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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047720
Receipt No. R000054395
Scientific Title Development of AI to diagnose the corneal infection
Date of disclosure of the study information 2022/05/11
Last modified on 2022/05/11

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Basic information
Public title Development of AI to diagnose the corneal infection
Acronym Development of AI to diagnose the corneal infection
Scientific Title Development of AI to diagnose the corneal infection
Scientific Title:Acronym Development of AI to diagnose the corneal infection
Region
Japan Asia(except Japan)

Condition
Condition Corneal infection
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of AI to diagnose the corneal infection
Basic objectives2 Others
Basic objectives -Others NA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether AI shows accuracy to suggest causative organism >60%
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Gender Male and Female
Key inclusion criteria Corneal infection
Key exclusion criteria The causative organism was not detected.
Infection focus covers the whole area of the cornea.
Insufficient quality of anterior segment images.
Patients who are not willing to be involved in the study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Okumura
Organization Doshisha University
Division name Department of Biomedical Engineering
Zip code 610-0394
Address 1-3 tatara MIyakodani, Kyotanabe, Japan
TEL 0774656508
Email nokumura@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Okumura
Organization Doshisha University
Division name Department of Biomedical Engineering
Zip code 610-0394
Address 1-3 tatara MIyakodani, Kyotanabe, Japan
TEL 0774656508
Homepage URL
Email nokumura@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology, MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB
Address 1-3 tatara MIyakodani, Kyotanabe, Japan
Tel 075-251-3158
Email ji-rinri@mail.doshisha.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
2022 Year 05 Month 11 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
2022 Year 02 Month 21 Day
Date of IRB
2022 Year 02 Month 21 Day
Anticipated trial start date
2022 Year 02 Month 21 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2022 Year 05 Month 11 Day
Last modified on
2022 Year 05 Month 11 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054395

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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