Glaucoma, Open-AngleNCT00981422
Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression
An observational study of Glaucoma, Open-Angle, run by University of Parma at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Glaucoma, Open-Angle
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic in Parma (University hospital of Parma)
Who may be able to join
- Clinical diagnosis of primary open-angle glaucoma
- age between 19 an 85 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search for Biomarkers in Human Glaucoma: Possible Correlations Between Alterations in Peripheral Lymphocytes and Disease Severity
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.
- Conditions
- Glaucoma, Open-Angle
- Keywords
- glaucoma, immunology, immunophenotype
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age
Measured: the same day of bloodwithdrawal
Secondary outcomes (1)
correlate the immunophenotype of POAG patients to the severity of disease
Measured: within 3 months after blood withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJun 2007
- Primary completionDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Investigators
- Stefano A Gandolfi, MD, Principal investigator, Ophthalmology Institute, University of Parma, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981422
- Sponsor's protocol ID
- PARMABIOMARKERS001
- Status last verified
- Sep 2009
- First submitted
- 21 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Biomarkers in Human Glaucoma: Possible Correlations Between Alterations in Peripheral Lymphocytes and Disease Severity
- ClinicalTrials.gov ID
- NCT00981422
- Acronym / sponsor ID
- PARMABIOMARKERS001
- Conditions
- Glaucoma, Open-Angle
- Keywords
- glaucoma, immunology, immunophenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic in Parma (University hospital of Parma)
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary open-angle glaucoma
- age between 19 an 85 years old
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age
Time frame: the same day of bloodwithdrawal
1 secondary outcome
correlate the immunophenotype of POAG patients to the severity of disease
Time frame: within 3 months after blood withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano A Gandolfi, MD principal investigator
Ophthalmology Institute, University of Parma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age (time frame: the same day of bloodwithdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.