UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014102 |
|---|---|
| Receipt number | R000016414 |
| Scientific Title | Fundus imaging and its association with prognosis in diabetic retinopathy |
| Date of disclosure of the study information | 2014/05/28 |
| Last modified on | 2015/01/12 10:43:32 |
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Basic information
Public title
Fundus imaging and its association with prognosis in diabetic retinopathy
Acronym
Fundus imaging in diabetic retinopathy
Scientific Title
Fundus imaging and its association with prognosis in diabetic retinopathy
Scientific Title:Acronym
Fundus imaging in diabetic retinopathy
Region
| Japan |
Condition
Condition
diabetic retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the novel methods to assess the fundus imaging and to evaluate its usefulness as prognostic factors in diabetic retinopathy
Basic objectives2
Others
Basic objectives -Others
clinical observation study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
qualitative and quantitative assessment of fundus imaging in diabetic retinopathy
Key secondary outcomes
association between prognosis and clinical parameters in fundus imaging
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
1)diabetic retinopathy
2)Patients who provided written informed consents to participate the study prior to enrollment
Key exclusion criteria
Other conditions considered inappropriate by attending physician
Patients with contraindication regarding the fundus imaging, including the allergy for fluorescein angiography
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagahisa Yoshimura |
Organization
Graduate school of medicine and faculty of medicine Kyoto University
Division name
Department of ophthalmology and visual sciences
Zip code
Address
54 syougoinkawara-machi, sakyo-ku, Kyoto-city, Kyoto 606-8507, Japan
TEL
075-751-3248
nagaeye@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Murakami |
Organization
Graduate school of medicine and faculty of medicine Kyoto University
Division name
Department of ophthalmology and visual sciences
Zip code
Address
54 syougoinkawara-machi, sakyo-ku, Kyoto-city, Kyoto 606-8507, Japan
TEL
075-751-3248
Homepage URL
mutomo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of ophthalmology and visual sciences, graduate school of medicine and faculty of medicine Kyoto University
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
none
Name of secondary funder(s)
none
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
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 28 | 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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 01 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 05 | Month | 28 | Day |
Last modified on
| 2015 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016414
