UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039648 |
|---|---|
| Receipt number | R000045221 |
| Scientific Title | Evaluation of eye disease with multi-contrast optical coherence tomography |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2024/09/02 09:51:23 |
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Basic information
Public title
Evaluation of eye disease with multi-contrast optical coherence tomography
Acronym
Evaluation of eye disease with multi-contrast optical coherence tomography
Scientific Title
Evaluation of eye disease with multi-contrast optical coherence tomography
Scientific Title:Acronym
Evaluation of eye disease with multi-contrast optical coherence tomography
Region
| Japan |
Condition
Condition
eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the characteristics of images of eye disease lesions obtained by multi-contrast OCT
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective outcomes with observation of images by multi-contrast OCT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of in vivo human eye with multi-contrast OCT
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
Patients with eye disease
a) retinochoroidal disease, b) optic nerve disease, c)glaucoma, d)intraocular inflammatory disease, e)corneal opacity
Key exclusion criteria
Patients without confirmation of agreement by themselves
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Medical University, Ibaraki Medical Center
Division name
Dept. of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo Ami, Inashiki, Ibaraki, Japan
TEL
0298871161
m-miura@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Medical University, Ibaraki Medical Center
Division name
Dept. of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo Ami, Inashiki, Ibaraki, Japan
TEL
0298871161
Homepage URL
http://www.tokyo-med.ac.jp/iba-eye/IRB_list.html
m-miura@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Medicine, University of Tsukuba
Name of secondary funder(s)
Topcon Co
IRB Contact (For public release)
Organization
Tokyo Medical University, Institutional Review Board
Address
6-1-1 Nishi-shinjuku, Shinjuku, Tokyo 1600023 Japan
Tel
03-3351-6141
irb@tokyo-med.ac.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
東京医科大学茨城医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.tokyo-med.ac.jp/iba-eye/IRB%20MCOCT%20T2019-0072.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-021-82563-z
Number of participants that the trial has enrolled
21
Results
Miura M, et al.Multimodal imaging analysis of autosomal recessive bestrophinopathy: Case series Medicine 2024,103 e38853
Results date posted
| 2021 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 03 | Day |
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
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2020 | Year | 02 | Month | 29 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045221
