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

Not Applicable

• Conditions: Entropion; Blepharochalasis, Superior; Blepharoptosis; Ectropion
• Interventions: Device: Cochet-Bonnet aesthesiometer

• Registration Number: NCT02638610
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-22
• Last Update Submitted: 2015-12-22
• Study First Posted: 2015-12-23
• Last Update Posted: 2015-12-23
• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sensation measurement	Cochet-Bonnet aesthesiometer	patients with eyelid pathology going through eyelid surgery.

Primary Outcome Measures

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