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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026772
Receipt No. R000030733
Scientific Title Analysis of toxic metals in hair in dry eye patients
Date of disclosure of the study information 2017/04/01
Last modified on 2018/09/29

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Basic information
Public title Analysis of toxic metals in hair in dry eye patients
Acronym Toxic metals in dry eye
Scientific Title Analysis of toxic metals in hair in dry eye patients
Scientific Title:Acronym Toxic metals in dry eye
Region
Japan

Condition
Condition Dry eye disease
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will be undergone for unveil the correlation between dry eye disease and harmful metal in the body by using hair sample.
Basic objectives2 Others
Basic objectives -Others The correlation between dry eye disease and harmful metal in the body
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Harmful metal volume in patients' hair
Key secondary outcomes Clinical dry eye evaluation factors,
Schirmer test, Tear Break Up Time, corneal staining score, subjective symptoms


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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We entry the people who meet all conditions below (No.1-4) as dry eye group.
And we entry the people who meet conditions (No.1-3) without dry eye disease (DED) as control group.
1. Those aged 40 and over, who gained informed consent of the person himself / herself voluntarily.
2. Those without systemic diseases affecting wound healing such as eye disease and diabetes.
3. Those without a history of corneal and conjunctival surgery within the past 1 year
4. Those diagnosed definite dry eye disease by Japanese DED diagnostic criteria.
Diagnosis was established according to the Japanese DED diagnostic criteria, as follows; (1) presence of dry eye symptoms; (2) a.presence of qualitative or b.quantitative disturbance of the tear film in 1 or both eyes (a.Shirmer test <= 5 mm or b.Tear Break Up Time <= 5 seconds); and (3) presence of conjunctivocorneal epithelial damage (total staining score => 3 points) in 1 or both eyes. The presence of all 3 criteria was necessary for a definite diagnosis of DED.

Key exclusion criteria People who meet one of the following conditions are excluded from both dry eye group and control group.
1.Those which can not obtain informed consent for ophthalmic examination.
2.Those that can not obtain informed consent for hair collection
3. Those taking supplements such as vitamin supplements
4. Those having a history of receiving corneal conjunctival surgery within the past one year
5. Those who have cataracts above age appropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Uchino
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL +81-3-3353-1211
Email hmpgx653@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Uchino
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL +81-3-3353-1211
Homepage URL
Email hmpgx653@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Department of Ophthalmology
Institute
Department

Funding Source
Organization Keio University School of Medicine
Department of Ophthalmology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 04 Month 01 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
2016 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Clinical dry eye evaluation factors
Schirmer test, Tear Break Up Time, corneal staining score, subjective symptoms

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030733

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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