A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 44
- 主要终点
- 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
研究概览
简要总结
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male subjects, at least 18 years of age, who are willing to participate in the study
- •Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator
排除标准
- •Previous history of NAION
- •Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
- •History of glaucoma in either one or both eyes
- •History of multiple sclerosis or diagnostic testing evidence of optic neuritis
- •Have dementia or other reasons for memory impairment in the opinion of the investigator
- •Have participated in other non-observational studies within 3 months of NAION onset
研究组 & 干预措施
Cohort 1
Participants with NAION who have used PDE5 inhibitors
干预措施: PDE5 Inhibitors (Drug)
结局指标
主要结局
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use
时间窗: 30 days prior to NAION onset
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
次要结局
未报告次要终点