An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retinal Detachment
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
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.
Clinical Details
Official title: Oral Fluoroquinolones and the Risk of Retinal Detachment
Study design: Time Perspective: Retrospective
Primary outcome: Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones
Secondary outcome: Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design)Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design) Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design) Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design) Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design) Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design)
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).
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria:
- At least 1 year of enrollment in the study for medical and pharmacy benefits after
their cohort (group) entry (the day of their first ophthalmologist visit) for
case-control design
- Oral fluoroquinolone like levofloxacin or ciprofloxacin must be dispensed to
participants for cohort design
- At least one visit to an ophthalmologist and enrolled at least for 1 year in the
study for medical and pharmacy benefits prior to the date of first occurrence of the
exposure of levofloxacin or ciprofloxacin for cohort design
- At least one visit to an ophthalmologist and enrolled at least for 1 year in the
study for medical and pharmacy benefits prior to the diagnosis of their first retinal
detachment (separation of the retina [the innermost layer of the eyeball] from its
connection at the back of the eye) for case-only design
Exclusion criteria:
- Prior diagnosis of retinal detachment , prior diagnosis or procedure for inflammatory
conditions of the eyeball, or hospital admission between cohort entry and the date of the
retinal detachment
Locations and Contacts
Additional Information
Starting date: January 2000
Last updated: June 18, 2013
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