Clinical trial NCT01840202: Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study
Official title: Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Normal Tension Glaucoma
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary referral center

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)

Detailed description: 1. Demographic and clinical ophthalmology-related examination data will be collected, including intraocular pressure measurement using dynamic contour tonometry
2. Visual field testing will be performed.
3. Structural damage will be documented by a retinal nerve fiber layer analysis (through Heidelberg Retinal Tomograph)
4. High Definition Optical coherent tomograph imaging of the submacular and peripapillary choroidal thickness will be performed.
5. Color Doppler Imaging of the retrobulbar vessels will be performed, with analysis of the Doppler waveform (peak systolic, end diastolic velocities and resistivity index)
6. Retinal oximetry will be performed with the analysis of the arterial and venous saturations of retinal vessels

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the Retrobulbar Arteries Doppler Waveform between glaucoma patients and healthy controls
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Ingeborg Stalmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Keer K, Abegao Pinto L, Willekens K, Stalmans I, Vandewalle E. Correlation Between Peripapillary Choroidal Thickness and Retinal Vessel Oxygen Saturation in Young Healthy Individuals and Glaucoma Patients. Invest Ophthalmol Vis Sci. 2015 Jun;56(6):3758-62. doi: 10.1167/iovs.14-16225.