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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032943
Receipt No. R000037558
Scientific Title Analysis of fundus image using artificial intelligence
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/11

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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
Middle name
Last name Toshihide Kurihara
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
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
Middle name
Last name Yusaku Katada
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 15 Day
Last follow-up date
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
2018 Year 06 Month 11 Day


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

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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