mRNA Expression in Lymphocytes of Glaucoma Patients

NCT ID: NCT00327509

Last Updated: 2009-08-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2007-12-31

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.

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.

Conditions

Glaucoma; Healthy Subjects

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1-HTG

high tension glaucoma highest IOP \> 21 mmHg

No interventions assigned to this group

2-NTG

normal tension glaucoma highest measured IOP \< 21 mmHg

No interventions assigned to this group

3-PEX

pseudoexfoliation glaucoma PEX material visible

No interventions assigned to this group

4-Juvenile

juvenile glaucoma

No interventions assigned to this group

5-Control1

healthy subjects (age group 1)

No interventions assigned to this group

6-Control2

healthy subjects (age group 2)

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bonn

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Basel, Switzerland

Principal Investigators

Selim Orgül, MD

Role: STUDY_DIRECTOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel, Eye Clinic

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

004-KAR-2004-001

Identifier Type: -

Identifier Source: org_study_id