Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study
Study Details
Study Description
Brief Summary
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 | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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Demographic and clinical ophthalmology-related examination data will be collected, including intraocular pressure measurement using dynamic contour tonometry
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Visual field testing will be performed.
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Structural damage will be documented by a retinal nerve fiber layer analysis (through Heidelberg Retinal Tomograph)
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High Definition Optical coherent tomograph imaging of the submacular and peripapillary choroidal thickness will be performed.
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Color Doppler Imaging of the retrobulbar vessels will be performed, with analysis of the Doppler waveform (peak systolic, end diastolic velocities and resistivity index)
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Retinal oximetry will be performed with the analysis of the arterial and venous saturations of retinal vessels
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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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| 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 |
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| 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 |
Outcome Measures
Primary Outcome Measures
- Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls [Participants will be followed for the duration of hospital stay, an expected average of 2 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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individuals over 18 years old
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willing to sign an informed consent and able to comply with the requirements of the study
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having no other ocular diseases besides glaucoma
Exclusion Criteria:
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history of ocular trauma
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intraocular surgery (except for cataract surgery)
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eye disease (except glaucoma)
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systemic diseases with ocular involvement like diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Leuven | Leuven | Vlaams-Brabant | Belgium | 3000 Leuven |
Sponsors and Collaborators
- Universitaire Ziekenhuizen Leuven
Investigators
- Principal Investigator: Ingeborg Stalmans, MD, PhD, UZ Leuven
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S140213