UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041308 |
|---|---|
| Receipt number | R000047125 |
| Scientific Title | Establishment of ocular blood flow measurement method at bedside using handheld Laser Speckle Flowgraphy, Examination by healthy volunteers |
| Date of disclosure of the study information | 2020/08/04 |
| Last modified on | 2023/02/05 09:56:21 |
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Basic information
Public title
Establishment of ocular blood flow measurement method at bedside using handheld Laser Speckle Flowgraphy
Acronym
Establishment of ocular blood flow measurement method at bedside
Scientific Title
Establishment of ocular blood flow measurement method at bedside using handheld Laser Speckle Flowgraphy, Examination by healthy volunteers
Scientific Title:Acronym
Establishment of ocular blood flow measurement method at bedside
Region
| Japan |
Condition
Condition
shock
Classification by specialty
| Ophthalmology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a bedside ocular blood flow measurement method and examine its reliability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coefficient of variation and intra-class correlation coefficient of ocular blood flow index measured using LSFG at rest
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
After resting for about 5 minutes , LSFG is used to measure the ocular blood flow three times in a row.After that, they become supine and raises his lower legs. after raising the lower limb, measure ocular blood flow and intraocular pressure at 2, 4, 6, 8, and 10 minutes.
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
Healthy people without systemic or eye diseases
Key exclusion criteria
Those who cannot measure ocular blood flow
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Matsumoto |
Organization
School of Medicine, Toho University
Division name
Department of Ophthalmology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
ganka-sec@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Watanabe |
Organization
School of Medicine, Toho University
Division name
Department of Ophthalmology
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
ganka-sec@med.toho-u.ac.jp
Sponsor or person
Institute
School of Medicine, Toho University, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Toho University, Department of Ophthalmology
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
School of Medicine, Toho University
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.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
東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 04 | 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
10
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
| 2020 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047125
