Protocol summary

Summary
Amblyopia is the most common cause of visual impairment by prevalence about 1-5 % of the total population. As a Definition, amblyopia is decrease in visual acuity without any visible structural damage in eyes. Despite such definition of amblyopia, many studies demonstrate that Amblyopia cause damage to other visual functions too. If amblyopia is diagnosed and treated early in life, in most cases will lead to increase visual acuity to normal levels But if the treatment be postponed after 7 to 8 years of age (critical period) clinically is considered incurable due to lack of sufficient plasticity. Untreated amblyopia can cause vision loss and even blindness and can affects personal and professional abilities. Because of the increasing effect of Fluoxetine on neuronal plasticity, use of it in treatment of amblyopia was considered by the authors of this study. In this study, the effect of Fluoxetine in the treatment of amblyopia after the critical period, and various aspects of visual functionwas assessed , including contrast sensitivity, Stereopsis and impact of Fluoxetine on VEP latency at 15 and 60 minute. For this purpose, a total of 35 patients, age range 11 to 37 years on drug and placebo groups were categorized and Treatment was applied for 90 days. In both groups occlusion of healthy eye for 4-6 hours a day with eye activities such as reading , watching TV and video games was considered. Visual acuity, contrast sensitivity, stereopsis and VEP was assessed before and after treatment. In both groups visual acuity, contrast sensitivity and stereopsis improved after treatment. More VA improvement was seen in Fluoxetine group (0.24 log MAR) compare to placebo (0.12 log MAR). VEP latency for 60 minute, improved to normal levels in both groups, but only in Fluoxetine group for 15 minute.

General information

Acronym
Adult Amblyopia
IRCT registration information
IRCT registration number: IRCT2016052428046N1
Registration date: 2016-07-04, 1395/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-04, 1395/04/14
Registrant information
Name
Mohammad Hossein Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 0182
Email address
mhsharif2013@gmail.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-04-15, 1392/01/26
Expected recruitment end date
2013-09-17, 1392/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Fluoxetine on treatment of amblyopia after critical period
Public title
Effect of Fluoxetine on treatment of adult amblyopic patients
Purpose
Treatment
Inclusion/Exclusion criteria
moderate amblyopic patients without any effective eye or systemic disorders
Age
From 11 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
karimkhan Zand street
City
Shiraz
Postal code
Approval date
2014-08-20, 1393/05/29
Ethics committee reference number
CT92-6471

Health conditions studied

1

Description of health condition studied
Amblyopia
ICD-10 code
H53
ICD-10 code description
Amblyopia

2

Description of health condition studied
amblyopia
ICD-10 code
H53
ICD-10 code description
Amblyopia

Primary outcomes

1

Description
Visual Acuity
Timepoint
monthly
Method of measurement
Snellen Chart

Secondary outcomes

1

Description
Contrast Sensitivity
Timepoint
Monthly
Method of measurement
CSV1000

2

Description
Stereopsis
Timepoint
Monthly
Method of measurement
Fly-so

3

Description
Visual Evoked Potential
Timepoint
Monthly
Method of measurement
Rplland Consolt

Intervention groups

1

Description
Fluoxetin, oral capsule, 0.50 mg/kg, onc a day, for 3 months
Category
Treatment - Drugs

2

Description
Placebo,oral capsule,once a day, for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poostchi Eye Research Center
Full name of responsible person
Dr Mohammad Reza Talebnejad
Street address
Setad sqr
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Karim Rastgar
Street address
Physiology Department, School of Medicine
City
ُShiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr karim Rastgar
Position
Associate Professor
Other areas of specialty/work
Street address
Physiology Department,School of Medicine,Setad Sqr.
City
Shiraz
Postal code
Phone
+98 71 3230 2026
Fax
Email
rastgark@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Poostchi Eye Research Center
Full name of responsible person
Dr Mohammad Reza Talebnejad
Position
Associate Professor
Other areas of specialty/work
Street address
Poostchi Eye Research Center, Setad Sqr.
City
Shiraz
Postal code
Phone
+98 71 3230 2830
Fax
talebmor@sums.ac.ir
Email
talebmor@sums.ac.ir; talebnejadmr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Scinces
Full name of responsible person
Mohammad Hossein Sharif
Position
Student
Other areas of specialty/work
Street address
Physiology Department,School of Medicine,Setad Sqr.
City
Shiraz
Postal code
Phone
+98 71 3230 2026
Fax
Email
mhsharif2013@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...