UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037352 |
|---|---|
| Receipt number | 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 | 2024/09/09 15:52:23 |
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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
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
mihosato@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese association for strabismus and amblyopia
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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, Chu-oh ku,Hamamatsu
Tel
0534352256
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
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044205
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10384-023-01023-5
Number of participants that the trial has enrolled
221
Results
A total of 221 patients with acquired esotropia were enrolled. The duration of digital device viewing, strabismus angle, and viewing method were compared among the age groups (children and young adults). The results showed that children spent less time watching digital devices, had a larger strabismus angle, and had a shorter time to medical examination.
Results date posted
| 2024 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients aged 5 to 35 years presenting within 1 year of the onset of strabismus
Participant flow
Patients were instructed on how to view their digital devices and came to the clinic 3 months later. Those that stopped coming to the clinic and those that underwent surgery in the meantime were excluded.
Adverse events
none
Outcome measures
Strabismus angle, subjective symptoms, duration of viewing digital devices, and method of viewing digital devices.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2022 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042499
