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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02815176
Other study ID # 2016-02-109
Secondary ID
Status Recruiting
Phase N/A
First received June 13, 2016
Last updated June 28, 2016
Start date June 2016
Est. completion date June 2017

Study information

Verified date June 2016
Source Samsung Medical Center
Contact Se Woong Kang, MD
Phone +82-2-3410-3548
Email swkang@skku.edu
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Thrombotic biomarkers and angiographic characteristics were compared among the de novo patients of central serous chorioretinopathy (CSC), polypoidal choroidal vasculopathy (PCV) and the control.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- CSC

- neurosensory detachment in optical coherence tomography (OCT)

- focal leakage in fluorescein angiography (FAG) and/or late choroidal hyperpermeability in indocyanine green angiography (ICGA)

- PCV

- subretinal and/or sub-retinal pigment epithelial fluid in OCT

- branching vascular network and/or polyps in ICGA

- Control

- epiretinal membrane (ERM)

- without underlying systemic, ophthalmic disease other than ERM

Exclusion Criteria:

- Previous history of using steroid (oral, topical)

- Previous history of CSC/PCV

- Previous history or evidence of intraocular inflammation including uveitis

- Co-existing retinal or choroidal diseases

- History of allergic reaction to fluorescein or indocyanine green dye

- Underlying systemic conditions that could affect the thrombotic profiles (e.g. diabetes, hypertension, metabolic syndrome, coronary artery disease, cerebrovascular diseases, stroke, chronic renal failure, current smoker, pregnancy, sleep disorder)

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Blood sampling
Sampling the blood including DNA to investigate the thrombotic profile

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum Fibrinogen in active PCV and CSC patients Serum Fibrinogen (mg/dl) Less than 1 week after initial diagnosis No
Primary Serum Factor VIII activity in active PCV and CSC patients Serum Factor VIII activity (%) Less than 1 week after initial diagnosis No
Primary Serum Plasminogen activity in active PCV and CSC patients Serum Plasminogen activity (%) Less than 1 week after initial diagnosis No
Primary Serum D-dimer in active PCV and CSC patients Serum D-dimer (µg/mL(FEU)) Less than 1 week after initial diagnosis No
Primary Serum Fibrin degradation product in active PCV and CSC patients Serum Fibrin degradation product (µg/mL) Less than 1 week after initial diagnosis No
Primary Serum PAI-1 antigen in active PCV and CSC patients Serum PAI-1 (plasminogen activator inhibitor-1) antigen (ng/mL) Less than 1 week after initial diagnosis No
Primary Serum PAI-1 SNP genotyping in active PCV and CSC patients Serum PAI-1 SNP(single nucleotide polymorphism) genotyping Less than 1 week after initial diagnosis No
Secondary Characteristics of fluorescein angiography in active PCV and CSC patients Numbers of leaking points of fluorescein dye in fluorescein angiography Less than 1 week after initial diagnosis No
Secondary Characteristics of indocyanine green angiography in active PCV and CSC patients Numbers of hyperfluorescent spots in indocyanine green angiography Less than 1 week after initial diagnosis No
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