UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024919 |
|---|---|
| Receipt number | R000028514 |
| Scientific Title | Analysis of retinal blood vessels and blood flow using optical coherence tomography |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2020/05/25 16:46:54 |
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Basic information
Public title
Analysis of retinal blood vessels and blood flow using optical coherence tomography
Acronym
Analysis of retinal blood vessels and blood flow using optical coherence tomography
Scientific Title
Analysis of retinal blood vessels and blood flow using optical coherence tomography
Scientific Title:Acronym
Analysis of retinal blood vessels and blood flow using optical coherence tomography
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of retinal blood vessels and blood flow by different optical coherence tomography models
Basic objectives2
Others
Basic objectives -Others
Evaluation of foveal avascular zone and retinal vascular density by optical coherence tomography
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of retinal blood vessels and blood flow by different optical coherence tomography models
Key secondary outcomes
Comparison with fluorescence fundus angiography examination
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy right eye
Visual acuity greater than or equal to 1.0 (logMAR0.1).
Key exclusion criteria
History of eye diseases
high myopia >6.0 diopters
Systemic diseases affecting eyes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
Homepage URL
tsakamot@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tests
Optical coherence tomography
optical interferometry
Visual acuity
Intraocular pressure
Refraction
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028514
