mRNA Expression in Lymphocytes of Glaucoma Patients

August 19, 2009 updated by: University Hospital, Basel, Switzerland

Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients

The aim of the study is to compare messenger ribonucleic acid (mRNA) expression of various genes in lymphocytes between glaucoma patients and sex and age-matched healthy subjects. A secondary objective is to analyze the impact of different forms of glaucoma or of a vasospastic propensity on the findings.

Study Overview

Status

Completed

Conditions

Detailed Description

Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The glaucoma patients will be divided into four groups: (1) high tension glaucoma, (2) normal tension glaucoma, (3) pseudoexfoliation glaucoma, and (4) juvenile glaucoma. Healthy subjects are separated into two age groups. Vasospastic propensity will be assessed with a questionnaire: patients and subjects answering yes to the questions: "do you have always cold hands, even during summer time?" and "do other people tell you that you have cold hands?" will be classified as vasospastic, and as normals if they deny a history of cold hands. Blood will be drawn from an arm vein, lymphocytes will be isolated and mRNA of following genes will be assessed in these lymphocytes:

Nuclear proteins: NF-kappa B, XPGC, P53, XIAP; Multi-drug resistance proteins: ABC 1, ABC 8, MDR 3; Adhesion protein: ICAM 1; Blood brain barrier breakdown protein: P2Y; Energy metabolism proteins: Adrenodoxin, Adrenodoxin-reductase, Cytochrome p450, Cytochrome-reductase, Alcohol-dehydrogenase; Tissue remodeling proteins: MMP 9, MMP 8, MMP 14, TIMP 1, TIMP 2, TIMP 3, TIMP 4.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel, Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

glaucoma patients, healthy subjects

Description

Inclusion Criteria:

Glaucoma patients

  • diagnosis of chronic glaucoma with typical glaucomatous disc and visual field damage
  • a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment HTG)
  • a present or past diurnal tension curve with an average intraocular pressure below 21 mmHg without treatment (NTG)
  • a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment and signs of pseudoexfoliation in the anterior segment (PEX)
  • a juvenile-onset open-angle glaucoma with a present or past diurnal tension curve with an average intraocular pressure above 21 mmHg without treatment (Juvenile Glaucoma)

Healthy subjects

  • no history of ocular disease
  • no history of systemic disease
  • no history of alcohol/drug abuse
  • normal blood pressure (100-140 / 60-90 mmHg)
  • best corrected visual acuity above 20/25 in both eyes
  • no pathological findings upon a slit-lamp examination and indirect fundoscopy
  • IOP < 20 mmHg in both eyes

Exclusion Criteria:

  • Ametropia > 3 dpt
  • Iridocorneal angle extremely narrow with complete or partial closure as determined by gonioscopy
  • Pigmentary dispersion
  • any abnormality which in the physician's view would prevent reliable applanation tonometry
  • History of chronic or recurrent severe inflammatory eye disease such as scleritis or uveitis
  • History of ocular trauma or intraocular surgery within the past 6 months
  • History of infection or inflammation within the past 3 months
  • History of clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment
  • Need for any concomitant medications that may interfere with the evaluation of ocular blood flow
  • significant history and/or active alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1-HTG
high tension glaucoma highest IOP > 21 mmHg
2-NTG
normal tension glaucoma highest measured IOP < 21 mmHg
3-PEX
pseudoexfoliation glaucoma PEX material visible
4-Juvenile
juvenile glaucoma
5-Control1
healthy subjects (age group 1)
6-Control2
healthy subjects (age group 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University of Bonn

Investigators

  • Study Director: Selim Orgül, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 17, 2006

First Submitted That Met QC Criteria

May 17, 2006

First Posted (Estimate)

May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

August 20, 2009

Last Update Submitted That Met QC Criteria

August 19, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004-KAR-2004-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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