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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041991
Receipt No. R000047926
Scientific Title Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants
Date of disclosure of the study information 2020/10/02
Last modified on 2020/10/02

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Basic information
Public title Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants
Acronym Analysis of eye movement development in infants
Scientific Title Investigation of the mechanism of strabismus onset from analysis of eye movement development in infants
Scientific Title:Acronym Analysis of eye movement development in infants
Region
Japan

Condition
Condition strabismus
Classification by specialty
Ophthalmology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate which developmental stage of which eye movement is associated with strabismus onset in childhood by analysis of eye movements of infants without strabismus and infants with strabismus with an eye tracker
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fixation stability
velocity of saccadic eye movement
binocular coordination of smooth pursuit
binocular coordination of convergence
Key secondary outcomes

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
Other
Interventions/Control_1 Recording eye movement by eye tracking device
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
3 months-old <=
Age-upper limit
4 years-old >
Gender Male and Female
Key inclusion criteria For those who meet the following (1) or (2)
(1) Normal person who is 3 months to less than 4 years old, has no strabismus / ocular motility disorder, and has no disease that may have strabismus / ocular motility disorder.
(2) Have strabismus between the ages of 3 months and 4 years (regardless of definitive diagnosis / suspected case, treatment history)
Key exclusion criteria Exclude if any of the following items apply
(1) Those who do not wish to participate in this research
(2) Those with irregular pupils
(3) Left-right difference in aversive reaction or left-right difference in visual acuity of 3 levels or more
Target sample size 80

Research contact person
Name of lead principal investigator
1st name MIHARU
Middle name
Last name MIHARA
Organization University of Toyama
Division name Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code 930-0194
Address 2630 Sugitani, Toyama, Toyama
TEL 076-434-7363
Email miharu@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name MIHARU
Middle name
Last name MIHARA
Organization University of Toyama
Division name Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code 930-0194
Address 2630 Sugitani, Toyama, Toyama
TEL 076-434-7363
Homepage URL
Email miharu@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee, University of Toyama
Address 2630 Sugitani, Toyama, Toyama
Tel 076-434-7681
Email rinri@adm.u-toyama.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
2020 Year 10 Month 02 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 Open public recruiting
Date of protocol fixation
2020 Year 06 Month 08 Day
Date of IRB
2020 Year 09 Month 07 Day
Anticipated trial start date
2020 Year 09 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
2020 Year 10 Month 02 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047926

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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