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IRCT20181109041596N1 IRCT 2019-01-07 Iran University of Medical Sciences Evaluation of effect of fluoxetine on the clinical prognosis in patients with anterior ischemic optic neuropathy (AION) Evaluation of effect of fluoxetine on the clinical prognosis in patients with anterior ischemic optic neuropathy (AION) according to evaluations of visual acuity and VEP tests as main outcomes, in comparison between drug and placebo groups. 2018-12-22 anticipated 100 Complete https://irct.ir/trial/35097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In order to randomize allocation of patients in each group of study, we'll use the permuted block randomization method by means of blocks with 4 in size. According to the number of patients in each group of study (100 patients in each group), 25 blocks of four by means of online website (www.sealedenvelope.com) will produce. For concealment, during randomization we'll use specific codes written on drug or placebo boxes which have been produced by computer. Each patient who enters the study will receive a box of drug or placebo according to the, Blinding description: During this study, participant will not be aware about if he receiving the drug or placebo because the shape and other features of boxes of both drugs and placebos are the same. The interviewer and investigator also will not be aware of which patients have received drug or placebo. But the analyzer knows the patients who received drug and the patients who received placebo. 3 AION; Anterior ischemic optic neuropathy: is a condition in which the optic nerve is affected by ischemia at its anterior section (intraocular), AION has two types: arteritic and non arteritic types. arteritic type dominantly results from giant cell arteritis. The etiologies suggested for non arteritic type contains: diabetes mellitus, hypertension and obstructive sleep apnea. This research spends to non arteritic type of disease.. Intervention 1: Intervention group: receivers of fluoxetine antidepressant, 20 mg daily. Intervention 2: Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Mohammad Hussein Abbasi
Faculty of medicine iran university of medical science hemmat highway tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2221 8220 m.h.abbasi9550@gmail.com Iran University of Medical Sciences scientific Mohammad Hussein Abbasi
Faculty of medicine, Iran university of medical science, Hemmat highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2221 8220 m.h.abbasi9550@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iranian patients Age over 18 years old Patients with diagnosis of AION; non-arteritic type 18 years no limit Both Pregnancy before or during study Past medical history of cataract, glaucoma ( open or close angle ) congenital eye disease such as cloboma and involvement with disease effecting the central visual field of patient Patients with past medication history of using fluoxetine or other psychological medications including antidepressants Patients suffering from psychological disease Patients who use medications including :arthemeterŲŒ astemizol, cisapride, eliglustat, goserelin, isocarboxazide, artemether, leuprolide, linezolid, lumefantrine, methylene blue, phenelzine, pimozide, procarbazine, selegiline, thioridazine, tranylcypromine Patients diagnosed with immunologic and collagen vascular disease Patients with symptoms of or diagnosed with giant cell arteritis and positive CRP more than 3+ or ESR more than 40 Trauma or surgery history of eyes Duration between involvement and interview more than 3 weeks Patients without compliance of using fluoxetine or disagrement of patient to continue accompanying the study Involvement by glaucoma Involvement by cataract Change in depression questionnaire score lower than 1 score in comparison to first and forth visit ( means the poor compliance of patient that has not used fluoxetine Death of patient Treatment - Drugs Placebo Intervention group: receivers of fluoxetine antidepressant, 20 mg daily Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine. 1)Visual acuity: visual acuity of each patient will measure by snelene chart. 2)Result of VEP test: both time( latency) and voltage parameters of VEP test will measure. Timepoint: 1)Visual acuity: in first visit and 6th month after initiation of treatment 2)VEP: in first visit and 6th month after initiation of treatment. Method of measurement: 1)Visual acuity: snelene chart 2)VEP test by means of VEP device. 1)NLR: neutrophil to lymphocyte ratio 2)OC: thickness of retina 3)Perimetry: percent of scotoma in visual field 4)Depression score 5)demographic informations ( age, gender, profession & etc. ). Timepoint: 1)NLR: In first visit and 6th month after initiation of treatment 2)OCT: In first visit and 6th month after initiation of treatment 3)Perimetry: In first visit and 6th month after initiation of treatment 4)Depression score: In first visit and 6th month after initiation of treatment 5)Demographic information ( age, gender, profession & etc.): at first visit. Method of measurement: 1)NLR: CBC diff 2)OCT: OCT device 3)Perimetry: digital perimetry device 4)Depression score: DSM 5 questionnaire 5)Demographic information ( age, gender, profession & etc. ): by means of personal information and epidemiology questionnaires. Eye research center of Rasool Akram hospital - Iran university of medical science Approved 2018-10-23 Ethics committee of medicine faculty of Iran university of medical science Faculty of medicine, Iran university of medical science, Hemmat highway, Tehran Tehran Tehran Iran (Islamic Republic of)