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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024919
Receipt No. R000028514
Scientific Title Analysis of retinal blood vessels and blood flow using optical coherence tomography
Date of disclosure of the study information 2016/11/21
Last modified on 2016/11/21

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Basic information
Public title Analysis of retinal blood vessels and blood flow using optical coherence tomography
Acronym Analysis of retinal blood vessels and blood flow using optical coherence tomography
Scientific Title Analysis of retinal blood vessels and blood flow using optical coherence tomography
Scientific Title:Acronym Analysis of retinal blood vessels and blood flow using optical coherence tomography
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of retinal blood vessels and blood flow by different optical coherence tomography models
Basic objectives2 Others
Basic objectives -Others
Evaluation of foveal avascular zone and retinal vascular density by optical coherence tomography
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of retinal blood vessels and blood flow by different optical coherence tomography models
Key secondary outcomes Comparison with fluorescence fundus angiography examination

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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Healthy right eye

Visual acuity greater than or equal to 1.0 (logMAR0.1).
Key exclusion criteria History of eye diseases

high myopia >6.0 diopters

Systemic diseases affecting eyes
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiji Sakamoto
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5402
Email tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiji Sakamoto
Organization Kagoshima University Graduate School of Medical and Dental Sciences
Division name Ophthalmology
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL 099-275-5402
Homepage URL
Email tsakamot@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
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
Address
Tel
Email

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 11 Month 21 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Tests
Optical coherence tomography
optical interferometry
Visual acuity
Intraocular pressure
Refraction

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028514

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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