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

NCT02638610 — Not applicable, Unknown, 60 participants, Meir Medical Center

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Registry	NCT02638610
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	60 (Estimated)
Sponsor	Meir Medical Center (Other)
Conditions	Blepharoptosis, Blepharochalasis, Superior, Ectropion, Entropion
Interventions	Cochet-Bonnet aesthesiometer (Device)
Dates	start 2016-01-01, primary completion 2016-07-01 (estimated), completion 2017-01-01 (estimated), first posted 2015-12-23, last updated 2015-12-23

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sensation measurement	Experimental	Device: Cochet-Bonnet aesthesiometer	patients with eyelid pathology going through eyelid surgery.

Cochet-Bonnet aesthesiometer (Device): 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.

+Outcome measures

Primary outcomes

Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters). [6 months]

+Eligibility

Sex: All, ages: 40 Years to 80 Years

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