UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028026 |
|---|---|
| Receipt number | R000032091 |
| Scientific Title | The analysis of ocular vascular structure with Optical Coherence Tomography Angiography. |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2021/07/02 17:24:57 |
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Basic information
Public title
The analysis of ocular vascular structure with Optical Coherence Tomography Angiography.
Acronym
The analysis of ocular vascular structure with OCT angiograophy.
Scientific Title
The analysis of ocular vascular structure with Optical Coherence Tomography Angiography.
Scientific Title:Acronym
The analysis of ocular vascular structure with OCT angiograophy.
Region
| Japan |
Condition
Condition
normal and ocular vascular disease
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of vascular structural change i
Basic objectives2
Others
Basic objectives -Others
Analysis of Reproducibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of vessel density
Key secondary outcomes
Coefficient of Variation
Intraclass Correlation Coefficients
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Taking image with light source one or twice a day
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
Men and women over 20 years
Key exclusion criteria
Age less than 20 yeas
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Shinoda |
Organization
SaimataMedicalUniversity
Division name
Ophthalmology
Zip code
Address
38 Morohongo Moroyammati Ituma Saitama
TEL
0492761250
shinok@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Shinoda |
Organization
SaimataMedicalUniversity
Division name
Ophthalmology
Zip code
Address
38 Morohongo Moroyammati Ituma Saitama
TEL
0492761250
Homepage URL
shinok@saitama-med.ac.jp
Sponsor or person
Institute
SaimataMedicalUniversity
Institute
Department
Personal name
Funding Source
Organization
SaimataMedicalUniversity
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 01 | 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
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032091
| 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 |
