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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003232
Receipt No. R000003911
Scientific Title Fundus imaging using novel high resolution optical coherence tomography (OCT)
Date of disclosure of the study information 2010/02/22
Last modified on 2013/10/09

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Basic information
Public title Fundus imaging using novel high resolution optical coherence tomography (OCT)
Acronym Fundus imaging using novel high resolution optical coherence tomography (OCT)
Scientific Title Fundus imaging using novel high resolution optical coherence tomography (OCT)
Scientific Title:Acronym Fundus imaging using novel high resolution optical coherence tomography (OCT)
Region
Japan

Condition
Condition "Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease"
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 "To take images of fundus oculi, and evaluate the equipment based on medical perspective.
To confirm equipment specific performance for healthy volunteers, and then assess fundus images for various cases, and improve the performance.
To develop software applications to extract high-accuracy information."
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine retinal layered structure.
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 OCT 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Male or female aged 20 to 80
2) Healthy volunteers, or patients with:
macular disease (age-related macular degeneration, macular hole, macular pucker etc.),
glaucoma,
diabetic retinopathy,
retinal vein occlusion,
adult disease (hypertension, diabetes mellitus)
3) Subjects who sign an informed consent form to participate in the clinical study"
Key exclusion criteria 1) Having any side-effects (hypersensitivity, rised intraocular pressure etc.) against mydriatics
2) Revealed narrow angle by slit-lamp examination
3) Subjects who a doctor in attendance declares ineligible for any reason"
Target sample size 400

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Graduate School of Medicine
Division name Ophthalmology & Visual Sciences
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
2010 Year 02 Month 22 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 02 Month 22 Day
Date of IRB
Anticipated trial start date
2010 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
2010 Year 02 Month 22 Day
Last modified on
2013 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003911

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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