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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05079854
Other study ID # TOP_VIGAMOX
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2021
Est. completion date November 1, 2023

Study information

Verified date November 2021
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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;


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 1, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - open globe trauma Exclusion Criteria: - endophthalmitis at the beginning

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intraocular Instillation Solution
Intracameral Moxifloxacin 0.5%
Moxifloxacin Ophthalmic
Topical Moxifloxacin 0.5%

Locations

Country Name City State
Brazil Dept of Ophthalmology - UNIFESP/Hospital São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endophthalmitis Evaluate the incidence of Endophthalmitis 90 days
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