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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01181713

Enrollment

200

Registered

2010-08-13

Start date

2010-06-30

Completion date

2011-12-31

Last updated

2021-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased Drug Resistance, Infection Resistant to Quinolones and Fluoroquinolones

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
ocular flora resistance to 4th generation fluoroquinolone	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).

Countries

Canada

Outcome results