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Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638610
Recruitment Status : Unknown
Verified December 2015 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

The aim of the study: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries.

Study design: an interventional study that will be conducted at the ophthalmology department, Meir hospital, Kfar Saba, Israel.

the study will include 60 healthy patients, at the ages of 40-80, which are candidates for eyelid surgery: blepharoptosis repair, blepharoplasty, ectropion repair and entropion repair.

The patients will be recruited from Meir's ophthalmology outpatient clinic. Each patient will undergo a full ophthalmologic examination including relevant assessment of the specific eyelid pathology.

The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet filament-type aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.


Condition or disease Intervention/treatment Phase
Blepharoptosis Blepharochalasis, Superior Ectropion Entropion Device: Cochet-Bonnet aesthesiometer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Study Start Date : January 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Sensation measurement
patients with eyelid pathology going through eyelid surgery.
Device: Cochet-Bonnet aesthesiometer

The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.

This instrument contains a 6 centimeters long, retractable, flexible monofilament. For any given length, when applied perpendicularly to a test surface, the filament will exert a precise pressure before visibly bending. The filament's length inversely corresponds to the pressure exerted by the aesthesiometer such that the shorter the filament length, the more pressure it exerts on the test surface.





Primary Outcome Measures :
  1. Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters). [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to give consent
  • Eyelid pathology: blepharoptosis, blepharochalasis, ectropion or entropion, with no additional eyelid pathology

Exclusion Criteria:

  • Children and pregnant women
  • Previous eyelid surgery
  • A systemic disease influencing eyelid position
  • Any neurologic disease
  • Previous facial herpetic infection

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): NCT02638610


Contacts
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Contact: Tal Koval, MD 972-54-7772874 talkovalr@gmail.com

Sponsors and Collaborators
Meir Medical Center
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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02638610    
Other Study ID Numbers: MMC 0110-15
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Blepharoptosis
Entropion
Ectropion
Eyelid Diseases
Eye Diseases