UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026202 |
|---|---|
| Receipt number | R000030097 |
| Scientific Title | Assessment of ocular blood flow alterations in response to intraocular pressure elevation with Laser speckle flowgraphy |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2017/02/24 15:09:25 |
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Basic information
Public title
Assessment of ocular blood flow alterations in response to intraocular pressure elevation with Laser speckle flowgraphy
Acronym
Assessment of ocular blood flow alterations in response to intraocular pressure elevation
Scientific Title
Assessment of ocular blood flow alterations in response to intraocular pressure elevation with Laser speckle flowgraphy
Scientific Title:Acronym
Assessment of ocular blood flow alterations in response to intraocular pressure elevation
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate ocular blood flow alterations in response to short-term intraocular elevation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Ocular blood flow ratio and coefficient of variation in the intraocular pressure elevation phase was calculated with reference to this baseline.
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
To investigate the ocular blood flow alterations in response to intraocular pressure elevation on two different days.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Normal findings in slit lamp and funduscopic examinations
No history of ophthalmic or general disorders, prior ocular laser or incisional surgery in either eye, and the use of systemic or topical medication
Obtain written-informed consent from the subjects.
Key exclusion criteria
A regular smoking habit
High myopia
Baseline intraocular pressure less than 22mmHg in both eyes
History of topical medication allergy
In pregnancy
History of unconfortable for periocular compression
History of ophthalmic or general disorders, prior ocular laser or incisional surgery in either eye, and the use of systemic or topical medication
No written-informed consent from the subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kunikata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1,Seiryo-cho, Aoba-ku
TEL
022-717-7294
kunikata@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Shiga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
1-1,Seiryo-cho, Aoba-ku
TEL
022-717-7294
Homepage URL
y.shiga@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grants-in-Aid for Scientific Research (B) (T.N. 26293372)
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
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
| 2017 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | 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
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030097
