UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Longitudinal changes of choroidal thickness in healthy pediatric individuals using swept-source optical coherence tomography(SS-OCT)
Title of the study (Brief title)	Longitudinal changes of choroidal thickness in healthy pediatric individuals
Region	Japan

Condition
Condition	healthy children
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate longitudinal changes of choroidal thickness in healthy pediatric individuals.
Basic objectives2	Others
Basic objectives -Others	To asses the relationship between choroidal thickness, and systemic and ocular parameters.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	changes of choroidal thickness between before and after follow-up.
Key secondary outcomes	changes in following items between between before and after follow-up. 1)body height 2)body weight 3)axial length

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	3 years-old <=
Age-upper limit	6 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy children volunteer visited Saneikai Tsukazaki Hospital anda Tokushima University Hospital who could be obtained clinical data and examined with the SS-OCT.
Key exclusion criteria	Subjects without history of prematurity,glaucoma and intraocular operation.
Target sample size	60

Research contact person
Name of lead principal investigator	Ohsugi Eiko
Organization	Saneikai Tsukazaki Hospital
Division name	Ophtahlmology
Address	Himeji city,Aboshi waku 68-1
TEL	0792-72-8555
Email	E.ohsugi@tsukazaki-eye.net

Public contact
Name of contact person	Ohsugi Eiko
Organization	Saneikai Tsukazaki Hospital
Division name	Ophtahlmology
Address	Himeji city,Aboshi waku 68-1
TEL	0792-72-8555
Homepage URL
Email	E.ohsugi@tsukazaki-eye.net

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 06 Month 21 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 21 Day
Anticipated trial start date	2017 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Longitudinal study of the changes of choroidal thickness of healthy children.

Management information
Registered date	2017 Year 06 Month 21 Day
Last modified on	2017 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031907