ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL

缺血性视神经病变减压试验

• 批准号: 3559917
• 负责人: SOPHIA M CHUNG
• 金额: $ 4.13万
• 依托单位: THE EYE INSTITUTE
• 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/3559917
• 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）是一个为期五年的试验