UMIN-CTR Clinical Trial

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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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