UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020454 |
|---|---|
| Receipt number | R000023633 |
| Scientific Title | Investigate of the image Enface or OCT angiography |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2019/07/11 18:04:18 |
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Basic information
Public title
Investigate of the image Enface or OCT angiography
Acronym
Investigate of the Enface or OCT angio
Scientific Title
Investigate of the image Enface or OCT angiography
Scientific Title:Acronym
Investigate of the Enface or OCT angio
Region
| Japan |
Condition
Condition
healthy volunteers or affected eye disease
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigated of the factor affected to the chorioretinal used by the swept source optical coherence tomography (en face image or OCT angiography).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Structure of choroidal vessel, Structure of retinal vessel
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
One trial. En face of choroid and OCT Angiography of retina is examined by OCT.
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
| 6 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Non history of the diabetes and cardiovascular failure, and eye disease, further more corrected visual acuity over 1.0, or affected each eye disease.
Key exclusion criteria
The subjects of difficult measurement.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Shiraga |
Organization
Okayama university hospital
Division name
Ophthalmology
Zip code
7008558
Address
2-5-1 Shikata-cho Kita-ku Okayama city
TEL
086-223-7151
atsushi@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Fujiwara |
Organization
Okayama university hospital
Division name
Ophthalmology
Zip code
7008558
Address
2-5-1 Shikata-cho Kita-ku Okayama city
TEL
086-223-7151
Homepage URL
atsushi@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama university hospital
Address
2-5-1 Shikata-cho Kita-ku Okayama city
Tel
086-235-6503
mae6605@adm.okayama-u.ac.jp
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
| 2016 | Year | 01 | Month | 07 | 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
150
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 06 | Day |
Last modified on
| 2019 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
