UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042974 |
|---|---|
| Receipt number | R000049064 |
| Scientific Title | Risk Factors Predicting Eyelid Closure Impairment after Brow Lift for Patients with Facial Paralysis |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2021/01/12 13:07:18 |
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Basic information
Public title
Risk Factors Predicting Eyelid Closure Impairment after Brow Lift for Patients with Facial Paralysis
Acronym
Brow lift-induced eyelid closure impairment
Scientific Title
Risk Factors Predicting Eyelid Closure Impairment after Brow Lift for Patients with Facial Paralysis
Scientific Title:Acronym
Risk Factors Predicting Eyelid Closure Impairment after Brow Lift for Patients with Facial Paralysis
Region
| Japan |
Condition
Condition
Facial paralysis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study was, first, to analyze the degree of eyelid-closure functional change in spontaneous blinking at the brow lift simulation, and then to estimate potential risk factors predicting postoperative deterioration of the eyelid closure after brow lift surgery.
Basic objectives2
Others
Basic objectives -Others
Brow lift simulation was conducted and closed palpebral fissure heights, namely corneal exposures, in spontaneous blinking were measured using high-speed videography.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The increase in corneal exposure at preoperative
brow lift simulation
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 200 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with unilateral facial paralysis with brow ptosis at their first visit to our clinic between October 2017 and December 2020
Key exclusion criteria
prior history of brow lift, bilateral paralysis, and congenital paralysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | Hidaka |
| Last name | Hidaka |
Organization
The University of Tokyo Hospital
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81338155411
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | Hidaka |
| Last name | Hidaka |
Organization
The University of Tokyo Hospital
Division name
Plastic, Reconstructive and Aesthetic Surgery
Zip code
1138655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81338155411
Homepage URL
tahidaka1986@gmail.com
Sponsor or person
Institute
Department of Plastic, Reconstructive and Aesthetic Surgery, The University of Tokyo Hospital
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
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN +813-5841-0818
Tel
+813-5841-0818
tahidaka1986@gmail.com
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 | 01 | Month | 12 | 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
50
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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 31 | Day |
Other
Other related information
Brow lift was simulated by elevating the paralyzed-side brow with surgical tapes. The corneal exposure was evaluated for each patient under at rest and under the brow lift simulation, and the values were compared.
Management information
Registered date
| 2021 | Year | 01 | Month | 12 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049064
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
