UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045261 |
|---|---|
| Receipt number | R000051683 |
| Scientific Title | The prospective study about the relationship between blepharoptosis and motor ability / social activity -based on Patient-Reported Outcomes- |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/03/04 19:07:00 |
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Basic information
Public title
The prospective study about the relationship between blepharoptosis and motor ability / social activity -based on Patient-Reported Outcomes-
Acronym
The prospective study about the relationship between blepharoptosis and motor ability / social activity -based on Patient-Reported Outcomes-
Scientific Title
The prospective study about the relationship between blepharoptosis and motor ability / social activity -based on Patient-Reported Outcomes-
Scientific Title:Acronym
The prospective study about the relationship between blepharoptosis and motor ability / social activity -based on Patient-Reported Outcomes-
Region
| Japan |
Condition
Condition
blepharoptosis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate how the treatment of blepharoptosis will change the patient's motor ability and social activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on the date of the severity of ptosis, walking speed and other motor skills(pre-ope, post 6 months), we evaluate the preoperative and postoperative changes.
Key secondary outcomes
After translation of FACE-Q, which is one of PRO, we make patients to answer it pre-operation and post 6 month and two weeks later and evaluate the preoperative and postoperative changes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who undergo blepharoptosis surgery and who can decide to participate in the study on their own initiative. The motor ability is evaluated at the age of 60 and over.
Key exclusion criteria
Those who cannot fill out the questionnaire by themselves, need a substitute, and do not speak Japanese as their mother tongue. In addition, those who have motor disorders due to musculoskeletal system or nervous system diseases, and those who have difficulty in implementing the evaluation items for other reasons are excluded from the motor ability evaluation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Uemura |
Organization
Institute of Science Tokyo
Division name
Plastic and Reconstruction Surgery
Zip code
113-8510
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo, JAPAN
TEL
03-5803-5923
noriplas@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Kato |
Organization
Institute of Science Tokyo
Division name
Plastic and Reconstruction Surgery
Zip code
113-8510
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo, JAPAN
TEL
03-5803-5923
Homepage URL
sayu.plas@tmd.ac.jp
Sponsor or person
Institute
Plastic and Reconstructive surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Takatsuki Orthopaedic Hospital
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45,Yushima,Bunkyo-ku,Tokyo, JAPAN
Tel
03-3813-6111
syomu1.adm@tmd.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
| 2021 | Year | 09 | 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
65
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the patient's eyelid findings, motor ability, and PRO results before and after surgery.
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051683
