Resistance to Antibiotics in Patients Receiving Eye Injections
NCT ID: NCT02126423
Last Updated: 2016-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2014-05-31
2014-09-30
Brief Summary
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This study compares 20 control patients without prior intravitreal injection to 20 patients who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical antibiotics for two days before and/or after the injection procedure. The lower, inner eyelid and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial sensitivity.
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Detailed Description
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Culture swabs are then plated onto 5% sheep blood plates and incubated at 37°C for 3 days. Colonies are isolated and identified with API (Analytical Profile Index) Microbial Identification Kits (bioMérieux Inc., Hazelwood, MO). Antibiotic susceptibility is determined using the Kirby Bauer disc diffusion method. Additional data collected includes age, ocular and systemic medical conditions, and the number of intravitreal injections along with anti-VEGF agents used.
Statistical calculations for antibiotic resistance comprises of t-test and and multivariate analysis.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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1st intravitreal injection
Conjunctival and nasopharyngeal swabs are obtained from each treatment-naive patient receiving their 1st intravitreal injection
Conjunctival and nasopharyngeal swabs
For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.
>20 intravitreal injections
Conjunctival and nasopharyngeal swabs are obtained from each patient with \>20 intravitreal injection therapies.
Conjunctival and nasopharyngeal swabs
For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.
Interventions
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Conjunctival and nasopharyngeal swabs
For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Prism Vision Group
OTHER
Responsible Party
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Principal Investigators
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Howard Fine, MD, MHSc
Role: PRINCIPAL_INVESTIGATOR
Prism Vision Group
Locations
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NJ Retina
Edison, New Jersey, United States
Countries
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Other Identifiers
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1001
Identifier Type: -
Identifier Source: org_study_id
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