Open-angle GlaucomaNCT01487655
Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients
An observational study of Open-angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open-angle Glaucoma, Low Tension Glaucoma
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- • 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
Who cannot join
- • history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- systemic diseases with ocular involvement like diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Primary Open-angle and Normal Tension Glaucoma Patients
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.
Read more
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.
Read the detailed description
- 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
- Keywords
- Open-angle glaucoma, Low tension glaucoma, Color Doppler Imaging
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy age matched controls | Not described | |
| normal tension glaucoma patients | Not described | |
| primary open angle glaucoma patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: Hospital stay, average 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487655
- Sponsor's protocol ID
- S271111
- Status last verified
- Sep 2011
- First submitted
- 29 Nov 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Primary Open-angle and Normal Tension Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01487655
- Acronym / sponsor ID
- S271111
- Conditions
- Open-angle Glaucoma, Low Tension Glaucoma
- Keywords
- Open-angle glaucoma, Low tension glaucoma, Color Doppler Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Color Doppler imaging of the ophthalmic artery will be performed 2. Visual field testing will be done 2. CSLO will be done
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy age matched controls | – | – |
| normal tension glaucoma patients | – | – |
| primary open angle glaucoma patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- • individuals over 18 years old
Key exclusion criteria (4 listed)
- • history of ocular trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Systolic Acceleration as a measure of vascular disfunction of the ophthalmic arteries in glaucoma patients
Time frame: hospital stay, average 3 hours
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Related trials for Open-angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open-angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Systolic Acceleration as a measure of vascular disfunction of the ophthalmic arteries in glaucoma patients (time frame: hospital stay, average 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.