UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005473 |
|---|---|
| Receipt number | R000006492 |
| Scientific Title | Diabetes-related Eye Disease Study |
| Date of disclosure of the study information | 2011/04/21 |
| Last modified on | 2014/04/28 15:07:21 |
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Basic information
Public title
Diabetes-related Eye Disease Study
Acronym
DREDS
Scientific Title
Diabetes-related Eye Disease Study
Scientific Title:Acronym
DREDS
Region
| Japan |
Condition
Condition
diabetes diabetic retinopathy dry eye
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the diabetes-induced changes of the retina and the ocular surface, and their influences on the visual function together with the patients' background including systemic condition.
Basic objectives2
Others
Basic objectives -Others
We investigate the diabetes-induced changes of the retina and the ocular surface.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The retinal thickness, condition of the ocular surface
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetic patients (300 participants)
1. Those who have diabetes and come to the clinic of the Department of Ophthalmology, Keio University Hospital, Japan
2. Aged 20-70, consecutive
3. Those who gave informed consent
Control patients (100 participants)
1. Those who do not have diabetes but have mild cataract (visual acuity>0.5)
2. Aged 20-70
3. Those who gave informed consent
Key exclusion criteria
Those who have severe cataract and/or glaucoma
Those who were not appropriate for the study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Ozawa |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology,Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/24569581
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24569581
Number of participants that the trial has enrolled
Results
A higher LDL cholesterol level was associated with increased central subfield macular thickness and volume in
diabetic patients without diabetic macular edema.
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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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
We investigate the diabetes-induced changes of the retina and the ocular surface, and their influences on the visual function together with the patients' background including systemic condition.
Management information
Registered date
| 2011 | Year | 04 | Month | 20 | Day |
Last modified on
| 2014 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006492
| Research Plan | |
|---|---|
| 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 |
