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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020454
Receipt No. R000023633
Scientific Title Investigate of the image Enface or OCT angiography
Date of disclosure of the study information 2016/01/07
Last modified on 2019/07/11

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Basic information
Public title Investigate of the image Enface or OCT angiography
Acronym Investigate of the Enface or OCT angio
Scientific Title Investigate of the image Enface or OCT angiography
Scientific Title:Acronym Investigate of the Enface or OCT angio
Region
Japan

Condition
Condition healthy volunteers or affected eye disease
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigated of the factor affected to the chorioretinal used by the swept source optical coherence tomography (en face image or OCT angiography).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Structure of choroidal vessel, Structure of retinal vessel
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 One trial. En face of choroid and OCT Angiography of retina is examined by OCT.
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
6 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Non history of the diabetes and cardiovascular failure, and eye disease, further more corrected visual acuity over 1.0, or affected each eye disease.
Key exclusion criteria The subjects of difficult measurement.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Fumio
Middle name
Last name Shiraga
Organization Okayama university hospital
Division name Ophthalmology
Zip code 7008558
Address 2-5-1 Shikata-cho Kita-ku Okayama city
TEL 086-223-7151
Email atsushi@okayama-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Fujiwara
Organization Okayama university hospital
Division name Ophthalmology
Zip code 7008558
Address 2-5-1 Shikata-cho Kita-ku Okayama city
TEL 086-223-7151
Homepage URL
Email atsushi@okayama-u.ac.jp

Sponsor
Institute Okayama university hospital
Institute
Department

Funding Source
Organization None
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 Okayama university hospital
Address 2-5-1 Shikata-cho Kita-ku Okayama city
Tel 086-235-6503
Email mae6605@adm.okayama-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
2016 Year 01 Month 07 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 150
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
2016 Year 01 Month 06 Day
Date of IRB
2015 Year 03 Month 02 Day
Anticipated trial start date
2016 Year 01 Month 07 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023633

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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