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Management of Eyelid Disorders by Ophthalmologists in Usual Medical Practice (MEIBUM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552174
First Posted: March 13, 2012
Last Update Posted: September 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Iris Pharma
Axial Biotech, Inc
Information provided by (Responsible Party):
Laboratoires Thea
  Purpose
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
Palpebral Pathologies Ocular Surface Disease Meibomian Gland Dysfunction

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Incidence of eyelid disorders in general ophthalmological practice [ Time Frame: 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:
  • Association between palpebral pathologies and ocular surface pathologies [ Time Frame: Day 1 ]
    To describe association between palpebral pathologies and ocular surface pathologies

  • Impact of eyelid disorder on patient's daily life [ Time Frame: Day 1 ]
    Consequences on vision, on daily life activities/work, on leisure, on contact lens wearing, on emotions, on sleeping,

  • Current recommended strategy to treat eyelids disorders [ Time Frame: Day 1 ]
    Description of recommended strategy


Enrollment: 185
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be eligible for inclusion if all these criteria are respected:

  • 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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552174


Locations
Germany
Consultation office
Heidelberg, Germany, 69121
Spain
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
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01552174     History of Changes
Other Study ID Numbers: MEIBUM survey
First Submitted: March 6, 2012
First Posted: March 13, 2012
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Laboratoires Thea:
MGD
ocular surface pathologies