High-dose Antioxidants for Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. The common risk factors are psychologic stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment is usually observation especially in the first three-months. The laser or photodynamic therapy should be considered when the condition does not improve after that time. Nevertheless, the pathogenesis of CSC is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. From this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. This study is to determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether they can improve the outcomes of the disease.

Official Title
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High-dose Antioxidants for Central Serous Chorioretinopathy

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Drug: antioxidants tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with acute central serous chorioretinopathy within 6 weeks of onset age between 30-50 years new or recurrent attack (the symptom-free period should longer than 6 months) fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid patients' ability for proper follow up. Exclusion Criteria: chronic central serous chorioretinopathy(longer than 6 weeks) complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antioxidant tablets<br>the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease | Drug: antioxidants tablets<br>* vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.<br>* Other names: Icaps;|
| Placebo Comparator: placebo tablets<br>the control arm received placebo tablets for 3 months or until the resolution of the disease | Drug: antioxidants tablets<br>* vitamin A 6600 IU, vitamin C 400 mg, vitamin E 150 IU, riboflavin 10 mg, zinc 60 mg, copper 4 mg, selenium 40 mg, manganese 4 mg and lutein/zeaxanthin 4000 micrograms.<br>* Other names: Icaps;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity and central macular thickness |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluorescein leakage at the third month |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central serous chorioretinopathy,antioxidants