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MEIBUM: Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT01552174
Collaborator
Iris Pharma (Industry), Axial Biotech, Inc (Industry)
185
Enrollment
2
Locations
25
Duration (Months)
92.5
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the incidence and characteristics of eyelid inflammatory disorders during general ophthalmological consultations and to demonstrate association between palpebral pathologies and ocular surface pathologies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    185 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Study Start Date :
    Mar 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Outpatients attending general ophthalmologic consultation

    Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation Patients informed of the objectives of the survey and agreeing to participate. Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of eyelid disorders in general ophthalmological practice [Day 1]

      Systematic description of the eyelid, the ocular surface and the dermatological aspect of the face Occurrence of Meibomian Gland Dysfunction(MGD).

    Secondary Outcome Measures

    1. Association between palpebral pathologies and ocular surface pathologies [Day 1]

      To describe association between palpebral pathologies and ocular surface pathologies

    2. Impact of eyelid disorder on patient's daily life [Day 1]

      Consequences on vision, on daily life activities/work, on leisure, on contact lens wearing, on emotions, on sleeping,

    3. Current recommended strategy to treat eyelids disorders [Day 1]

      Description of recommended strategy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Outpatients of either sex, aged at least 18 years, seen in general ophthalmological consultation

    • Patients informed of the objectives of the survey and agreeing to participate.

    • Patient attending to the ophthalmological consultation for any reasons: regular check-up of chronic disease, acute symptoms, or for surgery preparation or follow up.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Consultation office Heidelberg Germany 69121
    2 USIO Departamento de Oftalmologia Hospital Clínico San Carlos Madrid Spain 28040

    Sponsors and Collaborators

    • Laboratoires Thea
    • Iris Pharma
    • Axial Biotech, Inc

    Investigators

    • Principal Investigator: José Manuel Benitez del Castillo, Professor, USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laboratoires Thea
    ClinicalTrials.gov Identifier:
    NCT01552174
    Other Study ID Numbers:
    • MEIBUM survey
    First Posted:
    Mar 13, 2012
    Last Update Posted:
    Sep 1, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Laboratoires Thea
    MGD
    ocular surface pathologies
    Additional relevant MeSH terms:
    Meibomian Gland Dysfunction

    Study Results

    No Results Posted as of Sep 1, 2015