An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment

Completed

• Conditions: Retinal Detachment

• Registration Number: NCT01881438
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2013-06
• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Study First Posted: 2013-06-19
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119924

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones	11 years	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.

Secondary Outcome Measures

Name	Time	Method
Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design)	11 years	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Revised Case-control design is used for assessment of this outcome measure.
Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design)	11 years	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Revised Case-control design is used for assessment of this outcome measure.
Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design)	11 years	Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. Case-control design is used for assessment of this outcome measure.
Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design)	11 years	Cohort design is used for assessment of this outcome measure.
Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design)	11 years	Case-only design is used for assessment of this outcome measure.
Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design)	11 years	Case-only design is used for assessment of this outcome measure.