Dept of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, 04023-062, Brazil
NCT Number: NCT04192994
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
São Paulo, 04023-062, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal Antibiotic Injection
Other names: Tap Injection
Pars Plana Vitrectomy
Other names: PPV
Time frame: 1 year
The Final Visual acuity will be measured after 1 year
Time frame: 1 year
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Time frame: 1 year
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
Federal University of São Paulo
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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