Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

Phase 4

• Conditions: Endophthalmitis; Trauma, Corneal
• Interventions: Drug: Intraocular Instillation Solution; Drug: Moxifloxacin Ophthalmic

• Registration Number: NCT05079854
• Lead Sponsor: Federal University of São Paulo

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;

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-03
• Study First Submitted QC: 2021-10-03
• Study First Posted: 2021-10-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-10
• Primary Completion: 2022-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• open globe trauma

Exclusion Criteria

• endophthalmitis at the beginning

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTRACAMERAL MOXIFLOXACIN	Intraocular Instillation Solution	After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
TOPICAL MOXIFLOXACIN	Moxifloxacin Ophthalmic	After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.

Primary Outcome Measures

Name	Time	Method
Endophthalmitis	90 days	Evaluate the incidence of Endophthalmitis

Trial Locations

Locations (1)

Dept of Ophthalmology - UNIFESP/Hospital São Paulo; 🇧🇷 São Paulo, SP, Brazil