UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031747 |
|---|---|
| Receipt number | R000036250 |
| Scientific Title | Research on retinal / choroidal structure analysis by novel image analysis technique and machine learning. |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2020/11/10 11:50:58 |
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Basic information
Public title
Research on retinal / choroidal structure analysis by novel image analysis technique and machine learning.
Acronym
Research on retinal / choroidal structure image analysis
Scientific Title
Research on retinal / choroidal structure analysis by novel image analysis technique and machine learning.
Scientific Title:Acronym
Research on retinal / choroidal structure image analysis
Region
| Japan |
Condition
Condition
Chorioretinal diseases (central serous chorioretinopathy, age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, other diseases that cause abnormalities on macular)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze of retina and choroid by machine learning
Basic objectives2
Others
Basic objectives -Others
To analyze of retina and choroid in SLO and OCT images
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of retina and choroid in normal eyes and disease eyes
Analysis of choroidal vasculature by machine learning
Key secondary outcomes
Relationship between choroidal vasculature and disease
Relationship between choroidal vasculature and therapeutic effect
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
1. Cases with chorioretinal disease(central serous chorioretinopathy, age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, other diseases causing abnormality of the macular part)
2. Cases without chororetinal disease
Key exclusion criteria
Cases for which consent is not obtained for research
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Sonoda |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
099-275-5402
Homepage URL
shou@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima Unviersity
Institute
Department
Personal name
Funding Source
Organization
Ophthalmology, Kagoshima Unviersity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Tokushima university
Sonoda hospital
RIKEN
Topcon corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 03 | Month | 15 | 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
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
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze the structure of retina and choroid by image analysis and machine learning
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036250
