Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Not Applicable

Completed

• Conditions: Endophthalmitis
• Interventions: Drug: Intravitreal Antibiotic Injection; Procedure: Pars Plana Vitrectomy

• Registration Number: NCT04192994
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-10
• Primary Completion: 2020-01-01
• Study Completion: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Pars Plana Vitrectomy	Intravitreal Antibiotic Injection	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.
Group 1: Antibiotic injection	Pars Plana Vitrectomy	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.

Primary Outcome Measures

Name	Time	Method
Ocular Anatomy	1 year	The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Best Correct Visual Acuity	1 year	The Final Visual acuity will be measured after 1 year
Electroretinography Response (ERG Response)	1 year	The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)

Trial Locations

Locations (1)

Dept of Ophthalmology - UNIFESP/Hospital São Paulo; 🇧🇷 São Paulo, SP, Brazil