Clinical trial NCT00327509: mRNA Expression in Lymphocytes of Glaucoma Patients
Official title: Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Healthy Subjects
Keywords: mRNA
glaucoma
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Bonn
First posted: 2006-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma patients, healthy subjects

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Eye Clinic
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Selim Orgül, MD
role: STUDY_DIRECTOR
References: