Status:
COMPLETED
A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous Endophthalmitis
Lead Sponsor:
Moorfields Eye Hospital NHS Foundation Trust
Collaborating Sponsors:
University College, London
King's College London
Conditions:
Endophthalmitis Postoperative Acute
Eligibility:
All Genders
18-95 years
Phase:
NA
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 inves...
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 endophtha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04522661
Start Date
August 12 2021
End Date
February 4 2025
Last Update
July 3 2025
Active Locations (1)
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1
Moorfields Eye Hospital
London, United Kingdom