UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046121 |
|---|---|
| Receipt number | R000049433 |
| Scientific Title | Study on vascular lesions in retinal diseases using optical coherence tomography Angiography |
| Date of disclosure of the study information | 2021/11/19 |
| Last modified on | 2021/11/19 12:27:45 |
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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
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
snakao@med.kyushu-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049433
