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Completed

NCT Number: NCT01181713

Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

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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Key information

Conditions

Increased Drug Resistance Infection Resistant to Quinolones and Fluoroquinolones

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook Health and Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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