NAION Treatment With Oral Prednisolone and Erythropoietin Injection
Status:
Unknown status
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
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.