UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000037364