Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study
|ClinicalTrials.gov Identifier: NCT01840202|
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : May 29, 2015
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)
|Condition or disease|
|Open Angle Glaucoma Normal Tension Glaucoma|
- 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
|Study Type :||Observational|
|Actual Enrollment :||770 participants|
|Observational Model:||Case Control|
|Official Title:||Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
Primary open-angle glaucoma
Patients with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of >21 mmHg required
Normal Tension Glaucoma
Patients with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of < 21 mmHg
- Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840202
|Leuven, Vlaams-Brabant, Belgium, 3000 Leuven|
|Principal Investigator:||Ingeborg Stalmans, MD, PhD||UZ Leuven|