UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036582 |
|---|---|
| Receipt number | R000035308 |
| Scientific Title | Detection of Amblyopia in Vision Screening in 3-year-old Children in Japan |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2021/04/24 21:22:33 |
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Basic information
Public title
Detection of Amblyopia in Vision Screening
in 3-year-old Children in Japan
Acronym
Detection of Amblyopia in Vision Screening
in 3-year-old Children in Japan
Scientific Title
Detection of Amblyopia in Vision Screening
in 3-year-old Children in Japan
Scientific Title:Acronym
Detection of Amblyopia in Vision Screening
in 3-year-old Children in Japan
Region
| Japan |
Condition
Condition
amblyopia, strabismus
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated whether tests of refractive error and strabismus can be used to detect eye diseases such as amblyopia in screening 3 year-old children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and Specificity of the conventional test and the photoscreener test.
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
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The participants of the vision screening in 3 year old children
Key exclusion criteria
The participants whose guardians do not agree to the study,
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shion |
| Middle name | |
| Last name | Hayashi |
Organization
Yamagata University Faculty of Medicine
Division name
Ophthalmology
Zip code
990-9585
Address
2-2-2 Iidanishi Yamagata
TEL
023-628-5374
shionhaneda055@gmail.com
Public contact
Name of contact person
| 1st name | Shion |
| Middle name | |
| Last name | Hayashi |
Organization
Yamagata University Faculty of Medicine
Division name
Ophthalmology
Zip code
990-9585
Address
2-2-2 Iidanishi Yamagata
TEL
023-628-5374
Homepage URL
shionhaneda055@gmail.com
Sponsor or person
Institute
Yamagata University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Yamagata University Faculty of Medicine
Address
2-2-2 Iidanishi Yamagata
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-u.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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
800
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The criterion used to identify children requiring treatment was a corrected visual acuity in one eye of over 0.15 logMAR as indicated by the detailed examination.
Management information
Registered date
| 2019 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
