Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2014-09-30
2015-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ptosis
Device (measurement of levator strength in patients with upper lid ptosis)
FG-5000A
a measuring device for the assessment of levator muscle strength
Interventions
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FG-5000A
a measuring device for the assessment of levator muscle strength
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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shay ofir
Investigator
Principal Investigators
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Arik Nemet, Dr
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir Medical center
Kfar Saba, Israel, Israel
Countries
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Central Contacts
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Other Identifiers
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LEVATOR01
Identifier Type: -
Identifier Source: org_study_id
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