UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023767 |
|---|---|
| Receipt number | R000027380 |
| Scientific Title | Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with chorioretinal diseases |
| Date of disclosure of the study information | 2016/08/26 |
| Last modified on | 2017/02/28 13:27:37 |
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Basic information
Public title
Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with
chorioretinal diseases
Acronym
Comparison of efficacy between OCT angiography and fluorescein angiography
Scientific Title
Comparison of efficacy between OCT angiography and fluorescein angiography in the eyes with
chorioretinal diseases
Scientific Title:Acronym
Comparison of efficacy between OCT angiography and fluorescein angiography
Region
| Japan |
Condition
Condition
diabetic retinopathy (macular edema), branch retinal vein occlusion, wet type of age-related macular
degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the value of OCT angiography, we compare the result between OCT angigraphy and fluorescein angiography in the same eye
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of the lesion in each eyes
Key secondary outcomes
Duration (minutes) for each angiography test
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
the patients with diabetic retinopathy (macular edema), BRVO or wAMD, who are scheduled for fluorescein angiography to diagnose or follow-up, and the patients who have not media opacity or poor fixation.
Key exclusion criteria
The patients who have allergy to dye, or renal dysfunction.
The patients who have possibility of pregnant or pregnant patients
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ogura |
Organization
Nagoya City University Hospital
Division name
Ophthalmology
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
052(853)8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Nozaki |
Organization
Nagoya City University Hospital
Division name
Ophthalmology
Zip code
Address
1 Kawasumi Mizuho-cho Mizuho-ku Nagoya
TEL
052(853)8251
Homepage URL
nozakim@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Ophthalmic Instruments Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kagoshima University Hospital
Tokyo Women's Medical University Hospital
Kagawa University Hospital
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
東京女子医科大学病院（東京都）
名古屋市立大学病院（愛知県）
鹿児島大学病院（鹿児島県）
園田病院（鹿児島県）
香川大学病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 26 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
recruiting
Management information
Registered date
| 2016 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027380
