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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010700
Receipt No. R000012503
Scientific Title Optic nerve head blood flow of healthy volunteer
Date of disclosure of the study information 2013/05/12
Last modified on 2013/05/12

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Basic information
Public title Optic nerve head blood flow of healthy volunteer
Acronym Optic nerve head blood flow of healthy volunteer
Scientific Title Optic nerve head blood flow of healthy volunteer
Scientific Title:Acronym Optic nerve head blood flow of healthy volunteer
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to assemble a database of the optic nerve head blood flow in healthy volunteer for investigating the decrease of the blood flow in glaucoma patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mean blur rate as the relative blood flow socre in optic nerve head between a heat beat is measured.
Key secondary outcomes The blood flow waveform between a heat beat.

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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The healthy adult
Key exclusion criteria Ocular disease excluding mild cataract and mild reflective error.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Nakazawa
Organization Tohoku university hospital
Division name Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL 022-717-7294
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Tsuda
Organization Tohoku university hospital
Division name Ophthalmology
Zip code
Address 1-1, Seiryo-cho, Aoba-ku, Sendai
TEL
Homepage URL
Email

Sponsor
Institute Tohoku university hospital, Ophthalmology
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
2013 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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 retrospective study for the database of optic nerve head blood flow in healthy volunteer

Management information
Registered date
2013 Year 05 Month 12 Day
Last modified on
2013 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012503

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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