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mRNA Expression in Lymphocytes of Glaucoma Patients

19. august 2009 oppdatert av: University Hospital, Basel, Switzerland

Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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Studiesteder

Sveits
- BS
  - Basel, BS, Sveits, 4031
    - University Hospital Basel, Eye Clinic

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

glaucoma patients, healthy subjects

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Case-Control
Tidsperspektiver: Potensielle

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Basel, Switzerland

Samarbeidspartnere

University of Bonn

Etterforskere

Studieleder: Selim Orgül, MD, University Hospital, Basel, Switzerland

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2004

Primær fullføring (Faktiske)

1. desember 2007

Studiet fullført (Faktiske)