UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of fundus image using artificial intelligence
Acronym	Analysis of fundus image using artificial intelligence
Scientific Title	Analysis of fundus image using artificial intelligence
Scientific Title:Acronym	Analysis of fundus image using artificial intelligence
Region	Japan

Condition
Condition	Ischemic retinal disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Draw the retinal circulation dynamics from the fundus photograph by a program using artificial intelligence.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Probability prediction of nonperfusion region presence by program
Key secondary outcomes	Probability prediction of neovascular existence, retinal blood vessel, bleeding, exudate, edema, blood vessel abnormality detection accuracy

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	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Keio University Hospital Ophthalmologist Outpatients, patients who undergo or have undergone fluorescence fundus angiography examination
Key exclusion criteria	Patients who failed to acquire the fluorescence fundus contrast image due to some reasons, such as side effects during imaging, patients who could not acquire the fundus image for some reason, such as poor fixation and poor posture
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Toshihide Middle name Last name Kurihara
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	03-5363-3204
Email	kurihara@z8.keio.jp

Public contact
Name of contact person	1st name Yusaku Middle name Last name Katada
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	03-5363-3204
Homepage URL
Email	yusakukatada@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Self-sourcing
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	Keio University School of Medicine
Address	35 Shinanomachi, Shijuku-ku, Tokyo
Tel	0333531211
Email	med-rinri-jimu@adst.keio.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	2018 Year 06 Month 15 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	Enrolling by invitation
Date of protocol fixation	2018 Year 06 Month 15 Day
Date of IRB	2018 Year 04 Month 09 Day
Anticipated trial start date	2018 Year 06 Month 15 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analyze the fundus photograph.

Management information
Registered date	2018 Year 06 Month 11 Day
Last modified on	2021 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037558