UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012310 |
|---|---|
| Receipt number | R000014386 |
| Scientific Title | Choroidal structure on OCT images |
| Date of disclosure of the study information | 2013/11/16 |
| Last modified on | 2016/08/03 17:48:43 |
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Basic information
Public title
Choroidal structure on OCT images
Acronym
choroidal OCT
Scientific Title
Choroidal structure on OCT images
Scientific Title:Acronym
choroidal OCT
Region
| Japan |
Condition
Condition
retino choroidal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the qualitative analysis on OCT
Basic objectives2
Others
Basic objectives -Others
Comparison of OCT image of vessels and parenchima
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Choroidal structure on OCT 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Key exclusion criteria
Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5402
shou@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Sonoda |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaaoka, Kagoshima
TEL
099-275-5402
Homepage URL
tsakamot@m3.kufm.kagoshima-u..ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima Unviersity
Institute
Department
Personal name
Funding Source
Organization
Ophthalmology, Kagoshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Tokushima University
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
鹿児島大学病院眼科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 16 | 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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To the repeatability and reproducibility of the OCT image of choroid after image p@rocessing
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014386
