UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Lower Lid Entropion Surgery on tear dynamics.
Title of the study (Brief title)	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	Kanako Kimura
Organization	University of Fukui
Division name	Department of Ophthalmology
Address	23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL
Email

Public contact
Name of contact person
Organization	University of Fukui
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013169