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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010741
Receipt No. R000012548
Scientific Title Research on age-related macular degeneration and diabetic complications using non-invasive AGEs measurement equipment.
Date of disclosure of the study information 2013/05/16
Last modified on 2013/12/03

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Basic information
Public title Research on age-related macular degeneration and diabetic complications using non-invasive AGEs measurement equipment.
Acronym non-invasive AGEs measurement and ocular diseases.
Scientific Title Research on age-related macular degeneration and diabetic complications using non-invasive AGEs measurement equipment.
Scientific Title:Acronym non-invasive AGEs measurement and ocular diseases.
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether skin autofluorescene using non-invasive AGEs measurement is associated with ocular diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intensity of skin autofluorescence and frequency of treatment of ocular diseases.
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 Outpatients with ocular diseases and healthy volunteers
Key exclusion criteria Under 20 years
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Murata
Organization Shinshu University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Asahi, Matsumoto City, Nagano Pref., 390-8621, Japan
TEL 0263372664
Email ieganka@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Iesato
Organization Shinshu University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 3-1-1, Asahi, Matsumoto
TEL 0263372664
Homepage URL
Email ieganka@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Graduate School of Medicine, Department of Ophthalmology
Institute
Department

Funding Source
Organization Shinshu University
Organization
Division
Category of Funding Organization
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
2013 Year 05 Month 16 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2013 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012548

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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