UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028920 |
|---|---|
| Receipt number | 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 15:29:36 |
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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
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
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
Name of secondary funder(s)
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
| 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
Value
https://center6.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 | |
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| Registered date | File name |
