High-dose Antioxidants for Central Serous Chorioretinopathy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Serous Chorioretinopathy Eye Diseases Retinal Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Ophthalmology, Faculty of medicine, Prince of Songkla university

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

antioxidants tablets

Drug

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.

Other names: Icaps

Primary outcomes

visual acuity and central macular thickness

Time frame: 6 months

Secondary outcomes

fluorescein leakage at the third month

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Collaborators

Alcon Research

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2009
First posted: Aug 21, 2009
Registry last updated: Dec 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed