UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of retino-choroidal circulation state with difference of various conditions in healthy subjects
Title of the study (Brief title)	Change of retino-choroidal circulation state with difference of various conditions in healthy subjects
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the ocular blood flow of normal eyes when intraocular pressure increases by Laser Spekle Flowgraphy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood flow of retinal blood vessel
Key secondary outcomes	Choroidal vascular area Choroidal thickness

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Normal eyes
Key exclusion criteria	Presence of eye disease History of eye disease treatment
Target sample size	20

Research contact person
Name of lead principal investigator	Takeshi Iwase
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
Address	Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL	052-744-2275
Email	tiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tomohiko Akahori
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
Address	Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL	052-744-2275
Homepage URL
Email	akahori.tomohiko@g.mbox.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 20 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Investigate the relationship between ocular blood flow and other systemic and ocular factors.

Management information
Registered date	2016 Year 11 Month 24 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028736