High-dose Antioxidants for Central Serous Chorioretinopathy

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Brief Title

High-dose Antioxidants for Central Serous Chorioretinopathy

Official Title

High-dose Antioxidants for Central Serous Chorioretinopathy

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

visual acuity and central macular thickness

Secondary Outcome

 fluorescein leakage at the third month

Condition

Central Serous Chorioretinopathy

Intervention

antioxidants tablets

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

December 2004

Completion Date

June 2009

Primary Completion Date

December 2008

Eligibility Criteria

        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%).
      

Gender

All

Ages

30 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Mansing - Ratnasukon, MD, , 

Location Countries

Thailand

Location Countries

Thailand

Administrative Informations


NCT ID

NCT00963131

Organization ID

EC 47/362-023

Secondary IDs

PSU 2547


Study Sponsor

Prince of Songkla University

Collaborators

 Alcon Research

Study Sponsor

Mansing - Ratnasukon, MD, Principal Investigator, Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110


Verification Date

December 2009