High-dose Antioxidants for Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

High-dose Antioxidants for Central Serous Chorioretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963131
• Other study ID #: EC 47/362-023
• Secondary ID: PSU 2547
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2009
• Last updated: December 29, 2009
• Start date: December 2004
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics committee board of Faculty of medicine, Prince of Songkla university, Thailand:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• antioxidants tablets
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.

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology, Faculty of medicine, Prince of Songkla university	Hat Yai	Songkhla

Sponsors (2)

Lead Sponsor	Collaborator
Prince of Songkla University	Alcon Research

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity and central macular thickness		6 months	No
Secondary	fluorescein leakage at the third month		6 months	No