UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021450 |
|---|---|
| Receipt number | R000024738 |
| Scientific Title | Densitometry of Choroidal Vessels by Wide-Field Indocyanine Green Angiography |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2023/03/18 17:24:35 |
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Basic information
Public title
Densitometry of Choroidal Vessels by Wide-Field Indocyanine Green Angiography
Acronym
Choroidal Vessel Densitometry
Scientific Title
Densitometry of Choroidal Vessels by Wide-Field Indocyanine Green Angiography
Scientific Title:Acronym
Choroidal Vessel Densitometry
Region
| Japan |
Condition
Condition
Healthy eyes and eyes with central serous chorioretinopathy, Harada's disease, diabetic retinopathy, age-related macular degeneration, etc
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new method to quantify the choroidal vessel density by binarizing ultra-wide-field indocyanine green angiography (ICGA) images and determine whether values are altered in diseased eyes.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repeatability of densitometry
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy eyes and eyes with central serous chorioretinopathy, diabetic retinopathy, Harada's disease, age-related macular degeneration, etc
Key exclusion criteria
Patients with hypertension, and hypercholesterolemia that could affect ocular circulation, and high myopia (defined as SERE in phakic eyes < -8.0 D)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-853-8251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Science
Division name
Department of Ophthalmology and Visual Science
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
0528538251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku
Tel
0528538251
yasukawa@med.nagoya-cu.ac.jp
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 | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Case control series
Enrollment: all eligible patients visiting Nagoya City University since May 2015
Management information
Registered date
| 2016 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024738
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
