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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027848
Receipt No. R000031907
Scientific Title Longitudinal changes of choroidal thickness in healthy pediatric individuals using swept-source optical coherence tomography(SS-OCT)
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/21

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Basic information
Public title Longitudinal changes of choroidal thickness in healthy pediatric individuals using swept-source optical coherence tomography(SS-OCT)
Acronym Longitudinal changes of choroidal thickness in healthy pediatric individuals
Scientific Title Longitudinal changes of choroidal thickness in healthy pediatric individuals using swept-source optical coherence tomography(SS-OCT)
Scientific Title:Acronym 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
1st name
Middle name
Last name Ohsugi Eiko
Organization Saneikai Tsukazaki Hospital
Division name Ophtahlmology
Zip code
Address Himeji city,Aboshi waku 68-1
TEL 0792-72-8555
Email E.ohsugi@tsukazaki-eye.net

Public contact
Name of contact person
1st name
Middle name
Last name Ohsugi Eiko
Organization Saneikai Tsukazaki Hospital
Division name Ophtahlmology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 21 Day
Date of IRB
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

Other
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

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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