Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Primary Purpose
Endophthalmitis, Trauma, Corneal
Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Intraocular Instillation Solution
Moxifloxacin Ophthalmic
Sponsored by
About this trial
This is an interventional prevention trial for Endophthalmitis
Eligibility Criteria
Inclusion Criteria:
- open globe trauma
Exclusion Criteria:
- endophthalmitis at the beginning
Sites / Locations
- Dept of Ophthalmology - UNIFESP/Hospital São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
INTRACAMERAL MOXIFLOXACIN
TOPICAL MOXIFLOXACIN
Arm Description
After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.
Outcomes
Primary Outcome Measures
Endophthalmitis
Evaluate the incidence of Endophthalmitis
Secondary Outcome Measures
Full Information
NCT ID
NCT05079854
First Posted
October 3, 2021
Last Updated
November 3, 2021
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05079854
Brief Title
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Official Title
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Endophthalmitis is a severe inflammatory eye condition with profound impairment of vision, which can lead to irreversible visual loss and requires immediate treatment.
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis, Trauma, Corneal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INTRACAMERAL MOXIFLOXACIN
Arm Type
Active Comparator
Arm Description
After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
Arm Title
TOPICAL MOXIFLOXACIN
Arm Type
Active Comparator
Arm Description
After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.
Intervention Type
Drug
Intervention Name(s)
Intraocular Instillation Solution
Other Intervention Name(s)
Intracameral
Intervention Description
Intracameral Moxifloxacin 0.5%
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Ophthalmic
Intervention Description
Topical Moxifloxacin 0.5%
Primary Outcome Measure Information:
Title
Endophthalmitis
Description
Evaluate the incidence of Endophthalmitis
Time Frame
90 days
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
open globe trauma
Exclusion Criteria:
endophthalmitis at the beginning
Facility Information:
Facility Name
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinicius Campos Bergamo, MD
Phone
(11) 9 80589798
Email
viniciusbergamo.epm@gmail.com
First Name & Middle Initial & Last Name & Degree
Mauricio Maia, MD, PhD
Phone
5511-5572-6443
Email
maiamauricio@terra.com.br
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
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