UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007479 |
|---|---|
| Receipt number | R000008824 |
| Scientific Title | Normative data collection with OCT-HS100 and the software development for the model |
| Date of disclosure of the study information | 2012/03/12 |
| Last modified on | 2014/08/27 13:55:25 |
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Basic information
Public title
Normative data collection with OCT-HS100 and the software development for the model
Acronym
Normative data collection with OCT-HS100 and the software development for the model
Scientific Title
Normative data collection with OCT-HS100 and the software development for the model
Scientific Title:Acronym
Normative data collection with OCT-HS100 and the software development for the model
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create a normative database for OCT-HS100 based on the three-dimensional retinal tomographies near macula and optic nerve head taken with healthy subjects and to develop a diagnosis-supporting software for macular diseases and glaucoma for the model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Registered subjects take eye exams and those who meet the criteria to verify if the subjects have normal eyes will be imaged for his/her tomography data with OCT-HS100.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To examine eligibility and take fundus images in a day.
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
"1) Male or female aged 18 to 85
2) Healthy volunteers who are enable to visit the designated clinical site
3) Those who agree to take the eye exams for verifying healty eyes as well as the OCT-HS100 exam and follow the instruction.
4) Subjects who sign an informed consent form to participate in the clinical study"
Key exclusion criteria
"1) Having systemic diseases
2) Having a history of some specific ophthalmic diseases
3) Exceeding the cliteria for the specific eye exams
4) Phisically-difficult for the imaging with OCT-HS100"
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagahisa Yoshimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3248
nagaeye@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sotaro Ooto |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3248
Homepage URL
ohoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CANON INC.
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
| 2012 | Year | 03 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
Management information
Registered date
| 2012 | Year | 03 | Month | 09 | Day |
Last modified on
| 2014 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008824
