FLAME Data and Documents
FLAME Study Documents
Overview of FLAME Data
FLAME Case Report Forms
- Adverse Event Log
- Baseline Eye Examination Form
- Baseline Information Form
- Eligibility Form
- EQ-5D
- Exit Form
- Eye Pain Impact Questionnaire
- First Postoperative Complications Form
- Follow-up Health Review Form
- Missed Visit Form
- Month 6 and 12 Eye Examination Form
- Ocular Surface Disease Index
- Patient Death Form
- Primary Endpoint Assessment
- Protocol Deviation Reporting Form
- Randomization and Initial Treatment Form
- SAE Initial Reporting Form
- Satisfaction with TT Surgery
- Second Postoperative Complications Form
- Surgery Form
- Treatment Adherence Form
- Visual Function Questionnaire
- Week 4 Eye Examination Form
FLAME Data Files
- AE - Adverse Event Log
- BE - Baseline Eye Examination Form
- DD - Patient Death Form
- DS - Baseline Information Form
- DV - Protocol Deviation and Unanticipated Event Form
- EL - Eligibility Form
- EP - Eye Pain Impact Questionnaire
- EQ - EQ-5D Form
- EX - Exit Form
- FPO - First Post-Operative Visit Complications Form
- FR - Follow Up Heath Review Form
- ME - Month 6 and 12 Eye Examination Form
- MV - Missed Visit Form
- OSI - Ocular Surface Disease Index
- PE - Primary Endpoint Assessment Form
- RT - Randomization and Initial Treatment Form
- SAE - Serious Adverse Event Initial Reporting Form
- SI - Surgery Information Form
- SPO - Second Post-Operative Visit Complications Form
- SS - Satisfaction with TT Surgery
- TA - Treatment Adherence Form
- VF - Visual Function Questionnaire
- WE - Week 4 Eye Examination Form
FLAME Code
- Figure 1 Flowchart
- Figure 2 KM plot
- Setup
- Table 1 Baseline Characteristics
- Table 2 Baseline Ocular Characteristics
- Table 3 Primary Outcome
- Table 4 Secondary Outcome
- Table 5 Safety Outcome
- Table 6 Satisfaction
- Table 7 Visual Acuity
- Table 8 Infection Analysis