Surveillance of Ocular Surface Flora (SURFACE)

Completed

• Conditions: Cataract

• Registration Number: NCT00621933
• Lead Sponsor: Allergan

Brief Summary

Topical fluoroquinolones (FQs) have achieved widespread use in ophthalmology for both the treatment and prophylaxis of ocular infections. The present study is set to determine the bacteria present on the ocular surface in patients at the time of cataract surgery and to assess the rate of resistance of ocular isolates to commonly used topical antibiotics.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Results First Submitted: 2011-10-17
• Results First Submitted QC: 2012-07-16
• Results First Posted: 2012-07-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

• Scheduled to undergo cataract surgery
• Able to provide written informed consent

Exclusion Criteria

• NSAID in the eye to be swabbed within the past 30 days
• Topical anesthetic, topical antibiotic or antiseptic, or dilating drops in the eye to the swabbed within the past 7 days
• Over-the-counter artificial tear drops or astringent /redness reliever drops (e.g., Visine®, Clear eyes® in the eye to be swabbed on the day of trial
• History of conjunctivitis or any ocular infection within the past 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva	Baseline	Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the conjunctiva . The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant).
Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid	Baseline	Percentage of staphylococcus epidermidis species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus epidermidis, the oxacillin MIC breakpoints were \<= 0.25 ug/ml (susceptible) and \>= 0.50 ug/ml (resistant).

Secondary Outcome Measures

Name	Time	Method
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid	Baseline	Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the eyelid. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant).
Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Conjunctiva	Baseline	Percentage of staphylococcus aureus species susceptible and resistant to oxacillin on the conjunctiva. The minimum inhibitory concentrations (MIC) of each species were determined and compared to oxacillin MIC breakpoints. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. For Staphylococcus aureus, the oxacillin MIC breakpoints were \<= 2 ug/ml (susceptible) and \>= 4 ug/ml (resistant).