UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032760 |
|---|---|
| Receipt number | R000037364 |
| Scientific Title | Effectiveness of Triamcinolone Acetonide to surppress inflammation after eyelid surgery |
| Date of disclosure of the study information | 2018/05/30 |
| Last modified on | 2021/09/29 13:51:22 |
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Basic information
Public title
Effectiveness of Triamcinolone Acetonide to surppress inflammation after eyelid surgery
Acronym
Triamcinolone Acetonide for eyelid surgery
Scientific Title
Effectiveness of Triamcinolone Acetonide to surppress inflammation after eyelid surgery
Scientific Title:Acronym
Triamcinolone Acetonide for eyelid surgery
Region
| Japan |
Condition
Condition
blepharoptosis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if intraoperative injection of Triamcinolone acetonide in eyelid surgery can suppress inflammatory reaction safely.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire to evaluate the inflammation result
Upper Margin-Refrex distance
Levator function
Key secondary outcomes
complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inject Triamcinolone Acetonide into orbicularis oculi muscle at the end of the surgery
Interventions/Control_2
Not to Inject Triamcinolone Acetonide into orbicularis oculi muscle at the end of the surgery
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who needs both blepharoptosis repair simultaneously
Key exclusion criteria
Ongoing infection, steroid resopnder, Glaucoma, Uncontrolled Diabetes, history of trauma or surgery on face
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ikeda |
| Middle name | |
| Last name | Tsunehiko |
Organization
Osaka Medical College
Division name
Ophthalmology
Zip code
5698686
Address
2-7 Daigakumachi Takatsuki city, Osaka
TEL
0726831221
tikeda@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Mimura |
| Middle name | |
| Last name | Masashi |
Organization
Osaka Medical College
Division name
Ophthalmology
Zip code
5698686
Address
2-7 Daigakumachi Takatsuki city, Osaka
TEL
0726831221
Homepage URL
opt119@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Osaka Medical College
Address
2-7 Daigakumachi Takatsuki city, Osaka Japan
Tel
0726831221
rinri@osaka-med.ac.jp
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
大阪医科大学附属病院、大阪回生病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2021 | 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=R000037364
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
