UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019060 |
|---|---|
| Receipt number | R000022038 |
| Scientific Title | Choroidal structure on EDI-OCT images |
| Date of disclosure of the study information | 2015/09/17 |
| Last modified on | 2016/10/07 18:21:51 |
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Basic information
Public title
Choroidal structure on EDI-OCT images
Acronym
Choroidal EDI-OCT
Scientific Title
Choroidal structure on EDI-OCT images
Scientific Title:Acronym
Choroidal EDI-OCT
Region
| Japan |
Condition
Condition
retinal and choroidal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain information on the morphology of the choroid
Basic objectives2
Others
Basic objectives -Others
Comparision of the luminal and interstitial areas on EDI-OCT images
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Choroidal structure on EDI-OCT images with image processing
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with normal eyes and without apparent intraocular abnormalities. The criteria varies in the subgroup analysis.
Key exclusion criteria
Subjects with normal apparent intraocular abnormalities. The criteria varies in the subgroup analysis.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Mitamura |
Organization
Tokushima University Graduate School
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
+81-88-633-7163
ymitaymitaymita@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Egawa |
Organization
Tokushima University Graduate School
Division name
Department of Ophthalmology, Institute of Biomedical Sciences
Zip code
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
+81-88-633-7163
Homepage URL
egawa.m@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Institute of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Institute of Biomedical Sciences
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
university hospital(Tokushima)
university hospital(Kagoshima)
university hospital(Nara Medical)
hospital(Sapporo City General)
hospital(Saneikai Tsukazaki)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional, observational study.
Enrolling by invitation
(outpatients are not recruited publicly).
Examination: EDI-OCT, Intraocular pressure, Blood pressure, Heart rate, Axial length and refractive error of the eye
Management information
Registered date
| 2015 | Year | 09 | Month | 17 | Day |
Last modified on
| 2016 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022038
