Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre
First received: February 8, 2010
Last updated: December 2, 2011
Last verified: December 2011
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.
Increased Drug Resistance
Infection Resistant to Quinolones and Fluoroquinolones
||Observational Model: Case Control
Time Perspective: Prospective
||Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections
Primary Outcome Measures:
- ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
No prophylactic antibiotic post intravitreal injection
Group treated with 3 day course of prophylactic topic antibiotic, fourth generation fluoroquinolones, after each intravitreal injection
|Ages Eligible for Study:
||65 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology
- patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
- 65 years or older
- able to provide informed consent.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181713
|Sunnybrook Health and Sciences Centre
|Toronto, Ontario, Canada, M4N 3M5 |
Sunnybrook Health Sciences Centre
||Peter Kertes, MD, FRCSC
||Sunnybrook Health Sciences Centre
||Vivian T Yin, MD
||University of Toronto
||Daniel Weisbrod, MD, FRCSC
||Sunnybrook Health Sciences Centre
No publications provided by Sunnybrook Health Sciences Centre
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Dr. Peter Kertes, chief, department of ophthalmology, Sunnybrook Health Sciences Centre
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 8, 2010
||December 2, 2011
||Canada: Ethics Review Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 05, 2015