Early vitrectomy for treating postoperative endophthalmitis
Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)
This study is testing if early vitrectomy surgery, along with antibiotic treatment, can help people with acute postoperative endophthalmitis recover better than standard care alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Moorfields Eye Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04522661 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility and acceptability of performing early vitrectomy surgery compared to standard treatment for acute postoperative endophthalmitis. Patients diagnosed with this condition will be recruited within 48 hours of their initial presentation and randomized to receive either early vitrectomy plus intravitreal antibiotics or standard care with intravitreal antibiotic injections. The study aims to assess the effectiveness of the surgical intervention and gather data to inform a larger definitive trial. Follow-up assessments will include visual acuity and imaging techniques over a period of 6 months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with postoperative endophthalmitis and a best corrected visual acuity worse than 35 ETDRS letters.
Not a fit: Patients with a best corrected visual acuity of 35 ETDRS letters or better will not benefit from this study as they will continue with standard care.
Why it matters
Potential benefit: If successful, this approach could lead to improved visual outcomes for patients suffering from postoperative endophthalmitis.
How similar studies have performed: While this approach is being evaluated for feasibility, similar studies have shown promising results with early surgical interventions in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Moorfields Eye Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mahi MK Muqit, PhD FRCOphth — Moorfields Eye Hospital NHS Foundation Trust
- Study coordinator: Hayley Boston
- Email: moorfields.resadmin@nhs.net
- Phone: moorfields.resadmin@nhs.net
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.