UMIN-CTR Clinical Trial

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
Email	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
Email	ishii@nuhw.ac.jp

Sponsor
Institute	Niigata University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056395