Study on Ocular Choroidal Thickness and Ocular Blood Flow in Glaucoma Patients

This study is currently recruiting participants.
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: January 31, 2014
Last verified: January 2013
  Purpose

The choroid is one of the human body's most vascularized tissues. The choroidal tissue is mainly supplied by the short ciliary arteries, which are also the arteries responsible for most of the arterial vascularization of the optic nerve head. As this is the primary location where the majority of the glaucomatous neuron-related injury is thought to occur, the hypothesis remains as to whether a dysregulation in the vascular component of the choroidal tissue can be of significance in glaucoma pathogenesis. New technological advances in glaucoma imaging techniques, namely the enhanced depth imaging in optical coherent tomography (OCT) have recently allowed a non-invasive, non contact method for assessing the choroidal thickness.

By combining these new features with the existing methods for ocular blood flow analysis, including color Doppler Imaging, we try to determine if a correlation exists between the choroidal thickness and the blood flow of the ciliary arteries in glaucoma patients.


Condition
Open Angle Glaucoma
Normal Tension Glaucoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Correlation Between Submacular and Peripapillary Choroidal Tissue and Ocular Blood Flow in Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:
  1. Visual field testing will be performed.
  2. Structural damage will be documented by a retinal nerve fiber layer analysis (through OCT)
  3. High Definition OCT imaging of the submacular and peripapillary choroidal thickness will be performed.
  4. Color Doppler Imaging of the retrobulbar vessels will be performed, with analysis of the Doppler waveform (peak systolic, end diastolic velocities and resistivity index)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840202

Locations
Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000 Leuven
Contact: Luis Pinto, MD, PhD       luis.pinto@uzleuven.be   
Principal Investigator: Ingeborg Stalmans, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01840202     History of Changes
Other Study ID Numbers: S140213
Study First Received: April 17, 2013
Last Updated: January 31, 2014
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on April 15, 2014