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Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

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ClinicalTrials.gov Identifier: NCT01181713
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Dr. Peter Kertes, Sunnybrook Health Sciences Centre

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.

Condition or disease
Increased Drug Resistance Infection Resistant to Quinolones and Fluoroquinolones

Detailed Description:

Treatment with intravitreal (IVT) injections has increased during the last several years as evidence has accumulated demonstrating the efficacy of anti-vascular endothelial growth factor agents in the treatment of neovascular age-related macular degeneration (AMD) and various retinal vascular diseases.

Although IVT injections are generally safe, infectious endophthalmitis is a rare but devastating complication, and the risk of morbidity and vision loss from endophthalmitis is high. The objective is to examine the change in antibiotic resistance of ocular surface flora with repeated prophylactic use of antibiotics after IVT injection for AMD.

Yin, V. T., Weisbrod, D. J., Eng, K. T., Schwartz, C., Kohly, R., Mandelcorn, E., Lam, W., Daneman, N., Simor, A., & Kertes, P. J. (2013). Antibiotic resistance of ocular surface flora with repeated use of a topical antibiotic after intravitreal injection. JAMA ophthalmology, 131(4), 456-461.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections
Study Start Date : June 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort
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



Primary Outcome Measures :
  1. ocular flora resistance to 4th generation fluoroquinolone [ Time Frame: 1 year ]
    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).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient recruitment would be from the Sunnybrook Health and Sciences Centre Department of Ophthalmology
Criteria

Inclusion Criteria:

  • patients scheduled for intravitreal injection for neovascular age-related macular degeneration (ARMD)
  • 65 years or older
  • able to provide informed consent.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181713


Locations
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Canada, Ontario
Sunnybrook Health and Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Novartis
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Peter Kertes, chief, department of ophthalmology, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01181713    
Other Study ID Numbers: SBK-OcuFResis
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021