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Quantitative measurement of eyelid pressure using tactile sensor

Status Approved

First Submitted Date

2018/04/11
Registered Date

2018/04/26
Last Updated Date

2018/04/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002828
Unique Protocol ID	2016-I151
Public/Brief Title	Quantitative measurement of eyelid pressure using tactile sensor
Scientific Title	Quantitative measurement of eyelid pressure using tactile sensor
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2016-I151
Approval Date	2016-12-13
Institutional Review Board Name	Hallym University Sacred Heart Hospital Institutional Review Board
Institutional Review Board Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-380-1975
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Min Joung Lee
Title	MD
Telephone	+82-31-380-3834
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
Contact Person for Public Queries
Name	Min Joung Lee
Title	MD
Telephone	+82-31-380-3834
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 431-796
Contact Person for Updating Information
Name	Min Joung Lee
Title	MD
Telephone	+82-31-380-3834
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 431-796

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-01-03 Actual
Target Number of Participant	72
Primary Completion Date	2017-09-30 , Actual
Study Completion Date	2017-12-31 , Actual
Name of Study	Hallym University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2017-01-03 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Hallym University Medical Center
Organization Type	Medical Institute
Project ID	HURF-2015-50

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hallym University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	1. Background Functional nasolacrimal duct obstruction (FNLDO) is defined as an epiphora with patent lacrimal drainage system on lacrimal syringing test and absence of potential ocular or eyelid causative factors. Orbicularis oculi movement may create hydrostatic pressure and facilitate tear flow, and are important part of “lacrimal pumping mechanism”. However, quantitative measurement of blinking power has not yet to be investigated. 2. Purpose In this study, (1) the eyelid pressure was estimated using a blepharo-tensiometer and compared between the control and FNLDO groups. (2) The relationship between eyelid pressure and clinical variables, such as age, body mass index, and lid distraction test was analyzed. 3. Methods The present study included 36 eyes of 36 patients with FNLDO and 36 healthy eyes of 36 controls. The controls were recruited from patients who had visited our clinic for unilateral epiphora and were diagnosed with unilateral nasolacrimal duct obstruction. The main outcome was eyelid pressures measured using blepharon-tensiometer. The eyelid pressure was compared between two groups. The relationship between the eyelid pressure and clinical variables, such as age, body mass index, and lid distraction test was also analyzed.

Study Summary Information

Lay Summary

1. Background
Functional nasolacrimal duct obstruction (FNLDO) is defined as an epiphora with patent lacrimal drainage system on lacrimal syringing test and absence of potential ocular or eyelid causative factors. 
Orbicularis oculi movement may create hydrostatic pressure and facilitate tear flow, and are important part of “lacrimal pumping mechanism”. However, quantitative measurement of blinking power has not yet to be investigated. 

2. Purpose 
In this study, (1) the eyelid pressure was estimated using a blepharo-tensiometer and compared between the control and FNLDO groups. (2) The relationship between eyelid pressure and clinical variables, such as age, body mass index, and lid distraction test was analyzed.  

3. Methods 
The present study included 36 eyes of 36 patients with FNLDO and 36 healthy eyes of 36 controls. The controls were recruited from patients who had visited our clinic for unilateral epiphora and were diagnosed with unilateral nasolacrimal duct obstruction. The main outcome was eyelid pressures measured using blepharon-tensiometer. The eyelid pressure was compared between two groups. The relationship between the eyelid pressure and clinical variables, such as age, body mass index, and lid distraction test was also analyzed.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Diagnosis
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Medical Device
Intervention Description	measure eyelid tension using blepharotensiometer
Number of Arms	2
Arm 1	Arm Label Eyes with functional nasolacrimal duct obstruction
	Target Number of Participant 36
	Arm Type Experimental
	Arm Description measure eyelid tension using blepharotensiometer
Arm 2	Arm Label Normal control eyes
	Target Number of Participant 36
	Arm Type Others
	Arm Description measure eyelid tension using blepharotensiometer

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	(H00-H59)Diseases of the eye and adnexa
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description (1) epiphora sumptom (2) high tear meniscus higher than 0.5mm on slit lamp exam (3) positive fluorescein dye disappearance test findings (4) absence of focal stenosis or narrowing of the lacrimal drainage system on dacryocystography.
Exclusion Criteria	1) children aged less than 18 years 2) ocular or orbital surgery history other than phacoemulsification of cataract 3) eyedrop use history in 2weeks
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
Outcome	Eyelid pressure measured using Blepharo-tensiometer
Timepoint	At initial exam
Secondary Outcome(s) 1
Outcome	Eyelid laxity measured by eyelid distraction test
Timepoint	At initial exam
Secondary Outcome(s) 2
Outcome	Age
Timepoint	At initial exam
Secondary Outcome(s) 3
Outcome	Body mass index
Timepoint	At initial exam

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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