UMIN-CTR Clinical Trial

Basic information
Public title	Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Acronym	Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title	Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title:Acronym	Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina 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 difference of ocular blood flow determined by Laser Spekle Flowgraphy between the left and the right eye or the superior and the inferior retina in sitting or supine position in normal subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of retinal blood flow between the left and the right eye or the superior and the inferior retina.
Key secondary outcomes	Retinal vessel diameter, Retinal vessel velocity, Change of ocular blood flow between sitting and supine position.

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	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Iwase
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
Zip code
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	1st name Middle name Last name Ryo Tomita
Organization	Nagoya University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL	052-744-2275
Homepage URL
Email	tomitaryo1021@gmail.com

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 08 Month 25 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
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	Main results already published
Date of protocol fixation	2018 Year 08 Month 15 Day
Date of IRB	2013 Year 01 Month 13 Day
Anticipated trial start date	2018 Year 08 Month 25 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 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

Other
Other related information	To evaluate the change of the ocular blood flow and the relationship with other factors.

Management information
Registered date	2018 Year 08 Month 15 Day
Last modified on	2020 Year 07 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038518