ENDOPHTHALMITIS VITRECTOMY--CLINICAL CENTER

眼内炎玻璃体切除术--临床中心

• 批准号: 2162381
• 负责人: BERNARD H DOFT
• 金额: $ 11.24万
• 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: 1990-12-01 至 1994-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2162381
• 关键词: anterior chamber; antibiotics; bacterial cytopathogenic effect; biopsy; cataract surgery; clinical trials; cooperative study; drug administration routes; eye pharmacology; human subject; injection /infusion; longitudinal human study; postoperative complications; refractive keratoplasty; uveitis

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 late vitrectomy to clear non-clearing ocular media, or 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.

眼内炎玻璃体切除术研究 (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 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 时重新注射并重新注射 根据研究中的定义，眼睛表现不佳的小时数，或 2) 初始前房 腔室和玻璃体穿刺/活检并注射玻璃体内抗生素， 然后在 36-60 小时进行玻璃体切除术并重新注射抗生素 眼睛表现不佳。 此外，所有眼睛将被随机分配到 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 可以进行中膜切开术或囊切开术。 最终结果评估将 发生在9个月时。 该应用程序将成为眼内炎的临床中心 玻璃体切除研究，并与其他临床中心合作实现 研究招募目标是 42 个月内招募 420 只眼睛。