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Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01487655
First received: November 29, 2011
Last updated: February 5, 2013
Last verified: September 2011
History of Changes
  Purpose

Color Doppler Imaging (CDI) has been providing information about ocular blood flow over the past decades. This non-invasive procedure based on ultrasound technique has identified increased resistance and decreased systolic blood velocities to exist in the ophthalmic arteries of glaucoma patients. However, existing data has provided very little information regarding the analysis of the Doppler waveform in itself and to whether variables such as early systolic acceleration or systolic/diastolic velocity ratios are of any significance in glaucoma disease. In other medical specialties using CDI technology, such as nephrology or cardiology for instance, this analysis has been part of the normal routine. This information has been used in screening patients for disturbed circulation such as arterial stenosis or providing information regarding prognosis of renal and hepatic transplants have been used for decades now.

What is the normal characteristics of the waveform Doppler analysis? To answer this, the investigators will create a normative database using healthy controls.

Are there signs of altered stiffness or compliance in the ophthalmic arteries of glaucoma patients? To answer this, the analysis of early acceleration acceleration and detection of an early peak systolic will be done on the Doppler curves of glaucoma patients and compared to the healthy normative database.

Are there any difference between the two types of glaucoma [primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG)]? The investigators will compare the variables of the ophthalmic artery waveform in these two groups.

Do any of these Doppler waveform variables have any clinical significance? To answer this, the investigators will search for the existence of any correlation between the waveform data and both functional (visual field testing) and structural (Confocal scanning laser ophthalmoscopy - CSLO) variables of the glaucoma groups.


Condition
Open-angle Glaucoma
Low Tension Glaucoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Primary Open-angle and Normal Tension Glaucoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Early Systolic Acceleration as a measure of vascular disfunction of the ophthalmic arteries in glaucoma patients [ Time Frame: hospital stay, average 3 hours ] [ Designated as safety issue: No ]
    Color Doppler Imaging of the ophthalmic artery will provide the waveform of the vessel. There will be a operator-dependent identification of the slope at the beggining of the cardiac cycle and a quantification of the early systolic acceleration. This numberical data will then be compared between healthy and glaucoma groups. Such variables will further be compared to the clinical data (functional - visual field defects and structural - CSLO).


Secondary Outcome Measures:
  • Ratio between systolic and diastolic blood flow velocities as a measure of arterial compliance of the ophthalmic artery in glaucoma patients [ Time Frame: Hospital stay, average 3 hours ] [ Designated as safety issue: No ]
    Using the CDI-provided ophthalmic artery waveform, there will be an operator-dependent analysis of systolic and diastolic mean blood flow velocities. the ratio between these two variables will be calculated and the numerical data obtained will be compared between the healthy and glaucoma groups. Such ratio will furthermore be compared to functional and structural damage (visual field damage and CSLO, respectively).


Enrollment: 150
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy age matched controls
normal tension glaucoma patients
primary open angle glaucoma patients

Detailed Description:

1. Color Doppler imaging of the ophthalmic artery will be performed 2. Visual field testing will be done 2. CSLO will be done

  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: NCT01487655

Locations
Belgium
Department of Ophthalmology, UZLeuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Ingeborg Stalmans, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01487655     History of Changes
Other Study ID Numbers: S271111
Study First Received: November 29, 2011
Last Updated: February 5, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Open-angle glaucoma
Low tension glaucoma
Color Doppler Imaging

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

ClinicalTrials.gov processed this record on May 23, 2013