Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use
Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections
1 other identifier
observational
200
1 country
1
Brief Summary
The purpose of this study is to determine if antibiotic resistance of the ocular surface flora to the 4th generation fluoroquinolones will increase after repeated use of topical antibiotics for three days post intravitreal injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 18, 2021
March 1, 2021
1.3 years
February 8, 2010
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
ocular flora resistance to 4th generation fluoroquinolone
Outcome will examine the change in amount, type and antibiotic resistance profile of ocular surface flora over the 3 months. Charcoal swab of the conjunctiva will be cultured, organisms grown will be identified and resistance to moxifloxacin will be quantified by minimal inhibitory resistance (MIC).
1 year
Study Arms (2)
No Antibiotic
No prophylactic antibiotic post intravitreal injection
Prophylactic Antibiotic
Group treated with 3 day course of prophylactic topic antibiotic, fourth generation fluoroquinolones, after each intravitreal injection
Eligibility Criteria
Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology
You may qualify if:
- patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
- years or older
- able to provide informed consent.
You may not qualify if:
- diagnosed with an active ocular, periocular or systemic infection
- previously received treatment with an intravitreal injection
- previously treated with antibiotics in the past three months
- unable to attend the scheduled follow-up appointments or to complete treatment for any reason
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Novartiscollaborator
Study Sites (1)
Sunnybrook Health and Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
Yin VT, Weisbrod DJ, Eng KT, Schwartz C, Kohly R, Mandelcorn E, Lam WC, Daneman N, Simor A, Kertes PJ. Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA Ophthalmol. 2013 Apr;131(4):456-61. doi: 10.1001/jamaophthalmol.2013.2379.
PMID: 23430175DERIVED
Study Officials
- STUDY CHAIR
Peter Kertes, MD, FRCSC
Sunnybrook Health Sciences Centre
- STUDY DIRECTOR
Vivian T Yin, MD
University of Toronto
- STUDY DIRECTOR
Daniel Weisbrod, MD, FRCSC
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief, department of ophthalmology
Study Record Dates
First Submitted
February 8, 2010
First Posted
August 13, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
March 18, 2021
Record last verified: 2021-03