Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

NCT05079854 | Unknown Phase 4 DMC

• 1 other identifier: TOP_VIGAMOX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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;

Conditions

Endophthalmitis; Trauma, Corneal

Outcome Measures

Primary Outcomes (1)

• Endophthalmitis

  Evaluate the incidence of Endophthalmitis

  90 days

Study Arms (2)

INTRACAMERAL MOXIFLOXACIN

ACTIVE COMPARATOR

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

Drug: Intraocular Instillation Solution

TOPICAL MOXIFLOXACIN

ACTIVE COMPARATOR

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

Drug: Moxifloxacin Ophthalmic

Interventions

Intraocular Instillation Solution DRUG

Intracameral Moxifloxacin 0.5%

Also known as: Intracameral

INTRACAMERAL MOXIFLOXACIN

Moxifloxacin Ophthalmic DRUG

Topical Moxifloxacin 0.5%

TOPICAL MOXIFLOXACIN

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• open globe trauma

You may not qualify if:

• endophthalmitis at the beginning

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Dept of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, São Paulo, 04023-062, Brazil

RECRUITING

MeSH Terms

Conditions

Endophthalmitis; Corneal Injuries

Interventions

Intracameral Injection

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 15, 2021
• Study Start: October 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: November 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

BR (1)