Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 2:35 AM
Study NCT ID:
NCT04522661
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous Endophthalmitis
Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVIAN
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: