Eyelid Movement Sensor Device- Blinking Characterizing
Primary Purpose
Eyelid Movement Disorders
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eyelid motion sensor device (Hall-probe)
Sponsored by
About this trial
This is an interventional basic science trial for Eyelid Movement Disorders
Eligibility Criteria
Inclusion Criteria:
- healthy 18-67 year olds with no eye medical history
Exclusion Criteria:
- pregnancy
- head trauma history
- using contact lens
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eyelid motion sensor device
Arm Description
all volunteers will wear the monitor eyelid sensor device (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance.
Outcomes
Primary Outcome Measures
Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid)
Secondary Outcome Measures
Full Information
NCT ID
NCT02309814
First Posted
December 1, 2014
Last Updated
September 7, 2016
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02309814
Brief Title
Eyelid Movement Sensor Device- Blinking Characterizing
Official Title
Eyelid Movement Sensor Device- Blinking Characterizing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software.
Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.
Detailed Description
Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Movement Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eyelid motion sensor device
Arm Type
Experimental
Arm Description
all volunteers will wear the monitor eyelid sensor device (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance.
Intervention Type
Device
Intervention Name(s)
eyelid motion sensor device (Hall-probe)
Intervention Description
all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance
Primary Outcome Measure Information:
Title
Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid)
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy 18-67 year olds with no eye medical history
Exclusion Criteria:
pregnancy
head trauma history
using contact lens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
daniel briscoe
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Eyelid Movement Sensor Device- Blinking Characterizing
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