Evaluation of efficacy of using oral Amiloride-H for treatment of central serous chorioretinopathy
Design
Two arm parallel group randomized clinical trial, double blinded
Settings and conduct
This study will be done in Isfahan Feiz hospital on patient suffering central serous chorioretinopathy. the patient divided in two groups. One group with drug and other with placebo will be following. The patient one and three month after beginnig study will be followed and their information such as best corrected visual acuity, central thickness of macula, central thickness of choroid record.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age greater than 18 and less than 50
Presence of acute central serous choriorethinopathy
Lack of existence of other ophthalmic pathology such as glaucoma and chorioretinits disease
Exclusion criteria: Patient dissatisfaction with completion study
No return of patient for following examination
Intervention groups
intervention group includes patients suffer from central serous chorioretinopathy who receive Amiloride-h
control group includes patients suffer from central serous chorioretinopathy who receive placebo
Main outcome variables
Best corrected visual acuity, central thickness of macula, central thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043009N1
Registration date:2019-05-09, 1398/02/19
Registration timing:registered_while_recruiting
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Mohammad hossein Taghdiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3447 6011
Email address
dr.taghdiri@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of amiloride-H for treatment of patients suffer from central serous chorioretinopathy
Public title
effect of amiloride-h in central serous chorioretinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of acute central serous chorioretinopathy less than past month
Exclusion criteria:
presence of ophthalmologic pathology same as glaucoma, retinal disease and uveitis
use of previuos treatment, like as medical, PDT, laser photocoagulation
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study all the patient an researcher are blind. The patient know they are in a study but they don't know that they use drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
modares Ave, Feiz hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.MUI.MED.REC.1397.296
Health conditions studied
1
Description of health condition studied
Central serous chorioretinopathy
ICD-10 code
H35.719
ICD-10 code description
Central serous chorioretinopathy, unspecified eye
Primary outcomes
1
Description
Best corrected visual acuity based on snellen chart
Timepoint
Measurement of best corrected visual acuity of the patient at first and 1, 3 month after begining treatment
Method of measurement
Snellen chart board
Secondary outcomes
1
Description
Central macular thickness
Timepoint
At first and 1, 3 months after treatment
Method of measurement
Imaging of the retina with use of optical coherence tomography
Intervention groups
1
Description
Intervention group: This group will be treated with Amiloride-h that is combination of Amiloride and Hydrochlorothiazide . This drug exists as 5mg tablet that use one time in day for 3 months after beginning.
Category
Treatment - Drugs
2
Description
Control group: this group will use placebo one time in day for 3 month of beginning.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Mohammad hossein taghdiri
Street address
Aodarres Ave, Feiz Hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 2033
Email
dr.taghdiri@resident.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjuy javanmard
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 9000
Email
dr.taghdiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hossein Taghdiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Modares Ave, feiz hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3447 6011
Fax
Email
dr.taghdiri@resident.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali salehi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Modarres Ave, Feiz hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3445 2033
Email
a_salehi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hossein Taghdiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Modares Ave, feiz hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3447 6011
Fax
Email
dr.taghdiri@resident.mui.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
Visual acuity in study
When the data will become available and for how long
one year
To whom data/document is available
Valid jurnals
Under which criteria data/document could be used
Evaluation of study
From where data/document is obtainable
Responsible author
What processes are involved for a request to access data/document