UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029060 |
|---|---|
| Receipt number | R000033237 |
| Scientific Title | Image Analysis Using Next-generation Optical Coherence Tomography |
| Date of disclosure of the study information | 2017/09/09 |
| Last modified on | 2020/11/12 13:26:36 |
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Basic information
Public title
Image Analysis Using Next-generation Optical Coherence Tomography
Acronym
Image Analysis Using Next-generation Optical Coherence Tomography
Scientific Title
Image Analysis Using Next-generation Optical Coherence Tomography
Scientific Title:Acronym
Image Analysis Using Next-generation Optical Coherence Tomography
Region
| Japan |
Condition
Condition
Age-related macular degeneration, Retinitis Pigmentosa, Vogt-Koyanagi-Harada disease, iPS-derived retina transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical usefulness of next-generation optical coherence tomography.
Basic objectives2
Others
Basic objectives -Others
understanding of the disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Usefulness of image compared with existing optical coherence tomography images.
Key secondary outcomes
New findings obtained from next-generation optical
coherence tomography.
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
agreed to participate in the study
Key exclusion criteria
inappropriate as a study subject
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kurimoto |
Organization
Kobe City Eye Hospital
Division name
Department of Ophthalmology
Zip code
6500047
Address
2-1-8, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo
TEL
0783819876
ykurimoto@mac.com
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Matsuzaki |
Organization
Kobe City Eye Hospital
Division name
Department of Ophthalmology
Zip code
6500047
Address
2-1-8, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo
TEL
0783819876
Homepage URL
mmatsuzaki@me.com
Sponsor or person
Institute
Tomey corporation
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the institutional review board of Kobe City Medical Center General Hospital
Address
2-1-1, Minatojimaminamimachi, Chuo-ku, Kobe-city, Hyogo
Tel
0783024321
rinken@kcho.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Private accordance with the ethical guidelines
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033237
