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Protocol summary
This study is a randomized clinical trial (RCT). Ambulopia patients over 18 years of age who come to the Farabi Hospital from 1993 to 2013 will be included in the study if they have entry criteria and no exclusion criteria. For all patients, BCVA and VEP are initially requested and registered. The patients are then randomly divided into two groups, the group receiving fluoxetine and the group that received the placebo. This study is done in Double-blind. Patients are treated for a period of 90 days and then the results of VEP and BCVA are reviewed and compared to the previous results.
Intervention group: Fluoxetine 20 mg, Control group: Placebo
This study is a randomized clinical trial (RCT). Amblyopia patients over 18 years of age who come to the Farabi Hospital from 1993 to 2013 will be included in the study if they have entry criteria and no exclusion criteria. For all patients, BCVA and VEP are initially requested and registered. The patients are then randomly divided into two groups, the group receiving fluoxetine and the group that received the placebo. This study is done in Double-blind. Patients are treated for a period of 90 days and then the results of VEP and BCVA are reviewed and compared to the previous results.
Intervention group: Fluoxetine 20 mg, Control group: Placebo
This study is a randomized clinical trial (RCT). AmbulopiaAmblyopia patients over 18 years of age who come to the Farabi Hospital from 1993 to 2013 will be included in the study if they have entry criteria and no exclusion criteria. For all patients, BCVA and VEP are initially requested and registered. The patients are then randomly divided into two groups, the group receiving fluoxetine and the group that received the placebo. This study is done in Double-blind. Patients are treated for a period of 90 days and then the results of VEP and BCVA are reviewed and compared to the previous results. Intervention group: Fluoxetine 20 mg, Control group: Placebo
Inclusion criteria:
1. Patients who are more than a line between two eyes and have vision should be 25/20 or better
2. age above 18 years
3. Patients with anisometropic or strabismic ambliotics
Exclusion criteria:
1. Any eye disorder (cornea and retina, etc.)
2. Patients who do not cooperate with VEP
3. History of seizure
4. History of bipolar disorder
5. History of current or current use of SSRI or SNRI drugs
6. Patients who do not go to follow up
7. Female sex and people under the age of 18
Inclusion criteria:
1. Patients who have at least one line between two eyes and have vision should be 20/25 or better
2. age above 18 years
3. Patients with anisometropic or strabismic ambliotics
Exclusion criteria:
1. Any eye disorder (cornea and retina, etc.)
2. Patients who do not cooperate with VEP
3. History of seizure
4. History of bipolar disorder
5. History of current or current use of SSRI or SNRI drugs
6. Patients who do not go to follow up
7. people under the age of 18
Inclusion criteria: 1. Patients who are more than ahave at least one line between two eyes and have vision should be 20/25/20 or better 2. age above 18 years 3. Patients with anisometropic or strabismic ambliotics Exclusion criteria: 1. Any eye disorder (cornea and retina, etc.) 2. Patients who do not cooperate with VEP 3. History of seizure 4. History of bipolar disorder 5. History of current or current use of SSRI or SNRI drugs 6. Patients who do not go to follow up 7. Female sex and people under the age of 18
شرایط ورود:
1. بیمارانی که بیشتر از یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 25/20 یا بهتر باشد
2. سن بالای 18 سال
3. بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک
شرایط عدم ورود:
1. هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..)
2. بیمارانی که برای VEP همکاری نمی کنند
3. سابقه تشنج
4. سابقه اختلال روانپزشکی دوقطبی
5. سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI
6. بیمارانی که برای پیگیری مراجعه نمی کنند
7. جنس مونث و افراد زیر 18 سال
شرایط ورود:
1. بیمارانی که حداقل یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 20/25 یا بهتر باشد
2. سن بالای 18 سال
3. بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک
شرایط عدم ورود:
1. هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..)
2. بیمارانی که برای VEP همکاری نمی کنند
3. سابقه تشنج
4. سابقه اختلال روانپزشکی دوقطبی
5. سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI
6. بیمارانی که برای پیگیری مراجعه نمی کنند
7. افراد زیر 18 سال
شرایط ورود: 1. بیمارانی که بیشتر ازحداقل یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 20/25/20 یا بهتر باشد 2. سن بالای 18 سال 3. بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک شرایط عدم ورود: 1. هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..) 2. بیمارانی که برای VEP همکاری نمی کنند 3. سابقه تشنج 4. سابقه اختلال روانپزشکی دوقطبی 5. سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI 6. بیمارانی که برای پیگیری مراجعه نمی کنند 7. جنس مونث و افراد زیر 18 سال
General information
Male
Both
maleboth
empty
Typographical errors were corrected. Female sex had been erroneously entered as exclusion criteria that corrected. In inclusion criteria, the correct sentence was 'at least one line difference' that corrected.
Typographical errors were corrected. Female sex had been erroneously entered as exclusion criteria that corrected. In inclusion criteria, the correct sentence was 'at least one line difference' that corrected.
empty
اشکالات املایی در ثبت وجود داشت که تصحیح شد. به اشتباه، جنس مونث جزو exclusion نوشته شده بود که تصحیح شد. جمله "حداقل یک خط بین دو دید تفاوت داشته باشند" نیز تصحیح شد.
اشکالات املایی در ثبت وجود داشت که تصحیح شد. به اشتباه، جنس مونث جزو exclusion نوشته شده بود که تصحیح شد. جمله "حداقل یک خط بین دو دید تفاوت داشته باشند" نیز تصحیح شد.
The Effect of Fluoxetine on Amlibopenia Treatment
The Effect of Fluoxetine on Amblyopia Treatment
The Effect of Fluoxetine on AmlibopeniaAmblyopia Treatment
Effect of fluoxetine on visual acuity and VEP indices in ambuliosis patients over 18 years of age
Effect of fluoxetine on visual acuity and VEP indices in amblyopia patients over 18 years of age
Effect of fluoxetine on visual acuity and VEP indices in ambuliosisamblyopia patients over 18 years of age
Patients who are more than a line between two eyes and have vision should be 25/20 or better
age above 18 years
Patients with anisometropic or strabismic ambliotics
Patients who had at least one line difference between two eyes and have vision should be 20/25 or better
age above 18 years
Patients with anisometropic or strabismic amblyopia
Patients who are more than ahad at least one line difference between two eyes and have vision should be 20/25/20 or better age above 18 years Patients with anisometropic or strabismic amblioticsamblyopia
بیمارانی که بیشتر از یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 25/20 یا بهتر باشد
سن بالای 18 سال
بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک
بیمارانی که حداقل یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 20/25 یا بهتر باشد
سن بالای 18 سال
بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک
بیمارانی که بیشتر ازحداقل یک خط بین دو دید تفاوت داشته باشند و دید چشم بهتر باید 20/25/20 یا بهتر باشد سن بالای 18 سال بیماران با آمبلیوپی آنیزومتروپیک یا استرابیسمیک
Any eye disorder (cornea and retina, etc.)
Patients who do not cooperate with VEP
History of seizure
History of bipolar disorder
History of current or current use of SSRI or SNRI drugs
Patients who do not go to follow up
Female sex and people under the age of 18
Any eye disorder (cornea and retina, etc.)
Patients who do not cooperate with VEP
History of seizure
History of bipolar disorder
History of current or current use of SSRI or SNRI drugs
Patients who do not go to follow up
people under the age of 18
Any eye disorder (cornea and retina, etc.) Patients who do not cooperate with VEP History of seizure History of bipolar disorder History of current or current use of SSRI or SNRI drugs Patients who do not go to follow up Female sex and people under the age of 18
هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..)
بیمارانی که برای VEP همکاری نمی کنند
سابقه تشنج
سابقه اختلال روانپزشکی دوقطبی
سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI
بیمارانی که برای پیگیری مراجعه نمی کنند
جنس مونث و افراد زیر 18 سال
هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..)
بیمارانی که برای VEP همکاری نمی کنند
سابقه تشنج
سابقه اختلال روانپزشکی دوقطبی
سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI
بیمارانی که برای پیگیری مراجعه نمی کنند
افراد زیر 18 سال
هرگونه اختلال ساختمانی چشم(قرنیه و رتین و ..) بیمارانی که برای VEP همکاری نمی کنند سابقه تشنج سابقه اختلال روانپزشکی دوقطبی سابقه مصرف یا مصرف فعلی داروهای خانوادهSSRI یا SNRI بیمارانی که برای پیگیری مراجعه نمی کنند جنس مونث و افراد زیر 18 سال
Recruitment centers
#1
Name of recruitment center - English: Farabi Hospital
Name of recruitment center - Persian: بیمارستان فارابی
Full name of responsible person - English: Arash Mir Mohammad Sadeghi
Full name of responsible person - Persian: آرش میرمحمد صادقی
Street address - English: south Karegar St
Street address - Persian: خیابان کارگر جنوبی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 5561848331
Phone:
Fax:
Email: ammsadeghi@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Farabi Hospital
Name of recruitment center - Persian: بیمارستان فارابی
Full name of responsible person - English: Arash Mir Mohammad Sadeghi
Full name of responsible person - Persian: آرش میرمحمد صادقی
Street address - English: south Karegar St
Street address - Persian: خیابان کارگر جنوبی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 5561848331
Phone: +98 912 792 7992
Fax:
Email: ammsadeghi@sina.tums.ac.ir
Web page address:
Name of recruitment center - English: Farabi Hospital Name of recruitment center - Persian: بیمارستان فارابی Full name of responsible person - English: Arash Mir Mohammad Sadeghi Full name of responsible person - Persian: آرش میرمحمد صادقی Street address - English: south Karegar St Street address - Persian: خیابان کارگر جنوبی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 5561848331 Phone: +98 912 792 7992 Fax: Email: ammsadeghi@sina.tums.ac.ir Web page address:
Protocol summary
Study aim
The effect of fluoxetine on improving indicators VEP visual acuity and amblyopia in patients over 18 years between 2016 to 2018 at Farabi Hospital in Tehran
Design
This study is a randomized clinical trial (RCT). Amblyopia patients over 18 years of age who come to the Farabi Hospital from 1993 to 2013 will be included in the study if they have entry criteria and no exclusion criteria. For all patients, BCVA and VEP are initially requested and registered. The patients are then randomly divided into two groups, the group receiving fluoxetine and the group that received the placebo. This study is done in Double-blind. Patients are treated for a period of 90 days and then the results of VEP and BCVA are reviewed and compared to the previous results.
Intervention group: Fluoxetine 20 mg, Control group: Placebo
Settings and conduct
The study is double-blind study of patients in the study, the type of drug are blind and do not know that fluoxetine or placebo consumption. The principal investigator, responsible for data collection and therapist are also not aware of the type of consumer arbitration.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients who have at least one line between two eyes and have vision should be 20/25 or better
2. age above 18 years
3. Patients with anisometropic or strabismic ambliotics
Exclusion criteria:
1. Any eye disorder (cornea and retina, etc.)
2. Patients who do not cooperate with VEP
3. History of seizure
4. History of bipolar disorder
5. History of current or current use of SSRI or SNRI drugs
6. Patients who do not go to follow up
7. people under the age of 18
Intervention groups
Patients are randomly divided into two groups. One group receiving fluoxetine and the second group receiving placebo. The dose of fluoxetine is 20 mg per day, and each capsule is consumed every morning.
Main outcome variables
BCVA
General information
Reason for update
Typographical errors were corrected. Female sex had been erroneously entered as exclusion criteria that corrected. In inclusion criteria, the correct sentence was 'at least one line difference' that corrected.
Acronym
IRCT registration information
IRCT registration number:IRCT20180316039110N1
Registration date:2018-06-05, 1397/03/15
Registration timing:registered_while_recruiting
Last update:2024-05-15, 1403/02/26
Update count:1
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Arash Mirmohammadsadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1020
Email address
ammsadeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of fluoxetine on visual acuity and VEP indices in amblyopia patients over 18 years of age
Public title
The Effect of Fluoxetine on Amblyopia Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had at least one line difference between two eyes and have vision should be 20/25 or better
age above 18 years
Patients with anisometropic or strabismic amblyopia
Exclusion criteria:
Any eye disorder (cornea and retina, etc.)
Patients who do not cooperate with VEP
History of seizure
History of bipolar disorder
History of current or current use of SSRI or SNRI drugs
Patients who do not go to follow up
people under the age of 18
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation sequence was determined from a computer-generated, random-number table, assigning patients in to two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind study of patients in the study, the type of drug are blind and do not know that fluoxetine or placebo consumption. The principal investigator, responsible for data collection and therapist are also not aware of the type of consumer arbitration.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
south Karegar St
City
tehran
Province
Tehran
Postal code
5561848331
Approval date
2016-09-11, 1395/06/21
Ethics committee reference number
IR.TUMS.FARABIH.REC.۱۳۹۵.۵۹۹
Health conditions studied
1
Description of health condition studied
Amblyopia
ICD-10 code
H53.033
ICD-10 code description
Strabismic amblyopia, bilateral
Primary outcomes
1
Description
BCVA
Timepoint
Every month for 90 days
Method of measurement
Based on the chart
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fluoxetine 20 mg
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Arash Mir Mohammad Sadeghi
Street address
south Karegar St
City
Tehran
Province
Tehran
Postal code
5561848331
Phone
+98 912 792 7992
Email
ammsadeghi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahra'iyan
Street address
south Karegar St
City
Tehran
Province
Tehran
Postal code
5561848331
Phone
+98 21 8163 3698
Email
ammsadeghi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Arash Mir Mohammad Sadeghi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
south Karegar St
City
Tehran
Province
Tehran
Postal code
5561848331
Phone
+98 912 792 7992
Email
ammsadeghi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Mousavi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
south Karegar St
City
Tehran
Province
Tehran
Postal code
5561848331
Phone
+98 66907846
Email
dr.mousavi@icloud.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi aminizade
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
south Karegar St
City
Tehran
Province
Tehran
Postal code
5561848331
Phone
+98 919 525 5337
Email
Mehdiaminizade@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available