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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014102
Receipt No. R000016414
Official scientific title of the study 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

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Basic information
Official scientific title of the study Fundus imaging and its association with prognosis in diabetic retinopathy
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Nagahisa Yoshimura
Organization Graduate school of medicine and faculty of medicine Kyoto University
Division name Department of ophthalmology and visual sciences
Address 54 syougoinkawara-machi, sakyo-ku, Kyoto-city, Kyoto 606-8507, Japan
TEL 075-751-3248
Email nagaeye@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Tomoaki Murakami
Organization Graduate school of medicine and faculty of medicine Kyoto University
Division name Department of ophthalmology and visual sciences
Address 54 syougoinkawara-machi, sakyo-ku, Kyoto-city, Kyoto 606-8507, Japan
TEL 075-751-3248
Homepage URL
Email mutomo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of ophthalmology and visual sciences, graduate school of medicine and faculty of medicine Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 28 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016414


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