UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the relation between Central serous chorioretinal disease and stress-related factors
Title of the study (Brief title)	The relation between Central serous chorioretinal disease and Stress
Region	Japan

Condition
Condition	Central serous chorioretinal disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relation between Central serous chorioretinal disease and Stress-related factors
Basic objectives2	Others
Basic objectives -Others	To asses the relation between stress hormone levels, and mental status and ocular parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stress hormone levels
Key secondary outcomes	Background, Profile of Mood States-Brief Form Japanese Version,The Center for Epidemiologic Studies Depression Scale, Visual acuity, Choroidal thickness, Retinal thickness, Fluorescence /Indocyanine Green angiography findings.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	blood sampling
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	15 years-old <
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Pitients with central serous chorioretinopathy on fluorescein angiography (FA) and indocyanine green angiography (IA) 2) Willingness to provide written informed consent
Key exclusion criteria	None
Target sample size	100

Research contact person
Name of lead principal investigator	Gomi Fumi
Organization	Hyogo College Of Medicine
Division name	Department of Ophthalmology
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6111
Email	fgomi@hyo-med.ac.jp

Public contact
Name of contact person	Iwami Hisashi
Organization	Hyogo College Of Medicine
Division name	Department of Ophthalmology
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6111
Homepage URL
Email	hi-iwami@hyo-med.ac.jp

Sponsor
Institute	Hyogo College Of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 07 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 20 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 24 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032453