Case Crossover Study of PDE5 Inhibitor Exposure as a Potential "Trigger Factor" for Acute NAION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 673
- 试验地点
- 1
- 主要终点
- Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged ≥45 years;
- •Experienced abrupt visual change in only 1 eye
排除标准
- •Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
- •History of NAION or optic neuritis.
- •Participation in other studies within 60 days prior to entry in the study.
研究组 & 干预措施
Case Group
干预措施: No intervention (Drug)
结局指标
主要结局
Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases
时间窗: 30-day period prior to onset of NAION symptoms
Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.
次要结局
未报告次要终点