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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037352
Receipt No. R000042499
Scientific Title Prospective multi-center study for the relationship between acquired comitant esotropia and digital device usage of young adults in Japan
Date of disclosure of the study information 2019/07/23
Last modified on 2019/07/23

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Basic information
Public title Prospective multi-center study for the relationship between acquired comitant esotropia and digital device usage of young adults in Japan
Acronym ACE-DD study in Japan
Scientific Title Prospective multi-center study for the relationship between acquired comitant esotropia and digital device usage of young adults in Japan
Scientific Title:Acronym ACE-DD study in Japan.
Region
Japan

Condition
Condition Acquired comitant esotropia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clear the relationship between acqiured esotropia in young adults and digital device usages
Basic objectives2 Others
Basic objectives -Others To clear if acquired esotropia in young adults improves by restricting the usage of digital device.
To propose a diagnostic method with protocol treatment and propose a new clinical classification of acquired esotropia in young population
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Age distribution, frequency and associated findings with acquired esotropia in young adults
Key secondary outcomes Relationship between the restriction of digital device usage and acquired esotropia improvement.
To identify the time and methods of digital device usage related to the onset of acquired esotropia.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 restrictions of digital device usage
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
5 years-old <=
Age-upper limit
35 years-old >=
Gender Male and Female
Key inclusion criteria Acquired comitant esotropia occured within one yyear
Key exclusion criteria Traumatic esotropia
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Miho
Middle name
Last name Sato
Organization Hamamatsu university School of Medicine
Division name Ophthalmology
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku,Hamamatsu
TEL 0534352256
Email mihosato@hama-med.ac.jp

Public contact
Name of contact person
1st name Miho
Middle name
Last name Sato
Organization Hamamatsu university school of medicine
Division name Ophthalmology
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku,Hamamatsu
TEL 0534352256
Homepage URL
Email mihosato@hama-med.ac.jp

Sponsor
Institute Hamamatsu university school of medicine
Institute
Department

Funding Source
Organization Japanese association for strabismus and amblyopia
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Child Health and Development
Name of secondary funder(s) National Center for Child Health and Development

IRB Contact (For public release)
Organization Hamamatsu university school of medicine
Address 1-20-1 Handayama, Higashi-ku,Hamamatsu
Tel 0534352256
Email mihosato@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

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 23 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
2019 Year 06 Month 20 Day
Date of IRB
2019 Year 07 Month 02 Day
Anticipated trial start date
2019 Year 07 Month 21 Day
Last follow-up date
2022 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
2019 Year 07 Month 12 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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