UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047189 |
|---|---|
| Receipt number | R000053829 |
| Scientific Title | Prevalence of refractive-error and its associated factors among Japanese preschool children. |
| Date of disclosure of the study information | 2022/03/16 |
| Last modified on | 2022/03/16 22:17:02 |
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Basic information
Public title
Prevalence of refractive-error and its associated factors
Acronym
Prevalence of refractive-error and its associated factors
Scientific Title
Prevalence of refractive-error and its associated factors among Japanese preschool children.
Scientific Title:Acronym
Prevalence of refractive-error and its associated factors
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the prevalence of early onset myopia as well as the factors associated with longer axial length, myopic spherical equivalent among Japanese preschool children
Basic objectives2
Others
Basic objectives -Others
Risk Factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myopia
Key secondary outcomes
High myopia, Axial length, Spherical Equivalent
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects aged 4-6 years from a preschool
Key exclusion criteria
Children with chronic eye diseases, such as congenital cataracts, undergoing myopia-suppressing treatment, chronic medical disorders, and Down syndrome
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Saiko |
| Middle name | |
| Last name | Matsumura |
Organization
Toho University School of Medicine
Division name
Department of Ophthalmology
Zip code
1438540
Address
6-11-1 Omori-Nishi, Otaku
TEL
0337624151
saiko.matsumura@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Saiko |
| Middle name | |
| Last name | Matsumura |
Organization
Toho University School of Medicine
Division name
Department of Ophthalmology
Zip code
1438540
Address
6-11-1 Omori-Nishi, Otaku
TEL
0337624151
Homepage URL
saiko.matsumura@med.toho-u.ac.jp
Sponsor or person
Institute
Eiwakai
Institute
Department
Personal name
Funding Source
Organization
None
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
Eiwakai
Address
3-23-24 Kamisyotanaka Nakahara-ku, Kawasaki
Tel
044-777-7700
saiko.matsumura@med.toho-u.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 | 03 | Month | 16 | 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
400
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
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 03 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053829
