A Randomised Controlled Trial of Early Vitrectomy and Intravitreal Antibiotics for Post-operative Exogenous Endophthalmitis (EVIAN study): study protocol for a feasibility trial

早期玻璃体切除术联合玻璃体内注射抗生素治疗术后外源性眼内炎的随机对照试验(EVIAN 研究):可行性试验研究方案

阅读:1

Abstract

Postoperative bacterial endophthalmitis is an infection of the eye's internal tissues resulting from an intraocular procedure. The condition is uncommon but can cause severe and irreversible impairment of sight. Standard management involves administration of antibiotics with or without subsequent removal of the infected vitreous gel by vitrectomy surgery. Surgical intervention is typically reserved for infections that persist despite a period of medical management alone. We aim to determine whether outcomes can be improved by performing surgery without delay. To explore the feasibility of a definitive randomised controlled trial and to determine the number of participants required, we will conduct a multicentre feasibility trial. This trial will include 40 affected individuals, allocated randomly to either standard of care, being intravitreal antibiotic administration alone, or to early vitrectomy surgery in addition to antibiotic administration. We will determine the feasibility and size of a definitive trial by evaluating the participants and the outcomes for their sight. Research Ethics Committee approval (REC 20/WM/0264). Here we describe the trial protocol. Trial registration number:ClinicalTrials.gov NCT04522661.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。