UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020556
Receipt number 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 18:26:24

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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 or person

Institute

Keio University

Institute

Department

Personal name



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

Value
https://center6.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