Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery

Not Applicable

Completed

• Conditions: Endophthalmitis; Cataract Surgery; Prophylaxis
• Interventions: Drug: mupirocin ointment; Other: SOC sterilization

• Registration Number: NCT00406913
• Lead Sponsor: University of Chicago

Brief Summary

The purpose of this study is to evaluate the conjunctival flora prior to cataract or vitrectomy surgery comparing mupirocin ointment applied to the conjunctiva along with standard ocular sterilization vs. standard ocular sterilization alone.

Detailed Description

Bacterial endophthalmitis is a rare but devastating complication of intraocular surgery. Given the devastating ocular sequelae of endophthalmitis, one cannot underestimate the need to develop a sterilization strategy which most effectively prevents intraocular infection. The most common organisms causing bacterial postoperative endophthalmitis are gram-positive cocci, particularly coagulase-negative staphylococci and Staphylococcus Aureus. It is thought that the most common sources of bacterial contamination predisposing to endophthalmitis are the eyelids and conjunctiva (Ariyasu).

The two main techniques used to reduce the bacterial flora on the ocular surface include treatment of the ocular surface with topical antibiotics prior to surgery and the instillation of 5% povidone-iodine during the prep immediately prior to beginning the surgical procedure (Speaker). Mupirocin ointment is a logical choice for surgical prophylaxis as it has been reported that mupirocin treatment applied to the nose resulted in elimination rates (of S. Aureus from the nares) of 91% directly after therapy (Doebbeling). Use of mupirocin ointment applied to the nares prior to eye surgery resulted in a significant decrease in the bacterial load on the conjunctiva at the time of surgery (Alexandrou, in press). Using mupirocin ointment directly to the conjunctiva, in addition to standard ocular sterilization techniques, may result in an even greater decrease in conjunctival flora prior to eye surgery.

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Included in the study will be any patient eligible for cataract or vitrectomy surgery. No populations will be excluded on the basis of demographics.

Exclusion Criteria

• Excluded will be those patients who have known sensitivity or allergy to mupirocin ointment, or patients using topical ocular or systemic antibiotics during a two week period prior to entry into the study. Additionally, patient's using topical corticosteroids will be excluded as well

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mupirocin ointment	mupirocin ointment	-
Mupirocin ointment	SOC sterilization	-
Standard of Care sterilization	SOC sterilization	-

Primary Outcome Measures

Name	Time	Method
Positive conjunctival culture	pre and post op

Trial Locations

Locations (1)

University of Chicago Hospitals; 🇺🇸 Chicago, Illinois, United States