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Surveillance of Ocular Surface Flora (SURFACE)

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.
 
ClinicalTrials.gov Identifier: NCT00621933
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : July 18, 2012
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease
Cataract

Study Design
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Study Type : Observational
Actual Enrollment : 399 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : December 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
All Patients Receiving Cataract Surgery
All Patients Receiving Cataract Surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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 :
  1. 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).

  2. 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

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
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United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00621933    
Other Study ID Numbers: MA-Zymar-08-001
First Posted: February 22, 2008    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: April 26, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases