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Surveillance of Ocular Surface Flora (SURFACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621933
First Posted: February 22, 2008
Last Update Posted: July 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition
Cataract

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Eyelid [ Time Frame: 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).

  • Percentage of Staphylococcus Epidermidis Species Susceptible and Resistant to Oxacillin on the Conjunctiva [ Time Frame: 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).


Secondary Outcome Measures:
  • Percentage of Staphylococcus Aureus Species Susceptible and Resistant to Oxacillin on the Eyelid [ Time Frame: 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 [ Time Frame: 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).


Biospecimen Retention:   Samples Without DNA
Culture Swabs of the conjunctiva and eyelids

Enrollment: 399
Study Start Date: December 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Patients Receiving Cataract Surgery
All Patients Receiving Cataract Surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cataract Surgery Patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621933


Locations
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00621933     History of Changes
Other Study ID Numbers: MA-Zymar-08-001
First Submitted: February 13, 2008
First Posted: February 22, 2008
Results First Submitted: October 17, 2011
Results First Posted: July 18, 2012
Last Update Posted: July 18, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases