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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038775
Receipt No. R000044205
Scientific Title A multicenter prospective study of the relationship between acquired esotropia and the use of digital devices in young people
Date of disclosure of the study information 2019/12/03
Last modified on 2019/12/03

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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

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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