High-dose Antioxidants for Central Serous Chorioretinopathy

Phase 2

Completed

• Conditions: Central Serous Chorioretinopathy
• Interventions: Drug: antioxidants tablets

• Registration Number: NCT00963131
• Lead Sponsor: Prince of Songkla University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Study First Submitted: 2009-08-20
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-29
• Last Update Posted: 2009-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. patients with acute central serous chorioretinopathy within 6 weeks of onset
2. age between 30-50 years
3. new or recurrent attack (the symptom-free period should longer than 6 months)
4. fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid
5. patients' ability for proper follow up.

Exclusion Criteria

1. chronic central serous chorioretinopathy(longer than 6 weeks)
2. complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA
3. 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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antioxidant tablets	antioxidants tablets	the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease
placebo tablets	antioxidants tablets	the control arm received placebo tablets for 3 months or until the resolution of the disease

Primary Outcome Measures

Name	Time	Method
visual acuity and central macular thickness	6 months

Secondary Outcome Measures

Name	Time	Method
fluorescein leakage at the third month	6 months

Trial Locations

Locations (1)

Department of Ophthalmology, Faculty of medicine, Prince of Songkla university; 🇹🇭 Hat Yai, Songkhla, Thailand