mRNA Expression in Lymphocytes of Glaucoma Patients

This study has been completed.
Sponsor:
Collaborator:
Friedrich-Wilhelms-University of Bonn, Germany
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00327509
First received: May 17, 2006
Last updated: August 19, 2009
Last verified: August 2009

May 17, 2006
August 19, 2009
January 2004
December 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00327509 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
mRNA Expression in Lymphocytes of Glaucoma Patients
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

white cells

Probability Sample

glaucoma patients, healthy subjects

  • Glaucoma
  • Healthy Subjects
Not Provided
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00327509
004-KAR-2004-001
No
Selim Orgul, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Friedrich-Wilhelms-University of Bonn, Germany
Study Director: Selim Orgül, MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP