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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029060
Receipt No. 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

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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
Email 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
Email mmatsuzaki@me.com

Sponsor
Institute Tomey corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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