UMIN-CTR Clinical Trial

Basic information
Public title	The research of identification of lacrimal obstruction by artificial intelligence
Acronym	The research of identification of lacrimal obstruction by AI
Scientific Title	The research of identification of lacrimal obstruction by artificial intelligence
Scientific Title:Acronym	The research of identification of lacrimal obstruction by AI
Region	Japan

Condition
Condition	lacrimal duct obstruction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the ability of AI to diagnose the lacrimal duct obstruction and the site of obstruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ability of AI to diagnose the lacrimal duct obstruction and the site of obstruction.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Anterior-OCT
Interventions/Control_2	control
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	No other ophthalmic disorders without lacrimal duct obstruction
Key exclusion criteria	The presence of functional lacrimal duct obstructions; congenital nasolacrimal duct obstructions; and lacrimal passage obstructions caused by trauma, tumor, and chemotherapy; and previous lacrimal passage surgery.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Imamura
Organization	Tsukazaki Hospital
Division name	Department of Ophthalmology
Zip code	671-1227
Address	68-1, Waku, Aboshi-ku, Himeji-city
TEL	079-272-8555
Email	h.imamura@tsukazaki-eye.net

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Imamura
Organization	Tsukazaki Hospital
Division name	Department of Ophthalmology
Zip code	671-1227
Address	68-1, Waku, Aboshi-ku, Himeji-city
TEL	079-272-8555
Homepage URL
Email	saneikai@tsukazaki-hp.jp

Sponsor
Institute	Tsukazaki Hospital
Institute
Department

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	Tsukazaki Hospital
Address	68-1, Waku, Aboshi-ku, Himeji-city
Tel	079-272-8555
Email	saneikai@tsukazaki-hp.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	2020 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	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 11 Day
Last modified on	2020 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039365

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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