UMIN-CTR Clinical Trial

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

Contact us.