Levator Muscle Strength Evaluation

August 23, 2014 updated by: shay ofir, Meir Medical Center

Quantitative Evaluation of Levator Palpebra Muscle Strength

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

previous eyelid surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Arik Nemet, Dr, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 23, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Estimate)

August 26, 2014

Last Update Submitted That Met QC Criteria

August 23, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEVATOR01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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