Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Conditions
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Endophthalmitis

Intervention / Treatment
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* Drug: Intravitreal Antibiotic Injection
* Procedure: Pars Plana Vitrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute endophthalmitis with a history of ocular surgical procedures and a follow-up time of less than 6 weeks will be included. Exclusion Criteria: Patients with endophthalmitis lasting more than 6 weeks and no history of eye surgery will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Antibiotic injection<br>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. | Procedure: Pars Plana Vitrectomy<br>* Pars Plana Vitrectomy<br>* Other names: PPV;|
| Active Comparator: Group 2: Pars Plana Vitrectomy<br>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. | Drug: Intravitreal Antibiotic Injection<br>* Intravitreal Antibiotic Injection<br>* Other names: Tap Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |