UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of relationship between retinal microaneurysm and macular edema in eyes with branch retinal vein occlusion (BRVO)
Title of the study (Brief title)	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	Yoshio Hirano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual science
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan
TEL	052-853-8251
Email	yoshio.hirano@gmail.com

Public contact
Name of contact person	Yoshio Hirano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Ophthalmology and Visual science
Address	1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 4678601, Japan
TEL	052-853-8251
Homepage URL
Email	yoshio.hirano@gmail.com

Sponsor
Institute	Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038202