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

NCT04522661 | Completed

• 1 other identifier: MUQM1006
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Endophthalmitis Postoperative Acute

Keywords

vitrectomy; intravitreal antibiotics

Outcome Measures

Primary Outcomes (1)

• Patient recruitment

  Number of participants

  Trial study period (Week 1 to Week 104)

Secondary Outcomes (1)

• Distance Best Corrected Visual Acuity change from baseline

  Trial study period (Week 1 to Week 24)

Study Arms (2)

Early Vitrectomy Group

EXPERIMENTAL

Vitrectomy surgery plus intravitreal antibiotics

Procedure: Vitrectomy; Procedure: Intravitreal antibiotics

Control Group

ACTIVE COMPARATOR

Intravitreal antibiotics

Procedure: Intravitreal antibiotics

Interventions

Vitrectomy PROCEDURE

Vitrectomy within 48 hours of randomisation

Early Vitrectomy Group

Intravitreal antibiotics PROCEDURE

Intravitreal Antibiotics at 48 hours

Control Group; Early Vitrectomy Group

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• University College, London: collaborator
• King's College London: collaborator

Study Sites (1)

Moorfields Eye Hospital

London, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 7487614 BACKGROUND

• 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.

  PMID: 32258421 BACKGROUND

• 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.

  PMID: 15288977 BACKGROUND

• 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.

  PMID: 39139269 DERIVED

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mahi MK Muqit, PhD FRCOphth

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised control trial

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: August 12, 2021
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• 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.

Locations

GB (1)