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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Laboratoires Thea.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
IRIS Pharma
AIXIAL
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01552174
First received: March 6, 2012
Last updated: October 2, 2012
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Incidence of eyelid disorders in general ophthalmological practice [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    To describe association between palpebral pathologies and ocular surface pathologies

  • Impact of eyelid disorder on patient's daily life [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Description of recommended strategy


Estimated Enrollment: 6550
Study Start Date: March 2012
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552174

Contacts
Contact: José manuel Benitez del Castillo, Professor benitezcastillo@terra.es

Locations
Germany
Consultation office Recruiting
Heidelberg, Germany, 69121
Contact: Thomas Kaercher, Doctor    06221 / 400888      
Principal Investigator: Thomas Kaercher, Doctor         
Spain
USIO Departamento de Oftalmologia Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Contact: José Manuel Benitez del Castillo, Professor       benitezcastillo@terra.es   
Principal Investigator: José Manuel Benitez del Castillo, Professor         
Sponsors and Collaborators
Laboratoires Thea
IRIS Pharma
AIXIAL
Investigators
Principal Investigator: José Manuel Benitez del Castillo, Professor USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01552174     History of Changes
Other Study ID Numbers: MEIBUM survey
Study First Received: March 6, 2012
Last Updated: October 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Laboratoires Thea:
MGD
ocular surface pathologies

ClinicalTrials.gov processed this record on November 25, 2014