UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010700 |
|---|---|
| Receipt number | 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 23:58:52 |
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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
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
Sponsor or person
Institute
Tohoku university hospital, Ophthalmology
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
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
| 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
Value
https://center6.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 | |
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| Registered date | File name |
