UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of refractive-error and its associated factors
Acronym	Prevalence of refractive-error and its associated factors
Scientific Title	Prevalence of refractive-error and its associated factors among Japanese preschool children.
Scientific Title:Acronym	Prevalence of refractive-error and its associated factors
Region	Japan

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

Objectives
Narrative objectives1	To investigate the prevalence of early onset myopia as well as the factors associated with longer axial length, myopic spherical equivalent among Japanese preschool children
Basic objectives2	Others
Basic objectives -Others	Risk Factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Myopia
Key secondary outcomes	High myopia, Axial length, Spherical Equivalent

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	4 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects aged 4-6 years from a preschool
Key exclusion criteria	Children with chronic eye diseases, such as congenital cataracts, undergoing myopia-suppressing treatment, chronic medical disorders, and Down syndrome
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Saiko Middle name Last name Matsumura
Organization	Toho University School of Medicine
Division name	Department of Ophthalmology
Zip code	1438540
Address	6-11-1 Omori-Nishi, Otaku
TEL	0337624151
Email	saiko.matsumura@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Saiko Middle name Last name Matsumura
Organization	Toho University School of Medicine
Division name	Department of Ophthalmology
Zip code	1438540
Address	6-11-1 Omori-Nishi, Otaku
TEL	0337624151
Homepage URL
Email	saiko.matsumura@med.toho-u.ac.jp

Sponsor
Institute	Eiwakai
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Eiwakai
Address	3-23-24 Kamisyotanaka Nakahara-ku, Kawasaki
Tel	044-777-7700
Email	saiko.matsumura@med.toho-u.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	2022 Year 03 Month 16 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	400
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	Completed
Date of protocol fixation	2021 Year 01 Month 01 Day
Date of IRB	2021 Year 05 Month 18 Day
Anticipated trial start date	2021 Year 06 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 03 Month 16 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053829