Use Of Intracameral Moxifloxacin For Prophylaxis Of Open Globe Endophthalmitis

NCT05079854 — Phase 4, Unknown, 100 participants, Federal University of São Paulo

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Registry	NCT05079854
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	100 (Estimated)
Sponsor	Federal University of São Paulo (Other)
Conditions	Endophthalmitis, Trauma, Corneal
Interventions	Intraocular Instillation Solution, Moxifloxacin Ophthalmic (Drug)
Dates	start 2021-10-01, primary completion 2022-11-01 (estimated), completion 2023-11-01 (estimated), first posted 2021-10-15, last updated 2021-11-10
Locations	1 site in Brazil

-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;

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+Arms and interventions

Arm	Type	Interventions	Description
INTRACAMERAL MOXIFLOXACIN	Active comparator	Drug: Intraocular Instillation Solution	After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL.
TOPICAL MOXIFLOXACIN	Active comparator	Drug: Moxifloxacin Ophthalmic	After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL.

Intraocular Instillation Solution (Drug), also known as Intracameral: Intracameral Moxifloxacin 0.5%
Moxifloxacin Ophthalmic (Drug): Topical Moxifloxacin 0.5%

+Outcome measures

Primary outcomes

Endophthalmitis [90 days]: Evaluate the incidence of Endophthalmitis

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* open globe trauma

Exclusion Criteria:

* endophthalmitis at the beginning

+Locations (1)

Facility	City	Country	Status
Dept of Ophthalmology - UNIFESP/Hospital São Paulo	São Paulo, São Paulo	Brazil	Recruiting