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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020556
Receipt No. R000023735
Scientific Title Association between retinal and macrophage conditions
Date of disclosure of the study information 2016/01/13
Last modified on 2016/01/13

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Basic information
Public title Association between retinal and macrophage conditions
Acronym Association between retinal and macrophage conditions
Scientific Title Association between retinal and macrophage conditions
Scientific Title:Acronym Association between retinal and macrophage conditions
Region
Japan

Condition
Condition age-related macular degeneration and diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To show the association between visul function and ocular findings, and systemic condition including data of blood and macrophage samples.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual function, ocular findings, and blood findings.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who are over 20 years old, healthy people having no ocular diseases except for refractive error, and obese people due to high fat diet who visited Department of Ophthalmology, Keio University, School of Medicine for ocular medical check.
Key exclusion criteria Those who has serious ocular diseases
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ozawa
Organization Keio University, School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjukuku Tokyo
TEL 03-3353-1211
Email ozawa@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoko Ozawa
Organization Keio University, School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjukuku Tokyo
TEL 03-3353-1211
Homepage URL
Email ozawa@a5.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
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
2016 Year 01 Month 13 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 13 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 ocular examinatins, Food Frequency Questionnaire, blood examinations

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2016 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023735

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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