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

Primary Purpose

Endophthalmitis Postoperative Acute

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Vitrectomy

Intravitreal antibiotics

About this trial

This is an interventional treatment trial for Endophthalmitis Postoperative Acute focused on measuring vitrectomy, intravitreal antibiotics

Eligibility Criteria

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

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 within 6 weeks of ocular surgery/procedure/injection
Best corrected visual acuity worse than 35 ETDRS letters

Exclusion Criteria:

Patient suffered a major thromboembolic event within the past 3 months as (defined as transient ischaemic attack, Stroke, or myocardial infarction)
Patient has major surgery planned over the next 12 months defined as requiring general anaesthesia or reduced mobilisation
Known adverse reaction to intravitreal antibiotics (amikacin/vancomycin/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

Sites / Locations

Moorfields Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Vitrectomy Group

Control Group

Arm Description

Vitrectomy surgery plus intravitreal antibiotics

Intravitreal antibiotics

Outcomes

Primary Outcome Measures

Patient recruitment

Number of participants

Secondary Outcome Measures

Distance Best Corrected Visual Acuity change from baseline

Early Treatment Diabetic Retinopathy Study (ETDRS) letters

Full Information

NCT ID

NCT04522661

First Posted

August 13, 2020

Last Updated

August 19, 2021

Sponsor

Moorfields Eye Hospital NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04522661

Brief Title

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

Acronym

EVIAN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 12, 2021 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Moorfields Eye Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Endophthalmitis Postoperative Acute

Keywords

vitrectomy, intravitreal antibiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised control trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Vitrectomy Group

Arm Type

Experimental

Arm Description

Vitrectomy surgery plus intravitreal antibiotics

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Intravitreal antibiotics

Intervention Type

Procedure

Intervention Name(s)

Vitrectomy

Intervention Description

Vitrectomy within 48 hours of randomisation

Intervention Type

Procedure

Intervention Name(s)

Intravitreal antibiotics

Intervention Description

Intravitreal Antibiotics at 48 hours

Primary Outcome Measure Information:

Title

Patient recruitment

Description

Number of participants

Time Frame

Trial study period (Week 1 to Week 104)

Secondary Outcome Measure Information:

Title

Distance Best Corrected Visual Acuity change from baseline

Description

Early Treatment Diabetic Retinopathy Study (ETDRS) letters

Time Frame

Trial study period (Week 1 to Week 24)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 within 6 weeks of ocular surgery/procedure/injection Best corrected visual acuity worse than 35 ETDRS letters Exclusion Criteria: Patient suffered a major thromboembolic event within the past 3 months as (defined as transient ischaemic attack, Stroke, or myocardial infarction) Patient has major surgery planned over the next 12 months defined as requiring general anaesthesia or reduced mobilisation Known adverse reaction to intravitreal antibiotics (amikacin/vancomycin/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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahi MK Muqit, PhD FRCOphth

Organizational Affiliation

Moorfields Eye Hospital NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moorfields Eye Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

7487614

Citation

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.

Results Reference

result

PubMed Identifier

32258421

Citation

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.

Results Reference

result

PubMed Identifier

15288977

Citation

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.

Results Reference

result

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

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