Endophthalmitis Postoperative AcuteEVIANNCT04522661
A Feasibility Randomised Controlled Trial of Early Vitrectomy for Post-operative Exogenous Endophthalmitis
A study testing Vitrectomy and Intravitreal antibiotics in people with Endophthalmitis Postoperative Acute, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Endophthalmitis Postoperative Acute
- What is being tested?
- Vitrectomy and Intravitreal antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2021to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)
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.
- Conditions
- Endophthalmitis Postoperative Acute
- Being tested
- Vitrectomy, Intravitreal antibiotics
- Keywords
- vitrectomy, intravitreal antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Vitrectomy within 48 hours of randomisation
Intravitreal antibioticsProcedure or surgery
Intravitreal Antibiotics at 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Early Vitrectomy Group | Experimental | Vitrectomy surgery plus intravitreal antibiotics Receives: Procedure: Vitrectomy; Procedure: Intravitreal antibiotics |
| Control Group | Active comparator | Intravitreal antibiotics Receives: Procedure: Intravitreal antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment
Number of participants
Measured: 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
Measured: Trial study period (Week 1 to Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start12 Aug 2021
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endophthalmitis Postoperative AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, King's College London
- Responsible party
- Sponsor
- Investigators
- Mahi MK Muqit, PhD FRCOphth, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522661
- Sponsor's protocol ID
- MUQM1006
- Acronym
- EVIAN
- Status last verified
- Jun 2025
- First submitted
- 13 Aug 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
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 7487614Negretti 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 32258421Busbee 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 15288977Muqit MM, Pavesio C, Wang Y, Cobb S, Spink C, Pizzo E, Clare G, Hay G, Wafa HA, Wang J, Boston H, Sriharan K; Early Vitrectomy, Intravitreal Antibiotics for Endophthalmitis (EVIAN) Study Group; Bainbridge J. Early vitrectomy and intravitreal antibiotics for post-operative exogenous endophthalmitis (EVIAN): a randomised control trial of feasibility. Commun Med (Lond). 2026 Jul 16;6(1):419. doi: 10.1038/s43856-026-01664-w.
PubMed 42463897Muqit 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)
- ClinicalTrials.gov ID
- NCT04522661
- Acronym / sponsor ID
- EVIAN / MUQM1006
- Conditions
- Endophthalmitis Postoperative Acute
- Keywords
- vitrectomy, intravitreal antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London, King's College London
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Early Vitrectomy Group | Experimental | Procedure: Vitrectomy, Procedure: Intravitreal antibioticsVitrectomy surgery plus intravitreal antibiotics |
| Control Group | Active comparator | Procedure: Intravitreal antibioticsIntravitreal antibiotics |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitrectomyVitrectomy within 48 hours of randomisation | Procedure or surgery | Early Vitrectomy Group |
| Intravitreal antibioticsIntravitreal Antibiotics at 48 hours | Procedure or surgery | Control Group, Early Vitrectomy Group |
Primary outcome
Patient recruitment
Time frame: Trial study period (Week 1 to Week 104)
Number of participants
1 secondary outcome
Distance Best Corrected Visual Acuity change from baseline
Time frame: Trial study period (Week 1 to Week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 7487614Results 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.
- Background: PubMed 32258421Negretti 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.
- Background: PubMed 15288977Busbee 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.
- Derived from this study: PubMed 42463897Muqit MM, Pavesio C, Wang Y, Cobb S, Spink C, Pizzo E, Clare G, Hay G, Wafa HA, Wang J, Boston H, Sriharan K; Early Vitrectomy, Intravitreal Antibiotics for Endophthalmitis (EVIAN) Study Group; Bainbridge J. Early vitrectomy and intravitreal antibiotics for post-operative exogenous endophthalmitis (EVIAN): a randomised control trial of feasibility. Commun Med (Lond). 2026 Jul 16;6(1):419. doi: 10.1038/s43856-026-01664-w.
- Derived from this study: PubMed 39139269Muqit 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.
- Individual participant dataSharing planned: 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)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahi MK Muqit, PhD FRCOphth principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy and Intravitreal antibiotics in people with Endophthalmitis Postoperative Acute, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment (time frame: Trial study period (Week 1 to Week 104)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522661, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.