Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics

Completed · Not applicable

Conditions studied: Bacterial Resistance

In brief

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 of 0.02 - 0.1% per injection. Techniques aimed at prevention of this complication have been studied, though emergence rates of antibiotic resistant bacteria in a single clinic population comparing antiseptic technique with iodine vs. use of post-injection second generation fluoroquinolones has not been reported in the literature. 2. Objectives: The purpose of the study is to help determine the best way to prevent infection and limit antibiotic resistance in patients receiving eye injections. 3. Procedures Involved (Research Interventions): After the patient is chosen based on inclusion criteria and agrees to participate in the study, exclusion criteria will be reviewed, cognizance will be determined, informed consent and HIPAA compliance forms will be signed. At this point and prior to the instillation of ophthalmic medications, a Rayon swab will be passed along the inferior fornix of the study eye while the patient looks up and the examiner lowers the lower eyelid. The swab will then be used to inoculate chocolate agar and a blood agar culture plates and a glass slide. These will be brought to the FMO microbiology department for culture and Gram stain. All Staphylococcus aureus and coagulase negative Staphylococcus species identified will be subjected to sensitivity testing using the Gram Positive antibiotic panel available at Loma Linda, with the addition of ciprofloxacin.

Key facts

Study ID

NCT02223338

Run by

Loma Linda University

People needed

120

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2017-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Loma Linda University of Health Sciences Faculty Medical Offices — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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