UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033771 |
|---|---|
| Receipt number | R000038518 |
| Scientific Title | Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects. |
| Date of disclosure of the study information | 2018/08/25 |
| Last modified on | 2020/07/10 23:56:56 |
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Basic information
Public title
Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Acronym
Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title
Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title:Acronym
Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Region
| Japan |
Condition
Condition
Normal eyes
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the difference of ocular blood flow determined by Laser Spekle Flowgraphy between the left and the right eye or the superior and the inferior retina in sitting or supine position in normal subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of retinal blood flow between the left and the right eye or the superior and the inferior retina.
Key secondary outcomes
Retinal vessel diameter, Retinal vessel velocity, Change of ocular blood flow between sitting and supine position.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal eyes
Key exclusion criteria
Presence of eye disease
History of eye disease treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Iwase |
Organization
Nagoya University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
tiwase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryo Tomita |
Organization
Nagoya University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL
052-744-2275
Homepage URL
tomitaryo1021@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
| 2018 | Year | 08 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
To evaluate the change of the ocular blood flow and the relationship with other factors.
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038518
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
