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Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

Sponsor
Federal University of São Paulo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05079854
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

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;

Condition or Disease Intervention/Treatment Phase
  • Drug: Intraocular Instillation Solution
  • Drug: Moxifloxacin Ophthalmic
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: INTRACAMERAL MOXIFLOXACIN

After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.

Drug: Intraocular Instillation Solution
Intracameral Moxifloxacin 0.5%
Other Names:
  • Intracameral

    		•
    Active Comparator: TOPICAL MOXIFLOXACIN

    After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.

    Drug: Moxifloxacin Ophthalmic
    Topical Moxifloxacin 0.5%

    Outcome Measures

    Primary Outcome Measures

    1. Endophthalmitis [90 days]

      Evaluate the incidence of Endophthalmitis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • open globe trauma
    Exclusion Criteria:
    • endophthalmitis at the beginning

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Ophthalmology - UNIFESP/Hospital São Paulo São Paulo SP Brazil 04023-062

    Sponsors and Collaborators

    • Federal University of São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mauricio Maia, Clinical Professor, Federal University of São Paulo
    ClinicalTrials.gov Identifier:
    NCT05079854
    Other Study ID Numbers:
    • TOP_VIGAMOX
    First Posted:
    Oct 15, 2021
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Endophthalmitis
    Corneal Injuries
    Moxifloxacin

    Study Results

    No Results Posted as of Nov 10, 2021