UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038775
Receipt number 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 18:36:14

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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 or person

Institute

Hamamatsu Medical University

Institute

Department

Personal name



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

Value
https://center6.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