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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007479
Receipt No. 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

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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
Email 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
Email ohoto@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008824

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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