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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020347
Receipt No. 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

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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
Email 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
Email hamamasa@luke.ac.jp

Sponsor
Institute St lukes international hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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