UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049527 |
|---|---|
| Receipt number | R000056395 |
| Scientific Title | Measurement experiment of the angle of convergence when watching videos on a smartphone |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2022/11/16 12:51:48 |
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Basic information
Public title
Measurement experiment of the angle of convergence when watching videos on a smartphone
Acronym
Measurement experiment of the angle of convergence when watching videos on a smartphone
Scientific Title
Measurement experiment of the angle of convergence when watching videos on a smartphone
Scientific Title:Acronym
Measurement experiment of the angle of convergence when watching videos on a smartphone
Region
| Japan |
Condition
Condition
No disease
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating the pathogenesis of acute esotropia by analyzing the angle of convergence (degree of cross-eyedness) during video viewing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using SiB eye tracking to measure changes in viewing distance and angle of convergence for 30 minutes while watching a video on a smartphone.
Key secondary outcomes
Objective refraction test, binocular visual function test, binocular vision test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
SiB eye-tracking is used to measure changes in viewing distance and angle of convergence for 30 minutes while watching videos on a smartphone.Comparative study of changes in convergence angle due to video type and speed.
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
| 20 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
College students who use smartphones on a daily basis.Those who are interested in research in the area of visual function and voluntarily apply as subjects.
Key exclusion criteria
There are no exclusion criteria.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Department of Visual Science, Faculty of Medical Technology
Zip code
950-3198
Address
1398 Shimamicho, Kita ku, Niigata City
TEL
025-257-4533
ishii@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Ishii |
Organization
Niigata University of Health and Welfare
Division name
Department of Visual Science, Faculty of Medical Technology
Zip code
950
Address
1398 Shimamicho, Kita ku, Niigata City
TEL
025-257-4533
Homepage URL
ishii@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita ku, Niigata City
Tel
025-257-4533
ishii@nuhw.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
| 2023 | Year | 01 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056395
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
