UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036633 |
|---|---|
| Receipt number | 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 | 2024/11/08 08:36:02 |
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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 | Kosuke |
| Middle name | |
| Last name | Masaoka |
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
puyoman1004@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Masaoka |
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
puyoman1004@yahoo.co.jp
Sponsor or person
Institute
Department of Plastic Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
kainyu@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
29
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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 11 | 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
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041663
