UMIN-CTR Clinical Trial

Basic information
Public title	Development of artificial intelligence in ophthalmology
Acronym	Development of artificial intelligence in ophthalmology
Scientific Title	Development of artificial intelligence in ophthalmology
Scientific Title:Acronym	Development of artificial intelligence in ophthalmology
Region	Japan

Condition
Condition	Cataract, dry eye disease, allergic conjunctivitis, glaucoma, corneal disease, etc
Classification by specialty	Ophthalmology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of artificial intelligence using ophthalmology data
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Performance of artificial intelligence in the diagnosis or/and evaluation of ophthalmologic data.
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	16 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	All patients
Key exclusion criteria	no opt-in cases
Target sample size	905

Research contact person
Name of lead principal investigator	1st name Eisuke Middle name Last name Shimizu
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	0333531211
Email	ophthalmolog1st.acek39@keio.jp

Public contact
Name of contact person	1st name Eisuke Middle name Last name Shimizu
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	0333531211
Homepage URL
Email	ophthalmolog1st.acek39@keio.jp

Sponsor
Institute	Keio University School
Institute
Department

Funding Source
Organization	AMED
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	Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku
Tel	0333531211
Email	ophthalmolog1st.acek39@keio.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 01 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	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 02 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 02 Month 01 Day
Last modified on	2022 Year 02 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049318