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临床试验/NCT03715881
NCT03715881Unknown2 期

Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2018年12月1日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Oral prednisolone administration

Active Comparator

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

Active Comparator
  1. 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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Rabbani Khah

Clinical Professor

Shahid Beheshti University of Medical Sciences

研究点 (1)

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