Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

Federal University of São Paulo

Status and phase: Unknown; Phase 4

Conditions: Endophthalmitis; Trauma, Corneal

Treatments: Drug: Moxifloxacin Ophthalmic; Drug: Intraocular Instillation Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05079854

TOP_VIGAMOX

Details and patient eligibility

About

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;

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• open globe trauma

Exclusion criteria

• endophthalmitis at the beginning

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

INTRACAMERAL MOXIFLOXACIN

Active Comparator group

Description:

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

Treatment:

Drug: Intraocular Instillation Solution

TOPICAL MOXIFLOXACIN

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin Ophthalmic