UMIN-CTR Clinical Trial

Basic information
Public title	Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Acronym	Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Scientific Title	Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Scientific Title:Acronym	Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure ocular blood flow in eye movement in healthy volunteer.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To measure ocular blood flow during eye movement in normal eyes and to compare with previously measured data in glaucoma patients
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Mydriatic (tropicamide 0.4%) eye drops before measurement
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	The participant who - doesn't have ophthalmological diseases that affect blood flow measurement other than refractive error. - doesn't be diagnosed of cardiovascular disease or diabetes mellitus. - systolic blood pressure is less 150mmHg and diastolic blood pressure is less 90 mmHg. - doesn't take drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors). - has corrected visual acuity more than 0.8. - doesn't have refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism. - doesn't have axial length of exceeding 26.5 mm. - has intraocular pressure of 21mmHg or less. - doesn't have history of refractive surgery.
Key exclusion criteria	The participant who - has ophthalmological diseases that affect blood flow measurement other than refractive error. - diagnosed of cardiovascular disease or diabetes mellitus. - systolic blood pressure exceeding 150 mmHg and diastolic blood pressure exceeding 90 mmHg. - Patients taking drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors). - has corrected visual acuity less than 0.8. - has refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism. - has axial length exceeding 26.5 mm - has intraocular pressure of 21 mmHg or more - has patients with a history of refractive surgery.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Goseki
Organization	Kitasato University School of Medicine
Division name	Department of Ophthalmology
Zip code	2500374
Address	1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
TEL	0427788464
Email	toshiaki.goseki@gmail.com

Public contact
Name of contact person	1st name Kazunoei Middle name Hirasawa Last name Hirasawa
Organization	Kitasato University School of Medicine
Division name	Department of Ophthalmology
Zip code	2520374
Address	1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
TEL	0427788464
Homepage URL
Email	hirasawa@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion Of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Research Ethics Committee of the Kitasato University Hospital
Address	1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
Tel	0427788273
Email	rinrib@med.kitasato-u.ac.jp

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	2021 Year 03 Month 03 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	Completed
Date of protocol fixation	2021 Year 01 Month 21 Day
Date of IRB	2021 Year 05 Month 11 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 03 Day
Last modified on	2022 Year 07 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049679