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Sponsor study identifier
observational
150
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
November 29, 2011
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)December 7, 2011
Actual (reported)Early Systolic Acceleration as a measure of vascular disfunction of the ophthalmic arteries in glaucoma patients
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).
hospital stay, average 3 hours
Ratio between systolic and diastolic blood flow velocities as a measure of arterial compliance of the ophthalmic artery in glaucoma patients
Hospital stay, average 3 hours
primary care clinic
Department of Ophthalmology, UZLeuven
Leuven, Belgium
Ingeborg Stalmans, MD, PhD
Universitaire Ziekenhuizen KU Leuven
150 participants (actual enrollment reported by the registry).
First Submitted
November 29, 2011
First Posted
December 7, 2011
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
February 6, 2013
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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