LASIK, PRK PHAKIC IOLs and Intacs™
Outcomes Analysis Software
Manual version 4.0

by
Perry S. Binder, MS MD
Outcomes
Analysis Software, Inc.
San Diego
Customer
Support:
www.refractiveoutcomes.com
Copyright
Notice
Copyright
©1996 Outcomes Analysis Software, Inc.
All
rights reserved. No part of this manual may be reproduced without
permission from Outcomes Analysis Software, Inc.
Trademarks
Outcomes Analysis Software, Inc. and
LASIK and

FileMaker®
Pro is a registered trademark of
Claris Corporation.
Software License and Warranty Statement
IMPORTANT
Please read the following terms and
conditions carefully to determine if you agree to be bound by them.
This software program (LASIK/
This license agreement is a legal contract between the
user of this software and OAS.
Installing the software indicates that you agree to be bound by the
terms of this agreement.
If you do not agree to be bound by the terms of this
license agreement, promptly return the software to OAS, or to the place where
you obtained it, for a refund.
1. Grant of
License. OAS grants you a
non-exclusive license for the use of the software as follows. You may either:
(a) install the software on multiple computers, provided that
those computers are used solely by you at all times; or
(b)
install
the software on a single computer, which may be used by different users from
time to time.
(c)
If the software is to be used by more than three
users under option (a) above or on more than one computer under option (b)
above, you must purchase a number of copies (or a multi-user package
representing multiple copies) of the software equal to the multiple of three
users under option (a) or computers under option (b) as well as a version of
FileMakerPro™ for each additional computer.
2. Copy Restrictions. Ownership
of the legal rights contained in the software and the associated documentation
shall remain solely with OAS and its suppliers.
These may include trade secret, trademark, copyright, patent,
international treaty and other rights as applicable. You may not sublicense, rent, lease,
decompile, disassemble, create derivative works or otherwise distribute the software. You may not copy the written materials
accompanying the software. You may make
an archival copy of the software. You
may permanently transfer the complete software and accompanying materials by
delivering the original software media and materials to a third party who
accepts the terms and conditions of this agreement and by simultaneously
destroying all copies of the software and accompanying materials in your
possession. Such a transfer terminates
your license to use the software.
3. Export Control. The software may be subject to
4.
5. Limited Warranty. OAS warrants that the media on which the
software is recorded will be free of defects in materials and workmanship under
normal use for 90 days after the date of original purchase. If a defect occurs during the 90-day period,
you may return the disk(s) to OAS for free replacement. OAS will replace the disk(s) provided that
you have previously returned the product registration card accompanying the
software to OAS. OAS does not warranty
that the software will meet your requirements or that the operation of the
software will be uninterrupted or error-free.
6. Disclaimer of
Warranties. There are no other
warranties with respect to the software or accompanying materials. OAS disclaims all other warranties, express
or implied, including but not limited to the implied warranties of
merchantability and fitness for a particular purpose or those arising from
trade usage or course of dealing. No
oral or written information or advice given by OAS, its employees,
distributors, dealers or agents shall increase the scope of the above warranties
or create any new warranties.
7. Some states/jurisdictions do not allow the exclusion of
implied warranties, so the above exclusion may not apply in certain
states/jurisdictions. In that event, any
implied warranties are limited to the maximum extent permitted by applicable
law or ninety (90) days from the date of delivery. This warranty gives you specific legal
rights. You may have other rights, which
vary by state/jurisdiction.
8. In no event will OAS be liable to you for damages,
whether based on contract, tort, warranty or other legal or equitable grounds,
including any lost profits, lost savings, or other incidental or consequential
damages arising out of your use or inability to use the software, even if OAS,
or an authorized representative of OAS, has been informed of the possibility of
such damage. OAS’s entire liability and
your exclusive remedy shall be at OAS’s option to either return the price paid
for the software or to repair or replace the software that does not meet OAS’s
Limited Warranty and which is returned to OAS, provided that you have
previously returned the product registration card or provide a copy of your
purchase receipt. This Limited Warranty
does not apply if the failure of the software has resulted from accident, abuse
or misapplication. In no event shall OAS’s
liability exceed the purchase price of the software. Some states/jurisdictions do not allow the
exclusion or limitation of liability for consequential or incidental damages;
therefore, the above limitations may not apply to you.
9. This agreement is governed by the laws of the State of
User’s Manual v. 4.0
Page
CHAPTER 1
GETTING STARTED 9
ADVANTAGES
AND FEATURES 9
WHAT
IS NEW IN VERSION 4.0 ? 10
GETTING
HELP 11
CHAPTER 2
LEARNING TO USE YOUR COMPUTER
INSTALLING
THE PROGRAM 12
HOW
TO OPEN PROGRAM 14
HARDWARE
REQUIREMENTS 17
USING
THE MOUSE 17 USING
ENTERING
STARTING
THE PROGRAM 21
ENTERING
DATA 22
SCREENS:
LIST VIEW OF PATIENTS 23
QUICK
ENTRY LAYOUT 24
NAVIGATION
MENU 24 PATIENT BACKGROUND 25-27
REFERRAL
INFORMATION 28
OCULAR
HISTORY 30
CONTRAST
SENSITIVITY 31
WAVEFRONT
DATA ENTRY PREOP 32
PREOPERATIVE
EXAMINATION 33-36
SURGICAL
PROCEDURE 36-45
PRIMARY
SURGERY: FIRST POSTOPERATIVE
LISTING
OF POSTOP VISITS 48
QUICK
ENTRY FOR POSTOP VISITS 49
POSTOPERATIVE
VISITS 50-54
ENHANCEMENT
DATE(S) SUMMARY 54
FIRST
INCISIONAL ENHANCEMENT 55
LASIK/PRK/IOL
ENHANCEMENTS 56-59
PATIENT
SATISFACTION 60-62
SAVING
YOUR CHANGES 62
MAKING
EMPTY PROGRAM COPIES (CLONES; NO RECORDS) 63
MAKING
BACK UP COPIES) 64
USER
PRIVILEGES, PROGRAM SECURITY, REGISTRATION 64
CHAPTER 3
ADDING
CORRECTING (EDITING) MISTAKES 72
CALCULATION FIELDS 72
COMMENT FIELDS 72
USING TAB BUTTONS 72
ADDING A NEW EYE (RECORD) 72
CHAPTER
4
UPDATING PREVIOUSLY ENTERED PATIENTS 73
FINDING PREVIOUSLY ENTERED PATIENTS 73
ELIMINATING UNWANTED RECORDS 74
DUPLICATING RECORDS FOR ENTERING
MATE EYES 74
CHAPTER
5
SEARCHING
FOR SURGICAL OR PATIENT PARAMETERS 75
WHAT IS A SEARCH? 76
WHY DO I NEED TO PERFORM A SEARCH? 76
PERFORMING A SIMPLR FIND 77
PERFORMING A CUSTOM FIND 78
PERFORMING A COMPLEX FIND 79
PERFORMING A MICROKERATOME FIND 79
PERFORMING A FLAP THICKNESS FIND 81
PERFORMING A LASER FIND 82
PERFORMING AN ENHANCEMENT FIND 83
PERFORMING A SURGEON COMPARISON FIND 84
PERFORMING A SERIES (TIME PERIOD)
FIND 84
PERFORMING AN ABERROMETER FIND 85
PERFORMING A NOMOGRAM FIND 85
PERFORMING A CUSTOM FIND 86-89
SETTING UP SEARCH CRITERIA 89
MULTIPLE SEARCH CRITERIA 89
DUPLICATING REQUESTS 90
OMIT REQUESTS 90
OR REQUESTS 90
SAVING A FOUND SET 92
RESTORING A FOUND SET 93
HOW TO CORRECT ANALYSIS FINDS (DATA) 94
CHAPTER
6
THE
REPORTS MENU 94
DATA REPORTING – STUDYING THE RESULTS OF A
FIND 94
THE REPORTS MENU 94
PREOPERATIVE FOUND DATA SET FINDINGS 95
PRINTING REPORTS 95-97
OUTCOMES ANALYSIS: POSTOP REFRACTIVE
DATA SUMMARY 97
OUTCOMES ANALYSIS: POSTOP
RERFRACTIVE DATA 2 98
OUTCOMES ANALYSIS: LASER RESECTION 98
OUTCOMES ANALYSIS: KERATOMETRY &
ASTIGMATISM 99
OUTCOMES ANALYSIS: VISUAL ACUITY
SUMMARY 100
OUTCOMES ANALYSIS: VISUAL ACUITY
PREDICTABILITY 100
OUTCOMES ANALYSIS: PATIENT
SATISFACTION SUMMARY 101
OUTCOMES ANALYSIS: CONTACT LENS
HISTORY
OUTCOMES ANALYSIS: CONTRAST
SENSITIVITY SUMMARY
OUTCOMES ANALYSIS: ENHANCEMENT
RESULTS
OUTCOMES ANALYSIS: FLAP DATA SUMMARY 102
OUTCOMES ANALYSIS: WAVEFRONT SUMMARY 102
SURGERY PLANNING
NOMOGRAM SUMMARY 105
INDUCED ASTIGMATISM SUMMARY 106
INDIVIDUAL EYE ANALYSIS
VISUAL ACUITY 107
UCVA VS TIME 108
PREOPERATIVE OCULAR PARAMETERS 109
FLAP CREATION PARAMETERS 110
COMPLICATIONS SUMMARY 111
ENHANCEMENT COMPLICATIONS 113
CHART OPTIONS 116
SURGICAL PROCEDURE SUMMARY 116
REFERRAL SOURCE SUMMARY 116
ENHANCEMENT COMPLICATIONS SUMMARY 117
NEW PATIENT PROJECTION LETTER 118
CHAPTER
7
THE
OPTIONS MENU 122
HOW TO PRINT REPORTS - THE PRINT
COMMAND 122
MODIFYING PRINTING OPTIONS 122
CREATING A REFERRAL LETTER 123
PRINTING AN ABSTRACT FOR PUBLICATION 125
PRINTING AN OPERATIVE NOTE 126
CHAPTER
8
PRINTING
REPORTS, REFERRAL LETTERS, OP NOTES,
HOW TO PRINT REPORTS - THE PRINT
COMMAND 127
MODIFYING PRINTING OPTIONS 132
CREATING A REFERRAL LETTER 138
PRINTING AN ABSTRACT FOR PUBLICATION 140
PRINTING AN OPERATIVE NOTE 145
CHAPTER
9
ADDING
PHOTOGRAPHS OR TOPOGRAPHY 147
HOW TO IMPORT CLINICAL PHOTOGRAPHS 147
HOW TO IMPORT TOPOGRAPHY 148
HOW TO IMPORT
HOW TO IMPORT PREVIOUS
CHAPTER
10
EXPORTING
FOUND
SOFTWARE REQUIREMENTS 154 HOW TO EXPORT
HOW TO EXPORT
HOW TO PRINT THE EXPORTED
CHAPTER
11
THE PROGRAM WILL NOT LOAD OR
THE PROGRAM WILL NOT SAVE 158
ELIMINATING 0’S
THE PROGRAM CRASHED - ERROR MESSAGES 160
HOW TO RECOVER DAMAGED FILES 161
CHAPTER
12
FREQUENTLY ASKED QUESTIONS 166
CHAPTER
1
Getting Started 1-1
We are pleased you have purchased this new
software program and we hope it will meet your needs. It is written using
FileMaker® Pro, version 7.0
(Apple Computer).
•
Up to 38 surgeons can be analyzed at any time.
•
User-friendly
interface; pop-up lists; keyboard, mouse navigation from field to field and layout to layout. One page Preoperative and Postoperative Data entry.
•
Automatically
develops Surgical Nomogram and
performs Regression Analysis
•
On-screen
customizing of Op Note, Referral letters.
•
Built-in Graphic Analyses for predictability, Attempted vs. Achieved
correction, Lines Gained & lost, Cumulative UCVA, Distribution of
Preop Sphere and/or Cylinder.
•
Predicts New Patient Outcomes ; performs lead tracking.
•
Extensive Preprogrammed Data Analyses.
•
User may
add more than 250,000 cases.
•
Table
analysis of Achieved Flap Thickness.
•
The program
will run on Windows95-2000, XP™ and Macintosh OS.
•
Wavefront analysis Preop,
Intraop, and Postop analysis and charting
•
Back-up
copy is
easily made with a click of a button.
•
Tests
surgeon data input against Laser-specific Regression
Analyses
•
Performs Safety Check of Surgical Plan for postoperative corneal
thickness and power.
•
Prints a
one page surgery form or patient satisfaction questionnaire.
•
Auto
Import-from Excel, Access, or
other spreadsheet formats.
•
Records are
automatically imported from previous versions.
•
Analyzes
two LASIK and/or two incisional enhancements.
•
LogMAR visual
acuity and vector-induced astigmatism.
•
Performs
analysis of Phakic IOL
or cataract surgery
•
Import
topography, wavefront printouts, or digital photographs
automatically.
•
Custom Find allows
one to search simultaneously on 80 different fields.
•
Can be run
on multiple computers with or without a network.
•
Data can be
transferred over modem.
COMPARISON with PREVIOUS VERSIONS
What is New In Version 4.0?
Features
|
3.06
& 3.1 |
3.5 |
3.9 |
4.0 |
|
Automated
Searches |
5 |
7 |
8 |
12 |
|
Regressions |
Visx |
Visx/Summit/
Autonomous
|
Visx/Summit / Autonomous
|
Regression Analysis + Visx/Summit/ Autonomous/ Wavelight |
|
Referral
Summary Letter |
Yes
(1) |
Yes
(2) |
Yes
(2) |
Yes
(2) |
|
Custom
Help |
No |
No |
No |
Yes |
|
Safety
Test of Surgical Plan |
Keratometry |
Keratometry
and Pachymetry |
Keratometry
Pachymetry FlapThickness |
Keratometry
Pachymetry Flap
Thickness |
|
Vector
Induced Astigmatism |
No |
Yes
|
Yes
|
Yes
|
|
Custom
Data Entry |
No |
Yes
|
5 Pages
|
6 pages |
|
Active
Help Menu |
No |
No |
No |
Yes |
|
Potential
New Patient Outcome Projection |
No |
Yes
|
Yes
|
Yes |
|
Custom
find |
40
fields |
70
fields |
80
Fields |
120 Fields |
|
Help
Movies |
10 |
25 |
30 |
35 |
|
Excel Import |
37
fields |
39
fields |
54
Fields |
60
Fields |
|
Excel
Export |
37
fields |
50
fields |
60
Fields |
147
Fields |
|
Charts |
2 |
3 |
5 |
22 |
|
Interface |
Original |
Original |
Original |
New |
|
Import
Topography |
No |
No |
Yes |
Plus Wavefront |
A troubleshooting guide is in this manual. Many
problems are easily solved by reading the manual. The CD comes with a file: FREQUENTLY ASKED QUESTIONS (see
appendix) to help you find quick answers.
There are many other Help files to assist in specific problems; many of
these files are incorporated into this manual. There is a Help Icon on each layout in the form of a question mark.

Clicking this icon takes you to a Help listing
of topics related to that layout.

This is a listing of the subjects in the
particular help menu relating to the subject matter on the layout where the
help question mark was selected.. There is a scrolling function on the top,
right that lists the total number of help items on this Help layout.

Selecting one of the arrows scrolls down the
list of choices.
Selecting the Details button takes one to the
specific help instructions for tha particular subject.

When satistified, one clicks the back button on
the top, right to return to the layout from where the ehlp icon was selected.
Most questions can be answered using the Help. A
Help Menu
can be used from every screen to assist in any questions. In addition, there
are also many Help
movies that demonstrate the use of the program. You have them on the
installation CD and they may also be viewed on our website: www.refractiveoutcomes.com.
Sophisticated computer users will have little difficulty using this
program, but it is understandable that users new to computers may have problems
understanding terminology and the keyboard/mouse system.
To avoid major calamity, it is best to
make back-up copies of your work each time you use the program.
TIP! ALWAYS MAKE BACK-UP COPIES!!!
Most errors occur with incorrect data input.
This program allows you to make changes and to add items to the pop-up lists.
Rarely, the main program will become corrupted if the computer is shut down
before closing the program, or if the user forces a shutdown before closing the
program. You can use your back-up copy to restore the program (see instructions in
Frequently asked Questions or in the Help Menu, or you can simply reload the
original program.
ALWAYS KEEP
ORIGINAL CD
IT IS ALSO ADVISED TO MAKE
PERIODIC “CLONES” (PROGRAM WITHOUT RECORDS) IN THE EVENT THE RECOVER PROGRAM
DOES NOT
BE SURE TO REGISTER YOUR PROGRAM WITHIN THIRTY
DAYS (30) SO THAT YOU WILL RECEIVE
CHAPTER 2
Make a back up copy of your Outcomes Analysis
Software on Zip™ disks or “burn” backup copies on a CD and always
make back-up copies of your program as you add data (see Sections
2-8, 2-9, and 2-10). Once a day is
recommended. If you have problems installing the program, re-read the installation
instructions that came with the software package.
Windows™ CD-ROM Installation
To install the program, place the CD in your CD tray and allow it to boot up. Open the CD icon which is labeled LASIKDBv4.0 . If the CD icon does not appear on your desktop,
open the icon for My Computer and
then open the CD icon LASIKDBv4.0. Open the file labeled SetupLASIK to start the installation of the Outcomes Analysis
Software program. In the default mode,
the program will be installed onto your C drive, in the Program Files folder,
in a new folder LASIKDBv4.0.
NOTE
If, during the installation
process, you may see error messages that a file cannot be found, click the OK button and wait for the installation
to continue and complete. The program
will place all files into your program folder in spite of the error messages.
After the installation is complete, close the CD icon window LASIKDBv4.x that contains the file SetupLASIK.
To start the LASIK,
Figure 1. Registration data entry in Preferences Menu

IMPORTANT: If you do not register as described
above, you will only be allowed to enter 49 records, after which you will be
told your demo version has expired. The next time you open the program, you
will be asked if you wish to Evaluate or Register. Click Register and enter
your registration data. Whenever you open the program, you will be taken
automatically to the HOME page.
Figure 2. Home Page

Click the Preferences button to
specify surgeon(s),
Figure 3. Preferences Menu –
Specify Surgeon(s)

Figure 4. Preferences - Start Up and Screen Size
On this layout, one may change the screen size
of the program, determine which page of the layout the program will open to, or
one install the default fields that will appear in every new record. In the
startup layout, one decides where the program will open every time you open the
program. Most users choose the home
page. The size of the sceeen is also selected; 100% is the best for viewing.
Figure 5. Preferences Menu – Auto
Enter Fields

In this
layout, one selects the MOST COMMON parameters that would normally be used for
a given case. When a new record is selected, the program will automatically
enter these defaults into the proper fields saving data entry time. Each field
can be edited by the user; as one clicks into a field, as in the side cut angle
field above, the popup menu appears. One selects the item, in this case, 65
degrees as the default.
When you have finished, click HOME – the solid black
icon on the upper right of every screen that looks like a little house
(home). Then press the View Patients button to view this
exciting program.
Before you begin, READ THE HELP
1. View the Help Movies that are
in the Help Movies Folder:
How to register to learn how to enter registration data
Opening Database to learn how to enter surgeon name in Preferences
2.
Read the
Frequently Asked Questions file that is in the Help Files folder.
3.
When you
first open the program, you will be asked to enter a surgeon name in the
Preferences menu.
a.
Enter
surgeon name in the first blank field.
Next, click on the blank field in the upper, right of the layout next to
the button labeled HOME until the same surgeon name appears in the field. Then click the Home button.
Figure 3. Preferences Menu –
Specify Surgeon(s)

On this layout, one may enter up to 38 surgeons.
Starting in the left most side of the field, enter the surgeon name, First,
middle initial, and Last name. In order to have that surgeon name appear in a
new record, one next clicks into the field on the upper right until the name of
the surgeon appears in that field.
Figure 6. Preferences Menu – Logo

One can import their company logo into the
container field. The logo can be imported as a tif, jpg, gif, or as a pict file.
Click the import logo button to locate and then to bring in the logo. One also
fills in the company information in the fields below the logo. The logo and
company information will appear on most of the printed letters. If you have
properly registered, a red YES appears next to the word Registered: on the
bottom, left of the screen.
When you have entered the data on the
preferences menu, click the home button to begin using the program.
Figure 7. Preferences Menu – Menus

The final screen in the Preferences list is the
Menus. We will show you how to automatically update the many pop up menus in
this manual.
The PC version requires Windows98™ through
Windows XP™ and NT. A hard disk with a minimum of 156 MB of
memory will be necessary to load the Outcomes Analysis software. Twenty MB of
Using the Keyboard.
If you are familiar with the operation of a
computer, you may skip Sections 2-3 to 2-6.
The keyboard is like a typewriter with many additional
keys.
Pressing the unique Ctrl or Alt keys will
display additional characters. Press one
of these keys with or without pressing the Shift key as you press one of the
keyboard’s typewriter keys to show what special characters can be created. To
advance forward one screen, press ctrl and 1 key. To move back one screen, press ctrl and 2
keys. To advance forward one layout, press ctrl and 3 key. To move back one layout, press ctrl and the 4
key . More information is available
in your computer instruction manual
The mouse is an input device. It permits the computer operator to place a
cursor anywhere on the screen. Clicking the button on the mouse places the
cursor at the point of activity. Your
mouse may be a moveable device, requiring you to move it about on a desk
surface. A second type of mouse may be a
moving ball held stationary in a holder; you simply move the ball in the
direction desired to move the cursor. A third type of mouse is a flat surface
over which your finger may move; moving your finger moves the cursor. See your
computer instruction manual for further instructions on usage of the mouse.
FileMaker® Pro uses a standard screen
format common to all PC and Macintosh software (see Figure 1). A vertical bar on the right side contains a
square. Clicking the mouse with the cursor inside of the Scroll Bar will advance the pages of
the program. Clicking the arrows advances the screen forward or back.
Figure
2. Home Page

Placing the cursor directly on the square in the
Scroll Bar (far right side of the page)and holding down the mouse button allows
you to “drag” the square anywhere along the Scroll Bar, thereby rapidly
advancing across the pages. Your
Outcomes Analysis Software has installed keys (buttons) that you can click with
the mouse to advance from one part of the program to another to simplify the
process, but you can always use the Scroll Bar to advance more rapidly. If you wish to advance one line at a time,
click the arrow of the Scroll Bar; click the right-pointing arrow to go to the
right one line at a time. Read the
instructions in your computer manual for further explanation of how to move
through a program using key and mouse movements. It will save you a great deal of time if you
learn these simple keystrokes.
Your Outcomes Analysis Software is streamlined
to allow you to enter data rapidly without error. This is accomplished by using
pop-up menus. One enters a pop-up menu
by tabbing (using the tab key) into it or by clicking on it. As you enter data
in a given field (line) in a pop-up menu, the program will offer you choices.
Some menus will be entered by typing the first letter(s) of the item you wish
to select; simply hit the return (enter) key to select the item and the program
will automatically move to the next field.
Clicking on a choice or pressing the return key automatically places
that information into that field. You can also modify most fields in the
PREFERENCES MENU by clicking on the line labeled Edit in the
pop-up menu.
Figure
7. Editing Menu Layout

Alternatively, in some popup menus there is an
Edit field; you can type the desired addition to the list; clicking the OK button inserts the new data.
Clicking the line labeled Edit in the pop-up menu will permit you to type anything you want, to
correct or delete anything in the list, OR TO CLEAR THE FIELD ENTIRELY. After
typing in the designated information box, click the OK button to return to the main program. One can also modify the
pop-up menus through the PREFERENCES layout reached from the HOME
Tip: If you want to clear the contents of a
field that uses a pop-up menu, one way is to use the Edit line from the pop-up
menu and then use the Delete key to erase your entry. Then click OK. Or, simply highlight the entry and
press the delete key
NOTE
If you use the Edit line in a field’s pop-up
menu to enter new data, after you click the OK button and move to the next field,
the computer will beep to ask permission to add the new item to the list of
choices. If you decide yes, click on the OK
button and move on.
You may enter numeric data wherever there is a field that does not have a
pop-up menu. Be sure to enter negative (-) values for myopia. But…
THE PROGRAM WILL NOT ALLOW YOU TO ENTER
A “+” FOR POSITIVE OR HYPEROPIC ERRORS,
If you
enter the plus sign, an error message will appear.
You may enter decimal values as well; e.g.,
43.50 for corneal curvature. The program adds the second decimal digit if you
don’t; e.g. 45.5 entered will appear as 45.50 on the field line. Visual acuity data are entered as the
Snellen acuity; you are asked to insert the denominator of the Snellen acuity in this
assisting field and the field returns the decimal fraction to an adjacent
column. The program will then enter the
logMar equivalent into the appropriate visual acuity
field for you.
Figure
8. Preop Examination - Entering Visual Acuity Data

Very Important Tip: If you
want to analyze visual acuity data, be sure to enter some data for the field
you want to analyze. If you have no
data, in the Custom Find Layout enter: >0 in the acuity field from the menu on the Postop LAYOUT. The program will accurately calculate the
acuity results only for records that have some visual acuity
information.



You can
change any entry that has been entered to a non-pop up field by dragging the
mouse over the items you wish to change so that they
are highlighted. Once this happens, type in the correction and it will be
listed in the place of the previous typing. Use this approach to add any new
items to your pop-up lists.
A spelling dictionary has been installed in your
FileMaker® Pro program, which is called USR.upr so that any
misspelled words will cause the program to beep. Refer to your personal computer manual for
further information about entering and modifying previously typed data and
information. One selects the dictionary through the Preferences/Spelling menu
found under the Edit menu.
This program is organized to tell you what data
to enter and what data format to use. When you press certain fields, a beep
will sound and a message will appear on your screen directing you to the type
of data and/or format to enter on a given field. Clear the message by pressing
the Enter (return) key or clicking
on the OK button. You will then be
taken to the proper field to allow entry of the requested data.
VERY Important: There are certain fields highlighted in
PINK that must be filled in for the program to work properly. The program will
NOT let you advance off a layout until this minimal data is entered. The program
will also not let the user enter data in a field that is a calculation; these
fields are “grayed out” and the tab order skips over them.
If these fields are NOT filled in, when you perform a search (find),
the program will return an error message: NO RECORDS HAVE BEEN FOUND!
To start your program, double-click on the
desktop shortcut icon or the icon labeled LASIKDBv4.0 (PC version) or LASIK DB
(Mac version) in the file on your hard disk where you directed the program to
be copied. For the PC this will be in the PROGRAMS
This
back-up support is in addition to your always making back-up copies of
your program.
Every time you start the program, you will be
taken to the Home page that carries the title of the program (Figure 6)The
program will beep and the screen in Figure 6 will appear.
To adjust the screen size to fit your screen,
click the appropriate buttons found in the PREFERENCES MENU under the startup tab.
NOTE
Throughout this manual when a button is referred
to, it will be highlighted in bold, capital letters; for example, BUTTON
Figure
9. ABOUT OUTCOMES ANALYSIS SOFTWARE

This is the introduction (Splash screen) page, About
Outcomes Analysis Software.
Click the HOME button on the
top, right of the layout, or wait for the program to take you there
automatically to begin the program.
You will now find yourself at the beginning of
the first page of the program, the Program Home Page (Figure 2). The home page is the place the program will take you
whenever you click the HOME icon
that looks like a house (home). At the bottom left of the page are radio
buttons that have specific actions. The function of each button is explained
below.
Click the VIEW
PATIENTS button on the HOME
Figure
10. PATIENT LIST VIEW

The List View screen shows every record that has
been entered into the database. Clicking the down arrow on the left of each
record line will take you to that specific record. One may scroll down the
right scroll list or drag the record locator box rapidly down the scroll bar to
advance through records. The patients are listed by last name, first name, date
of surgery, the surgical procedure, eye operated, and the date of the LATEST
visit. If you wish to delete a record, simply click on the trash can icon seen
on the right of each record line. REMEMBER: ONCE YOU DELETE A RECORD, IT CANNOT
BE RECOVERED. If you wish a printout of
Tip:
The list view screen allows
one to
If you are adding a new record, click the ADD RECORD button on
the top of the Home page list of options (Figure 2 – Home Page). YOU will be
given a choice of entering the
Figure
11. New Record - Quick Entry Layout

This layout has
the minimal fields that the program requires in order to perform minimal analyses. If the user wishes only to have minimal
data analysis with the advantage of minimal data (and time) entry, use this
layout. The user is required to fill out
Pull down the white field to select the layout you desire, then click the button to the right of that popup menu to go where desired.
Figure
12. Navigation Menu (Present
on all layouts)

To navigate the program, the easiest and fastest
way is to use the Navigation menu. In the left column, select the layout you
seek. Once that layout appears in the RIGHT column, simply click it and you
will be taken immediately to that layout.
The Patient Contact screen will appear when
the user clicks Add a Normal Record (Figure 13).
Figure
13. Patient Contact Layout


Tip: If you want to have a copy of ANY
page in this program, click the PRINT icon
(anywhere you see the print icon which is usually in the top, right of each
screen) , and you may print that report.
The patient’s name is entered in two fields, First Name and Last Name
(the middle initial is added to the first name). Once you have typed in the name, and pressed
the Tab key, the program will take you to the next field (line) where the
program is ready to accept new data. You will know where the program’s cursor is located by the blinking, black, vertical
cursor. The next series of field entries
are for the patient’s Race, Profession, Address, City,
State, Zip Code, and Phone No. The
next fields are pop-up menus. In order to select Race, click the cursor by pressing on the mouse key and dragging
the mouse key to select the proper item. Release the mouse key and the selected
item will be entered in the field. The next field is patient Profession; select the proper item on
the pop-up menu.
Figure 14. Contact Patient Layout -Profession Popup Menu

All popup menus in this program work the same
way. One clicks into the field and a list appears. One types the first letters
of the topic for that field and the program automatically selects the proper
subject. Clicking the return or tab key selects the subject. If one wishes to
modify the specific list, one clicks on the small icon next to that field. The
program takes the user to the Menu layout (Figure 7) and from there the user
makes the changes and will be brought back to that same field on the original
layout.
If you add a new patient with the same first,
last name, and date of birth, the program will so notify you and ask for your
permission to add a new patient, which could represent a duplicate entry.
Figure
15. Duplicate Record Warning

The program moves to the right column. Enter the
Date [of] Birth and the Date of the Examination.
Tip: If you fail to enter a required field, the program will not allow you to move to another layout.
Tip: Always enter your dates in
this full format mo/dd/yyyy format(
Note some
fields are in pink. They
must be filled in. if you make an entry error, highlight the
entry and press the delete key. The program will not allow you to go to the
next screen until this important data is filled in. (Required fields)
Note: For European Users, the program automatically looks at the way
Windows formats the date entry. If the European style is in Windows, then it is
OK to enter the same format in this program: Date Day/Month Month/Year Year
Year Year e.g.
The program automatically calculates the patient’s age. Enter the gender from the pop-up menu. At Office/Chart #, enter a number or letters or a combination of
the two. Next go to SS#, the social security number field. Enter the number; the hyphens (-) are entered
automatically, so that you will be able to search by social security number if you so desire. Record No.is a field automatically inserted by the
program. It increases by one (1) for each record that is entered. You will not
be able to alter the record number because it will be unique for this patient’s
eye records (one eye per record).
At the bottom of the screen you will see a
created date reflecting the date that record was made for the first time. Under
that you will see a Modification date which is the date the record was last
opened. This allows a user to confirm any changes made on a record to avoid
duplication of data.
Note: FOR
You will see a print icon on
the top right of this layout and all subsequent layouts. Clicking on it will print the related layouts
in addition to the data on the current layout.
At the bottom left of each screen you will see the eye operated. On the
bottom right, you will see patient Last, First name so one can confirm which
record they are working on. The numbers below show which record number of the
total number of records in the particular search is active. The arrow keys on the bottom right will take
the user one record forward or backward, or clicking the outside arrow will
take the user to the first or last record in that particular search.
Figure
16. Referral Source

Clicking into the field “Referred by” brings up a popup menu allowing the user to select a referral source. If one plans on analyzing referral sources and/or writing referral source(s) later, it is important that these fields be filled in.
Figure
17. Referral Name(s)

This screen is to record data from the referring
optometrist or physician. If you plan to send a referral letter, you
must fill out this portion of the screen so that when you later click the REFERRAL
LETTER radio button, the program will know to whom to address the letter.
The left column is for office data of the referring practitioner. If a previous patient or other referral
source was determined, be sure to list it as well so
that when you perform a report on REFERRAL
SOURCE, you will be able to see the distribution of
the referral sources and/or send a referral summary letter to an individual
doctor to show
When you have completed entering data in the last
field, you will have completed the first data-entry screen. You may now click the right going arrow on
the right of the screen right to go to the next layout, or you can click the
left going arrow to go to the previous layout. Alternatively, one can simply
click the tab buttons to navigate to a layout.
Tip: At the top of this layout and all subsequent
layouts, you will find what are termed “tab buttons.“ Clicking the cursor on a blue tab button
causes a specific action to occur. What
each button is programmed to do is written on each button. For example, on the PATIENT CONTACT REFERRAL
layout, clicking the REFERRAL blue Tab takes one to the Referral layout. The arrow that is inside a circle found on
the upper fourth of each layout takes one to the next series of layouts. In the
Patient contact layout, clicking the right facing arrow takes one to the
History series of layouts. Similarly,
the top, left going arrow takes the user to the previous layout series.
Tip: You may use keyboard
commands to advance as well as the mouse. Click ctrl 1 to advance one tab and
ctrl 2 to return one tab; click ctrl 3 to advance one LAYOUT and crtl 4 to
return back one layout.
If at any time you want to go to a different
record, look at the two fields on
the top right of any screen. (Figure 12 – Navigation Buttons). Click on the
left most field and a pop-up menu of possible locations shows up. Select the location you desire.
Tip: If you want to move
rapidly to the layouts most often visited (Surgery, Postop visits) simply click
those buttons found on the upper, right of every layout.
If you want to add or delete a record, click on
the add or delete blue tabs found on each layout.
VERY IMPORTANT:
If you want to
add a new second eye for the SAME patient, click the DUPLICATE RECORD button which will go to the first page of the
program; the total number of records will be increased by one. Then change the eye from a right eye to a
left eye. If you fail to add the second eye at this point, attempting to do so
at a later date will make the program think you are trying to enter a duplicate
record; it will not allow this to happen.
In this circumstance, remove one (1) letter from the end of first name
and enter the record. . It is best to enter as much data for the first eye including
the surgery date
Anytime you want to quit the program, click the QUIT PROGRAM button
found on the home page (Figure 2).
Closing your computer without closing this program will
corrupt the program and make it inoperable.
A back-up copy of the program can be automatically made from
the OPTIONS Menu. If you made an error and entered the incorrect record, click
the DELETE RECORD tab. If
you want to enter a blank record, click the ADD RECORD tab.
Figure 18 – Eye Examination - The Ocular History

The second pop-up field on the Ocular
History screen is Dominant Eye. You will not see a cursor mark for fields
where there is a pop-up menu. When duplicating records to enter the mate
eye, be sure to enter the OPPOSITE eye in the Eye Operated field, otherwise the
program will not allow you to exit this layout because it thinks there is a
duplication of records.
Tip: You can tell where you
are by striking the Tab key, which will take you to the next field. You may
move one line up by pressing the Shift key and then the Tab key or simply by
moving the cursor with the mouse to the line you desire and then clicking the
mouse button. If you use the tab key to
enter a pop-up menu, you can type the first letter of the item you wish to
select and it will automatically be selected; press the return/entry key to
enter that item on that field.
The eye operated will be entered automatically
on all of the screens so the user will always know for which eye the data are
being entered. Previous Contact Lens
History allows
the user to analyze results based on what lens was previously worn, and is a
pop-up menu. The patient’s Reason for Surgery and a second Reason for Surgery are the
next pop-up menus to choose. There are extra fields for a user to customize:The
Insurance/Study Group and the Miscellaneous field. One may place ANY data in
these fields; the user can search on these fields when using the Custom Find
script.
Note: A user cannot add fields to the program
VERY IMPORTANT!! The Refractive Diagnosis is an important field. If the eye has no
astigmatism, you, the user, can define this level; less than 0.75 diopters of
refractive astigmatism is usually considered surgically insignificant. By
selecting the myopia surgery (Spheres only) category, the user can subsequently
select all such cases to assess induced astigmatism since only cases with
≤ 0.5 D of astigmatism will be entered in this category. The
myopia-plus-astigmatism (spherocylinders) category is for eyes with 0.75 or
more diopters of refractive astigmatism (or any degree of astigmatism you plan
to correct surgically) that will be expected to be corrected by some form of
astigmatism surgery. By selecting this diagnosis field, the user will be able
to assess how effective the astigmatism procedures have been as well as to
compare the results of spherical procedures with astigmatic procedures.
The Previous
[eye] Surgery field
permits retrospective analysis of the effects of previous radial keratotomy,
corneal transplantation, retinal surgery, cataract/IOL surgery, or strabismus
surgery. If an eye has amblyopia, one might not want to consider the visual and
refractive outcomes from such cases. By eliminating amblyopic eyes (or any
category) from a search in the Custom Find layouts, one improves the quality
and specificity of the analysis. The Both
[eyes] Operated? field permits a
retrospective analysis of the results in mate eyes when checked. If same-day
bilateral surgery is performed, there is a field to check on the Surgery page 1
screen. There are two more fields to
enter, the Study Group Field and the Miscellaneous Field. These are separate pop-up fields for the user
to fill in for specific studies or specific finds to be performed at a later
date. Any procedure or diagnosis or any
number or combination of letters and numbers can be placed here and searched
for in the Custom Find layouts.
Figure
19 – Eye Examination: Contrast Sensitivity

This screen is a similar to the standard
contrast sensitivity charts. One tests each eye individually. On the contrast
vision test, there are rows of circles. Each circle has a specific frequency/cycles
per degree of contrast acuity. The examiner asks the patient to identify the
circle on the top (t) or bottom (b) of the test that they can still see the
contrast lines. The examiner than clicks the appropriate button. For example,
in the test without glare (the right side of the figure 19 above), the patient
says they see number 5 on the bottom in the first row. The examiner then clicks
the 5b button. The program keeps track of these buttons and will report the
results of a series of eyes before and after surgery. The same screen will be
available for each postop visit.
OCULAR
HISTORY WAVEFRONT
Figure
20 – Eye Examination: Wavefront Data

This layout allows one to enter data from any
aberrometer. The aberrometer used is found
on the top, right of this layout. If one desires to analyze wavefront data,
these fields need to be filled in. The Zernicke number representing each field
is listed. The fields are formatted to screen for data within the proper ranges
for a given wavefront number. The second column allows one to study the effect
of flap creation on the wavefront error. One performs a flap and at a later
time (minutes to days) the wavefront data is repeated. One analyzes this
specific data by either using the export to Excel button, or through the
Reports Menu. If one wishes to import wavefront data, the import and paste
buttons on the right can be used.
Figure
21 –Preoperative Examination: Visual Acuity Layout

The Pre operative Examination screen
allows entry of the pre- operative visual and refractive data
for the eye to be operated. The first field is the Date of Examination (carried
forward from Figure 13. To enter the decimal visual acuity into the decimal
acuity column, or the denominator of Snellen visual acuity into the the Snellen
Acuity column, (these are your assistance fields) and then press the Tab key.
The appropriate acuity is automatically entered in the logMar fields above that are greyed out. This number
is then entered in the logMar Distance
uncorrected visual acuity (UCVA) and in the logMar Distance Best Corrected visual
acuity (BSCVA) fields.
Note
these acuity fields are in pink. They
must be filled in. if you make an entry error, highlight the
entry and press the delete key. The program will not allow you to go to the
next screen until this important data is filled in. (Required fields)
Figure
22. Preoperative Examination: Keratometry

In
Keratometry Method, the user is asked to enter what instrumentation was
used to obtain the keratometry data that was recorded. The user next enters
the flattest keratometry (K1)
reading and flat K1 axis, then the steepest
keratometry (K2) and steep
Tip: Remember that there is a
difference in the absolute values of corneal power calculated by topography
units when compared to keratometry data. To obtain accurate (and consistent)
results, use the same technique every time to obtain corneal powers.
The field on the right is where you may import
topography or digital photographs and/or drawings. Click the IMPORT button to
locate the file you wish to import and then press the PASTE button to
permanently place it in the record. To enlarge your view, simply click on the
imported figure. To return to the layout, click the Back button.
Figure
23. Preoperative Examination – Import Topography Menu

This is the insert screen to import topography,
or a digital photo. Locate the file and click open. Then click the PASTE
button. REMEMBER: Imported topography and photos take up memory which will
limit the number of records the program can have and slow down the analysis
processes.
Figure
24. Preoperative Examination: Refraction

The fields that follow are the Manifest Sphere, manifest cylinder Astigmatism, and cylinder Astigmatism axis. The Vertex
Distance can be recorded.
If you enter a number out of the expected range,
the computer will alert you with an error message. Be sure to enter a 0 (zero, not a letter O)
if there is no astigmatism or enter180 for the axis if the astigmatism
axis was recorded at 0 degrees. If you
forget these rules, the program will remind you if you enter the data
improperly. The program automatically records the Spherical Equivalent on this
screen and in appropriate fields on subsequent screens.
The Cycloplegic Sphere refractive data can be similarly entered. If you use the cycloplegic refractive data
for your surgery entry, place the data into the manifest fields so the program
will make the appropriate calculations; it
does NOT use the cycloplegic fields for calculations.
The column on the right is for
aberrometer-measured refractive data so the user can compare the manifest
refraction with the aberrometer refraction. The middle column corrects the
manifest refraction to the corneal plane. The spherical equivalent for all
three measurements is listed.
Figure 25: Preoperative Examination: Other Layout
(Pupils, Eyelids, Retina)

The Pupil data, which includes mesopic and
scotopic diameters and color are next entered in case
the user wishes to compare refractive outcome with pupil size, followed by the
eyelid exam. The Retina Status and the Lens Status are entered next. There
is a field to enter comments such as expectations, reservations, special
considerations, etc.
Tip: The automatic finds and
analyses use the dark (mesopic) diameter for certain analyses. Be sure to enter
data here if you wish to determine the impact of pupil diameter on your
outcomes.
Figure
26 – Surgical Information: Laser Data

The Surgical Procedure screen is a ten-page
screen. In the Surgical Procedure, the Surgery Date will be
used to calculate the follow-up period for the Follow-up Month field of
subsequent screens.
Note
some fields are in pinkThey must be filled in. if you make an entry error, highlight the
entry and press the delete key. The program will not allow you to go to the
next screen until this important data is filled in. (Required fields
Tip: You must enter the date of surgery;
otherwise, you will not be able to assess follow-up timing.
This is the main screen for the program that
will permit you to analyze the results of your surgery. The next field is the Surgical Procedure field.
Surgical Procedure allows you to
list what operation you are performing. The major ones will be for LASIK SURGERY,
ASTIGMATIC LASIK, OR HYPEROPIC LASIK; PRKor any other refractive (including
cataract or clear lens surgery) surgical procedure, and any additional
procedures may be entered Remember, if
you operate to correct astigmatism of any degree, enter ASTIGMATIC LASIK.
Tip: You must fill in the
Surgical Procedure field to be able to analyze a given procedure.
Surgeon - whomever
performs the surgery should be listed here.
Up to three surgeons may be listed (with each program license; a maximum
of 38 surgeons may be ultimately listed). Type the name of the surgeon; if you
wish to permanently enter a surgeon to the list, click the Edit line in the
pop-up menu and add the name.
Additional surgeons may be entered in the Preferences menu
Note:
When the program is opened for the first time, you will be shown a
screen to enter up to three surgeon’s names (Figure 3). Anytime thereafter, you
may update the surgeon list by clicking the UPDATE SURGEON LIST button on the Preferences Button
reached from HOME
The Preoperative
Diagnosis entered automatically from
Figure 18. This allows the user to analyze the results of a given preoperative
diagnosis. Please refer to the instructions for Figure 18 to understand the
importance of the Diagnosis field.
Erodible
(
If this is a bilateral, same-day procedure, the
so-called bilateral, simultaneous
procedure, mark it here so one may compare the results of surgery
performed on separate days with same-day bilateral surgery. If Bilateral Simultaneous surgery was
performed, it is recorded so you will be able to compare unilateral with
bilateral results (simultaneous versus non-simultaneous).
You next enter the desired spherical correction
based on the spectacle plane refractive error. For astigmatic procedures, enter
the desired cylinder correction in minus cylinder format and then the cylinder
axis. The desired correction (the Attempted
Sphere (D) field)
is the diopters of refractive change entered into the laser computer. If one uses custom software and an abberometer
to acquire the laser data, one enters the aberrometer recommended refractive
information and not the refraction into the laser surgery fields.
Tip: You must enter what you enter into the laser computer here.
For custom procedures, enter the number entered by the custom software. This is
an important field so that later you may compare your desired or attempted
change with the preoperative
spherical equivalent and/or the achieved change.
Tip:
Placing the incorrect sign in the Attempted
Sphere (D) field
will confuse your analysis.
The Intended
Final Correction field is
for Intended Monovision cases. If you want to leave the eye with any
refractive error other than zero (0), place the desired postoperative
refraction here, e.g. –1.50 D. By doing
so, you will flag the program (on the postoperative visit screens in a field
labeled: Intended Monovision?) that this is a monovision case so you will be able to search for all
monovision cases or exclude all monovision cases. If you enter any number other
than leaving this field blank, the program will assume you are correcting for
monovision and will so notify you in the Last Visit screen.
Figure
27 – Surgical Informatiuon: Microkeratome Data

Microkeratome is a
pop-up menu to select the instrument you are using. The
next pop-up field in is the Microkeratome Headpiece. The Blades
Used follows.
The Fixation Ring that was
used, if applicable. This field allows you to select the fixation ring number
that was used; fixed-dimension rings are also available as choices. Translation
Speed and Blade Oscillation speed can be entered if these factors are important
for a future analysis to assess their impact on cap parameters and refractive
results. The translation speed and the Blade speed in
TIP: Note
the small icon next to the pop-up fields. Clicking here will take you to the
preferences menu (Editing
menus, Figure 6) where you may edit the menus and after clicking SAVE, you will be
returned to the same location you just left.
Figure
28 – Surgical Information: Intralase (Femtosecond laser) Data

All data entered into the Intralase laser are
entered here. Several of these fields may be auto entered (see Figure 5)
SURGICAL
PROCEDURE – SURGERY Plan
Figure
29 – Surgical Information: Surgery Plan

The layout is the surgical plan to be used for
the particular eye. It takes the information previously entered on previous
screens and places them here. If you are performing an astigmatic procedure,
the attempted spherical equivalent from Surgical Procedure will be entered
into the field Attempted SphEq. The
program then compares the attempted sphere to the preoperative spherical
equivalent as a percentage (% Attempted
Sphere vs. Preop Spheq) and
compares the attempted astigmatic spherical equivalent to the preoperative
spherical equivalent (% Attempted Spheq
Change vs. PreOp Spheq). These
numbers will be the same if you only perform a spherical procedure.
Tip: For this important
layout to work, the user needs to enter the preoperative corneal thickness as
0.XXX, the ablation diameter to be used, and the planned laser resection (data
obtained from the laser computer) from subsequent screens.
This layout allows the user to place the planned
surgical procedure data and to then test the results for the possibility of the
postoperative corneal power being less than 37 diopters by pressing the Corneal
Power button.
Figure
30 – Surgical Procedure: Surgical Test for Postop Corneal Power

The data may also be tested for the possibility
of the surgical plan leaving the cornea with LESS THAN 250 microns of stroma by
pressing the Corneal Thickness button.
If data is missing from any of the fields on this layout, the program
alerts the user to fill in the missing data IF THEY WISH TO TEST THEIR
Figure
31 – Surgical Procedure: Surgical Test for Residual Corneal Thickness

Note: If any fields are
empty that are needed for these calculations, the program will warn the user
and take them to the field that is required.
SURGICAL
PROCEDURE – Surgical Regression Test
Figure
32 – Surgical Procedure: Previously Calculated Specific Laser Regression Formulas

This screen consists of four regression analyses of cases previously that were performed on each of the lasers (The Wavelight Allegretto is the fourth laser regression included). The regression formulas are tested against your individual data for the surgical case you have just entered. The program will suggest the refractive outcome based on these regression analyses.
Remember: The regression
data have been generated from another surgeon’s data and does not come from
your data. The formulas only compare
your surgical plan to the set regression analyses It is here to provide you
with an idea of the outcome based on your planned entry data. If you wish to
generate your own nomogram (not a regression analysis) you may do so in this
Outcomes Analysis Software program on a different layout (see below).
TIP: One means of analyzing your results is to compare the predicted outcome, planned outcome (your surgical goal) and the actual outcome. The user can compare the predicted data from this layout, e.g. +0.5 diopters, with the intended (desired surgical outcome, e.g. 0 diopters) and the actual result, e.g. –0.75 diopters. An anlaysis of these data will assist the surgeon in his surgical planning.
Figure
33 – Surgical Procedure: Flap (Cap) Analysis

The Planned
[cap] Diameter field
requests a number for the planned diameter (in mm) using applanation disks, adjustable
suction rings, or the diameter with other microkeratome systems. For the
Different pachymeters have different degrees of
accuracy. The surgeon may wish at a later date to compare cap thickness
measured by one pachometer with another. Pachymeter used is entered here.
Planned Cap Thickness in
reality is the thickness plate, the micrometer setting, or the planned depth on
the keratome or Intralase FS laser. The PreOp[erative]