NCT00981422

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

September 21, 2009

Last Update Submit

September 21, 2009

Conditions

Glaucoma, Open-Angle

Keywords

glaucomaimmunologyimmunophenotype

Outcome Measures

Primary Outcomes (1)

  • compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age

    the same day of bloodwithdrawal

Secondary Outcomes (1)

  • correlate the immunophenotype of POAG patients to the severity of disease

    within 3 months after blood withdrawal

Study Arms (2)

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 Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic in Parma (University hospital of Parma)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda ospedaliera universitaria

Parma, 43100, Italy

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Stefano A Gandolfi, MD

    Ophthalmology Institute, University of Parma, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

IT(1)