UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033595 |
|---|---|
| Receipt number | R000038202 |
| Scientific Title | Evaluation of relationship between retinal microaneurysm and macular edema in eyes with branch retinal vein occlusion (BRVO) |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/08/01 18:53:24 |
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Basic information
Public title
Evaluation of relationship between retinal microaneurysm and macular edema in eyes with branch retinal vein occlusion (BRVO)
Acronym
Evaluation of relationship between retinal microaneurysm and macular edema in eyes with BRVO
Scientific Title
Evaluation of relationship between retinal microaneurysm and macular edema in eyes with branch retinal vein occlusion (BRVO)
Scientific Title:Acronym
Evaluation of relationship between retinal microaneurysm and macular edema in eyes with BRVO
Region
| Japan |
Condition
Condition
Branch Retinal Vein Occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To classify retinal microaneurysms morphologically in eyes with branch retinal vein occulusion and investigate the frequency of occurrence, the risk factors, and the relationship with macular edema.
Basic objectives2
Others
Basic objectives -Others
Confirmatory
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
classification of retinal microaneurysms, the frequency of occurrence, the risk factors, and the relationship with macular edema.
Key secondary outcomes
the size of the retinal microaneurysms
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.BRVO eyes with retinal microaneurysms detected by fluorescein angiography or optical coherence tomography angiography
2.Japanese patients
3.Patients considered as eligible for this study by the investigator
Key exclusion criteria
1.Patients whose images were too poor quality to be analyzed, who had thick retinal hemorrhage, or severe macular edema
2.Presence of other macular disease
3.High myopia greater than -6.0 diopters(D)
4.Patients judged by the investigator to be ineligible for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Hirano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual science
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan
TEL
052-853-8251
yoshio.hirano@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Hirano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual science
Zip code
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan
TEL
052-853-8251
Homepage URL
yoshio.hirano@gmail.com
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
other
Name of secondary funder(s)
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
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
| 2018 | Year | 08 | Month | 01 | 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
Focal bulge and saccular types were frequently observed and strongly associated with macular edema. The risk factors for these microaneurysms formation were not identified. The size of microaneurysm was inversely correlated with the retinal thickness. The change of the size after treatment was not significant.
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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The structural subtypes of microaneurysm were defined as Focal Bulge, Saccular, Fusiform, Mixed (Saccular/Fusiform), Pedunculated, and Irregular as previously reported (Dubow et al. IOVS 2014).
Management information
Registered date
| 2018 | Year | 08 | Month | 01 | Day |
Last modified on
| 2018 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038202
