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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040444
Receipt No. R000046156
Scientific Title Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/19

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Basic information
Public title Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Acronym DREX Study
Scientific Title Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Scientific Title:Acronym DREX Study
Region
Japan

Condition
Condition diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Basic objectives2 Others
Basic objectives -Others To evaluate the relationship between the grade of diabetic retinopathy and visual function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual function measured by EvokeDx
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
100 years-old >
Gender Male and Female
Key inclusion criteria Healthy adults and Diabetic patients who have best-corrected visual acuity better than 0.7 in decimal.
Key exclusion criteria Patients with diabetic macular edema, galucoma, and who had been treated diabetic retinopathy within 12 weeks. If the researchers found the person not suitable for the study, the person will be excluded from the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Ozawa
Organization St Luke's International Hospital
Division name Department of Ophthalmology
Zip code 1048560
Address 9-1 Akashicho Chuoku Tokyo Japan
TEL 03-3451-5151
Email ozaway@luke.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name Department of Ophthalmology
Last name Ozawa
Organization St Luke's International Hospital
Division name Department of Ophthalmology
Zip code 1048560
Address 9-1 Akashicho Chuoku Tokyo Japan
TEL 03-3451-5151
Homepage URL
Email ozaway@luke.ac.jp

Sponsor
Institute St Luke's International University
Institute
Department

Funding Source
Organization SENJU PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of St Luke's International Hospital
Address 9-1 Akashicho Chuoku Tokyo Japan
Tel 03-3451-5151
Email kenkyukikaku@luke.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
2020 Year 05 Month 20 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NONE

Management information
Registered date
2020 Year 05 Month 19 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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