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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028656
Receipt No. R000032803
Scientific Title A study about clinical usability of optical coherence tomography angiography in retinal disease
Date of disclosure of the study information 2017/08/15
Last modified on 2017/08/14

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Basic information
Public title A study about clinical usability of optical coherence tomography angiography in retinal disease
Acronym OCT angiography in retinal disease
Scientific Title A study about clinical usability of optical coherence tomography angiography in retinal disease
Scientific Title:Acronym OCT angiography in retinal disease
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 evaluate the clinical usability of optical coherence tomography angiography in retinal disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Morphological condition of retina or retinal capillary, and retinal perfusion.
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 We include patients with good understanding of this study and agree to participate in this study.
We include patients with diabetic retinopathy, retinal vein occlusion, age-related macular degeneration and other retinal disease.
Key exclusion criteria We exclude patients who is allergic to mydriatics.
We exclude patients with angle-closure glaucoma or narrow angle.
Target sample size 160

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 Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan.
TEL 81-92-642-5648
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 Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan.
TEL 81-92-642-5648
Homepage URL
Email snakao@med.kyushu-u.ac.jp

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

Funding Source
Organization Graduate School of Medical Sciences, Kyushu University, Ophthalmology
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
2017 Year 08 Month 15 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retinal flow density and area of foveal avascular zone.

Management information
Registered date
2017 Year 08 Month 14 Day
Last modified on
2017 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032803

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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