UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of peripheral retinal abnormalities in branch retinal vein occlusion - a relationship with the visual prognosis -
Title of the study (Brief title)	Peripheral retinal abnormalities and visual prognosis in branch retinal vein occlusion
Region	Japan

Condition
Condition	Retinal Vein Occlusion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between visual prognosis and the location of retinal abnormal findings detected by a wide-field fluorescein angiography as well as retinal photocoagulation (PHC) for the peripheral nonperfused area in patients with branch retinal vein occlusion.
Basic objectives2	Others
Basic objectives -Others	Confirmatory
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	presence of microaneurysm, retinal hyperpermeability, and neovascularization
Key secondary outcomes	best-corrected visual acuity, central retinal thickness

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	1.RVO eyes with nonperfused areas 2.Japanese patients 3.Patients considered as eligible for 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 diseases 3.High myopia -6.0 diopter(D)or worse 4.Patients judged by the investigator to be ineligible for other reasons
Target sample size	40

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 467-8601, 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 467-8601, 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
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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 01 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	The presence rates of microaneurysms, vascular hyperpermeability, retinal neovascularization in the peripheral retina were significantly lower than in other areas. The presence of the retinal peripheral abnormalities or PHC for the retinal nonperfused area did not necessarily affect the visual prognosis and persistent macular edema.
Other related information	There was no association between the PHC application and vitreous hemorrhage.

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033065