Skip to content

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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181109041596N1
Enrollment
100
Registered
2019-01-07
Start date
2018-12-22
Completion date
Unknown
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AION

Interventions

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 featu

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Iranian patients Age over 18 years old Patients with diagnosis of AION; non-arteritic type

Exclusion criteria

Exclusion criteria: 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 :arthemeter? 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hussein Abbasi

Iran University of Medical Sciences

m.h.abbasi9550@gmail.com+98 21 2221 8220

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026