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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021644
Receipt No. R000024960
Scientific Title Usefulness of OCT angiography for retinal and chroidal diseases.
Date of disclosure of the study information 2016/03/27
Last modified on 2019/03/31

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Basic information
Public title Usefulness of OCT angiography for retinal and chroidal diseases.
Acronym OCT angiography for retinal and chroidal diseases.
Scientific Title Usefulness of OCT angiography for retinal and chroidal diseases.
Scientific Title:Acronym OCT angiography for retinal and chroidal diseases.
Region
Japan

Condition
Condition Various retinal and choroidal diseases.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate detailed structure of retina/choroid vessels using Optical coherence tomography angiography (OCT Angio)for various diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference between OCT Angio image and clinical evaluation.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those patients with retinal/choroidal diseases who can obtain ICs.
Key exclusion criteria 1)Difficulty for evaluation.
2)Patients can not obtain ICs(Especially patients under 20 yrs old)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Sugimoto
Organization Mie University, School of Medicine.
Division name Department of Ophthalmology
Zip code 514-8507
Address Edobashi
TEL 0592315027
Email sugmochi@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Sugimoto
Organization Mie University, School of Medicine.
Division name Department of Ophthalmology
Zip code 514-8507
Address Edobashi
TEL 0592315027
Homepage URL
Email hmatsu@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Mie University, School of Medicine.
Institute
Department

Funding Source
Organization Department of Ophthalmology, Mie University, School of Medicine.
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 Mie University
Address 2-174, Edobashi, Tsu, Mie
Tel 0592315027
Email sugmochi@clin.medic.mie-u.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
2016 Year 03 Month 27 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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 15 Day
Date of IRB
2016 Year 02 Month 15 Day
Anticipated trial start date
2016 Year 02 Month 15 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We use RS-3000 Advance(NIDEK).

Patients are evaluated fundus under mydriasis.
We compare result of OCT-Angio and fundus evaluation.

Management information
Registered date
2016 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024960

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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