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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011249
Receipt No. R000013169
Scientific Title The effect of Lower Lid Entropion Surgery on tear dynamics.
Date of disclosure of the study information 2013/08/01
Last modified on 2017/01/24

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Basic information
Public title The effect of Lower Lid Entropion Surgery on tear dynamics.
Acronym The effect of Lower Lid Entropion Surgery on tear dynamics.
Scientific Title The effect of Lower Lid Entropion Surgery on tear dynamics.
Scientific Title:Acronym The effect of Lower Lid Entropion Surgery on tear dynamics.
Region
Japan

Condition
Condition Lower Lid Entropion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of changes of tear dynamics by Lower Lid Entropion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tear meniscus, tear clearance, tear film breakup time, Schirmer test, Corneal and conjectival epithelial damage, subjective symptom
Key secondary outcomes visual function

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 Subjects with Lower Lid Entropion.
Subjects who operated on Lower Lid Entropion Surgery.
Key exclusion criteria Subjects who do not agree with the study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanako Kimura
Organization University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL
Homepage URL
Email

Sponsor
Institute University of Fukui
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 08 Month 01 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 Completed
Date of protocol fixation
2013 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 08 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 The observation of tear meniscus, tear clearance, tear film breakup time, Schirmer test before and after Lower Lid Entropion surgery.

Management information
Registered date
2013 Year 07 Month 22 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013169

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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