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

NCT ID: NCT01487655

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-12-31

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

Conditions

Open-angle Glaucoma; Low Tension Glaucoma

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

healthy age matched controls

No interventions assigned to this group

normal tension glaucoma patients

No interventions assigned to this group

primary open angle glaucoma patients

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

Department of Ophthalmology, UZLeuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S271111

Identifier Type: -

Identifier Source: org_study_id