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

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00981422
First received: September 21, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: STEFANO GANDOLFI, Professor of Ophthalmology and Chairman, UNIVERSITY OF PARMA
ClinicalTrials.gov Identifier: NCT00981422     History of Changes
Other Study ID Numbers: PARMABIOMARKERS001
Study First Received: September 21, 2009
Last Updated: September 21, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Parma:
glaucoma
immunology
immunophenotype

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

ClinicalTrials.gov processed this record on November 25, 2014