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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031419
Receipt No. R000035880
Scientific Title Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)
Date of disclosure of the study information 2018/02/23
Last modified on 2018/02/22

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Basic information
Public title Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)
Acronym Evaluation of macular disease by OCT angiography
Scientific Title Quantitative analysis of retinal microvasculature in macular disease using optical coherence tomography (OCT)
Scientific Title:Acronym Evaluation of macular disease by OCT angiography
Region
Japan

Condition
Condition macular disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of retinal circulation of macular diseases by OCT angiography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate retinal circulation of macular diseases by OCT angiography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravitreal vascular endothelial growth factor (VEGF) inhibitor injection
Interventions/Control_2 Retinal laser photocoagulation
Interventions/Control_3 Vitrectomy
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 macular desease
Key exclusion criteria Dense cataract
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Mizota
Organization Teikyo University
Division name School of Medicine, Department of Ophthalmology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL 03-3964-1211
Email mimurat@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Mimura
Organization Teikyo University
Division name School of Medicine, Department of Ophthalmology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605 Japan
TEL 03-3964-1211
Homepage URL
Email mimurat@med.teikyo-u.ac.jp

Sponsor
Institute Department of Ophthalmology,
Teikyo University School of Medicine
Institute
Department

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
Email

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 帝京大学医学部付属病院眼科学講座
埼玉医科大学病院眼科

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 23 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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 22 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035880

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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