UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031773
Receipt number R000036176
Scientific Title Evaluation of lacrimal duct using ultrasound biomicroscope
Date of disclosure of the study information 2018/03/17
Last modified on 2021/09/29 13:49:16

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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 or person

Institute

Osaka Medical College

Institute

Department

Personal name



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

Completed

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

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 06 Month 30 Day

Date analysis concluded

2021 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 17 Day

Last modified on

2021 Year 09 Month 29 Day



Link to view the page

Value
https://center6.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