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High-dose Antioxidants for Central Serous Chorioretinopathy

High-dose Antioxidants for Central Serous Chorioretinopathy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963131
Enrollment
60
Registered
2009-08-21
Start date
2004-12-31
Completion date
2009-06-30
Last updated
2009-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Serous Chorioretinopathy

Keywords

Central serous chorioretinopathy,antioxidants

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.

Interventions

DRUGantioxidants 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.

Sponsors

Alcon Research
CollaboratorINDUSTRY
Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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%).

Design outcomes

Primary

MeasureTime frame
visual acuity and central macular thickness6 months

Secondary

MeasureTime frame
fluorescein leakage at the third month6 months

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026