Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

  • Drug: Intravitreal Antibiotic Injection
    • Intravitreal Antibiotic Injection
  • Procedure: Pars Plana Vitrectomy
    • Pars Plana Vitrectomy

Arms, Groups and Cohorts

  • Active Comparator: Group 1: Antibiotic injection
    • 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.
  • Active Comparator: Group 2: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

18+

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Vinicius Campos Bergamo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mauricio Maia, Principal Investigator, Clinical Professor – Federal University of São Paulo

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.