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临床试验/NCT00963131
NCT00963131已完成2 期

High-dose Antioxidants for Central Serous Chorioretinopathy

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2004年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
60
试验地点
1
主要终点
visual acuity and central macular thickness

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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%).

研究组 & 干预措施

antioxidant tablets

Experimental

the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease

干预措施: antioxidants tablets (Drug)

placebo tablets

Placebo Comparator

the control arm received placebo tablets for 3 months or until the resolution of the disease

干预措施: antioxidants tablets (Drug)

结局指标

主要结局

visual acuity and central macular thickness

时间窗: 6 months

次要结局

  • fluorescein leakage at the third month(6 months)

研究者

申办方类型
Other

研究点 (1)

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