ENDOPHTHALMITIS VITRECTOMY STUDY

眼内炎玻璃体切除术研究

• 批准号: 3559707
• 负责人: BERNARD H DOFT
• 金额: $ 3.67万
• 依托单位: MONTEFIORE UNIVERSITY HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-10-01 至 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559707
• 关键词: anterior chamber; antibiotics; cataract surgery; cooperative study; drug administration routes; eye pharmacology; human subject; injection /infusion; longitudinal human study; postoperative complications; uveitis; vitrectomy

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.

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，主要目标是确定 玻璃体切割术在细菌性玻璃体切割中的初步应用 白内障手术或二次人工晶状体植入术后的眼内炎。 符合入院标准的患者目前将接受两种治疗之一 细菌性眼内炎的公认治疗策略。眼睛 将被随机分为1)初始玻璃体切割术 玻璃体内注射抗生素，然后在36-60小时内再次注射 对于研究中定义的眼睛表现不佳，或2)初始前部 玻璃体腔内注射抗生素，玻璃体抽吸活组织检查， 玻璃体切除后36-60小时复注效果不佳者。 此外，所有眼睛将被随机分为使用或不使用 静脉注射抗生素。 研究的终点是视力和眼中膜的清晰度，后者 从临床和摄影两方面进行评估。初始终端评估 将在3个月后发生，之后可能需要延迟手术 提高视力，如晚期玻璃体手术清除不透明的眼睛 媒体，可以执行。最终结果评估将在9个月后进行。 在一次招募过程中，多个中心将合作招募420只眼 为期42个月。 这是Lead申请，与一份 申请一个协调中心，以及一个照片阅读中心。 临床中心的申请将在研究设计完成后征集 已获批准。这项研究的操作手册草案包括在 此应用程序的组成部分。