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mRNA Expression in Lymphocytes of Glaucoma Patients

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00327509
Collaborator
University of Bonn (Other)
60
Enrollment
1
Location
47
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients
    Study Start Date :
    Jan 1, 2004
    Actual Primary Completion Date :
    Dec 1, 2007
    Actual Study Completion Date :
    Dec 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    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)

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 University Hospital Basel, Eye Clinic Basel BS Switzerland 4031

      Sponsors and Collaborators

      • University Hospital, Basel, Switzerland
      • University of Bonn

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00327509
      Other Study ID Numbers:
      • 004-KAR-2004-001
      First Posted:
      May 18, 2006
      Last Update Posted:
      Aug 20, 2009
      Last Verified:
      Aug 1, 2009
      Keywords provided by , ,
      mRNA
      glaucoma
      Additional relevant MeSH terms:
      Glaucoma

      Study Results

      No Results Posted as of Aug 20, 2009