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IRCT2016051627882N1 IRCT 2016-12-12 Vice Chancellor for research of Shahid Sadoughi University of Medical Science Clinical trial to investigate the efficacy of Spironolactone compared with placebo in patients with acute retinal edema Study of sprinolactone effect as a treatment for Acute Central Serous Chorio-Retinopathy 2015-08-08 anticipated 40 Complete https://irct.ir/trial/22750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of random numbers. 4 Acute Central Serous Chorio-Retinopathy (CSCR). Intervention 1: 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. Intervention 2: 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 . BACKGROUND AND OBJECTIVE:<br /> Central serous chorioretinopathy (CSCR) is a vision-threatening eye disease with no validated treatment and unknown pathogeny.The disease usually becomes better within 3-4 months but in some cases, recurrent or chronic, progressive loss of visual acuity is associated with. No effective drug therapy has not been seen for treatment of CSCR.<br /> Overaction of mineralocorticoid receptor (MR) pathways has been implicated in the pathophysiology of central serous chorioretinopathy (CSCR). The purpose of this study was to evaluate MR antagonists in the treatment of CSCR. the disease in young and middle ages can be seen so Reduce the duration of illness and increase the quality of life is considered in this study.<br /> STUDY DESIGN AND METHODS:<br /> The study randomized clinical trail (RCT) as a double-blind and 40 patients were admitted in 1394-1393 to Shahid Sadducees hospital were diagnosed with acute CSCR. In this study, patients treated with placebo control group and the group treated with spironolactone 25 mg daily, respectively. Demographic (age, gender, etc.) and visual acuity (bcva, logmar) and cmt at certain times pre-treatment, two weeks after treatment and one month after treatment were measured with the Snellen chart and OCT.<br /> RESULTS:<br /> After a month of treatment success in the group treated with spironolactone was 72.2% and 35.3% in the control group was shown. (0.028 p value) <br /> Visual acuity in the group treated with spironolactone became better and changes of visual acuity logmar 0.463 to 0.108 was observed after one month of therapy.In the treatment group Cmt before treatment was 550 μm after treatment (with significant reduction of 43.43% 239 μm) became 311 μm in one month after use spironolactone. There was no complication in the treatment.<br /> CONCLUSIONS:<br /> The study showed that the use of spironolactone 25 mg tablets in the acute phase (the first month) improvement in visual acuity and cmt in cscr disease, and the results of this study reinforce the Mineralocorticoid in the pathogenesis of the disease. Further analysis is required in the following reference.<br />
public Mr Mohammad Mohsen Keshmirshekan
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam BLVD, Yazd, Iran
Yazd Iran (Islamic Republic of) dr.mkeshmirshekan@yahoo.com; nooshin.yoshany@gmail.com; mkeshmirshekan@ssu.ac.ir Shahid Sadoughi University of Medical Science scientific Dr Masoud Reza Manaviat
Shahid Sadoughi Hospital, Yazd
Yazd Iran (Islamic Republic of) +98 35 3822 4000 mkeshmirshekan@ssu.ac.ir; dr.mkeshmirshekan@yahoo.com; nooshin.yoshany@yahoo.com Shahid Sadoughi University of Medical Science Iran (Islamic Republic of) 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 19 years 49 years Both H30.0 Chorioretinal Inflammation H30.0 Focal chorioretinal inflammation Focal: chorioretinitis choroiditis retinitis retinochoroiditis Treatment - Drugs Placebo 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. 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 . The volume of fluid under the retina and macular thickness. Timepoint: Upon entry, two weeks later, a month later. Method of measurement: OCT. Visual acuity. Timepoint: Upon entry, two weeks later, a month later. Method of measurement: Snellen chart. Drug adverse effect. Timepoint: Upon entry, two weeks later, a month later. Method of measurement: According to patient's statement. Vice Chancellor for research of Shahid Sadoughi University of Medical Science Approved 2015-05-16 Ethics Committee of Shahid Sadoughi University of Medical Science Shahid Sadoughi University of Medical Science Yazd Iran (Islamic Republic of)