UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018613
Receipt number R000011611
Scientific Title The efficacy of Brilliant Blue G in vitreoretinal surgery
Date of disclosure of the study information 2015/08/09
Last modified on 2015/08/10 19:33:25

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Basic information

Public title

The efficacy of Brilliant Blue G in vitreoretinal surgery

Acronym

The efficacy of Brilliant Blue G in vitreoretinal surgery

Scientific Title

The efficacy of Brilliant Blue G in vitreoretinal surgery

Scientific Title:Acronym

The efficacy of Brilliant Blue G in vitreoretinal surgery

Region

Japan


Condition

Condition

retinal and vitreous diseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety during retinal and vitreous surgery

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual Acuity

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

To stain the internal limiting membrane during retinal and vitreous surgery

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

Patients with retinal and vitreous diseases

Key exclusion criteria

Patients with other ocular diseases
Patients under 20 years of age

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuhei Kimura

Organization

Okayama University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-5-1 Shikata-chou, Kita-ku, Okayama city

TEL

086-223-7151

Email

opth@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Shiode

Organization

Okayama University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-5-1 Shikata-chou, Kita-ku, Okayama city

TEL

086-223-7151

Homepage URL


Email

opth@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Okayama University Graduate School of Medicine

Organization

Division

Category of Funding Organization

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 08 Month 09 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

Open public recruiting

Date of protocol fixation

2013 Year 02 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 04 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



Management information

Registered date

2015 Year 08 Month 09 Day

Last modified on

2015 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name