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Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics

Sponsored by Loma Linda University

Phase Quota
Phase N/A

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.

Study Start Date: October 2014

Estimated Completion Date: June 2016

Specialties: Infectious Disease: Antimicrobials Pharmacy: Antimicrobials Physician Assistant: Infectious Disease

Interventions

  • Drug: Ciprofloxacin
  • Drug: Standard Aseptic Technique

Inclusion criteria

  • 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 criteria

  • 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

Study Locations And Contact Information

  • Loma Linda University of Health Sciences Faculty Medical Offices, Loma Linda California
    Contact: David I Sierpina MD 815-319-0527 dsierpina@llu.edu

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