UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043408 |
|---|---|
| Receipt number | 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 | 2023/09/23 18:07:57 |
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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
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
seiji.takagi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Currently working on a paper
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
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049551
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
