NAION Treatment With Oral Prednisolone and Erythropoietin Injection
- Conditions
- Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
- Interventions
- Registration Number
- NCT03715881
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Erythropoietin injection Intravenous Erythropoietin injection 2. 1000 units of erythropoietin every 12 hours for three days Oral prednisolone administration Oral prednisolone administration 50 mg 50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
- Primary Outcome Measures
Name Time Method Improvement in indices visual field 6 months after the intervention Mean deviation and pattern standard deviation
Improvement in indices visual acuity compared to normal course of the disease 6 months after the intervention Snellen visual acuity chart
Improvement in indices retinal nerve fiber thickness 6 months after the intervention peripapillary Optical Coherence Tomography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of