Recruiting

Observational Study

Sponsor:

Unity Health Toronto

Code:

NCT04035369

Conditions

Endophthalmitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tap and Inject (TAI)

Pars Plana Vitrectomy (PPV)

Study Details

Brief 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

Study ID

NCT04035369

Start date

Mar 1, 2020

Status verified date

May, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 18 years and older
  • Intravitreal injections other than intravitreal steroids within the last 2 weeks
  • Diagnosed with presumed infectious endophthalmitis: patients presenting with vision loss and hypopyon
  • Visual acuity of light perception or better
  • Safety concern by the treating physician for patients enrolled in the study. That is to say, if the physician feels a patient's outcomes would be better with one intervention over the other, this patient should not be enrolled in the study.

Exclusion Criteria:

  • Prior intraocular surgery in the study eye within the last 3 months
  • Prior penetrating ocular trauma
  • Bleb or prior glaucoma filtration surgery in the study eye
  • Patients with other ocular conditions limiting vision in the study eye other than the retinal pathology for which they receive intravitreal injections for e.g. anterior segment pathology, retinal detachments, end-stage glaucoma
  • Previous vitreo-retinal surgery.
  • Unwilling or unable to follow or comply with all study-related procedures or sign consent form

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Endophthalmitis Post Intravitreal Injections - TAI

Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to TAI

active comparator: Endophthalmitis Post Intravitreal Injections - PPV

Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to PPV

Interventions

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

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.

Primary outcome measure

  • Visual acuity outcomes [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

St. Michael's Hospital Eye Clinic

Recruiting

Toronto, Ontario, Canada, M5C2T2

Contacts

Rajeev Muni, MD Msc FRCSC

4168677411rajeev.muni@gmail.com

Phillip To

4168677411top@smh.ca

More Information

Sponsor

Unity Health Toronto

Last update posted

May 11, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2023-05-11.