UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024631 |
|---|---|
| Receipt number | 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 07:23:43 |
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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
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
kenta.plas@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028325
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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