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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031773
Receipt No. R000036176
Scientific Title Evaluation of lacrimal duct using ultrasound biomicroscope
Date of disclosure of the study information 2018/03/17
Last modified on 2019/03/20

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Basic information
Public title Evaluation of lacrimal duct using ultrasound biomicroscope
Acronym Evaluation of lacrimal duct using ultrasound biomicroscope
Scientific Title Evaluation of lacrimal duct using ultrasound biomicroscope
Scientific Title:Acronym Evaluation of lacrimal duct using ultrasound biomicroscope
Region
Japan

Condition
Condition epiphora
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of invasive evaluation of lacrimal ducts using ultrasound biomicroscope for epiphora
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The measured dimensions of lacrimal passage using ultrasound biomicroscope
Key secondary outcomes Observation of lacrimal disorder(s)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Involve volunteers for control
Interventions/Control_2 To inject hydroxyethylcellulose, boric acid, inorganic salt formulation solution into lacrimal duct
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

Not applicable
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria Patients visited the ophthalmology clinic and signed on the agreement for the study.
Key exclusion criteria Volunteers under 20 years-old
Patients who have history of allergy to hydroxyethylcellulose, boric acid, inorganic salt formulation solution
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Mimura
Middle name
Last name Masashi
Organization Osaka Medical College
Division name Ophthalmology
Zip code 5698686
Address 2-7 Daigakumachi Takatsuki Osaka Japan
TEL 0726831221
Email opt119@osaka-med.ac.jp

Public contact
Name of contact person
1st name Mimura
Middle name
Last name Masashi
Organization Osaka Medical College
Division name Ophthalmology
Zip code 5698686
Address 2-7 Daigakumachi Takatsuki Osaka Japan
TEL 0726831221
Homepage URL
Email opt119@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka Medical College
Address 2-7 Daigakumachi Takatsuki city, Osaka, Japan
Tel 0726831221
Email rinri@osaka-med.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
2018 Year 03 Month 17 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 03 Month 12 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 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
2018 Year 03 Month 17 Day
Last modified on
2019 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036176

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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