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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTRACAMERAL MOXIFLOXACIN | Active Comparator | After the surgery, the antibiotic is intracameral administered, Moxifloxacin 0.5% 0.1mL. |
|
| TOPICAL MOXIFLOXACIN | Active Comparator | After the surgery, the antibiotic is topical administered, Moxifloxacin 0.5% 0.1mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular Instillation Solution | Drug | Intracameral Moxifloxacin 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endophthalmitis | Evaluate the incidence of Endophthalmitis | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Ophthalmology - UNIFESP/Hospital São Paulo | Recruiting | São Paulo | São Paulo | 04023-062 | Brazil |
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| ID | Term |
|---|---|
| D009877 | Endophthalmitis |
| D065306 | Corneal Injuries |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D005128 | Eye Diseases |
| D005131 | Eye Injuries |
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| ID | Term |
|---|---|
| D000097807 | Intracameral Injection |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Moxifloxacin Ophthalmic | Drug | Topical Moxifloxacin 0.5% |
|
| D005151 |
| Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D003316 | Corneal Diseases |
| D014947 | Wounds and Injuries |
| D013812 |
| Therapeutics |