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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024631
Receipt No. R000028325
Scientific Title The study of eye-blink disorder with high-speed video measurements.
Date of disclosure of the study information 2016/10/30
Last modified on 2016/10/30

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Basic information
Public title The study of eye-blink disorder with high-speed video measurements.
Acronym The study of eye-blink disorder with high-speed video measurements.
Scientific Title The study of eye-blink disorder with high-speed video measurements.
Scientific Title:Acronym The study of eye-blink disorder with high-speed video measurements.
Region
Japan

Condition
Condition Facial palsy, blepharoptosis, blepharospasm, entropion, ectropion
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We clarify pathophysiology of eye-blink disorder by analyzing movies recorded with high-speed camera.
Basic objectives2 Others
Basic objectives -Others We improve operative methods and develop new operations for eyelids.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analyzing the motions of eyelids in detail.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 To record motions of eye blink with high-speed videos for people with eye-blink disorder.
Interventions/Control_2 To record motions of eye blink with high-speed videos for people without eye-blink disorder; control group.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients sixteen years and over who diagnosed having the eye-blink disorder, or are suspicious.
Key exclusion criteria The patients who cannot follow the instructions among recording videos.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tanaka Kentaro
Organization Medical hospital, Tokyo Medical and Dental University
Division name Plastic and Aesthetic Surgery
Zip code
Address 1-5-45 yushima, bunkyo-ku, Tokyo, Japan.
TEL 03-5803-5923
Email kenta.plas@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tanaka Kentaro
Organization Medical Hospital, Tokyo medical and Dental University
Division name Plastic and Aesthetic Surgery
Zip code
Address 1-5-45 yushima, bunkyo-ku, Tokyo, Japan.
TEL 03-5803-5923
Homepage URL
Email kenta.plas@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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
Address
Tel
Email

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
2016 Year 10 Month 30 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
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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 30 Day
Last modified on
2016 Year 10 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028325

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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