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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name