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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name