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IRCT20151123025202N35 IRCT 2024-02-07 Shahid Beheshti University of Medical Sciences The effect of fampiridine on optic nerve imaging in patients with Anterior Ischemic Optic neuropathy Investigating the effect of Fampiridine on visual parameters and optic nerve imaging in patients with Anterior Ischemic Optic neuropathy 2024-03-20 anticipated 40 Complete https://irct.ir/trial/75267 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 cards will be prepared, 20 cards with letter I (meaning intervention) and 20 cards with letter C (meaning control) and each one is placed in an envelope with aluminum foil and the lid is glued and placed inside a box. to give At the time of patients' arrival, one of the letter envelopes will be randomly selected and opened. According to the selected letter, the patient will be assigned to the intervention or non-intervention group. 1-2 Anterior Ischemic Optic neuropathy. Intervention 1: Intervention group: In addition to standard treatment and control of underlying risk factors such as diabetes and blood pressure, they will be treated with 10 mg fampiridine tablets for 12 weeks (one tablet every 12 hours, the first week and 2 tablets from the second week onwards). Intervention 2: Control group: They will receive only standard treatment and control of underlying risk factors such as diabetes and blood pressure. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more Information
public Abbas Moradi
Shahid fahmideh
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0572 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Mohadese Feizi
بزرگراه شهید چمران، خیابان یــمن، خیابان شهید اعــرابی، جنب بیمارستان آیت الله طالقانی
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2259 1616 mohadeseh_feizi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with anterior ischemic optic neuropathy Consent to participate in the study At least 3 months have passed since the onset of symptoms no limit no limit Both Pregnancy History of seizures Renal failure H47.01 Ischemic optic neuropathy Treatment - Drugs Prevention Intervention group: In addition to standard treatment and control of underlying risk factors such as diabetes and blood pressure, they will be treated with 10 mg fampiridine tablets for 12 weeks (one tablet every 12 hours, the first week and 2 tablets from the second week onwards). Control group: They will receive only standard treatment and control of underlying risk factors such as diabetes and blood pressure Acuity Visual. Timepoint: Pre treatment and 12 weeks post treatment. Method of measurement: Using ETDRS chart. Field of vision. Timepoint: Pre treatment and 12 weeks post treatment. Method of measurement: Using automatic perimetry device. Change inthickness of nerve cells. Timepoint: Pre treatment and 12 weeks post treatment. Method of measurement: Using Peripapillary-OCT. Shahid Beheshti University of Medical Sciences Approved 2023-07-17 Ethics committee of Shahid Beheshti University of Medical Sciences Next to Taleghani Hospital, Shahid Abbas Arabi Street (Parvaneh), Yemen Street, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)