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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028920
Receipt No. R000033065
Scientific Title Evaluation of peripheral retinal abnormalities in branch retinal vein occlusion - a relationship with the visual prognosis -
Date of disclosure of the study information 2017/10/01
Last modified on 2017/08/31

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Basic information
Public title Evaluation of peripheral retinal
abnormalities in branch retinal vein
occlusion - a relationship with the
visual prognosis -
Acronym Peripheral retinal abnormalities and
visual prognosis in branch retinal vein
occlusion
Scientific Title Evaluation of peripheral retinal
abnormalities in branch retinal vein
occlusion - a relationship with the
visual prognosis -
Scientific Title:Acronym 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
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 467-8601, Japan
TEL 052-853-8251
Email 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 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
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.
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
2017 Year 02 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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