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Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981422
First Posted: September 22, 2009
Last Update Posted: September 22, 2009
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.
Information provided by:
University of Parma
  Purpose
The aim of this study was to evaluate the lymphocyte phenotype in primary open- angle glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm the importance of immune responses in glaucoma and the possible correlation to the severity of the disease.

Condition
Glaucoma, Open-Angle

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Search for Biomarkers in Human Glaucoma: Possible Correlations Between Alterations in Peripheral Lymphocytes and Disease Severity

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age [ Time Frame: the same day of bloodwithdrawal ]

Secondary Outcome Measures:
  • correlate the immunophenotype of POAG patients to the severity of disease [ Time Frame: within 3 months after blood withdrawal ]

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Glaucoma patients
POAG patients selected by an ophthalmologist from the Glaucoma Service, Ophthalmology Institute, University of Parma
Healthy
healthy subjects with negative history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection, (e) diabetes, and (f) systemic inflammation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic in Parma (University hospital of Parma)
Criteria

Inclusion Criteria:

  • Clinical diagnosis of primary open-angle glaucoma
  • age between 19 an 85 years old

Exclusion Criteria:

  • age less than 19 or more than 85 yrs
  • positive history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection and (e) diabetes, (f)systemic inflammation
  Contacts and Locations
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): NCT00981422


Locations
Italy
Azienda ospedaliera universitaria
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Stefano A Gandolfi, MD Ophthalmology Institute, University of Parma, Italy
  More Information

Responsible Party: STEFANO GANDOLFI, Professor of Ophthalmology and Chairman, UNIVERSITY OF PARMA
ClinicalTrials.gov Identifier: NCT00981422     History of Changes
Other Study ID Numbers: PARMABIOMARKERS001
First Submitted: September 21, 2009
First Posted: September 22, 2009
Last Update Posted: September 22, 2009
Last Verified: September 2009

Keywords provided by University of Parma:
glaucoma
immunology
immunophenotype

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