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Clinical trial

Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

ID
Name
END_2019
Description
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
Trial arms
Trial start
2019-01-01
Estimated PCD
2020-01-01
Trial end
2023-12-01
Status
Completed
Treatment
Intravitreal Antibiotic Injection
Intravitreal Antibiotic Injection
Arms:
Group 2: Pars Plana Vitrectomy
Other names:
Tap Injection
Pars Plana Vitrectomy
Pars Plana Vitrectomy
Arms:
Group 1: Antibiotic injection
Other names:
PPV
Size
25
Primary endpoint
Best Correct Visual Acuity
1 year
Ocular Anatomy
1 year
Electroretinography Response (ERG Response)
1 year
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin.\n\nGroup 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-05-24

1 organization

1 product

1 indication

Organization
Federal University of São Paulo
Product
Intravitreal Antibiotic
Indication
Endophthalmitis