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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020775
Receipt No. R000023965
Scientific Title The clinical study related to anterior and posterior ocular disease using OCT angiography
Date of disclosure of the study information 2016/01/28
Last modified on 2016/01/29

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Basic information
Public title The clinical study related to anterior and posterior ocular disease using OCT angiography
Acronym The clinical study related to anterior and posterior ocular disease using OCT angiography
Scientific Title The clinical study related to anterior and posterior ocular disease using OCT angiography
Scientific Title:Acronym The clinical study related to anterior and posterior ocular disease using OCT angiography
Region
Japan

Condition
Condition retinal disease such as; macular disease (such as age related macular degeneration, macular hole, epiretinal membrane), glaucoma, retinal detatchment, diabetic retinopathy, retinal vein occlusion, retinal artery occlusion, retinal degenerative disease,
optic neuritis, uveitis, scleritis, episcleritis, uveitis,
anterior occular disease such as; pterygium, hyperemia,
patients with history of surgery in anterior or posterior eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To inspect the clinical availability of OCT angiography such as pathological investigation or the treatment effect evaluation by comparing the blood vessel images in diseased eyes with those of healthy eyes.
Basic objectives2 Others
Basic objectives -Others To evaluate the difference in image quality and characteristics of OCT angiography image among some different types of OCTs.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Vessel diameter, vessel density, qualitative and quantitative image analyses of the vessel structures including aqueous out flow pathway, differences in outcomes beween imaging machines
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

Not applicable
Gender Male and Female
Key inclusion criteria [healthy eyes]
Subjects who a doctor in attendance confirms not having any ocular disease by observing with ophthalmoscope.
[diseased eyes]
patients with:
retinal disease such as; macular disease (such as age related macular degeneration, macular hole, epiretinal membrane), glaucoma, retinal detatchment, diabetic retinopathy, retinal vein occlusion, retinal artery occlusion, retinal degenerative disease,
optic neuritis, uveitis, scleritis, episcleritis, uveitis,
anterior occular disease such as; pterygium, hyperemia,
history of surgery in anterior or posterior eye.
Key exclusion criteria Subjects who a doctor in attendance declares ineligible for any reason
Target sample size 460

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 akihito1@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Uji
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 akihito1@kuhp.kyoto-u.ac.jp

Sponsor
Institute Nagahisa Yoshimura
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
2016 Year 01 Month 28 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design; case-control study
Participants: Patients who will visits the Kyoto University Hospital, Kyoto, Japan and nor mal volunteer.
Main outcom measures: vessel diameter, vessel density, qualitative and quantitative analyses of the vessel structures

Management information
Registered date
2016 Year 01 Month 28 Day
Last modified on
2016 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023965

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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