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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036633
Receipt No. R000041663
Scientific Title A study on the usefullness of lateral and medial horn transection in levator advancement for involutional blepharoptosis
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/01

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Basic information
Public title A study on the usefullness of lateral and medial horn transection in levator advancement for involutional blepharoptosis
Acronym A study on the usefullness of lateral and medial horn transection in levator advancement
Scientific Title A study on the usefullness of lateral and medial horn transection in levator advancement for involutional blepharoptosis
Scientific Title:Acronym A study on the usefullness of lateral and medial horn transection in levator advancement
Region
Japan

Condition
Condition involutional blepharoptosis
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In levator advancement for involutional blepharoptosis, it is examined whether the transection of lateral and medial horn contributes to the improvement of postoperative result.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a change amount of MRD-1, a change amount of levator function
Key secondary outcomes whether there is a change in the position of eye brows, the symptoms of headache, stiff shoulders, heavy eyelids

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 When performing levator advancement, the lateral and medial horns of levator aponeurosis are transected.
Interventions/Control_2 When performing levator advancement, the lateral and medial horns of levator aponeurosis are not transected.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Satisfy the following conditions
1.involutional blepharoptosis
2.MRD-1 is 2mm or less and can be measured
3.levator function is 8mm or more
Key exclusion criteria Any of the following conditions
1.congenital blepharoptosis
2.If the cause of involutional blepharoptosis is a factor other than levator aponeurosis
3.Re-operation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name takeo
Middle name
Last name osaki
Organization Kobe University Graduate School of Medicine
Division name Department of Plastic Surgery
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-Ku, Kobe-City
TEL 078-382-6251
Email yellowcox@yahoo.co.jp

Public contact
Name of contact person
1st name takeo
Middle name
Last name osaki
Organization Kobe University Graduate School of Medicine
Division name Department of Plastic Surgery
Zip code 650-0017
Address 7-5-2, Kusunoki-cho, Chuo-Ku, Kobe-City
TEL 078-382-6251
Homepage URL
Email yellowcox@yahoo.co.jp

Sponsor
Institute Department of Plastic Surgery, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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 Kobe University clinical research ethical committee
Address 7-5-2, Kusunoki-cho, Chuo-Ku, Kobe-City
Tel 0783826669
Email cerb@med.kobe-u.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 01 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041663

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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