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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040354
Receipt No. R000039365
Scientific Title The research of identification of lacrimal obstruction by artificial intelligence
Date of disclosure of the study information 2020/05/11
Last modified on 2020/05/11

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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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