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Finasteride effect as a treatment for chronic and recurrent central serous Chorioretinopathy(CSC)

Protocol summary

Summary
purpose:detremination of finasteride effect as a treatment for chronic and recurrent central serous retinopathy(CSC) in patients refer to Baghaeepour polyclinic ,Shaheed Sadoughi hospital study design:before-after,non-randomized,single-center,prospective, uncontrolled, unmasked sample: patients refer to Baghaeepour polyclinic ,Shahid Sadoughi hospital inclusion criteria:patients with chronic CSCR, which was defined in this study as 1) the presence of subretinal fluid, as determined by spectraldomain OCT;2)the subretinal fluid must have been present for at least 3 months or there was a recurrence of subretinal fluid in ipsilateral eye within the past 3 months. exclusion criteria:corticosteroid use,CNV or other ocular disease that disturb the study outcome,pregnant and nursery women sample size:30 intervention:finasteride tablet 5mg /daily up to 3 months outcome measurement:best corrected visual acuity, center-subfield thickness ,central subretinal fluid

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013083114530N1
Registration date: 2014-01-31, 1392/11/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Tahere Rezaee
Name of organization / entity
Shahid Sadoughi University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 6410
Email address
t.rezaee@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-22, 1393/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Finasteride effect as a treatment for chronic and recurrent central serous Chorioretinopathy(CSC)
Public title
Finasteride effect as a treatment for spontaneous retinal edema
Purpose
Treatment
Inclusion/Exclusion criteria
Eligibility criteria:patients with chronic CSCR, which was defined in this study as 1) the presence of subretinal fluid, as determined by spectraldomain OCT;2)the subretinal fluid must have been present for at least 3 months or there was a recurrence of subretinal fluid in ipsilateral eye within the past 3 months. exclusion criteria:corticosteroid use,CNV or other ocular disease that disturb the study outcome,pregnant and nursery women
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science,Ethics Committee
Street address
Shahid Sadoughi University of Medical Science, Hesabi prof. boulevard, Daneshjoo boulevard
City
Yazd
Postal code
Approval date
2013-12-18, 1392/09/27
Ethics committee reference number
p/17/1/186945

Health conditions studied

1

Description of health condition studied
Central Serous Chorioretinopathy
ICD-10 code
H35.7
ICD-10 code description
Separation of retinal layers

Primary outcomes

1

Description
best corrected visual acuity
Timepoint
by the intervention initiation,15 days,1,2 and 3 months after intervention,3months after discontinuation of intervention
Method of measurement
Snellen chart

2

Description
central macular thickness
Timepoint
by the intervention initiation,15 days,1,2 and 3 months after intervention,3months after discontinuation of intervention
Method of measurement
spectral domain OCT

3

Description
subretinal fluid volume
Timepoint
by the intervention initiation,15 days,1,2 and 3 months after intervention,3months after discontinuation of intervention
Method of measurement
spectral domain OCT

Secondary outcomes

1

Description
adverse effects(decreased libido,impotence,improper ejaculation,postural hypotension,dizziness)
Timepoint
15 days,1,2 and 3 months after intervention
Method of measurement
pation history taking

Intervention groups

1

Description
finasteride 5 mg tablet, 1 tablet per day up to 3 months(intervention group) no control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baghaee Pour clinic, Shahid Sadoughi hospital
Full name of responsible person
Tahere Rezaee
Street address
Shahid Sadoughi hospital, Ebnesina boulevard, Safaeiye
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
dr. Vakili
Street address
Shahid Sadoughi University of Medical Science, Hesabi prof. boulevard, Daneshjoo boulevard,
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science
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
Shahid Sadoughi University of Medical Science
Full name of responsible person
Tahere Rezaee
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Shahid Sadoughi hospital, Ebnesina boulevard, Safaeiye
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
t.rezaee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Tahere Rezaee
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Shahid Sadoughi hospital, Ebnesina boulevard, Safaeiye
City
Yazd
Postal code
Phone
+98 35 1811 3220
Fax
+98 35 1822 4100
Email
t.rezaee@ssu.ac.irt.rezaee@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Tahere Rezaee
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Shahid Sadoughi hospital, Ebnesina boulevard, Safaeiye
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
+98 35 1822 4100
Email
t.rezaee@yahoo.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
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