UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028853 |
|---|---|
| Receipt number | R000033024 |
| Scientific Title | Clarification of eye diseases using OCT angiography |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2019/08/31 23:41:46 |
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Basic information
Public title
Clarification of eye diseases using OCT angiography
Acronym
Clarification of eye diseases using OCTA
Scientific Title
Clarification of eye diseases using OCT angiography
Scientific Title:Acronym
Clarification of eye diseases using OCTA
Region
| Japan |
Condition
Condition
All eye diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarification of eye diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eye blood flow including the retina and choroid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient with eye disease and healthy subject without eye disease
Key exclusion criteria
unsuitable subject judged by medical doctor
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
6068507
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan.
TEL
075-751-3250
miyatam@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Miyata |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
6068507
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan.
TEL
075-751-3250
Homepage URL
miyatam@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committee
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto City, Kyoto Prefecture
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2017 | Year | 08 | Month | 28 | 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
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtaining images of OCT angiography
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033024
| 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 |
