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OpenTrials
Completed

NCT Number: NCT04192994

Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, 04023-062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal Antibiotic Injection

Drug

Intravitreal Antibiotic Injection

Other names: Tap Injection

pars plana vitrectomy

Procedure

Pars Plana Vitrectomy

Other names: PPV

Primary outcomes

  1. Best Correct Visual Acuity

    Time frame: 1 year

    The Final Visual acuity will be measured after 1 year

  2. Ocular Anatomy

    Time frame: 1 year

    The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)

  3. Electroretinography Response (ERG Response)

    Time frame: 1 year

    The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Luis Filipe Nakayama
  • Murilo Ubukata Polizelli
  • Natasha Ferreira Santos da Cruz
  • Nilva Simeren Bueno de Moraes
  • Vinicius Campos Bergamo

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Dec 10, 2019
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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