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

NCT01487655 | Completed

• 1 other identifier: S271111
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Open-angle Glaucoma; Low Tension Glaucoma

Keywords

Open-angle glaucoma; Low tension glaucoma; Color Doppler Imaging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

healthy age matched controls

normal tension glaucoma patients

primary open angle glaucoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• history of ocular trauma
• intraocular surgery (except for cataract surgery)
• eye disease (except glaucoma)
• systemic diseases with ocular involvement like diabetes

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Department of Ophthalmology, UZLeuven

Leuven, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Ingeborg Stalmans, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 7, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 6, 2013

Record last verified: 2011-09

Locations

BE (1)