Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
NCT ID: NCT05079854
Last Updated: 2021-11-10
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2021-10-01
2023-11-01
Brief Summary
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There is no way to completely prevent endophthalmitis, however, through prophylactic methods, it is possible to reduce its incidence. Currently, the only technique that has reached category II of evidence in reducing the risks of endophthalmitis is the use of 5% povidone-iodine eye drops, moments before surgery. In 2007, the European Society of Cataract and Refractive Surgery (ESCRS) released a large multicenter randomized clinical trial, with data on the reduction in the rates of endophthalmitis, using the intracameral antibiotic therapy technique of perioperative cefuroxime. However, much is discussed about the risks related to the technique, such as dilutional errors, contamination, anaphylaxis and cost-effectiveness, which still makes the conduct debatable.
The study evaluates the use of intracameral Moxifloxacin 0.5% (Vigamox®) as prophylaxis in cases of endophthalmitis after open ocular trauma;
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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INTRACAMERAL MOXIFLOXACIN
After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
Intraocular Instillation Solution
Intracameral Moxifloxacin 0.5%
TOPICAL MOXIFLOXACIN
After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.
Moxifloxacin Ophthalmic
Topical Moxifloxacin 0.5%
Interventions
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Intraocular Instillation Solution
Intracameral Moxifloxacin 0.5%
Moxifloxacin Ophthalmic
Topical Moxifloxacin 0.5%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Mauricio Maia
Clinical Professor
Locations
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Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, Brazil
Countries
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Facility Contacts
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Vinicius Campos Bergamo, MD
Role: primary
Mauricio Maia, MD, PhD
Role: backup
Other Identifiers
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TOP_VIGAMOX
Identifier Type: -
Identifier Source: org_study_id