- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356094
Posterior Cornea in Primary Open Angle Glaucoma
February 1, 2015 updated by: Pedro Gil, Centro Hospitalar do Baixo Vouga
Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.
Study Overview
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
Study Type
Observational
Enrollment (Anticipated)
100
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
-
-
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Aveiro, Portugal, 3814-501
- Recruiting
- Centro Hospitalar Baixo Vouga
-
Contact:
- Pedro Gil, MSc, MD
- Phone Number: 00351234378300
- Email: sec-geral@hdaveiro.min-saude.pt
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Contact:
- Rita Matos, MSc, MD
- Phone Number: 00351914452190
- Email: rita9matos@hotmail.com
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Principal Investigator:
- Pedro Gil, MSc, MD
-
-
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
Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.
Description
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
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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases
Patients with primary open angle glaucoma, randomly selected from the Glaucoma Outpatient Clinic to be submitted to Pentacam examination
|
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
|
Corneal topography using Scheimpflug Pentacam examination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Single point in time, at baseline at the moment of study enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Single point in time, at baseline at the moment of study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pedro Gil, MSc, MD, Centro Hospitalar Baixo Vouga
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2015
Primary Completion (Anticipated)
April 1, 2015
Study Completion (Anticipated)
April 1, 2015
Study Registration Dates
First Submitted
February 1, 2015
First Submitted That Met QC Criteria
February 1, 2015
First Posted (Estimate)
February 5, 2015
Study Record Updates
Last Update Posted (Estimate)
February 5, 2015
Last Update Submitted That Met QC Criteria
February 1, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHBaixoVouga2
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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