- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00327509
mRNA Expression in Lymphocytes of Glaucoma Patients
Messenger Ribonucleic Acid Expression in Lymphocytes of Glaucoma Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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BS
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Basel, BS, Suiza, 4031
- University Hospital Basel, Eye Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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1-HTG
high tension glaucoma highest IOP > 21 mmHg
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2-NTG
normal tension glaucoma highest measured IOP < 21 mmHg
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3-PEX
pseudoexfoliation glaucoma PEX material visible
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4-Juvenile
juvenile glaucoma
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5-Control1
healthy subjects (age group 1)
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6-Control2
healthy subjects (age group 2)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Selim Orgül, MD, University Hospital, Basel, Switzerland
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 004-KAR-2004-001
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