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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000042974 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Facial paralysis | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Department of Plastic, Reconstructive and Aesthetic Surgery, The University of Tokyo Hospital |
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 | 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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049064 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |