UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041900 |
|---|---|
| Receipt number | R000047820 |
| Scientific Title | Chronological analysis of tear dynamics on blinking using quantitative manometry in healthy humans and patients with epiphora |
| Date of disclosure of the study information | 2020/09/26 |
| Last modified on | 2020/09/26 19:23:00 |
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Basic information
Public title
Chronological analysis of tear dynamics on blinking using quantitative manometry in healthy humans and patients with epiphora
Acronym
Chronological analysis of tear dynamics on blinking using quantitative manometry
Scientific Title
Chronological analysis of tear dynamics on blinking using quantitative manometry in healthy humans and patients with epiphora
Scientific Title:Acronym
Chronological analysis of tear dynamics on blinking using quantitative manometry
Region
| Japan |
Condition
Condition
lacrimal duct obstruction, epiphora
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the chronological tear dynamics in the lacrimal drainage system during blinking, by performing direct quantitative manometry of the upper lacrimal drainage duct using a fiber optic pressure sensor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The eyelid pressure and the inner pressure of lacrimal duct.
Key secondary outcomes
Presence or absence of lacrimal duct obstruction, age
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal volunteer, lacrimal canaliculus obstruction, nasolacrimal duct obstruction, functional epiphora.
Key exclusion criteria
Patients with a history of trauma and surgery on the ocular appendage
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Mimura |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
0726831221
opt119@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Mimura |
Organization
Osaka Medical College
Division name
Department of Ophthalmology
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
0726831221
Homepage URL
opt119@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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 Institutional Review Board
Address
Department of Ophthalmology
Tel
0726831221
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
| 2020 | Year | 09 | Month | 26 | 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
| 2019 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective nonrandomized observational study.
To demonstrate the chronological tear dynamics in the lacrimal drainage system during blinking, by performing direct quantitative manometry of the upper lacrimal drainage duct using a fiber optic pressure sensor.
Management information
Registered date
| 2020 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047820
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| Registered date | File name |
| Research case data | |
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