UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of ocular blood flow alterations in response to intraocular pressure elevation with Laser speckle flowgraphy
Title of the study (Brief title)	Assessment of ocular blood flow alterations in response to intraocular pressure elevation
Region	Japan

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

Objectives
Narrative objectives1	To investigate ocular blood flow alterations in response to short-term intraocular elevation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Ocular blood flow ratio and coefficient of variation in the intraocular pressure elevation phase was calculated with reference to this baseline.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To investigate the ocular blood flow alterations in response to intraocular pressure elevation on two different days.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy volunteers Normal findings in slit lamp and funduscopic examinations No history of ophthalmic or general disorders, prior ocular laser or incisional surgery in either eye, and the use of systemic or topical medication Obtain written-informed consent from the subjects.
Key exclusion criteria	A regular smoking habit High myopia Baseline intraocular pressure less than 22mmHg in both eyes History of topical medication allergy In pregnancy History of unconfortable for periocular compression History of ophthalmic or general disorders, prior ocular laser or incisional surgery in either eye, and the use of systemic or topical medication No written-informed consent from the subjects
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Kunikata
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1,Seiryo-cho, Aoba-ku
TEL	022-717-7294
Email	kunikata@oph.med.tohoku.ac.jp

Public contact
Name of contact person	Yukihiro Shiga
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Ophthalmology
Address	1-1,Seiryo-cho, Aoba-ku
TEL	022-717-7294
Homepage URL
Email	y.shiga@oph.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine, Department of Ophthalmology
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grants-in-Aid for Scientific Research (B) (T.N. 26293372)
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 02 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 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

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2017 Year 02 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030097