UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Choroidal structure on OCT images
Title of the study (Brief title)	choroidal OCT
Region	Japan

Condition
Condition	retino choroidal diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To see the qualitative analysis on OCT
Basic objectives2	Others
Basic objectives -Others	Comparison of OCT image of vessels and parenchima
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Choroidal structure on OCT with image processing
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Key exclusion criteria	Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Target sample size	500

Research contact person
Name of lead principal investigator	Taiji Sakamoto
Organization	Kagoshima University
Division name	Ophthalmology
Address	8-35-1 Sakuragaoka, Kagoshima
TEL	099-275-5402
Email	shou@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Shozo Sonoda
Organization	Kagoshima University
Division name	Ophthalmology
Address	8-35-1 Sakuragaaoka, Kagoshima
TEL	099-275-5402
Homepage URL
Email	tsakamot@m3.kufm.kagoshima-u..ac.jp

Sponsor
Institute	Ophthalmology, Kagoshima Unviersity
Institute
Department

Funding Source
Organization	Ophthalmology, Kagoshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Ophthalmology, Tokushima University
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	鹿児島大学病院眼科

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2015 Year 04 Month 30 Day
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	To the repeatability and reproducibility of the OCT image of choroid after image p@rocessing

Management information
Registered date	2013 Year 11 Month 15 Day
Last modified on	2016 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014386