UMIN-CTR Clinical Trial

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
Email	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
Email	makimaki@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022446