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

Launched by MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST · Aug 20, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a surgical treatment called early vitrectomy for patients who develop a serious eye infection known as postoperative exogenous endophthalmitis after eye surgery. The goal is to see if this early surgery, combined with antibiotic injections directly into the eye, is more effective than the standard treatment, which involves only the antibiotic injections. This study is important because it will help researchers understand how well early vitrectomy might work, which could lead to a larger trial in the future.

To participate in this trial, you need to be at least 18 years old and have had eye surgery that resulted in this specific type of infection. You should also be able to give informed consent, meaning you understand what the study involves. There are some health conditions that might prevent you from joining, such as certain recent health events or serious medical issues. If you decide to take part, you’ll receive either the early vitrectomy plus antibiotics or the standard treatment, and your progress will be closely monitored. It's a chance to contribute to important research that could improve treatment options for this eye condition.

Gender

ALL

Eligibility 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