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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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Blepharoptosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 16, 2015
    Last Updated
    December 22, 2015
    Sponsor
    Meir Medical Center
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    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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