UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037827 |
|---|---|
| Receipt number | R000041874 |
| Scientific Title | EEG and systemic effects of short wavelength light |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2020/08/29 18:15:24 |
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Basic information
Public title
EEG and systemic effects of short wavelength light
Acronym
EEG and systemic effects of light
Scientific Title
EEG and systemic effects of short wavelength light
Scientific Title:Acronym
EEG and systemic effects of light
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate dry eye symptoms with EEG and expore associations with dry eye symptoms and other psychiatric parameters.
Eye opening and closing may affect irraiation of short wavelength light and dryness.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effects of dryness and short wavelength light on life and works.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ampritude and wavelength of EEG at symptomatic dry eye
Key secondary outcomes
questionnaires for psychiatric condition
ocular symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
free blinking for one minutes, then continuous eye opening for one minutes. When feeling disconfort, blink 2-3 times and repeat eye opening.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who can discontinue contact lens and eyedrop at the day of examination
Key exclusion criteria
Past corneoconjunctival surgery, lid surgery, or lacrimal surgery.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasue |
| Middle name | |
| Last name | Mitsukura |
Organization
Keio University
Division name
Technology and Engineering
Zip code
223-8522
Address
Yokohama, Japan
TEL
090-2211-8355
mitsukura@keio.jp
Public contact
Name of contact person
| 1st name | masahiko |
| Middle name | |
| Last name | ayaki |
Organization
Keio University
Division name
Ophthalmology
Zip code
1608582
Address
35 shinanomachi, shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
ayaki@keio.jp
Sponsor or person
Institute
keio university
Institute
Department
Personal name
Funding Source
Organization
keio University
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
Dept of Technology, Keio univ
Address
3-14-1 hiyoshi, yokohama2238522, Japan
Tel
045-566-1455
ecc-jimu@adst.keio.ac.jp
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
| 2019 | Year | 09 | 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
30
Results
Under investigation
Results date posted
| 2019 | Year | 05 | Month | 15 | Day |
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
Suspended
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041874
| Research Plan | |
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| 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 |
