ENDOPHTHALMITIS VITRECTOMY--CLINICAL CENTER

眼内炎玻璃体切除术--临床中心

• 批准号: 3559757
• 负责人: HERBERT L CANTRILL
• 金额: $ 0.68万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 1989
• 资助国家: 美国
• 起止时间: 1989-12-01 至 1993-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559757
• 关键词: anterior chamber; antibiotics; biopsy; cataract surgery; clinical trials; 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 multi-center clinical trial with a 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 of bacterial endophthalmitis. Eyes will be randomized to either 1) initial pars plana vitrectomy with intravitreal antibiotics, followed by re-tap and re-injection 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 re-injection of antibiotics at 36- 60 hours in eyes doing poorly. In addition, all eyes will be randomized to either 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 capsulotomy, may be performed. Final outcome assessment will occur at 9 months. This application is to be a clinical center in the Endophthalmitis Vitrectomy Study, and to cooperate with other clinical centers to achieve the study recruitment goal of 420 eyes over 42 months.

眼内炎玻璃体切割术研究(EVS)是一项前瞻性随机研究 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分再次注射 研究中定义的眼睛表现不佳的小时数，或2)初始 前房玻璃体抽吸/活检联合玻璃体腔内注射 抗生素，然后玻璃体切割术，并在36岁时重新注射抗生素- 在眼睛里呆了60个小时，表现很差。此外，所有眼睛都将被随机分配 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。初始终点 评估将在3个月后进行，之后可能会出现延迟程序 需要改善视力的，例如，可以进行囊膜切开术。 最终结果评估将在9个月后进行。 本应用是眼内炎的临床治疗中心 玻璃体切割研究，并与其他临床中心合作实现 这项研究的招募目标是在42个月内招募420只眼睛。