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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010500
Receipt No. R000012273
Scientific Title Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Date of disclosure of the study information 2013/04/15
Last modified on 2013/12/08

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Basic information
Public title Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Acronym Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Scientific Title Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Scientific Title:Acronym Incidence of deepening of the upper eyelid sulcus caused by opening eyes wide
Region
Japan

Condition
Condition 1 Healthy volunteers
2 Patients with blepharoptosis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the incidence of DUES by opening eyes wide
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of DUES
Key secondary outcomes The wrinkles on the brow
MRD

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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1 Younger and older healthy subjects
2 Patients with blepharoptosis
Key exclusion criteria 1 Subjects with any ocular diseases
2 Patients with previous blepharoptosis surgery
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Department of ophthalmology
Zip code
Address Himeji city Aboshi waku 68-1
TEL +81-79-272-8555
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Department of ophthalmology
Zip code
Address
TEL +81-79-272-8555
Homepage URL
Email

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 04 Month 15 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
 Our results indicated that wide-open eyes can cause a DUES-like appearance. Blepharoptosis itself is not a predictive factor; however, clinicians should take care  not to overestimate DUES, especially in patients with UES with natural-open eyes, because a DUES-like appearance can be caused by wide-open eyes, even in treatment-naive patients.
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
2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 13 Day
Last follow-up date
2013 Year 07 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 10 Day
Date trial data considered complete
2013 Year 12 Month 08 Day
Date analysis concluded
2013 Year 12 Month 08 Day

Other
Other related information DUES are evaluated by three observer using photographs.

Management information
Registered date
2013 Year 04 Month 15 Day
Last modified on
2013 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012273

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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