NCT02309814

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

December 1, 2014

Last Update Submit

September 7, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    10 minutes

Study Arms (1)

eyelid motion sensor device

EXPERIMENTAL

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.

Device: eyelid motion sensor device (Hall-probe)

Interventions

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

eyelid motion sensor device

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy 18-67 year olds with no eye medical history

You may not qualify if:

  • pregnancy
  • head trauma history
  • using contact lens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • daniel briscoe

    haemek medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of ophthalmology departement

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 5, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09