UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047050 |
|---|---|
| Receipt number | R000053674 |
| Scientific Title | Family awareness survey and analysis of clinical data on pediatric eyeglasses prescriptions |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2025/03/04 16:45:50 |
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Basic information
Public title
Family awareness survey and analysis of clinical data on pediatric eyeglasses prescriptions
Acronym
Data analysis of pediatric eyeglass prescriptions
Scientific Title
Family awareness survey and analysis of clinical data on pediatric eyeglasses prescriptions
Scientific Title:Acronym
Data analysis of pediatric eyeglass prescriptions
Region
| Japan |
Condition
Condition
Amblyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the psychological burden and anxiety of families regarding pediatric eyeglass prescriptions, and to extract clinical data from medical records and analyze the progress of pediatric eyeglass prescriptions in patients, under 9 years of age who prescribed spectacles to children with refractive error, anisometropia, and strabismus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Aggregate and compare the results of family questionnaires
Key secondary outcomes
Analyze whether there is a significant difference in visual acuity or stereoscopic vision depending on the age at which the spectacles were prescribed
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
| 6 | months-old | <= |
Age-upper limit
| 9 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under the age of 9 who started wearing eyeglasses for the treatment of amblyopia
Key exclusion criteria
Those with systemic complications
Those with developmental delay
Those with organic diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | miwa |
| Middle name | |
| Last name | komori |
Organization
Hamamatsu University School of Medicine
Division name
Ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-shi , Shizuoka-ken, Japan
TEL
053-435-2256
mihosato@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | miwa |
| Middle name | |
| Last name | komori |
Organization
Hamamatsu University School of Medicine
Division name
Ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-shi , Shizuoka-ken, Japan
TEL
053-435-2256
Homepage URL
komori@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu-shi , Shizuoka-ken, Japan
Tel
053-435-2680
rinri@hama-med.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
浜松医科大学医学部附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | 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 | 01 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtain consent by signing the consent form by the person or guardian, and also publish in information disclosure document.
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053674
