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IRCT20191116045458N1 IRCT 2020-05-12 Mashhad University of Medical Sciences Assessment of Eplerenone effects on the imaging findings in acute central serous chorioretinopathy: a randomized clinical trial Assessment of Eplerenone effects on the imaging findings in acute central serous chorioretinopathy: a randomized clinical trial 2019-12-22 anticipated 40 Complete https://irct.ir/trial/44352 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Acute central serous chorioretinopathy. Intervention 1: Intervention group: patients with definite diagnosis of acute CSCR will be under treatment of Eplerenone 25 mg BID treatment for 3 months. Intervention 2: Control group: will get placebo tablets BID for 3 months. Yes - There is a plan to make this available What will be shared: all information and details will be available for general population When: 6 months after final acceptance To whom: all academic and scientific organizations Conditions: Any analysis is acceptable Where to obtain: request to my E-mail: Asgharir961@mums.ac.ir How to obtain: data will be reachable maximum 1 month after request by E-mail Comments:
public Ghodsieh Zamani
Gharani Blvd., between Aboutaleb intersection and Ferdowsi square
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 1401 ZamaniGH@mums.ac.ir Mashhad University of Medical Sciences scientific Ghodsieh Zamani
Gharani Blvd., between aboutaleb intersection and Ferdowsi square. khatam eye hospital
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 1401 ZamaniGH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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). 18 years no limit Both any finding making CSCR diagnosis suspicious during treatment detection of any intraocular disease during treatment detection of any contraindication of Eplerenone during treatment H35.719 Central serous chorioretinopathy, unspecified eye Treatment - Drugs Placebo Intervention group: patients with definite diagnosis of acute CSCR will be under treatment of Eplerenone 25 mg BID treatment for 3 months Control group: will get placebo tablets BID for 3 months 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. Best corrected visual acuity. Timepoint: Before treatment starting, 1 month and 3 months later. Method of measurement: Examination by optometrist. Central macula thickness. Timepoint: Before treatment starting, 1 month and 3 months later. Method of measurement: Performing OCT. Subretinal fluid height. Timepoint: Before treatment starting, 1 month and 3 months later. Method of measurement: Performing OCT. Optic nerve head perfusion. Timepoint: Before treatment starting, 1 month and 3 months later. Method of measurement: Vessel density flow index in OCT Angiography. Mashhad University of Medical Sciences Approved 2019-05-07 Ethics committee of Mashhad University of Medical Sciences Mashhad. Vakil abad Blvd., Bahonar Ave., ferdowsi university, faculty of medical sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)