Levator Muscle Strength Evaluation
Primary Purpose
Ptosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
FG-5000A
Sponsored by
About this trial
This is an interventional diagnostic trial for Ptosis focused on measuring ptosis, blepharochalasis, dermatochalasis
Eligibility 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
Sites / Locations
- Meir Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ptosis
Arm Description
Device (measurement of levator strength in patients with upper lid ptosis)
Outcomes
Primary Outcome Measures
levator muscle strength quantified in grams using a unique measuring device.
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
repeatability of the measurements
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02226016
Brief Title
Levator Muscle Strength Evaluation
Official Title
Quantitative Evaluation of Levator Palpebra Muscle Strength
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis
Keywords
ptosis, blepharochalasis, dermatochalasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ptosis
Arm Type
Experimental
Arm Description
Device (measurement of levator strength in patients with upper lid ptosis)
Intervention Type
Device
Intervention Name(s)
FG-5000A
Other Intervention Name(s)
an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength
Intervention Description
a measuring device for the assessment of levator muscle strength
Primary Outcome Measure Information:
Title
levator muscle strength quantified in grams using a unique measuring device.
Description
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.
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.
Secondary Outcome Measure Information:
Title
repeatability of the measurements
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nemet Arik, DR
Phone
+972-9747-2154
Email
nemet.arik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ofir Shay, DR
Phone
+972-9747-2154
Email
shayofir1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arik Nemet, Dr
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical center
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
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Levator Muscle Strength Evaluation
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