A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAION.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Retrospective
|Official Title:||Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION|
- Acute NAION is the sole endpoint of interest in this study. [ Time Frame: 2 months prior to study entry ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Drug: No intervention
No intervention occurs in this observational study.
Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.
Show 105 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|