
Chapter 1 2
3
TABLE OF CONTENTS
OVERVIEW OF OPHTHALMOLOGY .........................................................
1.1 Background......................................................................................... 1.2 General Overview of Procedures ........................................................ 1.3 Integrated Survey Information System (ISIS) ....................................
Page
1-1
1-1
1-2
1-2
EQUIPMENT/SUPPLIES/MATERIALS .......................................................
2.1 Ophthalmology Equipment and Supplies ...........................................
2.1.1 Nonconsumables (Instruments and Equipment).................. 2.1.2 Supplies (Consumables)......................................................
2.2 Equipment Description, Setup and Operating Procedures..................
2.2.1 2.2.2
Humphrey Matrix Visual Field Instrument......................... Canon CR6-45NM Ophthalmic Digital Imaging System
and Canon EOS 10D Digital Camera..................................
PROTOCOL ....................................................................................................
3.1 Eligibility Criteria ...............................................................................
3.1.1 Safety Exclusion Questions Completed in
Ophthalmology....................................................................
3.2 Pre-examination Procedures ............................................................... 3.3 Visual Field Test (Frequency Doubling Technology Perimetry)........
3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7
Setting Up ISIS and FDT screens ....................................... SP Positioning for the Visual Field Test ............................. Starting the Visual Field Test.............................................. Saving Files to the ISIS Database ....................................... FDT Section Status ............................................................. Procedure for Testing One Eye Only .................................. Problems With Importing Files ...........................................
3.4 Digital Fundus Photography ...............................................................
3.4.1 3.4.2 3.4.3 3.4.4
ISIS Screen for Retinal Images ........................................... Positioning for Retinal Imaging .......................................... Achieving Maximum Pupil Dilation ................................... Explanation of Retinal Imaging ..........................................
2-1
2-1
2-1
2-2
2-2
2-2
2-10
3-1
3-1
3-2
3-5
3-6
3-6
3-9
3-11
3-12
3-14
3-15
3-16
3-21
3-22
3-23
3-23
3-23
iii
Chapter 4 5
TABLE OF CONTENTS (continued)
Page
3.4.5 3.4.6 3.4.7 3.4.8 3.4.9 3.4.10 3.4.11 3.4.12 3.4.13 3.4.14 3.4.15
Camera Alignment and Imaging Procedures ...................... Pupil Size and External Camera Alignment........................ Internal Eye Alignment ? Macula Image ............................ Internal Eye Alignment ? Optic Nerve Image .................... Labeling the Images ............................................................ Criteria for Taking Repeat Images ...................................... Ignore/Image Not Captured................................................. Imaging Procedures for Challenging Circumstances .......... Data Acquisition Screen...................................................... Completing the Exam.......................................................... Retinal Imaging Section Status ...........................................
3-24
3-25
3-26
3-27
3-27
3-29
3-32
3-33
3-37
3-40
3-41
3.5 Storing and Shipping Images .............................................................. 3-42
QUALITY CONTROL.................................................................................... 4-1
4.1 Overview............................................................................................. 4-1
4.2 Training............................................................................................... 4-1
4.2.1 4.2.2 4.2.3
Initial Training .................................................................... Followup Training Prior to Main Study.............................. Training of New Technologists...........................................
4-1
4-2
4-2
4.3 Equipment and Room Setup Checks................................................... 4-2
4.3.1 Quality Control Log-on Box ............................................... 4-2
4.3.2 Utilities Menu to Select Quality Control............................. 4-3
4.3.3 Quality Control Log-on Box ............................................... 4-4
4.3.4 Daily Quality Control Checks ............................................. 4-4
4.3.5 Weekly Quality Control Checks ......................................... 4-5
4.3.6 Start of Stand....................................................................... 4-6
4.4 Review of Images by Graders............................................................. 4.5 Observational Visits............................................................................
4-7
4-7
4.5.1 Site Visit Report Form ........................................................ 4-8
REFERRALS AND REPORT OF FINDINGS ............................................... 5-1
5.1 Report of Findings .............................................................................. 5-1
5.1.1 Early Reporting of Pathology.............................................. 5.1.2 Preliminary Grading............................................................
5-1
5-2
iv
TABLE OF CONTENTS (continued)
Chapter
Page
5.1.3 Detailed Grading ................................................................. 5-2 5.1.4 Final Report of Findings ..................................................... 5-2
Appendix A B C
Table 2-1 2-2
List of Appendixes
Step-By-Step Procedures and Scripts .............................................................. A-1 Step-By-Step Procedures and Scripts - Spanish .............................................. B-1 Equipment Diagrams ....................................................................................... C-1
List of Tables
Troubleshooting problems with the Humphrey Matrix Visual Field Instrument ........................................................................................................ 2-9 Settings for the Canon EOS 10D camera body................................................ 2-13
Figure 2-1 2-2 2-3 2-4 2-5 2-1 2-2
List of Figures
Humphrey Matrix Visual Field Instrument (examiner side)............................ 2-3 Humphrey Matrix Visual Field Instrument (SP side) ...................................... 2-3 SP Response Button......................................................................................... 2-4 Keyboard/Touchpad......................................................................................... 2-4 Power connector .............................................................................................. 2-4 Canon CR6-45NM ophthalmic digital imaging system................................... 2-10 Canon EOS 10D digital camera....................................................................... 2-10
v
Figure 3-1 3-2 3-3 3-4 3-5 3-6 3-7 3-8 3-9 3-10 3-11 3-12 3-13 3-14 3-15 3-16 3-17 3-18 3-19 3-20 3-21
TABLE OF CONTENTS (continued)
List of Figures (continued)
Safety exclusion observations from vision component.................................... Safety exclusion questions completed in ophthalmology ................................ Exclusion due to eye infection......................................................................... Component Status due to eye infection exclusion ........................................... Exclusion due to eye patch-both eyes.............................................................. Component Status due to eye patch exclusion................................................. FDT Data Capture Screen................................................................................ FDT Main Menu Screen .................................................................................. FDT View Patient Screen ................................................................................ FDT Enter New Patient Screen........................................................................ FDT View Patient Screen ................................................................................ FDT Testing Screen ......................................................................................... FDT Eye Positioning ....................................................................................... FDT SP Video Screen Pattern.......................................................................... Recall Test Screen-Saving files ....................................................................... Recall Test Screen ? Selecting format ............................................................. Recall Test Screen Files saved successfully .................................................... ISIS Data Capture Screen ................................................................................ FDT Selection Status Screen ........................................................................... Proceed without importing............................................................................... DOB and ID does not match............................................................................
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