UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative analysis of retinal microvasculature in normal eyes using optical coherence tomography (OCT) angiography
Title of the study (Brief title)	Analysis or retinal microvasculature in normal eyes using OCT angiography
Region	Japan

Condition
Condition	Normal eyes
Classification by specialty	Ophthalmology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To make a database of retinal circulation in normal eyes by OCT angiography
Basic objectives2	Others
Basic objectives -Others	To confirm the usefulness of OCT angiography
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Retinal circulation and vessel density measured by OCT angio graphy.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	16 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Best-corrected visual acuity is 10/20 or more
Key exclusion criteria	Dense Cataract and Glaucoma
Target sample size	50

Research contact person
Name of lead principal investigator	Atsushi Mizota
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Email	mimurat@med.teikyo-u.ac.jp

Public contact
Name of contact person	Tatsuya Mimura
Organization	Teikyo University
Division name	School of Medicine, Department of Ophthalmology
Address	2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL	03-3964-1211
Homepage URL
Email	mimurat@med.teikyo-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Teikyo University School 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	帝京大学医学部付属病院眼科学講座 埼玉医科大学病院眼科

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 22 Day
Anticipated trial start date	2018 Year 02 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
Publication of results	Unpublished
URL releasing results
Results
Other related information	Visual Acuity, Intraocular Pressure, Gender, Age

Management information
Registered date	2018 Year 02 Month 22 Day
Last modified on	2018 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035872