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
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
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
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
