UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026772 |
|---|---|
| Receipt number | 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 | 2021/04/06 07:10:40 |
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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
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
hmpgx653@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 04 | 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 | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | 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
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030733
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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