UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014212 |
|---|---|
| Receipt number | R000016557 |
| Scientific Title | Research on the ocular complications of diabetes, age-related macular degeneration and retinal vascular diseases using non-invasive lens autofluorescence measuring equipment. |
| Date of disclosure of the study information | 2014/06/10 |
| Last modified on | 2017/12/11 18:20:40 |
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Basic information
Public title
Research on the ocular complications of diabetes, age-related macular degeneration and retinal vascular diseases using non-invasive lens autofluorescence measuring equipment.
Acronym
non-invasive lens autofluorescence measurement and ocular disease
Scientific Title
Research on the ocular complications of diabetes, age-related macular degeneration and retinal vascular diseases using non-invasive lens autofluorescence measuring equipment.
Scientific Title:Acronym
non-invasive lens autofluorescence measurement and ocular disease
Region
| Japan |
Condition
Condition
The ocular complication of diabetes, age-related macular degeneration and retinal vascular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the lens AGEs and the ocular complications of diabetes, age-related macular degeneration and retinal vascular disease, using equipment that can be measured non-invasively the lens AGEs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of lens autofluorescence of the ocular diseases and control.
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 the ocular complication of diabetes, age-related macular degeneration and retinal vascular diseases.
Outpatients without ocular diseases.
Key exclusion criteria
Under 20 years
Type 1 diabetes
Ongoing hemodialysis
Current malignant disease
Inflammatory disease
Current chronic respiratory disease
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Murata |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL
0263-37-2664
ieganka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Iesato |
Organization
Shinshu University School of Medicine
Division name
Department of ophthalmology
Zip code
Address
3-1-1 Asahi,Matsumoto,390-8621 Japan
TEL
0263-37-2664
Homepage URL
ieganka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
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
| 2014 | Year | 06 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before start of trial
Management information
Registered date
| 2014 | Year | 06 | Month | 09 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016557
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
