Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Endophthalmitis Clinical Trial

Official title:

Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192994
• Other study ID #: END_2019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 1, 2023
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endophthalmitis

Intervention

Drug:
• Intravitreal Antibiotic Injection
Intravitreal Antibiotic Injection

Procedure:
• Pars Plana Vitrectomy
Pars Plana Vitrectomy

Locations

Country	Name	City	State
Brazil	Dept of Ophthalmology - UNIFESP/Hospital São Paulo	São Paulo	SP

Sponsors (6)

Lead Sponsor	Collaborator
Federal University of São Paulo	Luis Filipe Nakayama, Murilo Ubukata Polizelli, Natasha Ferreira Santos da Cruz, Nilva Simeren Bueno de Moraes, Vinicius Campos Bergamo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Correct Visual Acuity	The Final Visual acuity will be measured after 1 year	1 year
Primary	Ocular Anatomy	The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)	1 year
Primary	Electroretinography Response (ERG Response)	The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)	1 year