UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061194 |
|---|---|
| Receipt number | R000069856 |
| Scientific Title | A Prospective Intervention Study on the Progression of Myopia Using School Health Screenings |
| Date of disclosure of the study information | 2026/04/09 |
| Last modified on | 2026/04/08 10:00:42 |
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Basic information
Public title
A Prospective Intervention Study on the Progression of Myopia Using School Health Screenings
Acronym
A Prospective Intervention Study on the Progression of Myopia Using School Health Screenings
Scientific Title
A Prospective Intervention Study on the Progression of Myopia Using School Health Screenings
Scientific Title:Acronym
A Prospective Intervention Study on the Progression of Myopia Using School Health Screenings
Region
| Japan |
Condition
Condition
Progressive myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on myopia management in school health screenings, aiming to disseminate knowledge about myopia and raise awareness among parents and children,
while also conducting detailed evaluations of myopia using the latest ophthalmic diagnostic equipment. Through this, we aim to discover new biomarkers that can help predict the progression of myopia,with the goal of contributing to the development of effective future strategies for the diagnosis and treatment of myopia.
Basic objectives2
Others
Basic objectives -Others
This study evaluates changes in the rate of ophthalmology visits resulting from myopia awareness campaigns, based on the presence or absence of myopia screenings and educational materials.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of Eye Examination Rates Between Groups Based on the Presence or Absence of Myopia Screenings and Educational Materials
Key secondary outcomes
Changes in Ophthalmic Parameters
Correlation between refractive errors and corneal biomechanical factors (corneal thickness, corneal stiffness, etc.)
Correlation between axial length and corneal biomechanical factors (corneal thickness, corneal stiffness, etc.)
Correlation between the rate of myopia progression and corneal biomechanical factors (corneal thickness, corneal stiffness, etc.)
Correlation between the rate of axial length elongation and corneal biomechanical factors (corneal thickness, corneal stiffness, etc.)
Group-specific analysis of non-myopic (SE > -0.50 D), mild myopia (-0.50 D <= SE > -3.00 D), moderate myopia (-3.00 D <= SE > -5.00 D), and high myopia (<= -5.00)
7
Multivariate analysis to identify factors contributing to axial length growth
Comparison with the rate of ophthalmology visits at Tomiya City Elementary School over the past 5 years
*Evaluation and analysis will be performed using examination data from the 1st, 2nd, and 3rd years.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
We aim to raise awareness and improve understanding of myopia among parents and children through myopia screenings and educational materials.
Interventions/Control_2
No intervention
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elementary school students (grades 2-5 at the time of registration) who have obtained parental consent for school health screenings
Key exclusion criteria
(1) Individuals from whom consent cannot be obtained (including those who indicate on the day of the examination that they do not wish to participate in the study)
(2) Individuals deemed unsuitable for examination on the day of the examination
(3) Cases where the examination data is insufficient or the image data is unclear, hindering data analysis
Target sample size
1050
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Ophthalmic Precision Medicine Development, United Centers for Advanced Research and Translational Medicine (ART)
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
satoru.tsuda.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Tsuda |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
Homepage URL
satoru.tsuda.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Rohto Pharmaceutical Co., Ltd.
Tomey corporation.
Sekisui House, Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069856
