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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032760
Receipt No. 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

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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
Email 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
Email opt119@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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