ENDOPHTHALMITIS VITRECTOMY--CLINICAL CENTER

眼内炎玻璃体切除术--临床中心

• 批准号: 3559754
• 负责人: HERBERT L CANTRILL
• 金额: $ 2.4万
• 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/3559754
• 关键词: anterior chamber; antibiotics; biopsy; 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 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 公认的细菌性眼内炎管理策略。 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 ℃时重新穿刺和重新注射 研究中定义的眼睛表现不佳的时间，或2）初始 前房和玻璃体穿刺/玻璃体内注射活组织检查 抗生素，随后进行玻璃体切除术，并在36岁时重新注射抗生素。 60个小时的眼睛做得很差。 此外，将对所有眼睛进行随机化 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。 初始端点 评估将在3个月后进行，之后可能 可能需要进行晶状体囊切开术等改善视力的手术。 最终结局评估将在9个月时进行。 本申请将成为眼内炎的临床中心 玻璃体切除术研究，并与其他临床中心合作， 研究招募目标为42个月内招募420只眼睛。