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
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
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
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
