UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014842 |
|---|---|
| Receipt number | R000017246 |
| Scientific Title | Investigation about the myopia progress of the primary schoolchild |
| Date of disclosure of the study information | 2014/08/12 |
| Last modified on | 2025/08/20 10:11:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation about the myopia progress of the primary schoolchild
Acronym
Myopia progress investigation of the primary schoolchild
Scientific Title
Investigation about the myopia progress of the primary schoolchild
Scientific Title:Acronym
Myopia progress investigation of the primary schoolchild
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fact-finding of the myopia progress of the schoolchild
Basic objectives2
Others
Basic objectives -Others
myopia frequency
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
refractive erroe
axial length
Key secondary outcomes
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
| 5 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Testable
Key exclusion criteria
eye disease
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Kjii-cho, Kamigyu-ku, Kyoto City
TEL
075-251-5578
oheida@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Hieda |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Ophthalmology
Zip code
602-0841
Address
465 Kjii-cho, Kamigyu-ku, Kyoto City
TEL
075-251-5578
Homepage URL
ohieda@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
465 Kjii-cho, Kamigyu-ku, Kyoto City
Tel
075-251-5578
oheida@koto.kpu-m.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
| 2014 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
https://kpu.bvits.com/rinri/Common/
Publication of results
Partially published
Result
URL related to results and publications
http://journal.nichigan.or.jp/
Number of participants that the trial has enrolled
1149
Results
Prevalence of myopia among Japanese school children
Results date posted
| 2025 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Elementary school junior high school students
Participant flow
Measured once a year
Adverse events
none
Outcome measures
axial length
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Data entry is in progress.
Management information
Registered date
| 2014 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017246
