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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026778
Receipt No. R000030732
Scientific Title Construction of normal database of laser speckle flow graphy
Date of disclosure of the study information 2017/04/15
Last modified on 2018/11/12

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Basic information
Public title Construction of normal database of laser speckle flow graphy
Acronym normal databese of LSFG
Scientific Title Construction of normal database of laser speckle flow graphy
Scientific Title:Acronym normal databese of LSFG
Region
Japan

Condition
Condition Subjects of thorough medical checkup
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to make a normal cutoff level of evaluation items of ocular circulation by Laser speckle flowgraphy (LSFG) in many cases of Subjects of thorough medical checkup.
We propose a novel ophthalmologic physiological examination system which replaces arteriosclerosis judgment by the fundus photograph of the eye.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Revaluation of relationship between age, gender, blood pressure, visual acuity, spherical refraction, intraocular pressure, body mass index, pulse wave velocity,Questionnaire survey on exercise habits and items of LSFG.
Key secondary outcomes

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who can be measured ocular circulation by laser speckle flowgraphy
Key exclusion criteria Subjects who can not be measured ocular circulation by laser speckle flowgraphy
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Shiba
Organization School of Medicine, Toho University
Division name Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3761-4151
Email tomoaki-s@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Shiba
Organization School of Medicine, Toho University
Division name Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3761-4151
Homepage URL
Email tomoaki-s@med.toho-u.ac.jp

Sponsor
Institute Toho University
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
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
2017 Year 04 Month 15 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
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The purpose of this study was to make a normal cutoff level of evaluation items of ocular circulation by Laser speckle flowgraphy (LSFG) in many cases of Subjects of thorough medical checkup.
We propose a novel ophthalmologic physiological examination system which replaces arteriosclerosis judgment by the fundus photograph of the eye.

Management information
Registered date
2017 Year 03 Month 30 Day
Last modified on
2018 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030732

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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