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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035190
Receipt No. R000040023
Scientific Title Study on clinical utility of optical coherence tomography angiography in retinal disease
Date of disclosure of the study information 2018/12/09
Last modified on 2018/12/09

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Basic information
Public title Study on clinical utility of optical coherence tomography angiography in retinal disease
Acronym Utility of optical coherence angiography in retinal diseases
Scientific Title Study on clinical utility of optical coherence tomography angiography in retinal disease
Scientific Title:Acronym Utility of optical coherence angiography in retinal diseases
Region
Japan

Condition
Condition diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, and other retinal disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the superiority and usefulness of Optical coherence tomography angiography(OCTA) in retinal imaging of the healthy retina and various retinal diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of the OCTA imaging (retinal thickness, vessel density, foveal avascular zone, retinal nonperfused area, microaneurysms, retinal and choroidal neovascularization).
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diabetic retinopathy, retinal vein occlusion, and other retinal disease.
Key exclusion criteria 1. Patients who has an allergic reaction to mydriatic agent.Patients with glaucoma or narrow angle.
2. Patients with shallow anterior chamber.
3. Patients with severe cataract.
4. Patients who are not qualified as subjects for the study.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh-Hei Sonoda
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL 092-642-5648
Email sonodak@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Nakao
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-Ku, Fukuoka
TEL 092-642-5660
Homepage URL
Email snakao@med.kyushu-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Spatial pattern of vessel density was observed in eyes with diabetic retinopathy. Retinal nonperfused areas in eyes with diabetic retinopathy were quantitatively detected using OCTA.

Management information
Registered date
2018 Year 12 Month 09 Day
Last modified on
2018 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040023

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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