Status:
COMPLETED
Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
Lead Sponsor:
Loma Linda University
Conditions:
Bacterial Resistance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Background: Over 1 million intravitreal injections are performed annually in the United States. The most devastating complication related to these injections is endophthalmitis, with an incidence o...
Detailed Description
Previous studies have demonstrated that bacteria in the eye may become resistant to antibiotics used after injections when compared to the bacteria found in untreated eyes. However, no study published...
Eligibility Criteria
Inclusion
- Patients with choroidal neovascularization due to wet age-related macular degeneration or any other cause, clinically significant macular edema or cystoid macular edema over age 18 who have been treated with at least 3 monthly intravitreal injections of an anti-Vascular Endothelial Growth Factor (anti-VEGF) agent in the last 6 months. These injections must have been given in either Dr. Fan's clinic using povidone-iodine and post-injection topical ciprofloxacin 0.3% 4x daily for 3 days, or in Dr. Rauser's clinic where povidone-iodine only is applied to the injection site and conjunctival fornix but no post-injection antibiotics are given.
Exclusion
- Administration of anti-VEGF agents outside of Dr. Fan's or Dr. Rauser's clinics
- Intraocular surgery
- Use of topical antibiotics other than ciprofloxacin 0.3%
- Infections of the eye or ocular adnexa within the last 3 months
- Use of oral antibiotics within the last 30 days
- Contact lens wear.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02223338
Start Date
October 1 2014
End Date
May 1 2016
Last Update
November 7 2017
Active Locations (1)
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1
Loma Linda University of Health Sciences Faculty Medical Offices
Loma Linda, California, United States, 92354