UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043506 |
|---|---|
| Receipt number | R000049679 |
| Scientific Title | Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy. |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2022/07/06 13:29:04 |
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Basic information
Public title
Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Acronym
Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Scientific Title
Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Scientific Title:Acronym
Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure ocular blood flow in eye movement in healthy volunteer.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure ocular blood flow during eye movement in normal eyes and to compare with previously measured data in glaucoma patients
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Mydriatic (tropicamide 0.4%) eye drops before measurement
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participant who
- doesn't have ophthalmological diseases that affect blood flow measurement other than refractive error.
- doesn't be diagnosed of cardiovascular disease or diabetes mellitus.
- systolic blood pressure is less 150mmHg and diastolic blood pressure is less 90 mmHg.
- doesn't take drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors).
- has corrected visual acuity more than 0.8.
- doesn't have refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism.
- doesn't have axial length of exceeding 26.5 mm.
- has intraocular pressure of 21mmHg or less.
- doesn't have history of refractive surgery.
Key exclusion criteria
The participant who
- has ophthalmological diseases that affect blood flow measurement other than refractive error.
- diagnosed of cardiovascular disease or diabetes mellitus.
- systolic blood pressure exceeding 150 mmHg and diastolic blood pressure exceeding 90 mmHg.
- Patients taking drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors).
- has corrected visual acuity less than 0.8.
- has refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism.
- has axial length exceeding 26.5 mm
- has intraocular pressure of 21 mmHg or more
- has patients with a history of refractive surgery.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Goseki |
Organization
Kitasato University School of Medicine
Division name
Department of Ophthalmology
Zip code
2500374
Address
1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
TEL
0427788464
toshiaki.goseki@gmail.com
Public contact
Name of contact person
| 1st name | Kazunoei |
| Middle name | Hirasawa |
| Last name | Hirasawa |
Organization
Kitasato University School of Medicine
Division name
Department of Ophthalmology
Zip code
2520374
Address
1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
TEL
0427788464
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of the Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa
Tel
0427788273
rinrib@med.kitasato-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049679
