The aim of this study was to evaluate the effect of spironolactone on the choroidal vascular index in patients with central serous chorioretinopathy. All patients with central serous chorioronopathy who have recently been diagnosed and have not received treatment have been included in the study. Patients who have received any treatment related to central serous chorioronopathy, including intravitreal injection of bevasizumab (Avastin), laser therapy, photodynamic therapy and drug therapy, everybody who has been missed the follow-up of the treatment or are having side effects due to drug use, are excluded from the study.
The population of the study was referring to al-zahra eye hospital in Zahedan, which is randomly assigned to two groups of 15 patients. A group of oral drug spironolactone and another group received placebo. Duration of treatment is six months and the patients be evaluated 1 month, 3 months and six months after initiation of therapy and finally the effect of spironolactone on the choroidal vascular index and central retinal thickness will be studied. We expect that the visual acuity of the patients will also increase as the central retinal thickness decreases.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101536801N1
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Alireza Ataollahi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 4991
Email address
ataollahi.med@gmail.com
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spironolacton on Choroidal Vascular Index in Patients with Central Serous Chorioretinopathy
Public title
Effect of Spironolactone on Treatment of Central Serous Chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with central serous chorioretinopathy, whose condition has just been diagnosed and who have not received any treatment.
Exclusion criteria: Patients whohave been received any treatment for central serous chorioretinopathy, including intravitreal injection of bevasizumab, laser therapy, photodynamic therapy, and drug treatment; Failure to refer patients for follow-up treatment; Drug-related complications requiring drug discontinuation; Disagreement with the proposed treatment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan university of Medical Sciences
Street address
Faculty of medicine، Jannat Boulvar, Dr. Hesabi sq.
City
Zahedan
Postal code
98167-43175
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.ZAUMS.REC.1396.123
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
2
Description of health condition studied
Central Serous Chorioretinopathy
ICD-10 code
H33.2
ICD-10 code description
Serous retinal detachment
Primary outcomes
1
Description
Macular Central Thickness
Timepoint
At the beginning - One month later - Three months later - Six months later
Method of measurement
Based on OCT, Measured as the Thickness of the Macular Center
2
Description
Choroidal Vasculai Index
Timepoint
At the beginning - One month later - Three months later - Six months later
Method of measurement
The ratio of the luminal area to the total choroid tissue in the subfovea area using the image J software
3
Description
Visual Acuity
Timepoint
At the beginning - One month later - Three months later - Six months later
Method of measurement
Snellen Chart
4
Description
Recovery
Timepoint
Six months later
Method of measurement
Increase in visual acuity or a decrease in the thickness of the macula to less than 252 micrometers, or a rise in the choroid vascular index
Secondary outcomes
1
Description
Recurrence
Timepoint
At 1 year
Method of measurement
Based on OCT measurements, which, with the increase in the thickness of the macular center, precipitates as fluid re-accumulation in the sub-retinal substrate after the fluid has completely disappeared.
Intervention groups
1
Description
Tablet Spironolactone 100 mg Once Daily Orally for 6 Months and macular OCT will be obtained 1 month, 3 months and 6 months after initiation of therapy.
Category
Treatment - Drugs
2
Description
Placebo ( Eye drop Artificial tears) q6hr Topical for 6 Months and macular OCT will be obtained 1 month, 3 months and 6 months after initiation of therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ataollahi
Street address
Faculty of medicine، Jannat Boulvar, Dr. Hesabi sq.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshani
Street address
Faculty of medicine، Jannat Boulvar, Dr. Hesabi sq.
City
Zahedan
Grant name
طرح هزینه بر نمی باشد.
Grant code / Reference number
ندارد.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan Universty of Medical Sciences
Full name of responsible person
Alireza Ataollahi
Position
Resident of Opthalmology
Other areas of specialty/work
Street address
Faculty of medicine، Jannat Boulvar, Dr. Hesabi sq.
City
Zahedan
Postal code
Phone
+98 54 3322 4991
Fax
Email
ataollahi.med@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Al-Zahra Eye Hospital
Full name of responsible person
Alireza Maleki
Position
Fellowship of Vitreoretinal Disease
Other areas of specialty/work
Street address
Shahid Motahari Blvd (airport), Not reaching Khatam Square
City
Zahedan
Postal code
Phone
+98 54 3322 4991
Fax
Email
ataollahi.med@gmail.com eye@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Al-Zahra Eye Hospital
Full name of responsible person
Alireza Maleki
Position
Fellowship of Vitreoretinal Disease
Other areas of specialty/work
Street address
Shahid Motahari Blvd (airport), Not reaching Khatam sq.
City
Zahedan
Postal code
Phone
+98 54 3322 4991
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)