An interventional study of Intravitreal Antibiotic Injection and Pars Plana Vitrectomy in Endophthalmitis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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
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.
55 studies on the registry are indexed under Endophthalmitis; 8 are open to participants now.
This study's enrollment of 25 is below the median of 113 across 32 interventional studies indexed under Endophthalmitis.
Browse Endophthalmitis studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: Tap Injection
Pars Plana Vitrectomy
Also known as: PPV
Best Correct Visual Acuity
The Final Visual acuity will be measured after 1 year
Time frame: 1 year
Ocular Anatomy
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Time frame: 1 year
Electroretinography Response (ERG Response)
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo