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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
Intervention groups
1
-
Description
-
Intervention group: Fluoxetine 20 mg
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo
-
Category
-
Placebo
1
-
Sponsor
-
-
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
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
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable