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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028853
Receipt No. R000033024
Scientific Title Clarification of eye diseases using OCT angiography
Date of disclosure of the study information 2017/08/28
Last modified on 2017/08/28

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Basic information
Public title Clarification of eye diseases using OCT angiography
Acronym Clarification of eye diseases using OCTA
Scientific Title Clarification of eye diseases using OCT angiography
Scientific Title:Acronym Clarification of eye diseases using OCTA
Region
Japan

Condition
Condition All eye diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarification of eye diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Eye blood flow including the retina and choroid
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient with eye disease and healthy subject without eye disease
Key exclusion criteria unsuitable subject judged by medical doctor
Target sample size 460

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Miyata
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan.
TEL 075-751-3250
Email miyatam@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabu Miyata
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan.
TEL 075-751-3250
Homepage URL
Email miyatam@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 08 Month 28 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obtaining images of OCT angiography

Management information
Registered date
2017 Year 08 Month 28 Day
Last modified on
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033024

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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