UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021158 |
|---|---|
| Receipt number | R000024394 |
| Scientific Title | Effect of blue light on eye and systemic health |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2023/08/30 09:04:47 |
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Basic information
Public title
Effect of blue light on eye and systemic health
Acronym
Effect of blue light on eye and systemic health
Scientific Title
Effect of blue light on eye and systemic health
Scientific Title:Acronym
Effect of blue light on eye and systemic health
Region
| Japan |
Condition
Condition
sleep disorder, metablic disorder, cornea and retinal damage, dry eye, eye fatigue
Classification by specialty
| Endocrinology and Metabolism | Psychosomatic Internal Medicine | Ophthalmology |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of blue light contained in daily lighting on ocular and systemic health
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcomes:Sleep quality
Assessment at;[1] before each intervention, [2]one month, and [3]three months for intervention 1.
Key secondary outcomes
Key secondary outcomes:Metabolic parameters, vision, cornea and retinal damage, ocular symptoms.
Assessment at;[1] before each intervention, [2]one month, and [3]three months for intervention 1.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Washout period is two weeks when subjects live regular life as precisely as possible, specifically, no oversea travel or overnight work. blue light shield for 3 hours before bedtime for 3 months
Interventions/Control_2
Washout period is two weeks when subjects live regular life as precisely as possible, specifically, no oversea travel or overnight work.Then the subjects ordinary life without blue light shield for one month
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heathy subject proven by general health check.
Key exclusion criteria
Severe cataract or glaucoma.Vision worse than 16/20.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | masahiko |
| Middle name | |
| Last name | masahiko ayaki |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shijyuku, Tokyo, Japan
TEL
090-2211-8355
mayaki@olive.ocn.ne.jp
Public contact
Name of contact person
| 1st name | masahiko |
| Middle name | |
| Last name | masahiko ayaki |
Organization
Keio Univ Sch of Med
Division name
Ophthalmology
Zip code
1608582
Address
35 Shinanomachi, Shinjyuku
TEL
090-2211-8355
Homepage URL
mayaki@olive.ocn.ne.jp
Sponsor or person
Institute
Dept of Ophthalmol, Keio Univ Sch of Med
Institute
Department
Personal name
Funding Source
Organization
personal fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NOne
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba central Hospital
Address
Kashiwada 1589-3, Ushiku, Ibaragi
Tel
029-872-1771
mayaki@olive.ocn.ne.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
| 2016 | Year | 02 | Month | 24 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024394
