UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027848
Receipt number 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 14:35:11

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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 or person

Institute

Saneikai Tsukazaki Hospital

Institute

Department

Personal name



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

Value
https://center6.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