Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

Increased Drug Resistance Clinical Trial

Official title:

Antibiotic Resistance of Ocular Surface Flora After Continued Use of Topical Antibiotics Post Intravitreal Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181713
• Other study ID #: SBK-OcuFResis
• Status: Completed
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Increased Drug Resistance
• Infection Resistant to Quinolones and Fluoroquinolones

Locations

Country	Name	City	State
Canada	Sunnybrook Health and Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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