Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Posterior Cornea in Primary Open Angle Glaucoma

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.
ClinicalTrials.gov Identifier: NCT02356094
Recruitment Status : Unknown
Verified February 2015 by Pedro Gil, Centro Hospitalar do Baixo Vouga.
Recruitment status was:  Recruiting
First Posted : February 5, 2015
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Pedro Gil, Centro Hospitalar do Baixo Vouga

Brief Summary:
Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.

Condition or disease Intervention/treatment
Glaucoma Procedure: Pentacam

Detailed Description:
A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Posterior Cornea in Primary Open Angle Glaucoma
Study Start Date : January 2015
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015


Group/Cohort Intervention/treatment
Cases
Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination
Procedure: Pentacam
Corneal topography using Scheimpflug Pentacam examination

Controls
Control group of age and central corneal thickness matched healthy subjects, randomly selected from the General Ophthalmology Outpatient Clinic to be submitted to Pentacam examination
Procedure: Pentacam
Corneal topography using Scheimpflug Pentacam examination




Primary Outcome Measures :
  1. Mean posterior corneal elevation [ Time Frame: Single point in time, at baseline at the moment of study enrollment ]
    Mean posterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere


Secondary Outcome Measures :
  1. Mean anterior corneal elevation [ Time Frame: Single point in time, at baseline at the moment of study enrollment ]
    Mean anterior corneal elevation based on the relative elevation of the cornea related with the best-fit sphere



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.
Criteria

Inclusion Criteria:

  • Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
  • Healthy subjects from the General Ophthalmology Outpatient Clinic

Exclusion Criteria:

  • age inferior to 18 years old
  • primary closed angle glaucoma
  • secondary open angle glaucoma
  • previous intra-ocular surgery
  • known or suspected corneal disease
  • previous intra-ocular inflammation
  • previous ocular trauma

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): NCT02356094


Contacts
Layout table for location contacts
Contact: Pedro Gil, MSc, MD 00351915687941 pedroqgil@gmail.com
Contact: João Gil, MSc, MD 00351915821918 joaomqgil@hotmail.com

Locations
Layout table for location information
Portugal
Centro Hospitalar Baixo Vouga Recruiting
Aveiro, Portugal, 3814-501
Contact: Pedro Gil, MSc, MD    00351234378300    sec-geral@hdaveiro.min-saude.pt   
Contact: Rita Matos, MSc, MD    00351914452190    rita9matos@hotmail.com   
Principal Investigator: Pedro Gil, MSc, MD         
Sponsors and Collaborators
Centro Hospitalar do Baixo Vouga
Investigators
Layout table for investigator information
Principal Investigator: Pedro Gil, MSc, MD Centro Hospitalar Baixo Vouga

Publications of Results:
Layout table for additonal information
Responsible Party: Pedro Gil, Pedro Gil, MSc, MD, Centro Hospitalar do Baixo Vouga
ClinicalTrials.gov Identifier: NCT02356094     History of Changes
Other Study ID Numbers: CHBaixoVouga2
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Pedro Gil, Centro Hospitalar do Baixo Vouga:
glaucoma
primary open angle glaucoma
cornea

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases