Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis: A Feasibility Multicentre Randomised Controlled Trial (EVIAN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Patient recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient recruitment
时间窗: Trial study period (Week 1 to Week 104)
Number of participants
次要结局
- Distance Best Corrected Visual Acuity change from baseline(Trial study period (Week 1 to Week 24))