Objectives:
Effect of spironolactone in treatment of acute central serous chorioretinopathy
Design:
This study is a double blind randomized clinical trial which will be conducted on patients with diagnosis of acute CSCR based on clinical examination and OCT.
Setting and conduct:
Firstly, Informed consent will be obtained from patients, Later a questionnaire will be completed by researcher and patients will be assigned to placebo and drug groups through random number table. Both groups, 40 patients on the whole, will be treated by a doctor.
Inclusion criteria: patients with acute CSCR less than a month
Exclusion criteria: patients with history of corticosteroids use; CSCR receiving treatment; other eye diseases; multiple and recurring CSSR; pregnancy; heart disease; kidney disease and hypertension
Interventions:
Intervention group: Upon diagnosis of CSR, patients will undergo treatment with spironolactone, up to one month.
Control group: Upon diagnosis of CSR, patients will undergo placebo treatment, up to one month.
Follow up: 15 days, one month
Evaluation at each visit: Central macular thickness will be evaluated by OCT and visual acuity and subretinal fluied by Snellen chart
If patients respond well to treatment in second visit, drug treatment will continue for another 2 weeks and next visits will be scheduled in 1 month. If no improvement, fluorescein angiography will be performed and the patient will be introduced to medical centers for other treatments such as laser treatments or pdt.
Main outcome variables:
The volume of fluid under the retina and central macular thickness
Visual acuity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051627882N1
Registration date:2016-12-12, 1395/09/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-12, 1395/09/22
Registrant information
Name
Mohammad Mohsen Keshmirshekan
Name of organization / entity
Shahid Sadoughi University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
Email address
mkeshmirshekan@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Sadoughi University of Medical Science
Expected recruitment start date
2015-08-08, 1394/05/17
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of sprinolactone effect as a treatment for Acute Central Serous Chorio-Retinopathy
Public title
Clinical trial to investigate the efficacy of Spironolactone compared with placebo in patients with acute retinal edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from CSCR in its acute phase (duration of the disease being less than a month).
Exclusion criteria :
Patients with history of corticosteroids use; CSCR receiving treatment; other eye diseases such as corneal scar, cataract, retinopathy, and etc; multiple and recurring CSSR; pregnancy; heart disease; kidney disease and hypertension
Age
From 19 years old to 49 years old
Gender
Both
Phase
4
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
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Science
The volume of fluid under the retina and macular thickness
Timepoint
Upon entry, two weeks later, a month later.
Method of measurement
OCT
2
Description
visual acuity
Timepoint
Upon entry, two weeks later, a month later.
Method of measurement
Snellen chart
Secondary outcomes
1
Description
drug adverse effect
Timepoint
Upon entry, two weeks later, a month later.
Method of measurement
According to patient's statement
Intervention groups
1
Description
Intervention group: Upon diagnosis of CSR, patients will undergo treatment with 25 mg spironolactone, produced by Minoo Pharmaceutical Company, for four weeks. Patients will be monitored by the researcher in 15 days and 1 month respectively after treatment and the tracked data will be recorded by the researcher. Central macular thickness and sub retinal volume will constantly be evaluated by OCT, and visual acuity will be evaluated as well in each round of visit. If patients respond well to the treatment in second visit (two weeks after the beginning of treatment), the drug treatment will continue for another 2 weeks and next visits will be scheduled in 1 month. In the absence of improvement within 15 days, spironolactone treatment will be suspended and the patient will be re-examined by the doctor after 1 month and if no improvement is seen, fluorescein angiography will be performed and the patient will be introduced to medical centers for other treatments such as laser treatments or pdt.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will undergo placebo treatment taking one tablet a day for at least one month. Placebo will consist of distilled water and starch in 100 milligrams, with no side effects, and it will be produced by department of pharmacology in Shahid Sadoughi University of Medical Science. Patients with diagnosed CSCR will undergo treatment with placebo for two weeks. Patients will later be investigated by the researcher in 15 days and 1 month respectively after treatment and the tracked data will be recorded by the researcher. In each visit central macular thickness and sub retinal volume, along with visual acuity will be evaluated by OCT. For those patients who respond well to the treatment at the second visit (two weeks after the beginning of treatment) the drug treatment will continue for another 2 weeks in both groups and next visits will be scheduled in 1 month respectively. If no improvement is seen within 15 days, placebo treatment will be suspended and the patient will be re-examined by the doctor after 1 month and if lack of improvement persists, fluorescein angiography will be performed and the patient will later be introduced to medical centers for other treatments such as laser treatments or pdt .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Science
Full name of responsible person
Mr Mohammad Mohsen Keshmirshekan
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadoughi University of Medical Science
Full name of responsible person
Amir Hushang Mehrparvar
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam BLVD, yazd, Iran
City
Yazd
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
Mr Mohammad Mohsen Keshmirshekan
Position
Ophthalmology Resident
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam BLVD, Yazd, Iran