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Endophthalmitis Post Intravitreal Injections

NCT04035369 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-05-11

No results posted yet for this study

Summary

Intravitreal injection (IVI) is an ophthalmological procedure used worldwide to treat ocular conditions. Its use has been steadily increasing for several years, because this method of drug delivery minimizes systemic exposure and allows for intraocular drug levels not achievable through systemic or topical drug administration. IVI of agents such as anti-vascular endothelial growth factor (anti-VEGF) or corticosteroids are efficacious for several retinal diseases, including age-related macular degeneration, macular edema due to retinal vein occlusion or diabetic macular edema, and uveitis, among others. But IVIs are not without their risk of complications and the most feared of which is infectious endophthalmitis, which can occur following intravitreal injections and has potentially devastating visual consequences, including loss of vision and/or the eye itself. Although endophthalmitis´s incidence ranges from 0-0.2% per infection, the cumulative risk for patients under sequential treatment may equate to more than 1% after 2 years of treatment. Endophthalmitis management following IVIs generally consists of a vitreous tap and inject (TAI) and/or a pars plana vitrectomy (PPV) with intravitreal injection of antibiotics. However, there is no consensus on the optimal treatment of IVI-related endophthalmitis. Thus, an established treatment protocol for IVI-related endophthalmitis is warranted to optimize patient outcomes.

The aim of this study is to determine whether PPV or TAI is superior for the treatment of IVI-related endophthalmitis.

Conditions

  • Endophthalmitis

Interventions

PROCEDURE

Tap and Inject (TAI)

Patients randomized to the TAI group will have a 0.2 mL vitreous specimen collected and a 0.1 mL anterior chamber paracentesis performed to be sent for standard cultures, Gram stain, and sensitivities. Intravitreal injection of the following antibiotics: Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL (amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy) and an intravitreal injection of dexamethasone 400 mcg/0.1 mL

PROCEDURE

Pars Plana Vitrectomy (PPV)

Patients randomized to the PPV group will undergo a three-port PPV. The patient should be added to the OR list as an A-case (maximum 6 hours wait) and no intravitreal injection should be performed prior to the surgery. A 0.1 mL aqueous humor simple immediately before the surgery. A 0.2 mL vitreous specimen will be obtained after the sclerotomies are placed. The PPV procedure should be limited to core vitrectomy, air fluid exchange and intravitreal injections (antibiotics and dexamethasone - Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL or amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy and an intravitreal injection of dexamethasone 400 mcg/0.1 mL). Other tamponades such as silicone oil should be avoided if possible. The PPV will then be completed by the surgeon and the vitreous specimen will be sent for standard cultures, Gram stain, and sensitivities.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035369 on ClinicalTrials.gov