mRNA Expression in Lymphocytes of Glaucoma Patients - Full Text View

Sponsors and Collaborators:	University Hospital, Basel, Switzerland Friedrich-Wilhelms-University of Bonn, Germany
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00327509

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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 high tension glaucoma
2 normal tension glaucoma
3 pseudoexfoliation glaucoma
4 juvenile glaucoma
5 healthy subjects (age group 1)
6 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

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

Locations

Switzerland, BS
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

Responsible Party:	University Hospital, Basel, Switzerland ( Selim Orgul )
Study ID Numbers:	004-KAR-2004-001
Study First Received:	May 17, 2006
Last Updated:	June 30, 2008
ClinicalTrials.gov Identifier:	NCT00327509
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

mRNA
glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Healthy
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 14, 2009