Comparison of changes in choroidal perfusion in macula area in macular-OCTA and choroidal thickness in EDI-OCT before and after eplerenone tablet use in acute CSCR.
Design
In this clinical trial patients are simply randomized in double-blinded way in 2 parallel groups of 20 numbers of control (Placebo) and intervention (Eplerenone)
Settings and conduct
After confirmation of CSCR and Filling Informed consent, demographic data and clinical examinations like BCVA are documented then macular OCT-A, ONH OCT-A, macular EDI-OC will be done.
Choroidal thickness in fovea macula perfusion vessel density flow index in central 3 mm and radial peri-papillary capillary (RPC) vessel density and CMT and SRF height are assessed.
Simple double-blinded randomization make patients in 2 placebo and intervention groups. For all intervention groups we use eplerenone for 3 months . All parameters are repeated documented and re-analysed one and three months after treatment and finally analysis are done
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients that are referred to khatam eye hospital emergency or clinics with the definite first episode of acute CSCR under age of 18
No history of intraocular diseases
No contraindication of eplerenone use
Exclusion criteria:
Any finding making the diagnosis of CSCR suspiscious
Any intraocular disease happening
Any eplerenone contraindication happening
Intervention groups
Intervention group are patients under treatment of eplerenone 25 mg BID for 3 months.
Main outcome variables
Best corrected visual aquity (BCVA), central macular thickness, subretinal fluid height, subfoveal choroidal thickness, vessel density, flow index in central 3 mm and also in optic nerve head
at the beginning, 1 month and 3 months after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191116045458N1
Registration date:2020-05-12, 1399/02/23
Registration timing:registered_while_recruiting
Last update:2020-05-12, 1399/02/23
Update count:0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
Roozbeh Asghari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3217 4274
Email address
asgharir961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Eplerenone effects on the imaging findings in acute central serous chorioretinopathy: a randomized clinical trial
Public title
Assessment of Eplerenone effects on the imaging findings in acute central serous chorioretinopathy: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that are referred to khatam eye hospital emergency room or clinics with the definite first episode of acute CSCR diagnosis with decreased visual acuity or metamorphopsia for less than 3 months
No history of intraocular diseases
No contraindication for eplerenone use (renal, heart or liver failure, pregnancy, breast feeding, K serum level more than 5 mg/dl, ACEI ,ARB or k-sparing diuretic use, hypertention,type 2 DM with microalbuminuria, use of azoles and clarithromycin).
Exclusion criteria:
any finding making CSCR diagnosis suspicious during treatment
detection of any intraocular disease during treatment
detection of any contraindication of Eplerenone during treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done as individual units. closed classified envelopes is used . Making series is done by randomized table of numbers in www.randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
After definite diagnosis, researcher will refer participants to Statistician specialist for simple randomization by closed classified envelopes into 2 control and intervention groups. File number is obvious for patients, researcher and Statistician specialist. Grouping of patients is just obvious for secretory of Statistician specialist and is hidden for patients, researcher and Statistician specialist. After collecting and during data entrance, Statistician specialist will match the file number and groups and data analysis will be done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad. Vakil abad Blvd., Bahonar Ave., ferdowsi university, faculty of medical sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.475
Health conditions studied
1
Description of health condition studied
Acute central serous chorioretinopathy
ICD-10 code
H35.719
ICD-10 code description
Central serous chorioretinopathy, unspecified eye
Primary outcomes
1
Description
Choroidal perfusion
Timepoint
Before starting treatment, 1 month later and 3 months later
Method of measurement
According to parameters including subfoveal choroidal thickness, vessel density and flow rate in superficial , deep and choriocapillary level in 3mm center of macula.
Secondary outcomes
1
Description
Best corrected visual acuity
Timepoint
Before treatment starting, 1 month and 3 months later
Method of measurement
Examination by optometrist
2
Description
Central macula thickness
Timepoint
Before treatment starting, 1 month and 3 months later
Method of measurement
Performing OCT
3
Description
Subretinal fluid height
Timepoint
Before treatment starting, 1 month and 3 months later
Method of measurement
Performing OCT
4
Description
Optic nerve head perfusion
Timepoint
Before treatment starting, 1 month and 3 months later
Method of measurement
Vessel density flow index in OCT Angiography
Intervention groups
1
Description
Intervention group: patients with definite diagnosis of acute CSCR will be under treatment of Eplerenone 25 mg BID treatment for 3 months
Category
Treatment - Drugs
2
Description
Control group: will get placebo tablets BID for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam eye hospital
Full name of responsible person
Ghodsieh Zamani
Street address
Mashad, Gharani blvd., between Aboutaleb and Ferdowsi square. Khatam eye hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3724 5363
Email
KH.PR@mums.ac.ir
Web page address
http://khatam.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeid Eslami
Street address
Daneshgah Ave., beside Hoveizeh cinema, Gharashi apartment, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghodsieh Zamani
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Gharani Blvd., between Aboutaleb intersection and Ferdowsi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3724 5363
Email
ZamaniGH@mums.ac.ir
Web page address
http://khatam.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghodsieh Zamani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Gharani Blvd., between aboutaleb intersection and Ferdowsi square. khatam eye hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3724 5363
Email
ZamaniGH@mums.ac.ir
Web page address
http://khatam.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ghodsieh Zamani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
GaraniBlvd., between Aboutaleb intersection and Ferdowsi square. khatam eye hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3724 5363
Email
ZamaniGH@mums.ac.ir
Web page address
http://khatam.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all information and details will be available for general population
When the data will become available and for how long
6 months after final acceptance
To whom data/document is available
all academic and scientific organizations
Under which criteria data/document could be used
Any analysis is acceptable
From where data/document is obtainable
request to my E-mail: Asgharir961@mums.ac.ir
What processes are involved for a request to access data/document
data will be reachable maximum 1 month after request by E-mail