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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033019
Receipt No. 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

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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
Email 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
Email t-mizo@siren.ocn.ne.jp

Sponsor
Institute MizoguchiEye Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037642

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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