UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026778 |
|---|---|
| Receipt number | R000030732 |
| Scientific Title | Construction of normal database of laser speckle flow graphy |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2018/11/12 16:19:40 |
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Basic information
Public title
Construction of normal database of laser speckle flow graphy
Acronym
normal databese of LSFG
Scientific Title
Construction of normal database of laser speckle flow graphy
Scientific Title:Acronym
normal databese of LSFG
Region
| Japan |
Condition
Condition
Subjects of thorough medical checkup
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to make a normal cutoff level of evaluation items of ocular circulation by Laser speckle flowgraphy (LSFG) in many cases of Subjects of thorough medical checkup.
We propose a novel ophthalmologic physiological examination system which replaces arteriosclerosis judgment by the fundus photograph of the eye.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Revaluation of relationship between age, gender, blood pressure, visual acuity, spherical refraction, intraocular pressure, body mass index, pulse wave velocity,Questionnaire survey on exercise habits and items of LSFG.
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who can be measured ocular circulation by laser speckle flowgraphy
Key exclusion criteria
Subjects who can not be measured ocular circulation by laser speckle flowgraphy
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Shiba |
Organization
School of Medicine, Toho University
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3761-4151
tomoaki-s@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Shiba |
Organization
School of Medicine, Toho University
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3761-4151
Homepage URL
tomoaki-s@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 04 | Month | 15 | 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 | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study was to make a normal cutoff level of evaluation items of ocular circulation by Laser speckle flowgraphy (LSFG) in many cases of Subjects of thorough medical checkup.
We propose a novel ophthalmologic physiological examination system which replaces arteriosclerosis judgment by the fundus photograph of the eye.
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030732
