LASIK, PRK PHAKIC IOLs and Intacs™

Outcomes Analysis Software

Manual version 4.0

by

Perry S. Binder, MS MD

 

 

 


 

Outcomes Analysis Software, Inc.

2500 6th Avenue, Ste. 307

San Diego , California 92103 , USA

 

Customer Support:               (619) 702-7963 (Phone/Fax)

                                                lasiksupport@aol.com

                                                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 PRK Database are trademarks of Outcomes Analysis Software, Inc .

 

 

            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/PRK Outcomes Analysis) is a proprietary product of Outcomes Analysis Software, Inc. (OAS) and its suppliers.  It is protected by copyright laws, trade secret laws and international treaty.  Use of this software is governed by this license agreement and applicable law, including copyright law.

 

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 United States of America export control.  You agree to fully comply with all applicable United States of America export regulations.

 

4.             U.S. Government Restricted Rights.  If you are purchasing the software on behalf of the United States Government or any unit or agency thereof, you acknowledge that the software and accompanying materials were developed at private expense and that no part is in the public domain and that the software and documentation are provided with restricted rights.  Use, duplication, or disclosure by the government is subject to restrictions as set forth in Subparagraph (c)(1)(ii) of the Rights in Technical Data and Computer Software clause at DFARS 252.227-7013 or Subparagraphs (c)(1) and (2) of the Commercial Computer Software Restricted Rights at 48 CFR 52.227-19, as applicable.  Contractor/manufacturer is Outcomes Analysis Software, Inc., P. O. Box 1097, Rancho Santa Fe, California 92067, USA.

 

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 California.  Should you have any questions regarding this agreement, or wish to contact Outcomes Analysis Software, Inc. for any reason, please write: Outcomes Analysis Software, P. O. Box 1097, Rancho Santa Fe, California 92067, USA.

 


 

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 AND SOFTWARE                                

            INSTALLING THE PROGRAM                                                                             12

            HOW TO OPEN PROGRAM                                                                                 14

            HARDWARE REQUIREMENTS                                                                           17

            USING THE MOUSE                                                                                             17                        USING POP-UP MENUS                                                                                                                        19

            ENTERING AND CORRECTING ERRORS                                                         20

            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 DAY                           46-48

                  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 NEW PATIENTS                                                                                       70                        ENTERING DATA  71

            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,

            AND ABSTRACTS                                                                                             126

            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 AND RUN QUICKTIME MOVIES                                     149

            HOW TO IMPORT PREVIOUS FILE VERSIONS                                             152

CHAPTER 10                                                                                           

      EXPORTING FOUND DATA FOR GRAPHIC ANALYSIS                                 153

            SOFTWARE REQUIREMENTS                                                                          154                        HOW TO EXPORT DATA INTO A SPREADSHEET                                                                      155

            HOW TO EXPORT DATA INTO A GRAPHICS PROGRAM                            155

            HOW TO PRINT THE EXPORTED DATA                                                         155

CHAPTER 11                                                                                           

      TROUBLESHOOTING                                                                                            156

            THE PROGRAM WILL NOT LOAD OR RUN                                                   157

            THE PROGRAM WILL NOT SAVE                                                                    158

            ELIMINATING 0’S AND ODD DATA FROM REPORTS                                 159

            THE PROGRAM CRASHED - ERROR MESSAGES                                          160

            HOW TO RECOVER DAMAGED FILES                                                            161

CHAPTER 12

    CREATING DIFFERENT SEARCHES                                                       163

APPENDIX                                                                                           166

     FREQUENTLY ASKED QUESTIONS                                                                   166

ORDERING INFORMATION                                                            173

INDEX                                                                                                  174

 

   

 


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).

 

ADVANTAGES AND FEATURES                                               1-2

 

         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

Summit

 

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

 


GETTING HELP                                                                                                       1-3

 

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 AND REGISTRATION NUMBER IN A COOL AND CHILD-SAFE ENVIRONMENT. 

 

IT IS ALSO ADVISED TO MAKE PERIODIC “CLONES” (PROGRAM WITHOUT RECORDS) IN THE EVENT THE RECOVER PROGRAM DOES NOT WORK OR WHEN YOUR COMPUTER CRASHES. YOU WILL BE ABLE TO IMPORT YOUR SAVED RECORDS INTO THIS CLONE.

 

BE SURE TO REGISTER YOUR PROGRAM WITHIN THIRTY DAYS (30) SO THAT YOU WILL RECEIVE ALL UPGRADE INFORMATION.


CHAPTER 2

 

Learning to Use Your Computer and Software

 

INSTALLING THE PROGRAM (CD-ROM Installation)       2-1

 

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, PRK, and Phakic IOL Outcomes Analysis Database program, either click on the shortcut icon that has been placed on your desktop or open the folder labeled LASIKDBv4.x found in your Program Files folder.  Then open the application labeled LASIKDBv4.x Solution and follow the on-screen instructions.  A dialog box will ask you whether you want to register or evaluate the software.  If you have a demonstration version, click “Evaluate.” If you have a registration number, enter it now. Be sure to enter your name EXACTLY as it appears in your registration letter. Be sure the cursor is at the leftmost side of each data entry field. Once the data is entered, click the register button below. The message in the lower left of the screen changes from no to yes. Enter your registration data exactly as it is typed in your registration letter. If you list your company name in this section, it will appear in your form letters. Enter all data from the leftmost side of each field to properly register.

 

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 FILE “Frequently Asked Questions” that is now installed into your Program’s File folder in the file: LASIKDBv4.0 .

 

 How to Open Program

 

     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.

 

 


 

HARDWARE REQUIREMENTS                                                  2-2

 

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 RAM memory  is required, but 256 MB or more is recommended.  A monochrome monitor is acceptable, but to fully realize the color capabilities of FileMaker® Pro, it is best to have a color monitor with a video cardvideo card capable of creating millions of colors.

 

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

 

USING THE MOUSE                                                                     2-3

 

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 BarScroll 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 BarScroll 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.


 

USING POP-UP MENUS                                                               2-4

 

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 PAGE or by clicking the small folder icon that is next to a given pop up field.  Clicking this icon takes one to the preferences menu.  The user makes a change or addition to the particular menu, then clicks SAVE and RETURN TO LASIK to be taken back to the pop up menu in question. 

 

 

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.

ENTERING AND CORRECTING ERRORS                                2-5

 

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, JUST ENTER THE NUMBER AS IS.

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 acuityVisual 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) keyEnter(return) keyentering information 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!


 

STARTING THE PROGRAM                                                        2-6

 

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 FILE on the C drive.  Every time you wish to back up or close the LASIK/PRK/PHAKIC IOL Outcomes Analysis program, go to the OPTIONS Menu and click BACK-UP COPY and you will see a notation that a back-up copy has been placed in the file one above your current application. If you make a serious error in today’s entry, you will always have a back-up copy to work from. 

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.

 

ENTERING DATA                                                                          2-7

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 PAGE to advance to the Patient View List (Figure 10) to select which patient’s record you want to see.

 

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 ALL OF THE RECORDS, simply click the print icon at the top, right of the layout that looks like a printer.

 

Tip:

The list view screen allows one to SORT records. Clicking one of the sort icons (miniature charts located to the right of the field title) allows one to sort on the patient last name, surgery date, date of latest visit, OR surgical procedure.

 

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 NORMAL technique of layout by layout, OR the Quick Entry Layout that has the minimum fields that are required by the program in order to perform the minimal analyses. 

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 ALL of the PINK FIELDS listed on this layout. To enter the mate eye, click the DUPLICATE RECORD button and change the eye operated. If you want to exit this entry process in the middle of data entry, click the DELETE PATIENT button. If you have entered the required data, one uses the navigation fields on the upper right.

 

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(11/12/2002), not as 9/98.    

 

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.  24/2/2004 for February 22, 2004.

 

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 numberSocial Security number field.  Enter the number; the hyphens (-) are entered automatically, so that you will be able to searchsearch 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 ALL SCREENS

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 ALL cases that individual has referred. This will be important for patient tracking and marketing. Simply entering the first letter of the name will cause it to pop up; then hit the tab or return key to enter that information in the selected field. The program remembers the names for future entry.

 

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 AND THEN click duplicate record. This will save a lot of data entry time.

 

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 DATA

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 dataPreoperative 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 K2 axis. The program calculates the PreOp[erative] Mean K[eratometry] and PreOp[erative] K[eratometric] Astig[matism]]. 

 

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 PAGE.  In subsequent searchss, one may find all procedures performed by the same surgeon. 

 

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 (Summit) Mask, Vertex Distance (MM), and Laser Software Version are entered here. Ablation Diameters (short and long dimensions) and Ablation Profile for multi-zone programs are data to follow.  The next section deals with parameters of the resected tissues.  One enters the smallest and largest diameter of the ablation followed by the laser computer program’s estimated laser resection in microns.

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 RPM may be entered here.

 

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 DATA.

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 ACS LASIK Ring #, enter 8.5 or 9.0 for the planned diameter. For the Summit – Barraquer – Krumeich enter 9.0.  With the Intralase enter the final diameter that the computer’s program has attempted. For Measured [cap] Diameter (MM), enter what was measured with calipers or other software if you are interested in determining the cap diameter effect on refractive outcome.  The program calculates the difference in attempted versus measured cap diameter. The Corneal Diameter can be entered next to assess if it has any impact on outcome or complications.

 

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] Central Pachometry