Clinical trial to investigate the efficacy of Spironolactone compared with placebo in patients with acute retinal edema
- Conditions
- Acute Central Serous Chorio-Retinopathy (CSCR).Chorioretinal Inflammation H30.0 Focal chorioretinal inflammation Focal: chorioretinitis choroiditis retinitis retinochoroiditis
- Registration Number
- IRCT2016051627882N1
- Lead Sponsor
- Vice Chancellor for research of Shahid Sadoughi University of Medical Science
- Brief Summary
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 />
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Drug adverse effect. Timepoint: Upon entry, two weeks later, a month later. Method of measurement: According to patient's statement.