UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043409 |
|---|---|
| Receipt number | 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 | 2023/02/28 15:01:16 |
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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
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
110
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 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049558
