Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
NCT ID: NCT04192994
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-01-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.
TREATMENT
NONE
Study Groups
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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.
Pars Plana Vitrectomy
Pars Plana Vitrectomy
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.
Intravitreal Antibiotic Injection
Intravitreal Antibiotic Injection
Interventions
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Intravitreal Antibiotic Injection
Intravitreal Antibiotic Injection
Pars Plana Vitrectomy
Pars Plana Vitrectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vinicius Campos Bergamo
UNKNOWN
Nilva Simeren Bueno de Moraes
UNKNOWN
Luis Filipe Nakayama
UNKNOWN
Natasha Ferreira Santos da Cruz
UNKNOWN
Murilo Ubukata Polizelli
UNKNOWN
Federal University of São Paulo
OTHER
Responsible Party
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Mauricio Maia
Principal Investigator, Clinical Professor
Locations
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Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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END_2019
Identifier Type: -
Identifier Source: org_study_id
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