Change in Ocular Flora Resistance From Repeated Topical Antibiotic Use

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Infection Resistant to Quinolones and Fluoroquinolones; Increased Drug Resistance

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01181713

SBK-OcuFResis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

200 participants in 2 patient groups

No Antibiotic

Description:

No prophylactic antibiotic post intravitreal injection

Prophylactic Antibiotic

Description:

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