UMIN-CTR Clinical Trial

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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