Endophthalmitis
Conditions
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
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.
Interventions
DRUGIntravitreal Antibiotic Injection
Intravitreal Antibiotic Injection
PROCEDUREPars Plana Vitrectomy
Pars Plana Vitrectomy
Sponsors
Vinicius Campos Bergamo
Nilva Simeren Bueno de Moraes
Luis Filipe Nakayama
Natasha Ferreira Santos da Cruz
Murilo Ubukata Polizelli
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Outcome results
None listed