The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 主要终点
- Best corrected visual acuity using Snellen chart
研究概览
简要总结
Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy
排除标准
- •the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
- •a history of previous ocular surgery;
- •a history of prior treatment of any type for NAION;
- •systemic condition such as diabetes mellitus and poorly controlled hypertension
研究组 & 干预措施
prescription placebo
control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo
干预措施: placebo (Drug)
prescription Intravenous methylprednisolone
Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day
干预措施: Intravenous methylprednisolone (Drug)
prescription normobaric oxygen with face mask
Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks
干预措施: normobaric oxygen with face mask (Drug)
结局指标
主要结局
Best corrected visual acuity using Snellen chart
时间窗: until 6 months
Snellen chart
次要结局
- Visual field mean deviation index using the Humphrey Visual Field Analyzer(until 6 months)
研究者
Zahra Rabbani Khah
Shahid Beheshti Medical University
Shahid Beheshti University of Medical Sciences