UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015282
Receipt number R000010539
Scientific Title vitreous surgery with intravitreal tissue plasminogen activator(t-PA)
Date of disclosure of the study information 2014/09/30
Last modified on 2014/09/29 20:17:13

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Basic information

Public title

vitreous surgery with intravitreal tissue plasminogen activator(t-PA)

Acronym

vitreous surgery with intravitreal t-PA

Scientific Title

vitreous surgery with intravitreal tissue plasminogen activator(t-PA)

Scientific Title:Acronym

vitreous surgery with intravitreal t-PA

Region

Japan


Condition

Condition

globe rupture

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy of vitreous surgery with t-PA

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occurrence of adverse events after treatment

Key secondary outcomes



Base

Study type


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 Maneuver

Interventions/Control_1

Intravitreal injection of t-PA before vitreous surgery for globe rupture

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

Globe rupture with a massive clot in the vitreous cavity

Key exclusion criteria

Patients with drug allergy for t-PA
Pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shuhei Kimura

Organization

Okayama University Hospital

Division name

Department of Ophthalmology

Zip code


Address

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

TEL

086-223-7151

Email

shuheik@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Shiode

Organization

Okayama University Hospital

Division name

Department of Ophthalmology

Zip code


Address

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

TEL

086-223-7151

Homepage URL


Email

shiode2001@yahoo.co.jp


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okayama University Hospital

Organization

Division

Category of Funding Organization

Other

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

2014 Year 09 Month 30 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

2012 Year 10 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 10 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

2014 Year 09 Month 29 Day

Last modified on

2014 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name