Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Increased Drug Resistance Infection Resistant to Quinolones and Fluoroquinolones

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No Antibiotic

No prophylactic antibiotic post intravitreal injection

No interventions assigned to this group

Prophylactic Antibiotic

Group treated with 3 day course of prophylactic topic antibiotic, fourth generation fluoroquinolones, after each intravitreal injection

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No