Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression
This study has been completed.
Sponsor:
University of Parma
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
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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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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
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 Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 22, 2013