NCT01552174

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

March 6, 2012

Last Update Submit

August 31, 2015

Conditions

Keywords

MGDocular surface pathologies

Outcome Measures

Primary Outcomes (1)

  • Incidence of eyelid disorders in general ophthalmological practice

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

    Day 1

Secondary Outcomes (3)

  • Association between palpebral pathologies and ocular surface pathologies

    Day 1

  • Impact of eyelid disorder on patient's daily life

    Day 1

  • Current recommended strategy to treat eyelids disorders

    Day 1

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consultation office

Heidelberg, 69121, Germany

Location

USIO Departamento de Oftalmologia Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • José Manuel Benitez del Castillo, Professor

    USIO, Departamento de Oftalmología, Hospital Clínico San Carlos, 28040 Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations