UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008181
Receipt number R000009640
Scientific Title Japan Public Health Center-based Prospective Study-NEXT on Glaucoma, Age-related macular degeneration and diabetic retinopathy
Date of disclosure of the study information 2012/06/17
Last modified on 2015/10/02 09:40:36

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Basic information

Public title

Japan Public Health Center-based Prospective Study-NEXT on Glaucoma, Age-related macular degeneration and diabetic retinopathy

Acronym

JPHC-NEXT on Glaucoma, Age-related macular degeneration and diabetic retinopathy

Scientific Title

Japan Public Health Center-based Prospective Study-NEXT on Glaucoma, Age-related macular degeneration and diabetic retinopathy

Scientific Title:Acronym

JPHC-NEXT on Glaucoma, Age-related macular degeneration and diabetic retinopathy

Region

Japan


Condition

Condition

Glaucoma, AMD, DR and Dry Eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the prevalence,incidence and the risk factor for glaucoma, AMD, DR and Dry Eye.

Basic objectives2

Others

Basic objectives -Others

To evaluate the prevalence,incidence and the risk factor for glaucoma, AMD, DR and Dry Eye.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence and Incidence of glaucoma, AMD, DR and Dry Eye.

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

40 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects who live in the Saku area, Nagano aged 40-75

Key exclusion criteria

none

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoko Ozawa

Organization

Keio University School of Medicine

Division name

Ophthalmology

Zip code


Address

Shinanomachi 35, Shinjyuku-ku

TEL

03-5363-3869

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kenya Yuki

Organization

Keio University School of Medicine

Division name

Ophthalmology

Zip code


Address

Shinanomachi 35,Shinjyuku-ku

TEL

03-5363-3869

Homepage URL


Email

yukikenya@a6.keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

National Cancer Center

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

慶應義塾大学医学部眼科学教室(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 17 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

No longer recruiting

Date of protocol fixation

2012 Year 06 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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

OCT and fundus photograph is performed for the screening of glaucoma, AMD and diabetic retinopathy. After the screening, logistic regression is performed to investigate the risk factors for these disease.


Management information

Registered date

2012 Year 06 Month 16 Day

Last modified on

2015 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009640


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name