UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter prospective study of the relationship between acquired esotropia and the use of digital devices in young people
Acronym	Multicenter research on the use of digital devices
Scientific Title	A multicenter prospective study of the relationship between acquired esotropia and the use of digital devices in young people
Scientific Title:Acronym	Multicenter research on the use of digital devices
Region	Japan

Condition
Condition	aquired esotropia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Acquired acute esotropia in young people increasing in recent years. 1) Identify what ACE patients are attributed to digital devices. 2) Clarify if there are any ACEs that can be improved by limiting the use of digital devices. 3) Proposal of a new clinical diagnostic classification that enables accurate diagnosis through protocol treatment.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity, refraction test, adjusted paralysis refraction, possessed glasses or contact lens power, oclular deviation, stereoscopic vision, presence of intracranial disease.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Limiting the usage time of digital devices
Interventions/Control_2	No limit on digital device usage time
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	Intended for patients who meet all of the following criteria: 1. Patients who are 5 to 35 years old at the first visit. 2. Patients with esotropia who have visited within one year of symptom onset or abrupt worsening, and who have no abduction restrictions Including those who have fluctuations in symptoms and can maintain intermittent or oblique positions. 3. A person who keeps a daily record of digital device usage time by the person or guardian. 4). Those who have obtained consent for this study by signing the consent form by the person or the representative.
Key exclusion criteria	Patients who do any of the following will not be included in this study. 1. The cause of the occurrence of esotropia can be identified at the first visit (a head injury or infection that clearly triggers the onset) 2. Eye movement limitation (abduction limitation) 3. Head MRI or CT reveals intracranial disease or intraorbital disease 4. Those who have already been diagnosed at another hospital and require early surgery or botulinum toxin treatment 5. What the researcher judged inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Goseki
Organization	Kitasato University
Division name	Opthalmology
Zip code	252-0332
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	0427788429
Email	gosekikun@aol.com

Public contact
Name of contact person	1st name Satoru Middle name Last name Totsuka
Organization	Kitasato University
Division name	Opthalmology
Zip code	2520332
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	0427788429
Homepage URL
Email	satoru.totsuka@gmail.com

Sponsor
Institute	Hamamatsu Medical University
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kitasato University
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel	0427788429
Email	satoru.totsuka@gmail.com

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 12 Month 03 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	2019 Year 10 Month 01 Day
Date of IRB	2020 Year 01 Month 06 Day
Anticipated trial start date	2020 Year 01 Month 07 Day
Last follow-up date	2023 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 12 Month 03 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044205