UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020775 |
|---|---|
| Receipt number | 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 14:11:05 |
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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
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
akihito1@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Nagahisa Yoshimura
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023965
