Ophthalmology Procedures Manual

[Pages:107]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) ....................................

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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 ..........................................

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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 ...........................................

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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............................................................................

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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............................................................

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5-2

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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

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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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Figure 3-22 3-23 3-24 3-25 3-26 3-27 3-28 3-29 3-30 3-31 3-32 3-33 3-34 3-35 3-36 3-37 3-38 3-39 3-40 3-41 3-42

TABLE OF CONTENTS (continued)

List of Figures (continued)

Page

Import failed .................................................................................................... 3-17

Files not found ................................................................................................. 3-18

More than two sets of files............................................................................... 3-19

Data already imported...................................................................................... 3-19

Imported two sets of data already .................................................................... 3-20

FDT Section Status for one file imported ........................................................ 3-20

Diagram of optic fields for imaging................................................................. 3-21

Retinal Images Screen ..................................................................................... 3-22

Drop-down menu for estimating pupil size in mm .......................................... 3-26

Retinal Images Screen with drop-down menu ................................................. 3-29

Images required by protocol ............................................................................ 3-30

Image display for additional images ................................................................ 3-31

Missing entries message .................................................................................. 3-31

Ignore image .................................................................................................... 3-32

Image not captured........................................................................................... 3-33

Drop-down menu for pupil size setting ........................................................... 3-35

ISIS screen for changing pupil setting ............................................................. 3-35

Apply pupil size setting to all subsequent images ........................................... 3-36

ISIS screen for changing DA setting ............................................................... 3-37

Apply DA setting to all subsequent images ..................................................... 3-37

Data acquisition screen .................................................................................... 3-38

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Figure 3-43 3-44 3-45 3-46 3-47 3-48 3-49 3-50 4-1 4-2 4-3 4-4 4-5 4-6 4-7

TABLE OF CONTENTS (continued)

List of Figures (continued)

Page

Rating difficulty of taking image..................................................................... 3-39

Rating quality of the image.............................................................................. 3-40

Retinal Images Section Status Screen.............................................................. 3-41

Burn DVD menu.............................................................................................. 3-43

Burn DVD message ......................................................................................... 3-43

DVD burn status bar ........................................................................................ 3-44

Assign air bills ?assigned list........................................................................... 3-44

Assigned air bills- not assigned ....................................................................... 3-45

Quality control reminder message box ............................................................ 4-3

Utilities menu to select quality control ............................................................ 4-3

Quality control log-on...................................................................................... 4-4

Daily QC checks .............................................................................................. 4-5

Weekly QC checks........................................................................................... 4-6

Start of stand QC checks.................................................................................. 4-6

Site Visit Report form...................................................................................... 4-8

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1. OVERVIEW OF OPHTHALMOLOGY

1.1

Background

The leading causes of visual impairment in the United States are primarily age-related eye diseases including cataracts, diabetic retinopathy, glaucoma, and age-related macular degeneration. More than 3.4 million Americans aged 40 years and older are either blind or are visually impaired. Although it is believed that half of all blindness can be prevented, the number of people with blindness continues to increase in the United States. Unfortunately, scant data exist for national estimates and trends, and current estimates are based on data that are 25 years old and not nationally representative.

Glaucoma is the leading cause of irreversible blindness and is a prevalent disease associated with aging. Although glaucoma can usually be controlled by early detection and treatment, half of the people with glaucoma are not diagnosed, and glaucoma is still the number one blinding disease among African Americans.

Diabetic retinopathy is the leading cause of new cases of blindness among adults aged 20-74 years. It can affect almost anyone with diabetes and contributes to both individual and societal burden. With the growing epidemic of diabetes and demographic changes in the American society, vision loss and eye diseases due to diabetes will be a growing major public health problem. Efficacious and cost-effective strategies to detect and timely treat diabetic retinopathy are available, but among people with diabetes ocular eye examination is received by only about two-thirds of the persons for whom the exam is recommended and varies significantly across health care settings.

Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness in the U.S. among people aged 65 years or older. The frequency of AMD is expected to increase as the population lives longer. Population-based estimates of the prevalence and severity of AMD will help in allocating resources as treatment modalities become available.

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