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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endophthalmitis Postoperative Acute
• Intervention / Treatment: Procedure: Vitrectomy; Procedure: Intravitreal antibiotics

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayley Boston; Phone Number: moorfields.resadmin@nhs.net; Email: moorfields.resadmin@nhs.net
• Study Contact Backup: Name: Mahi Muqit, PhD FRCOphth; Email: mahi.muqit1@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Moorfields Eye Hospital
    • Contact: Hayley Boston
    • Principal Investigator: Mahi Muqit, PhD FRCOphth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Vitrectomy Group; Vitrectomy surgery plus intravitreal antibiotics	Procedure: Vitrectomy; Vitrectomy within 48 hours of randomisation; Procedure: Intravitreal antibiotics; Intravitreal Antibiotics at 48 hours
Active Comparator: Control Group; Intravitreal antibiotics	Procedure: Intravitreal antibiotics; Intravitreal Antibiotics at 48 hours

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust
• Collaborators: King's College London; University College, London
• Investigators: Principal Investigator: Mahi MK Muqit, PhD FRCOphth, Moorfields Eye Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.
• Negretti GS, Chan W, Pavesio C, Muqit MMK. Vitrectomy for endophthalmitis: 5-year study of outcomes and complications. BMJ Open Ophthalmol. 2020 Mar 24;5(1):e000423. doi: 10.1136/bmjophth-2019-000423. eCollection 2020.
• Busbee BG, Recchia FM, Kaiser R, Nagra P, Rosenblatt B, Pearlman RB. Bleb-associated endophthalmitis: clinical characteristics and visual outcomes. Ophthalmology. 2004 Aug;111(8):1495-503; discussion 1503. doi: 10.1016/j.ophtha.2004.01.028.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Estimated): September 10, 2024
• Study Completion (Estimated): September 10, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: vitrectomy; intravitreal antibiotics
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections; Endophthalmitis; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: MUQM1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results to be reported in an International Committee of Medical Journal Editors journal after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. The access should only be for individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No