- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01881438
An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment
June 18, 2013 updated by: Janssen Research & Development, LLC
Oral Fluoroquinolones and the Risk of Retinal Detachment
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
119924
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with exposure to oral fluoroquinolones
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Participants exposed to oral fluoroquinolones
Oral fluoroquinolones in this study are ciprofloxacin, levofloxacin, gatifloxacin, gemifloxacin, moxifloxacin, norfloxacin, and ofloxacin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones
Time Frame: 11 years
|
Oral fluoroquinolones in this study are gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin.
|
11 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Retinal Detachments With Exposure to Oral Ciprofloxacin or to Oral Fluoroquinolones (Revised Case-Control Design)
Time Frame: 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.
|
11 years
|
Number of Retinal Detachments With Exposure to Individual Oral Fluoroquinolones (Revised Case-Control Design)
Time Frame: 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.
|
11 years
|
Number of Retinal Detachments With Exposure to Oral Fluoroquinolones Along With Oral Beta-Lactam antibiotic (Case-Control Design)
Time Frame: 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.
|
11 years
|
Number of Retinal Detachments With Exposure to Oral Levofloxacin and Ciprofloxacin (Cohort Design)
Time Frame: 11 years
|
Cohort design is used for assessment of this outcome measure.
|
11 years
|
Number of Retinal Detachments During the Period of Exposure With Oral Levofloxacin and Ciprofloxacin (Case-Only Design)
Time Frame: 11 years
|
Case-only design is used for assessment of this outcome measure.
|
11 years
|
Number of Retinal Detachments During the Period of non-Exposure to Oral Levofloxacin and Ciprofloxacin (Case-Only Design)
Time Frame: 11 years
|
Case-only design is used for assessment of this outcome measure.
|
11 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 17, 2013
First Submitted That Met QC Criteria
June 18, 2013
First Posted (Estimate)
June 19, 2013
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100940
- RRA-7875 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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