Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

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;

Study Overview

• Status: Recruiting
• Conditions: Endophthalmitis; Trauma, Corneal
• Intervention / Treatment: Drug: Intraocular Instillation Solution; Drug: Moxifloxacin Ophthalmic

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04023-062
      • Recruiting
      • Dept of Ophthalmology - UNIFESP/Hospital São Paulo
      • Contact: Vinicius Campos Bergamo, MD; Phone Number: (11) 9 80589798; Email: viniciusbergamo.epm@gmail.com
      • Contact: Mauricio Maia, MD, PhD; Phone Number: 5511-5572-6443; Email: maiamauricio@terra.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• open globe trauma

Exclusion Criteria:

• endophthalmitis at the beginning

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endophthalmitis	Evaluate the incidence of Endophthalmitis	90 days

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: October 3, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Infections; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Corneal Diseases; Eye Infections; Facial Injuries; Eye Injuries; Corneal Injuries; Endophthalmitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: TOP_VIGAMOX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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