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Levator Muscle Strength Evaluation

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ClinicalTrials.gov Identifier: NCT02226016
Recruitment Status : Unknown
Verified August 2014 by shay ofir, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 26, 2014
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
shay ofir, Meir Medical Center

Brief Summary:

The purpose of this study is to assess a new technique of measurement for the levator muscle.

this measurement may be applied during a clinical evaluation of eyelid malposition.

our purpose is to quantify the levator muscle strength and to corelate it to standard levator muscle strength assessment techniques routinley used in the oculoplastic clinic.


Condition or disease Intervention/treatment Phase
Ptosis Device: FG-5000A Not Applicable

Detailed Description:

This study will include patients refered to our oculoplastic department for evaluation of eyelid disorders (ptosis or eyelid malpositions due to various mechanical, muscular, neurogenic factors).

all patients will be over 21 years old, with eligibility for signing an informed concent form.

all patients will undergo a full clinical standard evaluation of eyelid malposition made as part of the routine evaluation of eyelid malpositions. as part of this evaluation- the levator muscles strength will be measured by monitoring the amount of millimeters of difference between the uper lid closed and open position (a regular technique for levator muscles assessment).

a second levator muscle strength evaluation will include the study device. this device is used for weight evaluation of objects. an object is measured by attaching it to the device with a metal hook and a string. the device is hand held.

for measurements of the upper lid force the device will be temporarily attached to the upper eyelid using a specially designed base made in the shape of the eyelid. the attachment will be using a sterile medical tape (plaster). this sterile base is attached to the outer eyelid and does not involve in any point any harm to the continuity of the skin, injections , harm or contact to the eyeball or any other parts of the eye. this base is attached from its back to a string witch attaches to the measuring device. the investigator holds the measuring device and asks the patient to open and close his eyes. the force that is generated while opening the upper lid is measured (in grams) by the device.

this evaluation will allow a unique first proper estimation of the true levator palpebra strength. it will be compared to the levators' strength as estimated using the routine techniques for assessing their efficacy.

the assessment will be made one time for each patient. after the measurement- the sterile tape will be removed and will be disposed. no further interventions will be made for each patient.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Evaluation of Levator Palpebra Muscle Strength
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ptosis
Device (measurement of levator strength in patients with upper lid ptosis)
Device: FG-5000A
a measuring device for the assessment of levator muscle strength
Other Name: an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength




Primary Outcome Measures :
  1. levator muscle strength quantified in grams using a unique measuring device. [ Time Frame: each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study. ]
    we aim to accurately measure the levator muscle strength in grams. the levator muscle will be noninvasively attached to the device using a string. while changing eye position from closure to opening- the force generated by the eyelid will be reflected through the string to the measuring device and will be displayed in grams. this will reflect the levator muscles strength.


Secondary Outcome Measures :
  1. repeatability of the measurements [ Time Frame: each patient will undergo two measurments of the levator muscle strength using the study device during a single clinical evaluation. no further evaluations will be made for the same patient throughout the study. ]
    we wish to evaluate the validity of these muscle strength assessments. for each patient two muscle measurements will be done by a single clinician. their results will be furtherly assessed for repeatability of the measurement.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

eligible for signing an informed concent form refered for eyelid evaluation in the oculoplastic department, Meir Mc

Exclusion Criteria:

previous eyelid surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226016


Contacts
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Contact: Nemet Arik, DR +972-9747-2154 nemet.arik@gmail.com
Contact: Ofir Shay, DR +972-9747-2154 shayofir1@gmail.com

Locations
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Israel
Meir Medical center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Arik Nemet, Dr Meir Medical Center

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Responsible Party: shay ofir, Investigator, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02226016     History of Changes
Other Study ID Numbers: LEVATOR01
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014
Keywords provided by shay ofir, Meir Medical Center:
ptosis
blepharochalasis
dermatochalasis
Additional relevant MeSH terms:
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Prolapse
Pathological Conditions, Anatomical