UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054589 |
|---|---|
| Receipt number | R000062376 |
| Scientific Title | A web-based survey of parents' attitudes towards myopia in elementary and junior high school students |
| Date of disclosure of the study information | 2024/06/07 |
| Last modified on | 2025/09/01 14:22:17 |
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Basic information
Public title
A web-based survey of parents' attitudes towards myopia in elementary and junior high school students
Acronym
A web-based survey of parents' attitudes towards myopia in elementary and junior high school students
Scientific Title
A web-based survey of parents' attitudes towards myopia in elementary and junior high school students
Scientific Title:Acronym
A web-based survey of parents' attitudes towards myopia in elementary and junior high school students
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a web-based survey of parents with children in elementary and junior high school. To examine the anxiety caused by children's myopia and the impact of children's myopia on the quality of life of parents with children in elementary and junior high school, parents' understanding and desire for myopia, and the actual status of treatment in children with myopia.
Basic objectives2
Others
Basic objectives -Others
The anxiety caused by children's myopia and the impact of children's myopia on the quality of life of parents with children in elementary and junior high school
The parents' understanding and desire for myopia
The actual status of treatment in children with myopia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The anxiety caused by children's myopia and the impact of children's myopia on the quality of life of parents with children in elementary and junior high school
The parents' understanding and desire for myopia
The actual status of treatment in children with myopia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents with children of elementary or junior high school student living with them as of April 2024.
Parents who can check the results of the visual acuity test of the child in the 2024 school health examination and can answer the uncorrected visual acuity of both eyes
Key exclusion criteria
Medical professionals (doctors, pharmacists, nurses, etc.)
Subjects engaged in pharmaceuticals, medical devices industry, eyeglasses, and contact lenses manufacturing industries
Subjects engaged in pharmaceuticals distributor or eyeglasses/contact lenses distributor business.
Subjects engaged in information provision services, research services, and advertising
Parents of the children in the survey who have eye diseases affecting vision other than myopia
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Miyahara |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Etsuyo |
| Middle name | |
| Last name | Miyamoto |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Ethics Committe
Address
4-22-11 Jingumae, Shibuya-ku, Tokyo
Tel
03-6779-8166
chi-pr-ec-hillside@cmicgroup.com
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
| 2024 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://jjmps.jp/thesis/82_01_06.html?k=d8d178faf5ae932a05
Number of participants that the trial has enrolled
2454
Results
Refer to paper
Results date posted
| 2025 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To conduct a web-based survey of parents with children in elementary and junior high school.
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062376
