UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study about clinical usability of optical coherence tomography angiography in retinal disease
Title of the study (Brief title)	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	Koh-Hei Sonoda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Ophthalmology
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	Shintaro Nakao
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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