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Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

Primary Purpose

Endophthalmitis

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intravitreal Antibiotic Injection
Pars Plana Vitrectomy
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endophthalmitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept of Ophthalmology - UNIFESP/Hospital São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: Antibiotic injection

Group 2: Pars Plana Vitrectomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 15, 2019
Last Updated
December 5, 2021
Sponsor
Federal University of São Paulo
Collaborators
Vinicius Campos Bergamo, Nilva Simeren Bueno de Moraes, Luis Filipe Nakayama, Natasha Ferreira Santos da Cruz, Murilo Ubukata Polizelli
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1. Study Identification

Unique Protocol Identification Number
NCT04192994
Brief Title
Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
Official Title
Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Vinicius Campos Bergamo, Nilva Simeren Bueno de Moraes, Luis Filipe Nakayama, Natasha Ferreira Santos da Cruz, Murilo Ubukata Polizelli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endophthalmitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Antibiotic injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Pars Plana Vitrectomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravitreal Antibiotic Injection
Other Intervention Name(s)
Tap Injection
Intervention Description
Intravitreal Antibiotic Injection
Intervention Type
Procedure
Intervention Name(s)
Pars Plana Vitrectomy
Other Intervention Name(s)
PPV
Intervention Description
Pars Plana Vitrectomy
Primary Outcome Measure Information:
Title
Best Correct Visual Acuity
Description
The Final Visual acuity will be measured after 1 year
Time Frame
1 year
Title
Ocular Anatomy
Description
The Ocular Anatomy will be evaluated after 1 year, with axial length measured by ocular ultrasound (millimeters)
Time Frame
1 year
Title
Electroretinography Response (ERG Response)
Description
The ERG Response will be evaluated after 1 year, measured by Electroretinography (millivolts)
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
18+
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dept of Ophthalmology - UNIFESP/Hospital São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis

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