ENDOPHTHALMITIS VITRECTOMY STUDY

眼内炎玻璃体切除术研究（EVS）是一项前瞻性、随机、 多中心临床试验，主要目的是确定 睫状体平坦部玻璃体切除术在细菌性角膜炎初期治疗中的应用 白内障手术或二期透镜植入术后眼内炎。 符合入选标准的患者将接受目前两种治疗之一 治疗细菌性眼内炎的公认策略。 眼睛 将随机分配至1）初始睫状体平坦部玻璃体切除术， 玻璃体内抗生素，然后在36-60小时时重新敲击和重新注射 对于研究中定义的表现不佳的眼睛，或2）初始前房 腔和玻璃体穿刺/活组织检查，玻璃体内注射抗生素， 随后在36-60小时对表现不佳的眼睛进行玻璃体切除术和再注射。 此外，将所有眼睛随机分配至使用或不使用 静脉注射抗生素 研究终点是视力和眼介质的清晰度，后者 在临床和病理学上都进行了评估。 初始终点评估 将在3个月后发生，之后可能需要的后期程序 提高视力，如晚期玻璃体切除术以清除非透明眼 媒体可以进行。 最终结局评估将在9个月时进行。 多中心合作招募420只眼 为期42个月。 这是主要的应用程序，与一个 申请协调中心和申请照片阅读中心。 一旦研究设计完成，将征集临床中心的申请 已获批准。 研究的操作手册草案作为 本申请的组成部分。

The Endophthalmitis Vitrectomy Study (EVS) is a prospective, randomized, multicenter clinical trial with the primary goal of determining the role of pars plana vitrectomy in the initial management of patients with bacterial endophthalmitis following cataract surgery or secondary lens implantation. Patients who meet entry criteria will be treated with one of two presently accepted strategies for the management f bacterial endophthalmitis. Eyes will be randomized to either 1) initial pars plana vitrectomy with intravitreal antibiotics, followed by retap and reinjection at 36-60 hours for eyes doing poorly as defined in the study, or 2) initial anterior chamber and vitreous tap/biopsy with injection of intravitreal antibiotics, followed by vitrectomy and reinjection at 36-60 hours in eyes doing poorly. In addition, all eyes will be randomized to the use or non use of intravenous antibiotics. Study endpoints are visual acuity and clarity of ocular media, the latter assessed both clinically and photographically. Initial endpoint assessment will occur at 3 months, after which late procedures which may be required to improve vision, such as late vitrectomy to clear non-clearing ocular media, may be performed. Final outcome assessment will occur at 9 months. Multiple centers will cooperate in enrolling 420 eyes during a recruitment period of 42 months. This is the lead application, being submitted in conjunction with an application for a coordinating center, and for a photo reading center. Applications for clinical centers will be solicited once the study design is approved. A draft manual of operations for the study is included as an integral part of this application.