UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019406 |
|---|---|
| Receipt number | R000022446 |
| Scientific Title | Confirmatory clinical trials Radial optic neurotomy for central retinal vein occlusion |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2021/10/22 12:03:40 |
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Basic information
Public title
Confirmatory clinical trials Radial optic neurotomy for central retinal vein occlusion
Acronym
Confirmatory clinical trials Ron for CRVO
Scientific Title
Confirmatory clinical trials Radial optic neurotomy for central retinal vein occlusion
Scientific Title:Acronym
Confirmatory clinical trials Ron for CRVO
Region
| Japan |
Condition
Condition
central retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For macular edema secondary from central retinal vein occlusion cases with insufficient effect of anti-VEGF drugs, we underwent Radial optic neurotomy.
Compare visual acuity, central retinal thickness, and blood flow before and after surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of visual acuity at one year after operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For macular edema cases of insufficient effect of central retinal vein occlusion of anti-VEGF drugs, and underwent Radial optic neurotomy.
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
In patients with macular edema due to insufficient effect of central retinal vein occlusion of the anti-VEGF drugs in hospital in Nagasaki University Hospital Ophthalmology.
1)Patients with macular edema due to central retinal vein occlusion
2)central macular thicknes=>250,micro,m
3) Point visual acuity less than 0.7
4) It does not respond to treatment with anti-VEGF drugs against macular edema associated with central retinal vein occlusion, patient blood flow does not increase.
5)At the time of obtaining informed consent, age of more than 20-year-old patient
6)Patient after receiving a sufficient explanation Upon participation in this study,on the thorough understanding,that document consent is obtained by the free will of the patient himself
Key exclusion criteria
1)Patients leading to neovascular glaucoma.
2)Patients already collateral circulation are made.
3)Patients principal investigator has determined to be inappropriate as a subject.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi |
Organization
Nagasaki University Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7345
tkitaoka@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Mastumoto |
Organization
Nagasaki University Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7345
Homepage URL
makimaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
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
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
| 2015 | Year | 11 | 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
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022446
