A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous Endophthalmitis

Study Overview
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Brief Summary
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This randomised clinical trial will explore the feasibility and acceptability of carrying out early vitrectomy surgical treatment compared to standard treatment in acute endophthalmitis. We will investigate the effectiveness of early vitrectomy plus intravitreal antibiotics compared to standard care intravitreal antibiotic injections in the management of postoperative exogenous endophthalmitis. This is a feasibility trial that will evaluate the expected effect size with which to inform the design of a definitive randomized trial of this question.

Detailed Description
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The EVIAN Study is a multicentre, feasibility, randomised controlled trial to evaluate the effect of early vitrectomy surgery on acute endophthalmitis. Patients with postoperative exogenous endophthalmitis following any ocular surgery/procedure/injection intervention will be recruited at 48 hours following initial presentation. Patients with vision of 35 ETDRS letters or better are ineligible for the trial, and would continue on standard of care management. Patients with vision of worse than 35 ETDRS letters will be eligible for the study. At the 48-hour time-point, eligible patients will be randomised in a 1:1 ratio. The treatment group will undergo vitrectomy within 48 hours of randomisation. The control group will have continued intravitreal antibiotic eye injections according to local protocols. If the vision reaches perception of light, then a vitrectomy surgery would be considered as part of standard of care at 12-15 days. Follow up will be for 6 months in both groups. Visual acuity, funds photography, B-scan ultrasound, and optical coherence tomography (OCT) scanning will be performed from baseline until the final follow-up at 24 weeks.

Official Title
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Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)

Conditions
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Endophthalmitis Postoperative Acute

Intervention / Treatment
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* Procedure: Vitrectomy
* Procedure: Intravitreal antibiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient over 18 years of age Patient has capacity to give informed consent Patient has not previously been enrolled in this study in regards to their other eye Diagnosis of postoperative endophthalmitis at any time-point following an ocular surgery/procedure/injection Patient is healthy to undergo vitrectomy surgery Symptomatic Visual loss attributable to POE Best corrected visual acuity worse than 35 ETDRS letters, including CF, HM and POL vision Exclusion Criteria: Patient suffered a major thromboembolic event within the past 3 months as (defined as TIA, Stroke, or MI) Known adverse reaction to intravitreal antibiotics (amikacin/vancomyin/cephalosporins) Blood pressure greater than 200 systolic or 100 diastolic Any other condition that in the opinion of the investigator would preclude participation in the study (such as unstable medical status or severe disease that would make it difficult for the patient to be able to complete the study) The patient will use an investigational drug during the study History of optic atrophy in the study eye Corneal oedema/haze that would prevent visualisation of fundus to perform vitrectomy surgery Patient over the age of 95 who present with POE should immediately be placed on the pre-screening log as ineligible

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Vitrectomy Group<br>Vitrectomy surgery plus intravitreal antibiotics | Procedure: Vitrectomy<br>* Vitrectomy within 48 hours of randomisation<br>Procedure: Intravitreal antibiotics<br>* Intravitreal Antibiotics at 48 hours<br>|
| Active Comparator: Control Group<br>Intravitreal antibiotics | Procedure: Intravitreal antibiotics<br>* Intravitreal Antibiotics at 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient recruitment | Number of participants | Trial study period (Week 1 to Week 104) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance Best Corrected Visual Acuity change from baseline | Early Treatment Diabetic Retinopathy Study (ETDRS) letters | Trial study period (Week 1 to Week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitrectomy, intravitreal antibiotics