UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026307 |
|---|---|
| Receipt number | R000030212 |
| Scientific Title | Evaluation of Eye Disease with Optical Coherence Tomograpy |
| Date of disclosure of the study information | 2017/02/27 |
| Last modified on | 2022/03/01 17:38:50 |
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Basic information
Public title
Evaluation of Eye Disease with Optical Coherence Tomograpy
Acronym
Evaluation of Eye Disease with OCT
Scientific Title
Evaluation of Eye Disease with Optical Coherence Tomograpy
Scientific Title:Acronym
Evaluation of Eye Disease with OCT
Region
| Japan |
Condition
Condition
Eye Disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of prototype optical coherence tomography to evaluate eye disease
Basic objectives2
Others
Basic objectives -Others
To evaluate the microstructure in the eye disease using optical coherence tomography
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Microstructure change in molecular level
Ocular blood flow
Key secondary outcomes
Distribution of Melanin
Cicatrization
Distribution of blood flow
Blood flow volume
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Observation of Eye disease with optical coherence tomography
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with eye disease
Key exclusion criteria
Patient who withhold assent for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki 3000395
TEL
0298871161
m-miura@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Ibaraki Medical Center, Tokyo Medical University
Division name
Department of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki 3000395
TEL
0298871161
Homepage URL
http://www.tokyo-med.ac.jp/iba-eye/kenkyu.html
m-miura@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Ophthalmology
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology
Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1)Computational Optics Group, University of Tsukuba, 2) Dept of Ophthalmology, Osaka University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical University
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（茨城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.tokyo-med.ac.jp/iba-eye/kenkyu.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-017-03529-8
Number of participants that the trial has enrolled
100
Results
We evaluated the usefulness of prototype OCT for uveitis and AMD
Results date posted
| 2020 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 06 | Month | 09 | Day |
Baseline Characteristics
Patients with macular disease.
Participant flow
Recruiting at the department of Ophthalmology, Tokyo Medical University, Ibaraki Medeical Center
Adverse events
None
Outcome measures
Evaluation of retinal images obtained by prototype OCT.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030212
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/08/27 | 研究計画書OCT20170303.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/08/27 | 説明文書OCT2017_0207.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/08/27 | umin_data20170828.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/30212
