UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027635 |
|---|---|
| Receipt number | R000030401 |
| Scientific Title | Clinical evaluation of high resolution chorioretinal cell imaging |
| Date of disclosure of the study information | 2017/06/05 |
| Last modified on | 2018/12/17 13:36:51 |
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Basic information
Public title
Clinical evaluation of high resolution chorioretinal cell imaging
Acronym
Clinical evaluation of high resolution chorioretinal cell imaging
Scientific Title
Clinical evaluation of high resolution chorioretinal cell imaging
Scientific Title:Acronym
Clinical evaluation of high resolution chorioretinal cell imaging
Region
| Japan |
Condition
Condition
glaucoma, diabetic retinopathy, macular degeneration, choroidal degenerative disease, early stage age-related maculopathy, uvatis, retinal vein occlusion, retinal artery occlusion, strabismic amblyopia, primary macroglobulinemia, multiple myeloma, polycythemia vera, chronic myeloid leukemia, essential thrombocytosis, hypertension, dyslipidemia, systemic lupus erythematosus, etc."
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"To obtain images of the human ocular fundus using adaptive optics scanning laser ophthalmoscope (AOSLO) and spectral-domain optical coherence tomography (SS-OCT).
To confirm clinical utility by evaluating the index of retinal morphology or blood carculation acquired from high resolution fundus images."
Basic objectives2
Others
Basic objectives -Others
To search and evaluate novel index.
To study the essential factors of image quality.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Comparisons between healthy subjects and patients;photoreceptor density, photoreceptor arrangement regularity, capillary image, blood flow velocity, etc.
2) Comparison between AOSLO and other fundus imaging devices (OCT, etc.);
clinical findings of images and image analysis data
3) Comparison of the defference of physical charactaristics;image quality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient
1) Male or female older than 20 years-old
2) patients with:
glaucoma, diabetic retinopathy, macular degeneration, choroidal degenerative disease, early stage age-related maculopathy, uvatis, retinal vein occlusion, retinal artery occlusion, strabismic amblyopia, primary macroglobulinemia, multiple myeloma, polycythemia vera, chronic myeloid leukemia, essential thrombocytosis, hypertension, dyslipidemia, systemic lupus erythematosus, etc.
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
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitaka Tsujikawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
tujikawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Muraoka |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
Homepage URL
muraoka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | 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
| 2017 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030401
