UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020347 |
|---|---|
| Receipt number | R000023434 |
| Scientific Title | Observation of blood vessel construction By OCT angiography |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2017/12/27 11:40:03 |
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Basic information
Public title
Observation of blood vessel construction By OCT angiography
Acronym
OCT angiography
Scientific Title
Observation of blood vessel construction By OCT angiography
Scientific Title:Acronym
OCT angiography
Region
| Japan |
Condition
Condition
macular disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
comparative imaging of the conventional FA / IA image and OCT angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
comparative imaging of the conventional FA / IA image and OCT angiography
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
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
The patients who could get consent were examined Fluorescence angiography and OCT angiography. they were examined OCT angiography in a check day , one week, two weeks, 1, 2, 3 month later. Fluorescence angiography in a check day and three month later. If the patients need treatment of laser photocoagulation , Thay were underwent preoperative OCT angiography, fundus fluorescein angiography (FA IA) in the area which the microaneurysms cause of edema. Thay were examined OCT angio graphy after photocoagulation 1 hour, 1 week, 2 weeks 1.2.3 month later and fluorescence angiography beforephotocoagulation and three month later.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients was diagnosed macular disease who need fundus angiography from August to Desember in 2015.
Key exclusion criteria
1)the cases can not be taken fundus photographs at intermediate translucent opacities and small pupil .
2)the cace that we cannot obtained cooperation of the patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kishiko Ohkoshi |
Organization
St lukes international hospital
Division name
Ophthalmology
Zip code
Address
9-1 akashi tyo tyu-o-ku
TEL
03-3541-5151
kishiohk@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Hamada |
Organization
St lukes international hospital
Division name
Ophthalmology
Zip code
Address
9-1 akashi tyo tyu-o-ku
TEL
03-3541-5151
Homepage URL
hamamasa@luke.ac.jp
Sponsor or person
Institute
St lukes international hospital
Institute
Department
Personal name
Funding Source
Organization
Zeiss inc.
Organization
Division
Category of Funding Organization
Profit organization
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
15-R039
Org. issuing International ID_1
St lukes international hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 25 | 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
| 2015 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2017 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023434
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