Status:
COMPLETED
An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Retinal Detachment
Eligibility:
All Genders
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 ...
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 expo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
119924 Patients enrolled
Trial Details
Trial ID
NCT01881438
Start Date
January 1 2000
End Date
May 1 2013
Last Update
June 19 2013
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