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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028310
Receipt No. R000032406
Scientific Title Epidemiological study related to ocular surface factors for all residents in Takushima island, Hirado, Nagasaki
Date of disclosure of the study information 2017/07/20
Last modified on 2018/03/16

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Basic information
Public title Epidemiological study related to ocular surface factors for all residents in Takushima island, Hirado, Nagasaki
Acronym Epidemiological study related to ocular surface factors in Takushima island
Scientific Title Epidemiological study related to ocular surface factors for all residents in Takushima island, Hirado, Nagasaki
Scientific Title:Acronym Epidemiological study related to ocular surface factors in Takushima island
Region
Japan

Condition
Condition Ocular surface diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the epidemiology of ocular surface related factors
Basic objectives2 Others
Basic objectives -Others epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes questionnaire related to dry eye
questionnaire related to food
questionnaire related to life
tearfilm-related factors
ocular surface-related factors
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
6 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria (1) Subjects who agree to the joining to the study based on the informed consent
(2) Subjects less than 20 y-o whose parent(s) agree to joining to the study
Key exclusion criteria (1) People who cannot set their chin on the slitlamp microscope
(2) People who cannot communicate regularly
(3) People whom doctors judge to be inadequate to join the study
Target sample size 652

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiko Arita
Organization Lid and Meibomian gland working group
Division name Division for epidemiological study in Takushima island
Zip code
Address 626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL 048-686-5588
Email arita.reiko@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Reiko Arita
Organization Lid and Meibomian gland working group
Division name Division for epidemiological study in Takushima island
Zip code
Address 626-11 Minaminakano, minuma-ku, Saitama, Saitama
TEL 048-686-5588
Homepage URL
Email arita.reiko@gmail.com

Sponsor
Institute Lid and Meibomian gland working group
Institute
Department

Funding Source
Organization Lid and Meibomian gland working group
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
2017 Year 07 Month 20 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe the details related to the dry eye factors

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032406

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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