ENDOPHTHALMITIC VITRECTOMY STUDY

眼内炎玻璃体切除术研究

• 批准号: 3552177
• 负责人: BERNARD H DOFT
• 金额: $ 7.38万
• 依托单位: EYE AND EAR HOSPITAL OF PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-07-01 至 1994-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3552177
• 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、 多中心临床试验的主要目标是确定 平坦部玻璃体切除术在细菌性感染患者的初始治疗中的应用 白内障手术或二次晶状体植入后的眼内炎。 符合入组标准的患者将接受目前两种治疗方法之一 治疗细菌性眼内炎的公认策略。 眼睛 将被随机分配到 1) 初始平坦部玻璃体切除术 玻璃体内注射抗生素，然后在 36-60 小时重新注射 对于研究中定义的表现不佳的眼睛，或 2) 最初的前部 腔室和玻璃体穿刺/活检并注射玻璃体内抗生素， 随后进行玻璃体切除术，并在 36-60 小时内对状况不佳的眼睛进行重新注射。 此外，所有眼睛将被随机选择使用或不使用 静脉注射抗生素。 研究终点是视力和眼介质清晰度，后者 通过临床和摄影进行评估。 初始终点评估 3个月后发生，此后可能需要办理较晚的手续 改善视力，例如晚期玻璃体切除术以清除非透明眼部 媒体，可以执行。 最终结果评估将在 9 个月时进行。 多个中心将合作招募420只眼睛 期限为42个月。 这是主要申请，与 申请协调中心和照片阅读中心。 研究设计完成后将征集临床中心的申请 已获批准。 该研究的操作手册草案作为 该应用程序的组成部分。