NCT02329288Unknown3 期
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy
Second Military Medical University0 个研究点目标入组 60 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 主要终点
- Changes of Best corrected visual acuity(BCVA)
研究概览
简要总结
NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it.
Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)
排除标准
- •Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible
研究组 & 干预措施
Triamcinolone Acetonide
Active Comparator
40mg/1ml
干预措施: Triamcinolone Acetonide (Drug)
placebo
Placebo Comparator
1ml
干预措施: placebo (Drug)
结局指标
主要结局
Changes of Best corrected visual acuity(BCVA)
时间窗: baseline and 1month, 3month
次要结局
- Changes of Visual Field(baseline and 1month, 3month)
研究者
pandongyan
M.D.
Second Military Medical University
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