UMIN-CTR Clinical Trial

Basic information
Public title	Study of tear clearance for epiphora
Acronym	Tear clearance for epiphora
Scientific Title	Study of tear clearance for epiphora
Scientific Title:Acronym	Tear clearance for epiphora
Region	Japan

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

Objectives
Narrative objectives1	The analysis of tear dynamics for the patients with epiphora by the tear clearance examination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1, Efficacy of lacrimal duct intubation and dacryocystorhinostomy to the tear dynamics 2, Evaluation of tear dynamics for anatomical and functional obstruction
Key secondary outcomes	1, Availability of tear clearance examination for the treatment of epiphora

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with lacrimation or epiphora Patients with anatomical or functional obstruction
Key exclusion criteria	a) Patients who do not agree with this survey b) Patients who are judged to be unsuitable for participation in this study by the investigator c) Patients who are allergic to the drugs used in this survey
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Kamao
Organization	Ehime University
Division name	Ophthalmology
Zip code	7910295
Address	Shitsukawa, Toon-city, Ehime
TEL	+81-89-960-5361
Email	t-kamao@m.ehime-u.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Kamao
Organization	Ehime University
Division name	Ophthalmology
Zip code	7910295
Address	Shitsukawa, Toon-city, Ehime
TEL	+81-89-960-5361
Homepage URL
Email	t-kamao@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University
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	Institutional Review Board,Ehime University Hospital
Address	Shitsukawa, Toon-city, Ehime
Tel	+81-89-960-5172
Email	rinri@m.ehime-u.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	愛媛大学医学部附属病院（愛媛県）　Ehime University Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 10 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 05 Month 07 Day
Date of IRB	2018 Year 06 Month 30 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2040 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Retrospective nonrandomized observational study Patients with epiphora or lacrimation were recruited at Ehime University. AS-OCT (CASIA SS-1000, Tomey, Japan) with customized software was used to record the tear meniscus at the center of the lower eyelid. Five microlitres of lukewarm saline solution was dropped into the lower conjunctival sac, and an image of the tear meniscus was obtained immediately and again 30 seconds after natural blinking. The tear meniscus height (TMH) and tear meniscus area (TMA) were measured in the AS-OCT images, and the percentage decrease in the TMH and TMA was used as a measure of the tear clearance.

Management information
Registered date	2020 Year 06 Month 10 Day
Last modified on	2020 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046473