ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL

缺血性视神经病变减压试验

• 批准号: 3559919
• 负责人: Steven E Feldon
• 金额: $ 5.22万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-06-15 至 1995-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3559919
• 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 Goldmann perimetry) and incidence of 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）是一项为期五年的 旨在评估视神经鞘的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手术（ONDS）， 在视觉症状发作后一个月内确诊。 一个标准化， 治疗和数据收集的通用方案将由 所有中心。 这项多中心随机临床试验旨在 比较随机分配至两个治疗组之一的患者的差异 如下所示： 治疗组 治疗序列 的患者数量 1.试验治疗 视神经鞘 150 减压 2.对照处理 标准医疗护理 150 (no外科手术） 本试验要解决的主要假设是治疗是否 在（1）恢复或（2） 维持NAION患者的中心视力？ 本试验的主要结局（视力变化）将是 使用纽约灯塔海图测量。 三个或更多的增益 将考虑视力线（视角加倍） 改进. 次要结局包括外周视力的变化 功能（使用标准Goldmann视野检查法）和眼科 和全身并发症。 患者将在两年内招募 期间，并遵循至少一年。 研究中心将包括一个主席中心，26个临床中心， 集中设施，包括协调中心，阅读中心， 和国家眼科研究所的项目办公室。