UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of clinical condition in eyes with branch retinal vein occlusion
Title of the study (Brief title)	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	motohiro kamei
Organization	Aichi Medical University
Division name	Ophthalmology
Address	1-1 yazako, karimata, nagakute, aichi
TEL	0561-62-3311
Email	kamei.motohiro.169@mail.aichi-med-u.ac.jp

Public contact
Name of contact person	kotaro tsuboi
Organization	Aichi Medical University
Division name	Ophthalmology
Address	1-1 yazako, karimata, nagakute, aichi
TEL	0561-62-3311
Homepage URL
Email	tsuboi.koutarou.230@mail.aichi-med-u.ac.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029061