UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Screening of lacrimal duct obstruction using fluorescein dye dissapearing test by orthoptist
Title of the study (Brief title)	Screening of lacrimal duct obstruction by orthoptist
Region	Japan

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

Objectives
Narrative objectives1	To investigate usability of Screening of lacrimal duct obstruction using fluorescein dye dissapearing test by orthoptist
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sensitivity and specificity
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Application of fluorescein to conjunctiva
Interventions/Control_2
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	outpatients of our clinic
Key exclusion criteria	patients who rejected this research
Target sample size	100

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

Public contact
Name of contact person	Hitoshi Imamura
Organization	Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	68-1, Waku, Aboshi-ku, Himeji-city
TEL	079-272-8555
Homepage URL
Email	h.imamura@tsukazaki-eye.net

Sponsor
Institute	Tsukazaki Hotspital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 07 Month 11 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 11 Day
Anticipated trial start date	2017 Year 07 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 11 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032258