UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029391 |
|---|---|
| Receipt number | R000033590 |
| Scientific Title | Investigation of the clinical usefulness of next generation optical coherence tomography |
| Date of disclosure of the study information | 2017/10/03 |
| Last modified on | 2020/10/05 22:47:18 |
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Basic information
Public title
Investigation of the clinical usefulness of next generation optical coherence tomography
Acronym
clinical usefulness of next generation OCT
Scientific Title
Investigation of the clinical usefulness of next generation optical coherence tomography
Scientific Title:Acronym
clinical usefulness of next generation OCT
Region
| Japan |
Condition
Condition
retinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A new prototype of a wide-field OCT system can take images with the extended scan area and depth compared with commercially available instruments.
In the present study, we obtain the wide-field OCT images of retinal diseases mainly including the pathologic myopia, and lead to the practical application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clarify the usefulness of the prototype 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
application of prototype wide-field 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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the clinic of ophthalmology and agreed to participate the study
Key exclusion criteria
poor images because of the poor fixation or dense cataracts
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Ohno-Matsui |
Organization
Tokyo Medical and Dental University hospital
Division name
Ophthalmology
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-3813-6111
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Ohno-Matsui |
Organization
Tokyo Medical and Dental University hospital
Division name
Ophthalmology
Zip code
Address
Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
k.ohno.oph@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2017 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
