ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL

缺血性视神经病变减压试验

• 批准号: 2387172
• 负责人: SOPHIA M CHUNG
• 金额: $ 1.4万
• 依托单位: SAINT LOUIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2387172
• 关键词: clinical trials; cooperative study; eye surgery; human subject; human therapy evaluation; ischemia; longitudinal human study; nerve decompression; optic nerve disorder; pathologic process; perimetry; postoperative complications; vision tests; visual perception

The Ischemic Optic Neuropathy Decompression Trial (IONDT) is a five year study designed to assess the safety and efficacy of optic nerve sheath decompression surgery (ONDS) for non-arteritic ischemic optic neuropathy, diagnosed within one month of onset of visual symptoms. A standardized, common protocol for treatment and data collection will be used by all centers. This multicenter, randomized clinical trial is designed to compare differences in patients randomized to one of two treatment groups as follows: Treatment Group Treatment Sequences No. of Patients 1. Test Treatment Optic Nerve Sheath 150 Decompression 2. Control Treatment Standard Medical Care 150 (no surgery) The primary hypothesis to be addressed by this trial is whether treatment with ONDS is more effective than standard care in (1) restoring or (2) maintaining central visual acuity in patients with NAION? The primary outcome for this trial (change in visual acuity) will be measured using the New York Lighthouse chart. A gain of three or more lines of visual acuity (doubling of the visual angle) will be considered improvement. Secondary outcomes include change in peripheral visual function (using standard Goldman perimetry) and incidence ophthalmic and systemic complications. Patients will be recruited over a two year period and followed for a minimum of one year. Study Centers will include a Chairman's Center, 26 Clinical Centers, and centralized facilities, including a Coordinating Center, a Reading Center, and a Project Office at the National Eye Institute.

缺血性视神经病变减压试验(IONDT)为期五年 一项旨在评估视神经鞘安全性和有效性的研究 非动脉炎性缺血性视神经病变的减压术 在视觉症状出现后一个月内确诊。一个标准化的， 将使用共同的治疗和数据收集方案 各中心注意。这项多中心随机临床试验旨在 比较随机分为两个治疗组的患者的差异 详情如下： 治疗组治疗序号%的患者 1.测试治疗视神经鞘150 解压缩 2.控制治疗标准医疗150 (不做手术) 这项试验要解决的主要假设是，治疗 在(1)恢复或(2)恢复方面，DES比标准护理更有效 在NAION患者中维持中心视力？ 这项试验的主要结果(视力改变)将是 使用纽约灯塔图表进行测量。三个或更多的收益 视线敏锐度(视角加倍)将被考虑 进步。次要结果包括周边视力的改变 功能(使用标准的Goldman视野检查)和发病率眼科和 全身并发症。患者将在两年内被招募 并跟踪调查了至少一年。 研究中心将包括一个主席中心，26个临床中心，以及 中央设施，包括协调中心、阅读中心、 以及国家眼科研究所的项目办公室。