UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of Choroidal Structure and Circulation during a single administration of coffee in healthy subjects.
Acronym	Choroidal Structure and Circulation during a single administration of coffee
Scientific Title	Assessment of Choroidal Structure and Circulation during a single administration of coffee in healthy subjects.
Scientific Title:Acronym	Choroidal Structure and Circulation during a single administration of coffee
Region	Japan

Condition
Condition	Retinal and Choroidal disorder
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To asessment of choroidal structure and Circulation during a single administration of coffee
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Choroidal luminal area, stromal areas and circulation.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	a single administration of coffee
Interventions/Control_2	a single administration of water
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	non-smoking individuals with no ophthalmic or systemic disorders.
Key exclusion criteria	an age of <18 years or >60 years. high myopia defined as a refractive error (spherical equivalent) greater than -6.0 diopters or an axial length of >26.5 mm, poor quality EDI-OCT image defined as an image index of <30, abnormal EDI-OCT findings, and previous ocular surgeries.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Nagasato
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
Zip code	6711227
Address	68-1 Aboshikuwaku Himeji City Hyogo
TEL	079-272-8555
Email	d.nagasato@tsukazaki-eye.net

Public contact
Name of contact person	1st name Nagasato Middle name Last name Nagasato
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
Zip code	6711227
Address	68-1 Aboshikuwaku Himeji City Hyogo
TEL	079-272-8555
Homepage URL
Email	d.nagasato@tsukazaki-eye.net

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saneikai Tsukazaki Hospital
Address	68-1 Aboshikuwaku Himeji City Hyogo
Tel	079-272-8555
Email	d.nagasato@tsukazaki-eye.net

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 09 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	49
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 20 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 10 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 02 Day
Last modified on	2020 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033144