UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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

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