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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024149
Receipt No. 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 2017/04/14

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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
Middle name
Last name Kyoko Ishida
Organization Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name Department of Ophthalmology
Zip code
Address Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL 03-3468-1251
Email kyoko.ish@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hakuei Honda
Organization Department of Ophthalmology, Toho University Ohashi Medical Center.
Division name Department of Ophthalmology
Zip code
Address Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan
TEL 03-3468-1251
Homepage URL
Email 89ahonda@gmail.com

Sponsor
Institute Department of Ophthalmology, Toho University Ohashi Medical Center.
Institute
Department

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
Address
Tel
Email

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
Date of protocol fixation
2016 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 24 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
2016 Year 09 Month 24 Day
Last modified on
2017 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027356

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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