UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the etiology of central serous chorioretinopathy using en face OCT and indocyanine green angiography
Title of the study (Brief title)	Possible Etiologies of Central Serous Chorioretinopathy
Region	Japan

Condition
Condition	Central Serous Chorioretinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the etiology of central serous chorioretinopathy using indocyanine green angiography and en face-OCT imaging.
Basic objectives2	Others
Basic objectives -Others	To clarify the etiology of eye disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the abnormal areas in central serous chorioretinopathy using en face-OCT and indocyanine green angiography.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with central serous chorioretinopathy.
Key exclusion criteria	Patients with polypoidal choroidal vasculopathy and age-related macular diseases, based on fluorescein angiography, indocyanine green angiography and OCT findings, were excluded.
Target sample size	25

Research contact person
Name of lead principal investigator	Ari Shinojima
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Science
Address	1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	shinojima.ari@nihon-u.ac.jp

Public contact
Name of contact person	Ari Shinojima
Organization	Nihon University School of Medicine
Division name	Division of Ophthalmology, Department of Visual Science
Address	1-6, Surugadai, Kanda, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Homepage URL
Email	shinojima.ari@nihon-u.ac.jp

Sponsor
Institute	Nihon University Hospital
Institute
Department

Funding Source
Organization	Novartis Pharma (to A.S.)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pubmed/27532435
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27532435
Results	All 25 CSC eyes and 13 contralateral eyes showed abnormal hypofluorescent areas on late-phase ICGA and hyperreflective areas on en-face OCT from BrM to the choriocapillaris, and these findings correlated with the abnormal areas (r = 0.9988; p < 0.001).
Other related information	Study design (Observational case series study). We retrospectively studied all eyes of consecutive untreated patients at our Hospital, between April 2015 and December 2015. Items investigated (We investigated the area of the abnormal portion on en face images and the area of the abnormal portion in angiography images.)

Management information
Registered date	2016 Year 01 Month 19 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023821