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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043409
Receipt No. R000049558
Scientific Title Artificial Intelligence-assisted evaluation of ocular blood flow in diabetic patients using laser speckle flowgraphy
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-assisted evaluation of ocular blood flow in diabetic patients using laser speckle flowgraphy
Acronym AI analysis of LSFG in DM
Scientific Title Artificial Intelligence-assisted evaluation of ocular blood flow in diabetic patients using laser speckle flowgraphy
Scientific Title:Acronym AI analysis of LSFG in DM
Region
Japan

Condition
Condition Subjects diagnosed with diabetes mellitus
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to measure ocular circulation using laser speckle flowgraphy in subjects diagnosed with diabetes and to examine the relationship between various parameters using artificial intelligence(AI).
Another purpose was to investigate whether the characteristics of ocular circulation could be used to predict the progression of diabetic retinopathy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation, using artificial intelligence, of the relationship between age, gender, blood pressure, visual acuity, refraction, intraocular pressure, body mass index, pulse wave velocity and LSFG items.
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 diagnosed with diabetes whose ocular circulation could be measured by laser speckle flowgraphy.
Key exclusion criteria Subjects whose ocular circulation could not be measured by laser speckle flowgraphy.
Target sample size 500

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
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 Open public recruiting
Date of protocol fixation
2020 Year 08 Month 13 Day
Date of IRB
2020 Year 08 Month 13 Day
Anticipated trial start date
2020 Year 08 Month 13 Day
Last follow-up date
2023 Year 03 Month 31 Day
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 measure ocular circulation in subjects diagnosed with diabetes using laser speckle flowgraphy and to examine the relationship between various parameters using AI.
Another purpose was to investigate whether the characteristics of ocular circulation could be used to predict the progression of diabetic retinopathy.

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=R000049558

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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