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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027635
Receipt No. 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

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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
Last 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
Email tujikawa@kuhp.kyoto-u.ac.jp

Public contact
1st 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
Email muraoka@kuhp.kyoto-u.ac.jp

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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030401

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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