Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Ocular Blood Flow in Glaucoma Patients - the Leuven Eye Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01840202
First received: April 17, 2013
Last updated: May 15, 2014
Last verified: January 2013

April 17, 2013
May 15, 2014
February 2013
October 2014   (final data collection date for primary outcome measure)
  • Choroidal thickness correlation with short ciliary arteries blood flow velocities [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01840202 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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)

  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
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Tertiary referral center

  • Open Angle Glaucoma
  • Normal Tension Glaucoma
Not Provided
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
770
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Belgium
 
NCT01840202
S140213
No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP