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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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Eyelid Movement Disorders

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 1, 2014
    Last Updated
    September 7, 2016
    Sponsor
    HaEmek Medical Center, Israel
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    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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