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CompletedNCT04522661EVIANUpdated Jul 3, 2025

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

An interventional study of Vitrectomy and Intravitreal antibiotics in Endophthalmitis Postoperative Acute, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endophthalmitis Postoperative Acute

Keywords

  • vitrectomy
  • intravitreal antibiotics
03

In context

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Early Vitrectomy Group

    Vitrectomy surgery plus intravitreal antibiotics

    Procedure: Vitrectomy · Procedure: Intravitreal antibiotics

  • Active comparator
    Control Group

    Intravitreal antibiotics

    Procedure: Intravitreal antibiotics

Interventions

  • ProcedureVitrectomy

    Vitrectomy within 48 hours of randomisation

  • ProcedureIntravitreal antibiotics

    Intravitreal Antibiotics at 48 hours

06

What researchers measure

Primary outcomes

  1. Patient recruitment

    Number of participants

    Time frame: Trial study period (Week 1 to Week 104)

Secondary outcomes

  1. Distance Best Corrected Visual Acuity change from baseline

    Early Treatment Diabetic Retinopathy Study (ETDRS) letters

    Time frame: Trial study period (Week 1 to Week 24)

07

Study locations

1 site
  • Moorfields Eye Hospital
    London, United Kingdom
08

References and documents

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. PubMed 7487614 ↗
  • 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. PubMed 32258421 ↗
  • 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. PubMed 15288977 ↗
  • Muqit MMK, Pavesio C, Boston H, Sriharan K, Wang Y, Pizzo E, Cobb S, Spink C, Bainbridge J. A Randomised Controlled Trial of Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis (EVIAN study): study protocol for a feasibility trial. NIHR Open Res. 2023 Sep 28;3:47. doi: 10.3310/nihropenres.13469.1. eCollection 2023. PubMed 39139269 ↗

Individual participant data

Plan to share: Yes — 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)

Supporting information: Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04522661
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
University College, London, King's College London
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Aug 12, 2021
Primary completion
Feb 4, 2025
Completion
Feb 4, 2025
Last update
Jul 3, 2025

Study contacts

Mahi MK Muqit, PhD FRCOphth
principal investigator · Moorfields Eye Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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