High-dose Antioxidants for Central Serous Chorioretinopathy
Primary Purpose
Central Serous Chorioretinopathy
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
antioxidants tablets
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central serous chorioretinopathy,antioxidants
Eligibility Criteria
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%).
Sites / Locations
- Department of Ophthalmology, Faculty of medicine, Prince of Songkla university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
antioxidant tablets
placebo tablets
Arm Description
the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease
the control arm received placebo tablets for 3 months or until the resolution of the disease
Outcomes
Primary Outcome Measures
visual acuity and central macular thickness
Secondary Outcome Measures
fluorescein leakage at the third month
Full Information
NCT ID
NCT00963131
First Posted
August 20, 2009
Last Updated
December 29, 2009
Sponsor
Prince of Songkla University
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT00963131
Brief Title
High-dose Antioxidants for Central Serous Chorioretinopathy
Official Title
High-dose Antioxidants for Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prince of Songkla University
Collaborators
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central serous chorioretinopathy,antioxidants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
antioxidant tablets
Arm Type
Experimental
Arm Description
the study arm received antioxidant tablets (Icaps) for 3 months or until the resolution of the disease
Arm Title
placebo tablets
Arm Type
Placebo Comparator
Arm Description
the control arm received placebo tablets for 3 months or until the resolution of the disease
Intervention Type
Drug
Intervention Name(s)
antioxidants tablets
Other Intervention Name(s)
Icaps
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual acuity and central macular thickness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
fluorescein leakage at the third month
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansing - Ratnasukon, MD
Organizational Affiliation
Department of Ophthalmology, Faculty of medicine, Prince of Songkla university, Hat yai, Songkhla province, Thailand 90110
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Faculty of medicine, Prince of Songkla university
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
High-dose Antioxidants for Central Serous Chorioretinopathy
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