Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study

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)

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Low Tension Glaucoma Normal Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000 Leuven, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 25, 2013
Registry last updated: May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed