UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025286 |
|---|---|
| Receipt number | R000029061 |
| Scientific Title | Analysis of clinical condition in eyes with branch retinal vein occlusion |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2016/12/15 13:49:42 |
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Basic information
Public title
Analysis of clinical condition in eyes with branch retinal vein occlusion
Acronym
Analysis of BRVO
Scientific Title
Analysis of clinical condition in eyes with branch retinal vein occlusion
Scientific Title:Acronym
Analysis of BRVO
Region
| Japan |
Condition
Condition
branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is clarify the relationship between the occlusion pattern and good visual acuity at 1 year after onset.
To define good prognosis occlusion pattern, we analyze the occlusion site, occlusion grade and the area of macular edema.
Basic objectives2
Others
Basic objectives -Others
To observe the clinical conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Create a new method to estimate visual acuity at 1 year after onset by using multimodal images
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
The inclusion criteria included the cases with BRVO and a minimal follow-up period of 1 months.
Key exclusion criteria
The exclusion criteria included the cases without fundus photograph and optical coherence tomography at initial and 1 year visit.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | motohiro kamei |
Organization
Aichi Medical University
Division name
Ophthalmology
Zip code
Address
1-1 yazako, karimata, nagakute, aichi
TEL
0561-62-3311
kamei.motohiro.169@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kotaro tsuboi |
Organization
Aichi Medical University
Division name
Ophthalmology
Zip code
Address
1-1 yazako, karimata, nagakute, aichi
TEL
0561-62-3311
Homepage URL
tsuboi.koutarou.230@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
J CREST
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 | 12 | Month | 15 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi center, retrospective observational study
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2016 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029061
