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
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
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
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
