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
  Purpose

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.


Condition
Glaucoma
Healthy Subjects

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Biospecimen Retention:   Samples With DNA

white cells


Enrollment: 60
Study Start Date: January 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

glaucoma patients, healthy subjects

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327509

Locations
Switzerland
University Hospital Basel, Eye Clinic
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Friedrich-Wilhelms-University of Bonn, Germany
Investigators
Study Director: Selim Orgül, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Selim Orgul, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00327509     History of Changes
Other Study ID Numbers: 004-KAR-2004-001
Study First Received: May 17, 2006
Last Updated: August 19, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
mRNA
glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 22, 2014