Protocol summary

Study aim
1)Evaluation of effect of fluoxetine on the clinical prognosis in patients with AION 2) Evaluation of demographic parameters in those patients
Design
Randomized clinical trial containing placebo, a double blinded study
Settings and conduct
Patients with AION who sign the agreement papers, divide randomly in groups of 50 according to inclusion and exclusion criteria. Firstly, each patient completes the questionnaires for evaluate the demographic parameters. Then patients, besides receiving the main treatment for them disease according to guideline, randomly divide into two groups former the receivers of fluoxetine and later the receivers of placebo. Then according to evaluation protocol undergo: physical examination, fundoscopy, NLR, DSM-5 and HAM-D Questionnaires, VEP and OCT. Patient and interviewer are blinded but analyzer now which patient receive placebo and which patient receive the drug. This research will conduct in ophthalmology research center of Rasool Akram hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian Age over 18 Patients with non-arteritic AION Exclusion criteria: 1) Pregnancy 2) History of cataract, glaucoma, congenital eye disease, collagen vascular, immunologic disease, psychological disease 3) Fluoxetine or other psychological medications 4) GCA, CRP + or ESR >= 40 5) Trauma or surgery of eye 6) More than 3 weeks delay of visit from onset of disease 7) No positive improvement in the score of depression questionnaires in comparison between 1th and last visit. 8) Disagreement on using fluoxetine or continue study or death of patient
Intervention groups
Patients with AION in two groups: 1) Patients given fluoxetine 2) Patients given placebo
Main outcome variables
Visual acuity; VEP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181109041596N1
Registration date: 2019-01-07, 1397/10/17
Registration timing: registered_while_recruiting

Last update: 2019-01-07, 1397/10/17
Update count: 0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
mohammad hussein abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 8020
Email address
abbasi.mh@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Evaluation of effect of fluoxetine on the clinical prognosis in patients with anterior ischemic optic neuropathy (AION)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian patients Age over 18 years old Patients with diagnosis of AION; non-arteritic type
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of medicine faculty of Iran university of medical science
Street address
Faculty of medicine, Iran university of medical science, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.093

Health conditions studied

1

Description of health condition studied
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.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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 outcomes

1

Description
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.

Intervention groups

1

Description
Intervention group: receivers of fluoxetine antidepressant, 20 mg daily
Category
Treatment - Drugs

2

Description
Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ophthalmology research center of Rasool Akram hospital
Full name of responsible person
Dr Mostafa Soltan Sanjari
Street address
Ophthalmology research center of Rasool Akram hospital, Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9162
Email
m.h.abbasi9550@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr mostafa soltan sanjari
Street address
Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
msoltansanjari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Eye research center of Rasool Akram hospital - Iran university of medical science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hussein Abbasi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student and MPH student
Street address
Faculty of medicine iran university of medical science hemmat highway tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2221 8220
Email
m.h.abbasi9550@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hussein Abbasi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student and MPH student
Street address
Faculty of medicine, Iran university of medical science, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2221 8220
Email
m.h.abbasi9550@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Hussein Abbasi
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical student and MPH student
Street address
Faculty of medicine, Iran university of medical science, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2221 8220
Email
m.h.abbasi9550@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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