- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01840202
Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study
Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients
Glaucoma is a leading cause of blindness worldwide, whose treatment - intraocular pressure lowering - is only partially effective in preventing disease progression. Accordingly, other variables, such as ocular blood flow-related factors, have been implicated in disease pathogenesis. However, most findings involving vascular variables come from partial, small-scale studies. Furthermore, recent technological advances have identified a number of ocular blood flow variables that have yet to be tested in large scale trials. Therefore, a study that specifically aims at uncovering the role of vascular aspects in glaucoma is needed.
For this purpose, a cross-sectional, observational case-control study will be conducted in the University Hospitals Leuven. This will be the largest-yet study on the subject, involving more than 750 patients. This will allow the creation of a specific cohort of patients where the vascular aspects are thought to be particularly important (low-tension glaucoma). It will use the largest combination yet of vascular-related measuring techniques (dynamic contour tonometry, optic coherent tomography, colour Doppler imaging and retinal oximetry)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
- Demographic and clinical ophthalmology-related examination data will be collected, including intraocular pressure measurement using dynamic contour tonometry
- Visual field testing will be performed.
- Structural damage will be documented by a retinal nerve fiber layer analysis (through Heidelberg Retinal Tomograph)
- High Definition Optical coherent tomograph imaging of the submacular and peripapillary choroidal thickness will be performed.
- Color Doppler Imaging of the retrobulbar vessels will be performed, with analysis of the Doppler waveform (peak systolic, end diastolic velocities and resistivity index)
- Retinal oximetry will be performed with the analysis of the arterial and venous saturations of retinal vessels
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgien, 3000 Leuven
- UZ Leuven
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- individuals over 18 years old
- willing to sign an informed consent and able to comply with the requirements of the study
- having no other ocular diseases besides glaucoma
Exclusion Criteria:
- history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- systemic diseases with ocular involvement like diabetes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Primær åbenvinklet glaukom
Patienter med en karakteristisk optisk diskbeskadigelse (baseret på kop/disk-forhold, udtynding af neuroretinal kant, hak, diskblødninger osv.) og synsfeltdefekter med mindst én måling af IOP på >21 mmHg påkrævet
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Normal spændingsglaukom
Patienter med en karakteristisk optisk diskbeskadigelse (baseret på kop/disk-forhold, udtynding af neuroretinal kant, hak, diskblødninger osv.) og synsfeltdefekter med maksimalt registreret IOP på < 21 mmHg
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Control
Healthy volunteers with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 2 hours
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Participants will be followed for the duration of hospital stay, an expected average of 2 hours
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- S140213
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