Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1: Antibiotic injection 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
Pars Plana Vitrectomy
Other Names:
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| Active Comparator: Group 2: Pars Plana Vitrectomy 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
Intravitreal Antibiotic Injection
Other Names:
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Outcome Measures
Primary Outcome Measures
- Best Correct Visual Acuity [1 year]
The Final Visual acuity will be measured after 1 year
- Ocular Anatomy [1 year]
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
- Electroretinography Response (ERG Response) [1 year]
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept of Ophthalmology - UNIFESP/Hospital São Paulo | São Paulo | SP | Brazil | 04023-062 |
Sponsors and Collaborators
- Federal University of São Paulo
- Vinicius Campos Bergamo
- Nilva Simeren Bueno de Moraes
- Luis Filipe Nakayama
- Natasha Ferreira Santos da Cruz
- Murilo Ubukata Polizelli
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- END_2019