Clinical trial NCT01487655: Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients
Official title: Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Primary Open-angle and Normal Tension Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open-angle Glaucoma
Low Tension Glaucoma
Keywords: Open-angle glaucoma
Low tension glaucoma
Color Doppler Imaging
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: 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.

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 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: Early Systolic Acceleration as a measure of vascular disfunction of the ophthalmic arteries in glaucoma patients
timeFrame: hospital stay, average 3 hours
Secondary outcomes:
measure: Ratio between systolic and diastolic blood flow velocities as a measure of arterial compliance of the ophthalmic artery in glaucoma patients
timeFrame: Hospital stay, average 3 hours
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Ophthalmology, UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ingeborg Stalmans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: