UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041070 |
|---|---|
| Receipt number | R000046895 |
| Scientific Title | Changes in vessel structure and blood flow in retinal vein occlusion |
| Date of disclosure of the study information | 2020/07/18 |
| Last modified on | 2024/07/25 11:57:24 |
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Basic information
Public title
Changes in vessel structure and blood flow in retinal vein occlusion
Acronym
Changes in vessel structure and blood flow in retinal vein occlusion
Scientific Title
Changes in vessel structure and blood flow in retinal vein occlusion
Scientific Title:Acronym
Changes in vessel structure and blood flow in retinal vein occlusion
Region
| Japan |
Condition
Condition
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate changes in blood vessel structure and blood flow in retinal vein occlusion, to elucidate the pathology and to find prognostic factors.
Basic objectives2
Others
Basic objectives -Others
To clarify the pathophysiology of macular edema due to retinal vein occlusion and to identify prognostic factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate retinal blood flow and vascular structure at onset, 1 month, 3 months, and 6 months. To examine factors associated with the degree and prognosis of macular edema
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
Affected and fellow eyes of patients with retinal vein occlusion, and normal eyes of volunteers
Key exclusion criteria
Eyes with other ocular diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya University
Division name
Department of ophthalmology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi
TEL
0527442275
tomitaryo1021@gmail.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tomita |
Organization
Nagoya University
Division name
Department of ophthalmology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi
TEL
0527442275
Homepage URL
tomitaryo1021@gmail.com
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi
Tel
0527442479
ethics@med.nagoya-u.ac.jp
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
| 2020 | Year | 07 | Month | 18 | 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 rate of venous narrowing at the retinal arteriovenous crossing in patients with retinal vein occlusion was higher than in normal subjects, even in the unoccluded crossing or unaffected eye.
Results date posted
| 2024 | Year | 07 | Month | 25 | Day |
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To study changes in blood flow in patients with retinal vein occlusion and differences in blood vessel structure and blood flow in normal eyes
Management information
Registered date
| 2020 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046895
