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16. Visual Field Reading Center Procedures Ocular Hypertension Treatment Study (OHTS) Manual of Procedures Version 3.0 9/24/01 To view any section of this document please click on the bookmarks to your left. Click on the plus sign (+) to expand the chapter sections. Sections that have been revised are listed at the beginning of each chapter and are linked to the respective sections. Click on the search icon to search the complete document for key words and phrases. If you would like to print any section pay attention to the "print range" section of the printing options. Unless you would like to print the complete document (300+ pages) you should enter a specific range of pages for printing. Please direct any problems to the web master. Table of Contents 1 1. Introduction 1.1 Synopsis of Study ................................................................................. 1-2 1.2 Specific Aims........................................................................................ 1-2 1.3 Background and Significance ............................................................... 1-2 1.4 Progress Report/Preliminary Studies.................................................... 1-6 1.4.1 Long Term Timolol Study .................................................................... 1-6 1.4.2 Risk Factors in Ocular Hypertension.................................................... 1-7 1.4.3 Humphrey Visual Fields Criteria for Reliability and Normality .......... 1-8 1.4.4 Clinical Trials ....................................................................................... 1-8 1.4.5 Planning Sessions ................................................................................. 1-9 1.4.6 Study Milestones................................................................................ 1- 10 Table 1 (Studies of Medical Treatment in Glaucoma Suspects)………1-4 2. Study Design 2.1 Synopsis of Study Design ..................................................................... 2-4 2.2 Participant Selection ............................................................................. 2-5 2.2.1 Entry Criteria ........................................................................................ 2-5 2.2.2 Exclusion Criteria ................................................................................. 2-6 2.2.3 Rationale for Entry and Exclusion Criteria........................................... 2-7 2.3 Recruitment......................................................................................... 2-10 2.3.1 Audiences............................................................................................ 2-10 2.3.2 National Activities .............................................................................. 2-11 2.3.3 Local Activities................................................................................... 2-11 2.4 Qualifying and Baseline Studies......................................................... 2-11 2.4.1 History and Examination .................................................................... 2-11 2.4.2 Intraocular Pressure ............................................................................ 2-11 2.4.3 Visual Field......................................................................................... 2-12 2.4.4 Rationale for Visual Field Assessment............................................... 2-12 2.4.5 Optic Disc ........................................................................................... 2-12 2.4.6 Rationale for Optic Disc Assessment ................................................. 2-13 2.5 Treatment ............................................................................................ 2-13 2.5.1 Stepped Medical Regimen .................................................................. 2-13 2.5.2 Goals of Treatment ............................................................................. 2-14 2.5.3 Adverse Events and Drug-Related Side Effects ................................. 2-14 2.5.4 Medication Adherence........................................................................ 2-15 2.5.5 Rationale for Stepped Treatment Regimen......................................... 2-16 2.6 Participant Follow-up and Retention .................................................. 2-17 2.7 POAG Endpoint Determination.......................................................... 2-18 2.7.1 Optic Disc POAG Endpoint................................................................ 2-18 2.7.2 Rationale for Optic Disc POAG Endpoints ........................................ 2-19 2.7.3 Visual Field POAG Endpoint ............................................................. 2-20 http://www.vrcc.wustl.edu/mop/mop.htm Version 3.0 9/24/01 2 Table of Contents 2.7.4 Rationale for Visual Field POAG Endpoint ....................................... 2-21 2.7.5 When POAG Endpoint is Confirmed ................................................. 2-23 2.7.6 Open Arm............................................................................................ 2-23 2.7.7 Masking .............................................................................................. 2-24 2.7.8 Statistical Analysis of Participants Who Cannot be Evaluated .......... 2-24 2.8 Clinical Centers................................................................................... 2-24 2.9 Data Analysis...................................................................................... 2-24 2.9.1 Unit of Analysis: Eyes or Participants? ............................................. 2-24 2.9.2 Sample Size......................................................................................... 2-25 2.9.2.1 Projecting the Incidence of POAG in the Control Group................... 2-25 2.9.2.2 Estimating Treatment Effect on Incidence of POAG ......................... 2-28 2.9.2.3 Assumptions for Calculating Sample Size.......................................... 2-28 2.9.3.4 Effect of Medication Defaulting on Statistical Power........................ 2-29 2.9.4 Data Analysis...................................................................................... 2-30 2.10 Human Participants............................................................................. 2-33 2.10.1 Entry Criteria ...................................................................................... 2-33 2.10.2 Exclusion Criteria ............................................................................... 2-33 2.10.3 Confidentiality and Protection of Participants.................................... 2-34 2.10.4 Risks.................................................................................................... 2-35 2.10.5 Ethics .................................................................................................. 2-36 2.10.6 Benefits ............................................................................................... 2-37 2.11 Literature Cited................................................................................... 2-38 Table 1 (Randomized Clinical Trials of Medical Treatment of Ocular Hypertension)........................................................... 2-25 Table 2 (Incidence of Visual Field Loss in Collaborative Glaucoma Study) ................................................................. 2-26 Table 3 (Number of Participants per Group) ...................................... 2-28 3. Eligibility and Exclusion Criteria 3.1 Introduction........................................................................................... 3-3 3.2 Eligibility Criteria................................................................................. 3-3 3.3 Exclusion Criteria ................................................................................. 3-4 3.4 Eligibility Review................................................................................. 3-5 Version 3.0 9/24/01 http://www.vrcc.wustl.edu/mop/mop.htm Table of Contents 3 4. Participant Education and Informed Consent 4.1 Introduction........................................................................................... 4-3 4.2 Participant Education............................................................................ 4-3 4.3 Informed Consent.................................................................................. 4-4 4.4 Decline to Participate............................................................................ 4-5 4.5 Continuing Education ........................................................................... 4-5 4.6 Reconsenting Participants..................................................................... 4-5 Appendix............................................................................................... 4-6 5. Participant Entry and Randomization 5.1 Introduction........................................................................................... 5-3 5.2 Initial Individual Screening for Eligibility ........................................... 5-3 5.3 Assignment of Participant Identification Numbers .............................. 5-3 5.4 Procedure for Informed Consent/Decline to Participate....................... 5-4 5.5 Qualifying Assessment ......................................................................... 5-4 5.6 Eligibility Confirmation and Randomization Assignment .................. 5-5 5.7 Study Entry Date................................................................................... 5-6 5.8 Method of Computing Random Allocation .......................................... 5-6 6. Schedule of Visits and Form Completion 6.1 Introduction..........................................................................................
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