UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048639 |
|---|---|
| Receipt number | R000055038 |
| Scientific Title | Influence of myopia on neuroendocrine and quality of life |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/01/12 16:01:56 |
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Basic information
Public title
Influence of myopia on neuroendocrine and quality of life
Acronym
Influence of myopia on neuroendocrine and quality of life
Scientific Title
Influence of myopia on neuroendocrine and quality of life
Scientific Title:Acronym
Influence of myopia on neuroendocrine and quality of life
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between myopia and sleep quality, depression, and subjective happiness scale in youth
Basic objectives2
Others
Basic objectives -Others
To measure melatonin secretion which are closely related to circadian rhythms, and so on in myopic patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index : PSQI
Key secondary outcomes
-Refractive power
-Axial length
-Corneal radius
-Neuroendocrine measurement
-Choroidal thickness
-Hospital Anxiety and Depression Scale : HADS
-Center for Epidemiologic Studies Depression Scale : CES-D
-Subjective Happiness Scale : SHS
-Dry Eye related Quality of life Score : DEQS
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The person whose age is over 20 years old
2.The person who can give a written consent after understanding the contents of this study
3.The degree of the ametropia does not matter
Key exclusion criteria
1. The person who cannot give consent for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3821
Homepage URL
kazunonegishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-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
| 2022 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Visual Acuity, Refractive power, Optical biometry, OCT, Questionnaire (PSQI, HADS, SHS, DEQS, CES-D)
Management information
Registered date
| 2022 | Year | 08 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055038
| Research Plan | |
|---|---|
| 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 |
