Clincosm LogoSign in Get a demo

The Effect of Eyelid Surgery on Dry Eye - a Prospective Study

Sponsor
Sheba Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02376556
Collaborator
(none)
54
Enrollment
1
Location
36
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.

    The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.

    This data will help us assess the effect of these common surgical procedures on dry eye symptoms.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Prevalence of Dry Eye Syndrome Among Patients Who Underwent Upper Eyelids Blepharoplasty With and Without Muller Muscle Resection
    Actual Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Mar 1, 2018
    Actual Study Completion Date :
    Mar 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Blepharoplasty

    patients undergoing upper eyelid blepharoplasty
    blepharoplasty and muller muscle resection

    patients undergoing a combined blepharoplasty and muller muscle resection surgery

    Outcome Measures

    Primary Outcome Measures

    1. Objective assessment of dry eye syndrome [3 months postoperatively]

    Secondary Outcome Measures

    1. Subjective assessment of dry eye syndrome [3 months postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution

    • no other ophthalmic procedures planned for the patient in study period

    • ability to undergo full ophthalmic examination as stated in the study protocol

    • Ability to complete the dry eye questionnaire

    • ability to sign an informed consent form

    Exclusion Criteria:

    • previous eyelid surgery

    • other orbital or lacrimal gland disease

    • concurrent use of contact lenses

    • concurrent use of Restasis

    • previous glaucoma surgery

    • use of punctual plugs

    • pregnant or nursing women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba_Medical_Center Ramat Gan Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Guy J Ben Simon, MD, Sheba Medical Center, Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy Ben Simon, Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT02376556
    Other Study ID Numbers:
    • SHEBA-14-1496-GBS-CTIL
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Oct 15, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by Guy Ben Simon, Head, Orbital, Ophthalmic Plastic & Lacrimal Surgery department, The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel, Sheba Medical Center
    Dry eye syndrome
    Blepharoplasty
    Muller muscle resection surgery
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Cutis Laxa
    Syndrome

    Study Results

    No Results Posted as of Oct 15, 2019