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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028026
Receipt No. R000032091
Scientific Title The analysis of ocular vascular structure with Optical Coherence Tomography Angiography.
Date of disclosure of the study information 2017/07/01
Last modified on 2017/08/07

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Basic information
Public title The analysis of ocular vascular structure with Optical Coherence Tomography Angiography.
Acronym The analysis of ocular vascular structure with OCT angiograophy.
Scientific Title The analysis of ocular vascular structure with Optical Coherence Tomography Angiography.
Scientific Title:Acronym The analysis of ocular vascular structure with OCT angiograophy.
Region
Japan

Condition
Condition normal and ocular vascular disease
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of vascular structural change i
Basic objectives2 Others
Basic objectives -Others Analysis of Reproducibility
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Change of vessel density
Key secondary outcomes Coefficient of Variation
Intraclass Correlation Coefficients

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 Taking image with light source one or twice a day
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

Not applicable
Gender Male and Female
Key inclusion criteria Men and women over 20 years
Key exclusion criteria Age less than 20 yeas
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Shinoda
Organization SaimataMedicalUniversity
Division name Ophthalmology
Zip code
Address 38 Morohongo Moroyammati Ituma Saitama
TEL 0492761250
Email shinok@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Shinoda
Organization SaimataMedicalUniversity
Division name Ophthalmology
Zip code
Address 38 Morohongo Moroyammati Ituma Saitama
TEL 0492761250
Homepage URL
Email shinok@saitama-med.ac.jp

Sponsor
Institute SaimataMedicalUniversity
Institute
Department

Funding Source
Organization SaimataMedicalUniversity
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
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
2017 Year 07 Month 01 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
2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032091

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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