UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024149 |
|---|---|
| Receipt number | R000027356 |
| Scientific Title | The influence of posture change on ocular flood flow and intraocular pressure in normal subjects. |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2020/09/28 13:58:49 |
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Basic information
Public title
The influence of posture change on ocular flood flow and intraocular pressure in normal subjects.
Acronym
The influence of posture change on ocular blood flow and intraocular pressure in normal subjects.
Scientific Title
The influence of posture change on ocular flood flow and intraocular pressure in normal subjects.
Scientific Title:Acronym
The influence of posture change on ocular blood flow and intraocular pressure in normal subjects.
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of posture change on ocular blood flow and intraocular pressure using laser speckle flowgraphy.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between the change of ocular blood flow and the measurements of optical coherence tomography (OCT).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of mean blur rate measured by laser speckle flowgraphy before and after posture change.
Key secondary outcomes
Correlation between mean blur rate, measurements of OCT and IOP.
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
Assessment of mean blur rate measured by laser speckle flowgraphy in both a sitting and a supine position.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who met all of the following inclusion criteria are included:normal findings on slit-lamp biomicroscopy and funduscopic examination,intraocular pressure less tthan 21mmHg,best-corrected visual acuity of at least 15/25,spherical refractie errors between -6.00 and +6.00 diopters,and arefractive cylindrical error within +/-2.00D and axial lengths less than 26mm.
Key exclusion criteria
Subjects who aren't satisfied with inclusion criteria.Subjects who have a history of intraocular surgery except for cataract.
Subjects who have a clinically significant retina-choroidal disease,vitreous disease,or corneal disease.Subjects who have high systolic blood pressure over 150mmHg or high diastolic pressure over 90mmHg at rest.Subjects who are taking Ca blocker,or alpha-1 blocker,or beta-1 blocker,or Sildenafil.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ishida |
Organization
Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name
Department of Ophthalmology
Zip code
1538515
Address
Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
kyoko.ish@gmail.com
Public contact
Name of contact person
| 1st name | Hakuei |
| Middle name | |
| Last name | Honda |
Organization
Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name
Department of Ophthalmology
Zip code
1538515
Address
Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
89ahonda@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Toho University Ohashi Medical Center.
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
Ethics committee of Toho University Ohashi
Address
Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
Tel
03-3468-1251
secretary@oha.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 31 | 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
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027356
