Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
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
|Contact: Tal Koval, MDfirstname.lastname@example.org|