Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
试验速览
- 阶段
- 2 期
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Improvement in indices visual field
研究概览
简要总结
This randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. The first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. The second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. In addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. The third group will receive placebo. Eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. SITA standard visual field testing will be done using the Visual Field Analyzer Humphrey 750 Field (Carl Zeiss, USA). The thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (Cirrus Zeiss Cirrus HD-OCT, Carl Zeiss, USA). The q-q plot and Kolmogorov-Smirnov tests will be performed to test normal distribution of data. Descriptive statistics including frequency, percentages, standard deviation, median and range will be used. Other statistical test including ANOVA, Kruskal-Wallis, Chi-Square, and Fischer's exact tests will be performed. All statistical analyses will be performed in SPSS (version 20) at significance level of 0.05.
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, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral prednisolone administration
50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
干预措施: Oral prednisolone administration 50 mg (Drug)
Intravenous Erythropoietin injection
- 1000 units of erythropoietin every 12 hours for three days
干预措施: Intravenous Erythropoietin injection (Drug)
结局指标
主要结局
Improvement in indices visual field
时间窗: 6 months after the intervention
Mean deviation and pattern standard deviation
Improvement in indices visual acuity compared to normal course of the disease
时间窗: 6 months after the intervention
Snellen visual acuity chart
Improvement in indices retinal nerve fiber thickness
时间窗: 6 months after the intervention
peripapillary Optical Coherence Tomography
次要结局
未报告次要终点
研究者
Zahra Rabbani Khah
Clinical Professor
Shahid Beheshti University of Medical Sciences
