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| Name | Class |
|---|---|
| Vinicius Campos Bergamo | UNKNOWN |
| Nilva Simeren Bueno de Moraes | UNKNOWN |
| Luis Filipe Nakayama | UNKNOWN |
| Natasha Ferreira Santos da Cruz |
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Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy
Endophthalmitis, a severe inflammatory ocular condition with profound visual impairment that can lead to irreversible visual loss, requires immediate treatment.
The only multicenter randomized trial of different forms of acute endophthalmitis treatment was the Endophthalmitis Vitrectomy Study. The study concluded that intravitreal antibiotic injection improves visual prognosis, and pars plana vitrectomy (PPV) improves the final visual acuity (VA) when performed in patients with light perception or worse VA.
Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy.
Primary Endpoint: The final VA, ocular anatomy, retinal layer anatomy, and ERG response in the intravitreal injection group will be compared with the PPV group.
Secondary Endpoint: The final VA, eyeball anatomy, retinal layer anatomy, and ERG response in the group that underwent PPV will be compared with and without oral moxifloxacin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Antibiotic injection | Active Comparator | A total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected with a 30-gauge needle into the vitreous cavity of the affected eyes in the randomized group, as soon as the diagnosis is confirmed. |
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| Group 2: Pars Plana Vitrectomy | Active Comparator | Randomized patients will undergo PPV. Briefly, a blepharostat will be placed followed by instillation of a drop of 5% iodine-povidone over the eye. Under a surgical microscope, three 23-gauge or 25-gauge sclerotomies will be performed. Vitreous core vitrectomy will be performed, and a fluid-gas exchange with balanced saline solution (BSS) or 5,000 grams of silicone oil as a vitreous substitute. At the end of surgery, all sclerotomies will be sutured with Vicryl 7.0 and a total of 0.05 ml of vancomycin 1 mg and 0.05 ml of ceftazidime 2.25 mg will be injected into the vitreous cavity. As soon as the diagnosis is confirmed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Antibiotic Injection | Drug | Intravitreal Antibiotic Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Correct Visual Acuity | The Final Visual acuity will be measured after 1 year | 1 year |
| Ocular Anatomy | The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters) | 1 year |
| Electroretinography Response (ERG Response) | The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
18+
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Ophthalmology - UNIFESP/Hospital São Paulo | São Paulo | São Paulo | 04023-062 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39966901 | Derived | Bergamo VC, Nakayama LF, de Moraes NSB, Tavares IM, De Queiroz Campos MS, Hofling-Lima AL, Maia M. Postoperative endophthalmitis treatment with antibiotics associated or not with pars plana vitrectomy: a randomized clinical trial. Int J Retina Vitreous. 2025 Feb 18;11(1):18. doi: 10.1186/s40942-025-00640-1. |
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| ID | Term |
|---|---|
| D009877 | Endophthalmitis |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019152 | Paracentesis |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
| Murilo Ubukata Polizelli | UNKNOWN |
Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin.
Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.
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| Pars Plana Vitrectomy | Procedure | Pars Plana Vitrectomy |
|
|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |