UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with chorioretinal diseases
Title of the study (Brief title)	Comparison of efficacy between OCT angiography and fluorescein angiography
Region	Japan

Condition
Condition	diabetic retinopathy (macular edema), branch retinal vein occlusion, wet type of age-related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the value of OCT angiography, we compare the result between OCT angigraphy and fluorescein angiography in the same eye
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of the lesion in each eyes
Key secondary outcomes	Duration (minutes) for each angiography test

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	the patients with diabetic retinopathy (macular edema), BRVO or wAMD, who are scheduled for fluorescein angiography to diagnose or follow-up, and the patients who have not media opacity or poor fixation.
Key exclusion criteria	The patients who have allergy to dye, or renal dysfunction. The patients who have possibility of pregnant or pregnant patients
Target sample size	90

Research contact person
Name of lead principal investigator	Yuichiro Ogura
Organization	Nagoya City University Hospital
Division name	Ophthalmology
Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL	052(853)8251
Email	ogura@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Miho Nozaki
Organization	Nagoya City University Hospital
Division name	Ophthalmology
Address	1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL	052(853)8251
Homepage URL
Email	nozakim@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Funding Source
Organization	Japanese Ophthalmic Instruments Association
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kagoshima University Hospital Tokyo Women's Medical University Hospital Kagawa University Hospital
Name of secondary funｄer(s)

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	東京女子医科大学病院（東京都） 名古屋市立大学病院（愛知県） 鹿児島大学病院（鹿児島県） 園田病院（鹿児島県） 香川大学病院（香川県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
Anticipated trial start date	2016 Year 08 Month 26 Day
Last follow-up date
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	recruiting

Management information
Registered date	2016 Year 08 Month 25 Day
Last modified on	2017 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027380