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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043408
Receipt No. R000049551
Scientific Title Artificial Intelligence(AI) analysis of laser speckle flowgraphy data of healthy subjects
Date of disclosure of the study information 2021/02/22
Last modified on 2021/02/22

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Basic information
Public title Artificial Intelligence(AI) analysis of laser speckle flowgraphy data of healthy subjects
Acronym AI analysis of LSFG data of healthy subjects
Scientific Title Artificial Intelligence(AI) analysis of laser speckle flowgraphy data of healthy subjects
Scientific Title:Acronym AI analysis of LSFG data of healthy subjects
Region
Japan

Condition
Condition Subjects of thorough medical checkup(UMIN000026778)
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the construction of a new normal laser speckle flowgraphy(LSFG) database by using artificial intelligence(AI) in order to analyze the LSFG data and the subjects' background information obtained in the previous study(Umin000026778).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the classification and prediction performance of the subjects' background (age, gender, blood pressure, visual acuity, intraocular pressure, etc.) using machine learning of the features extracted from the LSFG time series data.
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 could be measured ocular circulation by Laser speckle flowgraphy.
Key exclusion criteria Subjects who could not be measured ocular circulation by Laser speckle flowgraphy.
Target sample size 1082

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

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Takagi
Organization School of Medicine, Toho University
Division name Ophthalmology
Zip code 143-8541
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 03-3761-4151
Homepage URL
Email seiji.takagi@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 School of Medicine, Toho University
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
Tel 03-3761-4151
Email med.rinri@ext.toho-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 02 Month 22 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 1082
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
2020 Year 07 Month 27 Day
Date of IRB
2020 Year 07 Month 27 Day
Anticipated trial start date
2020 Year 07 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation, using machine learning, of the classification and prediction performance of the features extracted from the time series data of LSFG and the subjects' background (age, gender, blood pressure, visual acuity, intraocular pressure, etc.) obtained from previous research data (UMIN000026778).

Management information
Registered date
2021 Year 02 Month 22 Day
Last modified on
2021 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049551

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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