UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010741 |
|---|---|
| Receipt number | 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 | 2021/05/24 19:59:43 |
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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 | Toshinori |
| Middle name | |
| Last name | Murata |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano Pref., 390-8621, Japan
TEL
0263372664
ieganka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Iesato |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto
TEL
0263372664
Homepage URL
ieganka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University, school of medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-3389
chiken@shinshu-u.ac.jp
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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 04 | Day |
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
| 2021 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012548
