跳至主要内容
临床试验/NCT01881438
NCT01881438已完成不适用

Oral Fluoroquinolones and the Risk of Retinal Detachment

Janssen Research & Development, LLC0 个研究点目标入组 119,924 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
119,924
主要终点
Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones

研究概览

简要总结

The purpose of this study is to assess the association of retinal detachment (separation of the retina [the innermost layer of the eyeball] from its connection at the back of the eye) with exposure to oral ciprofloxacin or oral fluoroquinolones.

详细描述

This is an observational (in which the investigators observe the outcomes of the study participants but do not intervene by, e.g, assigning the treatments) and retrospective (a study in which the exposures and outcomes occurred before the study began) study. It will use data from the Optuminsight and Truven Commercial Claims and Encounters databases, each of which will be evaluated separately using 3 designs: (1) Case-control (a design that compares the cases [study participants], ie, those with retinal detachment to controls, ie, a sample of similar people who did not have a retinal detachment) to assess whether their exposures to fluoroquinolones (FQs) differed. Two case-control studies are planned, one (replication) that mimics a previously reported study, the other (revised) that addresses more potential confounders than did that study , (2) Cohort (a design that follows the participants exposed to FQs and those not exposed to FQs to assess whether the two groups had different risks of developing retinal detachment), (3) Case-only (a design where the exposure history of individuals who had retinal detachment are examined to assess whether they were more likely to have had it when they were exposed to FQs than when they were not).

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones

时间窗: 11 years

Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

次要结局

  • Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design)(11 years)
  • Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design)(11 years)
  • Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design)(11 years)
  • Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design)(11 years)
  • Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design)(11 years)
  • Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design)(11 years)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验