UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048458 |
|---|---|
| Receipt number | R000055225 |
| Scientific Title | Examination of ophthalmic examination data for infants, school children, and students |
| Date of disclosure of the study information | 2022/08/13 |
| Last modified on | 2024/07/26 09:23:46 |
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Basic information
Public title
Examination of ophthalmic examination data for infants, school children, and students
Acronym
Examination of ophthalmic examination data for infants, school children, and students
Scientific Title
Examination of ophthalmic examination data for infants, school children, and students
Scientific Title:Acronym
Examination of ophthalmic examination data for infants, school children, and students
Region
| Japan |
Condition
Condition
Myopia, hyperopia, astigmatism
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The deterioration of eyesight and myopia of infants, school children, and school-aged children have become a hot topic. The purpose is to explore the actual state of visual function including visual acuity from ophthalmic medical examination data.
Basic objectives2
Others
Basic objectives -Others
Verify whether there are many children with myopia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ophthalmology medical examination data (question contents, eyesight, refraction, etc.)
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
| 3 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ophthalmology medical examination data for children's schools and schools that have been introduced by school doctors who have been involved in research so far.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Department of Visual and Science
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi
TEL
+819030943531
ishii@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Department of Visual and Science
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi
TEL
09030943531
Homepage URL
ishii@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi
Tel
+819030943531
ishii@nuhw.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 | 08 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will receive data from ophthalmic medical examinations conducted at children's gardens and schools, analyze data such as interview contents, eyesight, and refraction, and verify poor eyesight and myopia.
Management information
Registered date
| 2022 | Year | 07 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055225
