UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015143 |
|---|---|
| Receipt number | R000017611 |
| Scientific Title | Evaluation of Chorioretinal diseases using En Face OCT angiography |
| Date of disclosure of the study information | 2014/09/12 |
| Last modified on | 2016/09/13 11:47:26 |
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Basic information
Public title
Evaluation of Chorioretinal diseases using En Face OCT angiography
Acronym
En Face OCT Angiography
Scientific Title
Evaluation of Chorioretinal diseases using En Face OCT angiography
Scientific Title:Acronym
En Face OCT Angiography
Region
| Japan |
Condition
Condition
Chorioretinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate whether En Face OCT angiography (SSADA) is useful to evaluate chorioretinal diseases comparison with fluorescein angiography and indocyanine green angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of images taken by En Face OCT angiography and fluorescein angiography and indocyanine green angiography
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who are eligible for fluorescein angiography and indocyanine green angioraphy.
The patients who are eligible for Avanti OCT with SSADA analysis.
Key exclusion criteria
The patients who have allergy to fluorescein, indocyaninge green and Iode.
The patients who are considered as not eligible by investigators
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuihiro Ogura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Naoya JAPAN
TEL
052-853-8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Nozaki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Naoya JAPAN
TEL
052-853-8251
Homepage URL
nozakim@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical 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
YES
Study ID_1
1017
Org. issuing International ID_1
Nagoya City University Graduate School of Medical Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名古屋市立大学病院眼科（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
En Face OCT angiography can detect same findings compared with FA and ICGA
Management information
Registered date
| 2014 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017611
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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