UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033019 |
|---|---|
| Receipt number | R000037642 |
| Scientific Title | Eye Medical check for the 3rd grade of Ohno elementary school in Sasebo city in Nagasaki Prefecture |
| Date of disclosure of the study information | 2018/06/16 |
| Last modified on | 2018/06/16 12:02:50 |
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Basic information
Public title
Eye Medical check for the 3rd grade of Ohno elementary school in Sasebo city in Nagasaki Prefecture
Acronym
Eye medical check for the 3rd grade elementary school students
Scientific Title
Eye Medical check for the 3rd grade of Ohno elementary school in Sasebo city in Nagasaki Prefecture
Scientific Title:Acronym
Eye medical check for the 3rd grade elementary school students
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence and riskfactors of dry eye and meibomian gland dysfunction in the 3rd grade of the elementary school student.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship among diet, exercise and sleep
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LLT, CFS, Meiboscore, Meibum grade, NIBUT, BUT, Schirmer, papilla, lid margin findings, LLG
Key secondary outcomes
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
| 8 | years-old | <= |
Age-upper limit
| 9 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From a parent or protector of the child, the informed consent can be received.
Key exclusion criteria
Those who can not get the face on the chin-rest
Those who can not communicate each other
Those whom doctors decide inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic, LIMEworking group
Division name
Ophthalmology
Zip code
Address
6-13, Tawaramachi, Sasebo City, Nagasaki
TEL
0956-22-5681
t-mizo@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic, LIME working group
Division name
Ophthalmology
Zip code
Address
6-13, Tawaramachi, Sasebo City, Nagasaki
TEL
0956-22-5681
Homepage URL
t-mizo@siren.ocn.ne.jp
Sponsor or person
Institute
MizoguchiEye Clinic
Institute
Department
Personal name
Funding Source
Organization
Mizoguchi Eye Clinic
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
Address
Tel
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 | 06 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational cross-sectional study
Management information
Registered date
| 2018 | Year | 06 | Month | 16 | Day |
Last modified on
| 2018 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037642
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
