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
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
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
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
