UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017473 |
|---|---|
| Receipt number | R000020251 |
| Scientific Title | Study on the clinical utility in retinal diseases of the ultra-high resolution optical coherence tomography |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 21:05:36 |
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Basic information
Public title
Study on the clinical utility in retinal diseases of the ultra-high resolution optical coherence tomography
Acronym
Retinal disease research of ultra-high resolution optical coherence tomography
Scientific Title
Study on the clinical utility in retinal diseases of the ultra-high resolution optical coherence tomography
Scientific Title:Acronym
Retinal disease research of ultra-high resolution optical coherence tomography
Region
| Japan |
Condition
Condition
Retinal diseases including diabetic retinopathy and retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To image a healthy eye and retinal disease patients using an ultra-high -resolution optical coherence tomography apparatus and to estimate the clinical utility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Image quality evaluation of by comparison of conventional OCT and UHR-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
Ultra- high resolution 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
person who can understand this research with consent
Key exclusion criteria
Angle-closure glaucoma
Narrow angle
Severe Cataract
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro Nakao |
Organization
Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
81-92-642-5648
snakao@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Nakao |
Organization
Kyushu University
Division name
Department of Ophthalmology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
81-92-642-5648
Homepage URL
snakao@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
SPS KAKENHI, Grant-in-Aid for Young Scientists (A) No. 25713057
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kowa Inc.
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
| 2015 | Year | 05 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020251
| 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 |
