UMIN-CTR Clinical Trial

Basic information
Public title	Study on vascular lesions in retinal diseases using optical coherence tomography Angiography
Acronym	Study on vascular lesions in retinal diseases using optical coherence tomography Angiography
Scientific Title	Study on vascular lesions in retinal diseases using optical coherence tomography Angiography
Scientific Title:Acronym	Study on vascular lesions in retinal diseases using optical coherence tomography Angiography
Region	Japan

Condition
Condition	Diabetic retinopathy,Retinal vein occlusion,Age-related macular degeneration,Other retinopathy
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By performing fundus photography using the optical coherence tomography (OCTA), the retinal vascular network structure can be visualized non-invasively.The purpose of this study is to photograph the fundus of healthy subjects and patients with retinal diseases, compare OCTA with conventional OCT images, fluorescent fundus angiography images, etc., evaluate the superiority of OCTA, and evaluate its clinical usefulness.Is to evaluate comprehensively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of retinal structure, retinal blood vessel shape, and retinal blood vessel perfusion by comparison with conventional fluorescence fundus angiography and OCT. Specifically, the network thickness, vascular density, area of foveal avascular field and non-perfused area, visibility of retinal capillary aneurysm and retinal / choroidal neovascularization will be examined.
Key secondary outcomes	Correlation between Primary endpoint and the following clinical findings.Clinical findings: Information on age, gender, examination history and medical history (maximum corrected visual acuity, intraocular pressure, slit lamp microscopy, inversion ophthalmoscope examination, fundus photography, static quantitative visual field examination, conventional OCT analysis data, retinal electrocardiographyFigure, blood pressure, blood test)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	120 people 240 eyes Intervention content for individual subjects:Instill Midorin P and Neocinedin before using Angiography Dose:0.2ml frequency:Once
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	(1) Those who fully understand this research plan and can give their consent (2) Those who are 20 years old or older at the time of obtaining consent. (3) Those with diabetic retinopathy, branch retinal vein occlusion, age-related macular degeneration or other retinopathy
Key exclusion criteria	(1) Those who have a history of hypersensitivity to mydriatic agents, those who have a predisposition to increased intraocular pressure such as angle-closure glaucoma and narrow-angle angle, and those who have a history of increased blood pressure or palpitation due to mydriatic agents.Someone (2) Those who have a shallow anterior chamber by slit lamp microscopy (3) Those who are judged to be difficult to take due to cataract by slit lamp microscopy
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Nakao
Organization	National Hospital Organization Kyushu Medical Center
Division name	Ophthalmology
Zip code	8108563
Address	1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL	092-852-0700
Email	snakao@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name shintaro Middle name Last name nakao
Organization	National Hospital Organization Kyushu Medical Center
Division name	Ophthalmology
Zip code	810-8563
Address	1-8-1, Jigyohama, Chuo-ku, Fukuoka
TEL	092-852-0700
Homepage URL	http://kyumed.jp/chiken/index.html
Email	snakao@med.kyushu-u.ac.jp

Sponsor
Institute	National Hospital Organization Kyushu Medical Center Ophthalmology
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu Medical Center Clinical Research Center Clinical Trial Support Center
Address	1-8-1, Jigyohama, Chuo-ku, Fukuoka
Tel	092-852-0700
Email	602-rinri@mail.hosp.go.jp

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	独立行政法人　国立病院機構　九州医療センター（福岡県）

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 19 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	25
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	2020 Year 11 Month 14 Day
Date of IRB	2020 Year 12 Month 01 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 19 Day
Last modified on	2021 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049433