UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033771
Receipt No. R000038518
Scientific Title Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Date of disclosure of the study information 2018/08/25
Last modified on 2018/08/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Acronym Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Scientific Title:Acronym Difference of ocular blood flow between the left and the right eye or the superior and the inferior retina in healthy subjects.
Region
Japan

Condition
Condition Normal eyes
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of ocular blood flow determined by Laser Spekle Flowgraphy between the left and the right eye or the superior and the inferior retina in sitting or supine position in normal subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference of retinal blood flow between the left and the right eye or the superior and the inferior retina.
Key secondary outcomes Retinal vessel diameter, Retinal vessel velocity, Change of ocular blood flow between sitting and supine position.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Normal eyes
Key exclusion criteria Presence of eye disease
History of eye disease treatment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Iwase
Organization Nagoya University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Email tiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Tomita
Organization Nagoya University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Homepage URL
Email tomitaryo1021@gmail.com

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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
2018 Year 08 Month 25 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
2018 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 25 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information To evaluate the change of the ocular blood flow and the relationship with other factors.

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038518

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.