UMIN-CTR Clinical Trial

Basic information
Public title	Correlation between eye length and other each body length
Acronym	Correlation between eye length and each body length
Scientific Title	Correlation between axial length of the eye and other each body length
Scientific Title:Acronym	Correlation between eye length and each body length
Region	Japan

Condition
Condition	Healthy individuals
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate new factors that are associated with myopia by studying the correlation between the axial length of the eye and each part of the body.
Basic objectives2	Others
Basic objectives -Others	We collect the data regarding refraction, hand length, choroidal thickness, retinal thickness and recent external environment (desk work, PC, smartphone).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Axial length of the eye and foot length
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A person who was given a written explanation of this study and obtained their consent.
Key exclusion criteria	1. Those who cannot understand this study. 2. Those who have a history of eye surgery such as LASIK. 3. Those who have current eye diseases. 4. A person who feels pain when measuring eyes or feet. 5. Those with strong hallux valgus.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Ari Middle name Last name Shinojima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	03-5315-4132
Email	ari.shinojima@keio.jp

Public contact
Name of contact person	1st name Ari Middle name Last name Shinojima
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku
TEL	03-5315-4132
Homepage URL
Email	ari.shinojima@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
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	Keio University
Address	35 Shinanomachi, Shinjuku-ku
Tel	03-3353-1211
Email	med-rinri-jmu@adst.keio.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	2019 Year 12 Month 25 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	40
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	2019 Year 12 Month 24 Day
Date of IRB	2019 Year 12 Month 25 Day
Anticipated trial start date	2019 Year 12 Month 25 Day
Last follow-up date	2021 Year 02 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We collect the data regarding refraction, hand length, foot lenght, body height, choroidal thickness, retinal thickness, axial lenght and recent external environment (desk work, PC, smartphone) using non-invasive instruments.

Management information
Registered date	2019 Year 12 Month 24 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044450