Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

NCT04192994 | Completed

• 1 other identifier: END_2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Endophthalmitis

Outcome Measures

Primary Outcomes (3)

• Best Correct Visual Acuity

  The Final Visual acuity will be measured after 1 year

  1 year

• Ocular Anatomy

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

  1 year

• Electroretinography Response (ERG Response)

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

  1 year

Study Arms (2)

Group 1: Antibiotic injection

ACTIVE COMPARATOR

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

Group 2: Pars Plana Vitrectomy

ACTIVE COMPARATOR

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

Interventions

Intravitreal Antibiotic Injection DRUG

Intravitreal Antibiotic Injection

Also known as: Tap Injection

Group 2: Pars Plana Vitrectomy

Pars Plana Vitrectomy PROCEDURE

Pars Plana Vitrectomy

Also known as: PPV

Group 1: Antibiotic injection

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute endophthalmitis with a history of ocular surgical procedures and a follow-up time of less than 6 weeks will be included.

You may not qualify if:

• Patients with endophthalmitis lasting more than 6 weeks and no history of eye surgery will be excluded.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Vinicius Campos Bergamo: collaborator
• Nilva Simeren Bueno de Moraes: collaborator
• Luis Filipe Nakayama: collaborator
• Natasha Ferreira Santos da Cruz: collaborator
• Murilo Ubukata Polizelli: collaborator

Study Sites (1)

Dept of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (1)

• Bergamo VC, Nakayama LF, de Moraes NSB, Tavares IM, De Queiroz Campos MS, Hofling-Lima AL, Maia M. Postoperative endophthalmitis treatment with antibiotics associated or not with pars plana vitrectomy: a randomized clinical trial. Int J Retina Vitreous. 2025 Feb 18;11(1):18. doi: 10.1186/s40942-025-00640-1.

  PMID: 39966901 DERIVED

MeSH Terms

Conditions

Endophthalmitis

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin. Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: December 10, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)