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

Endophthalmitis Postoperative Acute Clinical Trial

— EVIAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522661
• Other study ID #: MUQM1006
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: September 10, 2024

Study information

• Verified date: February 2024
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: Hayley Boston
• Phone: moorfields.resadmin@nhs.net
• Email: moorfields.resadmin[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 10, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Endophthalmitis
• Endophthalmitis Postoperative Acute

Intervention

Procedure:
• Vitrectomy
Vitrectomy within 48 hours of randomisation
• Intravitreal antibiotics
Intravitreal Antibiotics at 48 hours

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	King's College London, University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient recruitment	Number of participants	Trial study period (Week 1 to Week 104)
Secondary	Distance Best Corrected Visual Acuity change from baseline	Early Treatment Diabetic Retinopathy Study (ETDRS) letters	Trial study period (Week 1 to Week 24)