Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Primary Purpose
Blepharoptosis, Blepharochalasis, Superior, Ectropion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cochet-Bonnet aesthesiometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Blepharoptosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sensation measurement
Arm Description
patients with eyelid pathology going through eyelid surgery.
Outcomes
Primary Outcome Measures
Changes of periocular skin sensation following eyelid and ocular surface surgeries (expressed in the length of the aesthesiometer's filament in centimeters).
Secondary Outcome Measures
Full Information
NCT ID
NCT02638610
First Posted
December 16, 2015
Last Updated
December 22, 2015
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02638610
Brief Title
Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Official Title
Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis, Blepharochalasis, Superior, Ectropion, Entropion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensation measurement
Arm Type
Experimental
Arm Description
patients with eyelid pathology going through eyelid surgery.
Intervention Type
Device
Intervention Name(s)
Cochet-Bonnet aesthesiometer
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Koval, MD
Phone
972-54-7772874
Email
talkovalr@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Assessment of Changes of Periocular Skin Sensation Following Eyelid and Ocular Surface Surgeries
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