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

August 31, 2015 updated by: Laboratoires Thea
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69121
        • Consultation office
  • Spain
      • Madrid, Spain, 28040
        • USIO Departamento de Oftalmologia Hospital Clínico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between palpebral pathologies and ocular surface pathologies
Time Frame: Day 1
To describe association between palpebral pathologies and ocular surface pathologies
Day 1
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,
Day 1
Current recommended strategy to treat eyelids disorders
Time Frame: Day 1
Description of recommended strategy
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 8, 2012

First Posted (Estimate)

March 13, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEIBUM survey

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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