UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040354
Receipt number 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 2020/09/14 20:05:55

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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 or person

Institute

Tsukazaki Hospital

Institute

Department

Personal name



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

2011 Year 08 Month 01 Day

Anticipated trial start date

2011 Year 08 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 09 Month 14 Day



Link to view the page

Value
https://center6.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