UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007500
Receipt number R000008846
Scientific Title Hypothetical clinical trial of safety improvement by Triamsinolone in vitreous surgery
Date of disclosure of the study information 2013/09/12
Last modified on 2013/09/12 17:47:57

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Basic information

Public title

Hypothetical clinical trial of safety improvement by Triamsinolone in vitreous surgery

Acronym

Safty of Triamsinolone in vitreous surgery

Scientific Title

Hypothetical clinical trial of safety improvement by Triamsinolone in vitreous surgery

Scientific Title:Acronym

Safty of Triamsinolone in vitreous surgery

Region

Japan


Condition

Condition

the patients who perform vitreous surgery

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, in the vitreous surgery , the triamcinolone acetonide which is a steroid hormone agent is used for into the trap for the purpose of visualizing a vitreous body organization, and comparison examination with a previous report is performed about the effect to the improvement in safety of an operation.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

complications in vitreous surgery

Key secondary outcomes

visual acuity, ocular pressure, fundus examination, postoerative complications


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Triamcinolone acetonide

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

the patient who will perform vitreous surgery

Key exclusion criteria

1)The contraindications item in a triamcinolone acetonide package leaflet
(1)This agent ingredient hypersensitivity

2)The contraindications item at the time of whole body medication of a steroid hormone agent
(1)The patient of the infection in which effective antibacterial medicine does not exist, and the mycosis of the whole body, (2) The patient of digestive ulcer, (3) The patient of a mental disease, (4) The patient of a tubercular disease, (5) The patient of simple herpetic keratitis, (6)The patient of after cataract, (7)The patient of glaucoma, (8)The patient of hypertension, (9)The patient with electrolyte abnormalities, (10)The patient of thromboses, (11)The patient with the operative wound of the recent internal organs, and (12) acute myocardial infarction, (13)The patient judged that medication of a steroid hormone agent is not desirable for the caused eye disease of a patient and others, or systemic illness

3)The patient who this research responsibility (assignment) doctor accepted was unsuitable as a subject

4)The participation in other clinical study is unquestioned.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Sonoda

Organization

Yamaguchi University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

Ube City, Yamaguchi 755-8505, Japan

TEL

+81-836-222278

Email

sonoda@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Kimura

Organization

Yamaguchi University Graduate School of Medicine

Division name

Ophthalmology

Zip code


Address

Ube City, Yamaguchi 755-8505, Japan

TEL

+81-836-222278

Homepage URL


Email

k.kimura@yamaguchi-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Yamaguchi University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Yamaguchi University Graduate School of Medicine

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

2013 Year 09 Month 12 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

2010 Year 10 Month 29 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2016 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 14 Day

Last modified on

2013 Year 09 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name