UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040709 |
|---|---|
| Receipt number | R000046473 |
| Scientific Title | Study of tear clearance for epiphora |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2020/06/10 14:30:57 |
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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
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
t-kamao@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon-city, Ehime
Tel
+81-89-960-5172
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046473
