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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
