Levator Muscle Strength Evaluation

NCT02226016 | Unknown

• 1 other identifier: LEVATOR01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ptosis

Keywords

ptosis; blepharochalasis; dermatochalasis

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• repeatability of the measurements

  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.

Study Arms (1)

Ptosis

EXPERIMENTAL

Device (measurement of levator strength in patients with upper lid ptosis)

Device: FG-5000A

Interventions

FG-5000A DEVICE

a measuring device for the assessment of levator muscle strength

Also known as: an experimental measurinf device for a mechanical evaluation of the levator palpebra superioris muscle strength

Ptosis

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• previous eyelid surgery

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical center

Kfar Saba, Israel, Israel

Location

MeSH Terms

Conditions

Blepharoptosis; Cutis Laxa

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Arik Nemet, Dr

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nemet Arik, DR

CONTACT

+972-9747-2154; nemet.arik@gmail.com

Ofir Shay, DR

CONTACT

+972-9747-2154; shayofir1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 26, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

IL (1)